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Background: Price setting and regulation serve as instruments to control volumes of services, while providing incentives for quality, coverage, and efficiency. In recognition of its complexity, many countries have established specific entities to carry out price setting and regulation., Methods: The aim of the study is to investigate institutions established for health care price setting and regulation and determine how countries have implemented pricing strategies. Eight settings were selected for case studies: Australia, England, France, Germany, Japan, Republic of Korea, Thailand, and Maryland in the United States. Each identified the agency responsible, their role and function, and resources for implementation., Results: In England, Japan, Korea, and Thailand, government entities conduct price setting and regulation. In Australia, France, Germany, and Maryland, independent entities were established. Their responsibilities include costing health services, establishing prices, negotiating with stakeholders, and publishing price and quality data for consumers., Conclusions: Dedicated institutions have been established to carry out costing, price setting, and negotiation, and providing consumer information. Characteristics of successful systems include formal systems of communication with stakeholders, freedom from conflicts of interest, and the mandate to provide public information. Substantial investments in price regulatory systems have been made to attain coverage, quality, and efficiency., (© 2019 The Authors. The International Journal of Health Planning and Management published by John Wiley & Sons Ltd.)

Medical ethics has become an important and recognized component of physician training. There is one area, however, in which medical students receive little guidance. There is practically no discussion of the financial aspects of medical practice. My objective in this paper is to initiate a discussion about the moral dimension of physician billing practices. I argue that physicians should expand their conception of professional responsibility in order to recognize that their moral obligations toward patients include a commitment to honest and forthright billing practices. I argue that physicians should aspire to a standard of clinical accuracy-not legal adequacy-in describing their activities. More generally, physicians should strive to promote an integrity-based professional culture, first and foremost by stigmatizing rather than celebrating creative billing practices, as well as condemning the misguided sense of solidarity that currently makes it taboo for physicians to criticize each other on this score., (© The Author(s) 2020. Published by Oxford University Press, on behalf of the Journal of Medicine and Philosophy Inc. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

A sound understanding of billing and coding is essential to start a successful interventional radiology endoscopy practice. While the codes utilized are similar to gastrointestinal and genitourinary endoscopy codes, physicians and institutional coders need to be familiar with the codes used for these types of procedures in the interventional radiology setting. The following manuscript gives a brief overview of aspects relating to credentialing, billing, and coding in interventional radiology endoscopy., (Copyright © 2019 Elsevier Inc. All rights reserved.)

A four-four Supreme Court decision may lead to a rehearing.

Under the Generic Drug User Fee Amendments (GDUFA) of 2012, Type II active pharmaceutical ingredient (API) drug master files (DMFs) must pay a user fee and pass a Completeness Assessment (CA) before they can be referenced in an Abbreviated New Drug Application (ANDA), ANDA amendment, or ANDA prior approval supplement (PAS). During the first year of GDUFA implementation, from October 1, 2012 to September 30, 2013, approximately 1,500 Type II API DMFs received at least one cycle of CA review and more than 1,100 Type II DMFs were deemed complete and published on FDA's "Available for Reference List". The data from CA reviews were analyzed for factors that influenced the CA review process and metrics, as well as the areas of DMF submissions which most frequently led to an incomplete CA status. The metrics analysis revealed that electronic DMFs appear to improve the completeness of submission and shorten both the review and response times. Utilizing the CA checklist to compile and proactively update the DMFs improves the chance for the DMFs to pass the CA in the first cycle. However, given that the majority of DMFs require at least two cycles of CA before being deemed complete, it is recommended that DMF fees are paid 6 months in advance of the ANDA submissions in order to avoid negatively impacting the filling status of the ANDAs.

Objectives: The income disparity between primary care and other physicians has been attributed in part to the evaluation and management (E/M) rules written by CMS. The purpose of this study was to examine the relationship between family physicians' work and their actual coding practices and fees collected under these widely used rules., Study Design: This was a direct observational time-motion study., Methods: A diverse group of 15 family physicians were shadowed over consecutive patient visits at their ambulatory practices, usually for a half-day of clinic. Data about each visit were recorded, including time parameters; number of issues covered; number of labs, images, and chronic prescriptions ordered; the physician fee code from the Current Procedural Terminology (CPT) system that was submitted; the actual payer for each patient; and the actual fee collected. The primary outcome was the correlation between the time spent for each patient's care and coding/financial measures., Results: The average total time a physician spent per patient including documentation time was 20.0 minutes. The average fee collected was $101.40, including patient co-pays. The correlation between the actual fee collected and the physician's time spent working on each patient's behalf was poor (R2 = 0.137, P < .001). There was a wide variation in times and fees for each CPT code category., Conclusions: The existing E/M rules and CPT coding system have created office visit fees that correlate poorly with family physician work. These findings provide another justification for disruptive primary care payment reform.

Long subject to legal scrutiny under the federal Anti-Kickback Statute, financial ties between physicians and drug manufacturers have recently come under additional pressure as a result of recently enacted state and federal disclosure laws and state gift restrictions, the latest coming in connection with the Federal Health Reform Law. These "sunshine" laws have been motivated by the concern that gifts and payments by manufacturers to physicians may lead to conflicts of interest and improperly influence physicians in their drug- or device-prescribing decisions. As a backdrop to these new laws, it is helpful to review prior guidance regarding manufacturer-physician financial relationships, both from the federal government and the industry itself. These laws do not prohibit physician involvement with industry in research and education, but they impose various new compliance requirements on these relationships, and also in many cases, require public disclosure of arrangements that previously were treated as confidential. It is still too early to tell if these laws will stifle innovation, but they do require a heightened degree of diligence to avoid, at a minimum, adverse publicity and embarrassment and, at worst, criminal and civil liability., (Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Federal agencies in the USA pay significantly different prices for the same prescription drugs because each agency uses a different approach to derive the payment rate. Because we do not identify any economic rationale or socially accepted moral reasoning that would justify the current level of price variation, we suggest that the federal government should pay a uniform price for each drug. Laws and regulations that give certain federal agencies the ability to earn rebates, use formularies, or permit other special arrangements would need to be eliminated in order to have a single payment rate. This could make some government agencies worse off than others; however, a uniform payment rate would not need to affect beneficiaries' current financial contributions, access to drugs, benefits or overall public expenditures. At the same time, having a single rate would permit the government to adopt a more effective approach to purchasing drugs and send a consistent message to pharmaceutical companies concerning which types of drugs the government wants them to develop for government beneficiaries. How this single price would be derived and how it would compare with the lowest or highest prices currently achieved by government agencies would depend on a variety of policy issues including the government's desire to encourage pharmaceutical research and development and the need to control health care spending.

Objective: To evaluate the compliance of donor and surrogacy agencies to American Society for Reproductive Medicine (ASRM) guidelines and assess regional differences in agency, donor, and surrogacy fees in the United States., Methods: A retrospective study was performed of websites from agencies that have signed an agreement with the Society for Reproductive Technology (SART) to abide by ASRM guidelines in governing egg donor prices and surrogacy compensation., Results: A total of 66 agencies are listed on the website, divided into 8 national regions; 24.5% of egg donor agencies deviated from ASRM guidelines. There was no significant difference in the agency fees among the different regions of United States, but the agency fees for egg donation trend higher in the west., Conclusion: A substantial number of egg donor agencies in the United States are not abiding by the ASRM guidelines. Oversight may be needed to correct improper marketing practices for egg donor recruitment.

Background: Recent changes have led to an upsurge of interest in pre-registration rotations in general practice. In 1998, a national pilot programme of >40 new rotations incorporating general practice was implemented., Objective: The aim of this study was to explore the experiences of GPs involved in the four pilot rotations established in South Thames region., Methods: Semi-structured interviews were conducted with trainers and partners., Results: The supervisory workload for pre-registration house officers (PRHOs) was much greater than that required by registrars. All GPs felt that increased remuneration was important for the future viability of the scheme. The majority of GPs remained supportive of the scheme, although a minority were concerned about the value of the experience gained by PRHOs. There were a few instances in which inadequacies in patient management had to be dealt with subsequently by trainers. The supervisory implications of such events will need to be addressed., Conclusion: This significant development in medical education has important implications for GPs and their patients which need further exploration through long-term evaluations.

With the advent of multicentre research ethics committees in the UK, local research ethics committees (LRECs) are required to advise only on issues relating to the local acceptability of a project. We looked at the handling of two commercially sponsored studies, one initiated before the change and one after, confining the analysis to 21 LRECs approached in both. As judged by the amount of paper per application, the new system for LRECs is simpler and should be less costly. However, there was an increasing tendency for LRECs to charge for their services (30% study 1, 47% study 2) and these charges varied by more than 400%. If such fees must be levied, a common scale is desirable.

The actuarially fair premium reduction in case of a deductible relative to full insurance is affected by: (1) out-of-pocket payments, (2) moral hazard, (3) administrative costs, and, in case of a voluntary deductible, (4) adverse selection. Both the partial effects and the total effect of these factors are analyzed. Moral hazard and adverse selection appear to have a substantial effect on the expected health care costs above a deductible but a small effect on the expected out-of-pocket expenditure. A premium model indicates that for a broad range of deductible amounts the actuarially fair premium reduction exceeds the deductible.

Introduction: With the German health care restructuring legislation ("Gesundheitsstrukturgesetz") the coding of diagnoses and operations according to ICD-9 and ICPM (OPS-301) was introduced for budget assignment ("Fallpauschalen/Sonderentgelte")., Methods: Application of the structured coding system "do it" in orthopedics and traumatology in combination with a surgical documentation system. Results of 8,664 documented operative cases within three years., Results: In total, 11,854 ICD-9 or ICD-10 and 20,178 ICPM (OPS-301) were coded. 2,914 "Fallpauschalen" and/or 3,456 "Sonderentgelte" were found. The System achieved high acceptance due to its userfriendliness and simple functionality., Discussion: In comparison with text- or thesaurus-based coding systems the "do it" coding system does not require any knowledge of the ICD or ICPM (OPS-301). It can be adapted to individual clinical requirements by implementing frequent diagnoses and individual therapy concepts. In combination with a medical information system the coding system can be integrated seamlessly into routine documentation.

The price is "right" when the buyer agrees to purchase goods or service. But is it "just"? That is, does the price include social costs such as pollution and discrimination? Cost shifting is the passing down of these costs from the seller to the buyer. The amount of cost shifting depends upon the inelasticity or elasticity of supply or demands, methods of assigning social costs, means used in promotion and the role of the market price. Wal-Mart and Body Shop International exemplify the problems of social costs. Recommendations for marketing managers concludes the article.

Objective: To predict the geographical effects of community rating of health insurance premiums on the amount individuals pay for insurance., Data Sources: We estimate premiums and health expenditures for a 5 percent sample of Californians from the 1990 U.S. Census (the Public Use Microdata Sample) and use data from Blue Cross of California to adjust for regional price differences in services., Study Design: We use an episodic health simulation model to estimate health expenditures for 975,074 Californians. Because the simulations do not reflect expenditure differences due to price variation in cost of services, we adjust these data for relative price differences by county. This leaves us with a sample of Californians for whom we have estimated health expenditures. We then compute average expenditures within areas of different sizes (all California, two regions, within counties) to estimate community-rated premiums. We then compare these premiums with actual expenditures on a county-by-county basis., Principal Findings: With a single California-wide premium, rural residents pay premiums that exceed their use of care, while urban residents pay premiums that are less than their use of care. These transfers are substantial. Dividing California into regional risk pools at the county level still results in poorer communities providing substantial subsidies to their more wealthy counterparts., Conclusions: Mandated community rating of premiums in a heterogeneous state such as California results in large unintended transfers of wealth from poorer, rural communities to urban, wealthier communities. Allowing premiums to vary with the regional cost of medical care would eliminate some of the transfers without sacrificing the benefits of community rating. Subsidies to low-income families could also effectively mitigate this redistribution. UTILITY: This article points out some potentially regressive consequences of geographic community rating and suggests ways to mitigate them.

When a tax-exempt hospital is sold, board members may wax eloquently about the synergies, mission and vision of the deal. But how much the facility sells for is becoming the key issue in many communities where tax-exempts have been purchased by investor-owned companies.