This article is intended for any physician, administrator, or cardiovascular catheterization laboratory (CCL) staff member who desires a fundamental understanding of finances and economics of CCLs in the United States. The authors\' goal is to illuminate general economic principles of CCL operations and provide details that can be used immediately by CCL leaders. Any article on economics in medicine should start by acknowledging the primacy of the principles of medical ethics. While physicians have been trained to act in the best interests of their patients and avoid actions that would harm patients it is vitally important that all professionals in the CCL focus on patients\' needs. Caregivers both at the bedside and in the office must consider how their actions will affect not only the patient they are treating at the time, but others as well. If the best interests of a patient were to conflict with any recommendation in this article, the former should prevail. KEY POINTS: To be successful and financially viable under current payment systems, CCL physicians, and managers must optimize the outcomes and efficiency of care by aligning CCL leadership, strategy, organization, processes, personnel, and culture. Optimizing a CCL\'s operating margin (profitability) requires maximizing revenues and minimizing expenses. CCL managers often focus on expense reduction; they should also pay attention to revenue generation. Expense reduction depends on efficiency (on-time starts, short turn-over time, smooth day-to-day schedules), identifying cost-effective materials, and negotiating their price downward. Revenue optimization requires accurate documentation and coding of procedures, comorbidities, and complications. In fee-for-service and bundled payment reimbursement systems, higher volumes of procedures yield higher revenues. New procedures that improve patient care but are expensive can usually be justified by negotiating with vendors for lower prices and including the \"halo effect\" of collateral services that accompany the new procedure. Fiscal considerations should never eclipse quality concerns. High quality CCL care that prevents complications, increases efficiency, reduces waste, and eliminates unnecessary procedures represents a win for patients, physicians, and CCL administrators.

While conducting a set of large-scale multi-site pragmatic clinical trials involving high-impact public health issues such as end-stage renal disease, opioid use, and colorectal cancer, there were substantial changes to both policies and guidelines relevant to the trials. These external changes gave rise to unexpected challenges for the trials, including decisions regarding how to respond to new clinical practice guidelines, increased difficulty in implementing trial interventions, achieving separation between treatment groups, and differential responses across sites. In this article, we describe these challenges and the approaches used to address them. When deliberating appropriate action in the face of external changes during a pragmatic clinical trial, we recommend considering the well-being of the participants, clinical equipoise, and the strength and quality of the evidence associated with the change; involving those charged with data and safety monitoring; and where possible, planning for potential external changes as the trial is being designed. Any solution must balance the primary obligation to protect the well-being of participants with the secondary obligation to protect the integrity of the trial in order to gain meaningful answers to important public health questions.

BACKGROUND: Single-level open lumbar microdiscectomy surgery is one of the most straightforward and effective spinal surgeries performed by spinal surgeons today to treat disk herniation. Although a common operation, little in the literature is reported on the exact overall time, cost, and effort associated with the performance of this surgery. The consistency of this operation across institutions and disciplines makes it a good starting point to accurately track the total time and effort of all phases of the surgical intervention.
METHODS: Eighteen patients undergoing elective single-level open lumbar microdiscectomy surgery were prospectively enrolled in this study. The time spent interacting with each patient by every member of the surgical team was tracked and recorded along will every phone call and e-mail. All perioperative times associated with the surgery were tracked and analyzed. Each patient was followed from their first interaction through surgery and for the first 3 months postoperatively.
RESULTS: The advanced practice providers spent the most time with the patient both pre- and postoperatively followed by the surgeon and resident. A total of 2.98 hours was spent with the patient preoperatively in clinic and 1.69 hours postoperatively. The total time commitment of an institution treating this condition was 12.56 hours.
CONCLUSIONS: Comparing our results with the Centers for Medicare and Medicaid Services data, a significant discrepancy and underestimation was observed. As such, we hope our results enable health care providers to more accurately allocate resources for the provision of high-quality medical care to patients with this increasingly common condition.

The founding members of the Coalition for Psychotherapy Parity present Clinical Necessity Guidelines for Psychotherapy, Insurance Medical Necessity and Utilization Review Protocols, and Mental Health Parity. These guidelines support access to psychotherapy as prescribed by the clinician without arbitrary limitations on duration or frequency. The authors of the guidelines first review the evidence that psychotherapy is effective, cost-effective, and often provides a cost-offset in decreased overall medical expenses, morbidity, mortality, and disability. They highlight the disparity between clinicians\' knowledge of generally accepted standards of care for mental health and substance use disorders and the much more limited \"crisis stabilization\" focus of many insurance companies. The clinical trials that health insurers cite as justification for authorizing only brief treatment for all patients involve highly selected, atypical populations that are not representative of the general population of patients in need of mental health care, who typically have complex conditions and chronic, recurring symptoms requiring ongoing availability of treatment. The standard for other medical conditions reimbursed by insurance is continuation of effective treatment until meaningful recovery, which is therefore the standard required by the Mental Health Parity and Addiction Equity Act for mental health care. However, insurance companies frequently evade the legal requirement to cover treatment of mental illness at parity with other medical conditions. They do this by applying inaccurate proprietary definitions of medical necessity and imposing utilization review procedures much more restrictively for mental health treatment than for other medical care to block access to ongoing care, thus containing insurance company costs in the short term without consideration of the adverse sequelae of undertreated illness (eg, increased costs of other medical services and increased morbidity, mortality, and costs to society in increased disability). The authors of the guidelines conclude that, given appropriate medical necessity guidelines at parity with other medical care, consistent with provider expertise and a broad range of psychotherapy research, there would be no need or place for utilization review protocols. Individuals and psychotherapy organizations are invited to visit the website psychotherapyparity.org to sign on to the guidelines to indicate agreement and support.

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In the last 3 years, Lutetium-177 prostate-specific membrane antigen radioligand therapy (Lu-177-PSMA-RLT) has received increasing attention in nuclear medicine as a new form of treatment for castration-resistant metastatic prostate cancer. This therapy combines the radionuclide Lutetium-177, which has been therapeutically used in nuclear medicine for many years, with a molecular target of the transmembrane prostate-specific membrane antigen expressed by prostate cancer cells. Since there are no prospective randomized studies on Lu-177-PSMA-RLT and the question of reimbursement has repeatedly been the subject of review by the MDK Nordrhein (Medischenische Dienst der Krankenversicherung), there was a desire because of the increasing number of patients being treated to clarify under which circumstances Lu-177-PSMA-RLT can be reimbursed by German statutory health insurance. The goals of this article are to help treating physicians understand how this new therapy option works, to integrate it in the overall therapy concept for castration-resistant metastatic prostate cancer, and, above all, to use Lu-177-PSMA-RLT-based on the current data-at the right place in the therapy sequence of castration-resistant metastatic prostate cancer.

OBJECTIVE: This study was a comparison of the statin therapy protocol issued by the European Society of Cardiology (ESC) and the Ministry of Health\'s Health Implementation Directive (SUT) in Turkey, performed in order to assess the adequacy of hyperlipidemia treatment indications for primary prevention.
METHODS: A total of 582 patients with first acute coronary syndrome were included in the study. Patients with noncritical stenosis observed on coronary angiography or a history of atherosclerotic disease were excluded. The risk calculation was determined using age, sex, smoking status, presence of diabetes mellitus, total cholesterol, and lipoprotein levels. Statin treatment indications were evaluated according to the ESC guidelines (2016) and the SUT (2016).
RESULTS: Statin treatment was indicated for 96% of diabetic patients, and according to the ESC, it was appropriate for 13.5% of nondiabetic patients, while the SUT recommendation included 13.3% of nondiabetic patients (p<0.05). For patients younger than 60 years of age, the SUT had more guidelines than the ESC; however, for patients aged 70 to 90, the ESC had more guidelines than the SUT. For patients over 90, the indications were the same. For patients with low-density lipoprotein-cholesterol (LDL-C) >190 mg/dL there was greater discrepancy between the SUT and ESC guidelines. According to the SUT, all patients >190 mg/dL are to receive treatment. The ESC had more guidelines than the SUT for cases of LDLC <160b mg/dL.
CONCLUSIONS: The scope of the SUT guidelines is generally not narrower than the ESC indications. However, the indications for patients >60 years of age and those with LDL-C >160 mg/ dL should be reassessed, as they are more limited than those of the ESC. A new treatment algorithm should be defined.

Successful sleep billing and reimbursement is dependent on correct reporting of proper diagnostic codes for sleep disorders and associated testing. Recent changes in disease classification systems have affected the coding for sleep disorders. Guidelines set forth by the American Academy of Sleep Medicine and followed by third-party payers provide direction for the required techniques and indications for sleep procedures.

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OBJECTIVE: Pulmonary embolism is the third most common cause of death in hospitalized patients. Vena cava filters (VCFs) are indicated in patients with venous thromboembolism with a contraindication to anticoagulation. Prophylactic indications are still controversial. However, the utilization of VCFs during the past 15 years may have been affected by societal recommendations and reimbursement rates. The aim of this study was to evaluate the impact of societal guidelines and reimbursement on national trends in VCF placement from 1998 to 2012.
METHODS: The National Inpatient Sample was used to identify patients who underwent VCF placement between 1998 and 2012. VCF placement yearly rates were evaluated. Societal guidelines and consensus statements were identified using a PubMed search. Reimbursement rates for VCF were determined on the basis of published Medicare reports. Statistical analysis was completed using descriptive statistics, Fisher exact test, and trend analysis using the Mann-Kendall test and considered significant for P < .05.
RESULTS: The use of VCFs increased 350% between January 1998 and January 2008. Consensus statements in favor of VCFs published by the Eastern Association for the Surgery of Trauma (July 2002) and the Society of Interventional Radiology (March 2006) were temporally associated with a significant 138% and 122% increase in the use of VCFs, respectively (P = .014 and P = .023, respectively). The American College of Chest Physicians guidelines (February 2008 and 2012) discouraging the use of VCFs were preceded by an initial stabilization in the use of VCFs between 2008 and 2012, followed by a 16% decrease in use starting in March 2012 (P = .38). Changes in Medicare reimbursement were not followed by a change in VCF implantation rates.
CONCLUSIONS: There is a temporal association between the societal guidelines\' recommendations regarding VCF placement and the actual rates of insertion. More uniform consensus statements from multiple societies along with the use of level I evidence may be required to lead to a definitive change in practice.