Federal Out-of-Network Balance Billing Legislation: Context and Implications for Radiology Practices.

Out-of-network (OON) balance billing, commonly known as surprise billing but better described as a surprise gap in health insurance coverage, occurs when an individual with private health insurance (vs a public insurer such as Medicare) is administered unanticipated care from a physician who is not in their health plan's network. Such unexpected OON care may result in substantial out-of-pocket costs for patients. Although ending surprise billing is patient centric, patient protective, and noncontroversial, passing federal legislation was challenging given its ability to disrupt insurer-physician good-faith negotiations and thus impact in-network rates. Like past proposals, the recently passed No Surprises Act takes patients out of the middle of insurer-physician OON reimbursement disputes, limiting patients' expense to standard in-network cost-sharing amounts. The new law, based on arbitration, attempts to protect good-faith negotiations between physicians and insurance companies and encourages network contracting. Radiology practices, even those that are fully in network or that never practiced surprise billing, could nonetheless be affected. Ongoing rulemaking processes will have meaningful roles in determining how the law is made operational. Physician and stakeholder advocacy has been and will continue to be crucial to the ongoing evolution of this process. © RSNA, 2021.

Understanding the Basics of Restrictive Covenants in Employment Agreements.

BACKGROUND: Restrictive covenants are common in contractual agreements involving physicians and need careful consideration to minimize potential conflict during the term of the contract and on physician departure from a group practice or hospital system. METHODS: A general overview of the different components of restrictive covenants is provided, including specific information related to noncompetes, nonsolicitations, and nondisclosure agreements. RESULTS: In general, states will uphold restrictive covenants if the elements of the noncompete are reasonable regarding geographic distance restrictions (e.g., <20 air miles), time restrictions (e.g., <2 years), and scope of services. However, states vary considerably in the interpretation of restrictive covenants. Other components of the contract, such as alternative dispute resolution (mediation and/or arbitration) and buy-out clauses (i.e., liquidated damages provisions), should be considered at the time the agreement is negotiated. CONCLUSIONS: States are balancing the protection of business interests with the protection of free trade. It is important that physicians seek counsel with an experienced health care attorney with respect to restrictive covenants in his or her specific state. A simple, well-written, and reasonable restrictive covenant can often help limit legal conflict and expense.

Are You Ready to Negotiate Your First Employment Contract? Experience of More Than 700 Plastic Surgeons.

BACKGROUND: Plastic surgeons have been shown to be unprepared to negotiate their first employment contracts. Previous survey studies have attempted to assess plastic surgeons' first employment contracts to outline common pitfalls in contract negotiation. With this study, the authors aim to expand these previous studies and help plastic surgeons become prepared to negotiate their employment contracts. METHODS: A seven-question, cross-sectional survey was sent to attending-level surgeon members of the California Society of Plastic Surgeons, the American Society of Plastic Surgeons, the Texas Society of Plastic Surgeons, and the American Cleft Palate-Craniofacial Association. Questions investigated plastic surgeons' first contracts. Correlations were determined using a two-sample Wilcoxon rank sum test in an attempt to link these questions with overall satisfaction. RESULTS: From the 3908 distributed surveys, 782 (20 percent) responses were collected, and 744 were included for analysis. The majority of respondents were found to join a group-centered, private practice following residency. Surprisingly, 69 percent of surgeons did not use attorney assistance when negotiating their contract. Although greater than 70 percent of respondents reported a salary of $200,000 or less, satisfaction with one's contract was most strongly correlated with a salary of greater than $300,000 (p < 0.0001). However, only 12 percent of respondent surgeons were able to secure such a salary. CONCLUSIONS: This study examined the largest, most diverse plastic surgeon cohort to date regarding surgeons' first employment contract. Although the authors' findings indicate that certain factors should be prioritized when approaching a first employment contract, they ultimately recommend that all surgeons take into account their personal priorities and attempt to proactively define their terms of employment before signing a contract.

How Internet Contracts Impact Research: Content Analysis of Terms of Service on Consumer Product Websites.

BACKGROUND: Companies use brand websites as a promotional tool to engage consumers on the web, which can increase product use. Given that some products are harmful to the health of consumers, it is important for marketing associated with these products to be subject to public health surveillance. However, terms of service (TOS) governing the use of brand website content may impede such important research. OBJECTIVE: The aim of this study is to explore the TOS for brand websites with public health significance to assess possible legal and ethical challenges for conducting research on consumer product websites. METHODS: Using Statista, we purposefully constructed a sample of 15 leading American tobacco, alcohol, psychiatric pharmaceutical, fast-food, and gun brands that have associated websites. We developed and implemented a structured coding system for the TOS on these websites and coded for the presence versus absence of different types of restriction that might impact the ability to conduct research. RESULTS: All TOS stated that by accessing the website, users agreed to abide by the TOS (15/15, 100%). A total of 11 out of 15 (73%) websites had age restrictions in their TOS. All alcohol brand websites (5/15, 33%) required users to enter their age or date of birth before viewing website content. Both websites for tobacco brands (2/15, 13%) further required that users register and verify their age and identity to access any website content and agree that they use tobacco products. Only one website (1/15, 7%) allowed users to display, download, copy, distribute, and translate the website content as long as it was for personal and not commercial use. A total of 33% (5/15) of TOS unconditionally prohibited or put substantial restrictions on all of these activities and/or failed to specify if they were allowed or prohibited. Moreover, 87% (13/15) of TOS indicated that website access could be restricted at any time. A total of 73% (11/15) of websites specified that violating TOS could result in deleting user content from the website, revoking access by having the user's Internet Protocol address blocked, terminating log-in credentials, or enforcing legal action resulting in civil or criminal penalties. CONCLUSIONS: TOS create complications for public health surveillance related to e-marketing on brand websites. Recent court opinions have reduced the risk of federal criminal charges for violating TOS on public websites, but this risk remains unclear for private websites. The public health community needs to establish standards to guide and protect researchers from the possibility of legal repercussions related to such efforts.

Halting the Vicarious Liability Juggernaut: Barclays Bank PLC v Various Claimants.

In Barclays Bank plc v Various Claimants [2020] UKSC 13, the Supreme Court rejected the claimants' argument that Barclays should be vicariously liable for the sexual assaults of a doctor hired on as a contractor to perform medical examinations on employees and job candidates at the bank. It upheld the traditional rule that a defendant is not vicariously liable for the torts of independent contractors. This commentary examines the law on liability for independent contractors and considers whether the Supreme Court decision is consistent with modern employment trends. The implications of the decision for medical law are then discussed.

Is Covid-19 sowing the seeds for future litigation?

We consider various types of litigation that may follow the Covid-19 pandemic, including: claims against National Health Service (NHS) Trusts by patients who have contracted the coronavirus (or by their bereaved families), claims by NHS staff against their employer for a failure to provide any or adequate personal protective equipment or testing, commercial claims arising from the procurement of medical supplies, the potential liabilities to those who suffer adverse reactions to any vaccine and the guidance issued by the regulators in relation to subsequent disciplinary action.

Evolving Outsourcing Landscape in Pharma R&D: Different Collaborative Models and Factors To Consider When Choosing a Contract Research Organization.

Outsourcing has become an integral part of how research and early development (R&D) is executed in biotech companies and large pharmaceutical organizations. Drug discovery organizations can choose from several operational models when partnering with a service provider, ranging from short-term, fee-for-service (FFS)-based arrangements to more strategic full-time-equivalent (FTE)-based collaborations and even risk-sharing relationships. Clients should consider a number of criteria when deciding which contract research organization (CRO) is best positioned to help meet their goals. Besides cost, other factors such as intellectual property protection, problem solving skills, value-creation ability, communication, data integrity, safety and personnel policies, ease of communication, geography, duration of engagement, scalability of capacity, and contractual details deserve proper consideration. In the end, the success of a drug discovery partnership will depend in large part on the people who execute the science.

La pandemia de la covid-19, la fuerza mayor y la alteración de las circunstancias en materia contractual / The covid-19 pandemic, force majeure and changed contractual circumstances / A pandemia da covid-19, a força maior e a alteração das circunstâncias em matéria contratual

La declaratoria del estado de emergencia, a causa de la pandemia de la covid-19, exige un análisis de la vigencia de las relaciones contractuales y cómo estas pueden verse afectadas por eventos extraordinarios, imprevisibles e irresistibles que impidan el cumplimiento de las prestaciones, así como aquellos casos en los que la alteración de las circunstancias puede llevar a que una de las partes exija al juez recomponga el contenido de la prestación pactada o la resolución del contrato.

The declaration of a state of emergency due to the covid-19 pandemic requires an analysis of the validity of the contractual relations and how these may be affected by extraordinary, unforeseeable and irresistible events that prevent the performance of the services, as well as those cases in which the alteration of circumstances may lead one of the parties to demand that the judge recompose the content of the agreed service or terminate the contract.

A declaração de estado de emergência, devido à pandemia da covid-19, exige uma análise da vigência das relações contratuais e como estas podem ser afetadas por eventos extraordinários, imprevisíveis e irresistíveis que impeçam o cumprimento das prestações, assim como aqueles casos em que a alteração das circunstâncias podem levar a que uma das partes exija que o juiz recomponha o conteúdo da prestação acordada ou a rescisão do contrato.

New Zealand Policy on Frozen Embryo Disputes.

Disputes between separated couples over whether frozen embryos can be used in an attempt to create a child create a moral dilemma for public policy. When a couple create embryos intending to parent any resulting children, New Zealand's current policy requires the consent of both people at every stage of the ART process. New Zealand's Advisory Committee on Assisted Reproductive Technology has proposed a policy change that would give ex-partners involved in an embryo dispute twelve months to come to an agreement before the embryos are destroyed. New Zealand's current policy and the proposed policy both favour the person who wishes to avoid procreation. Two alternative policy approaches that do not favour procreative avoidance are considered. Using pre-fertilisation contracts to determine the decision reached in embryo disputes allows the couple's wishes at the time the embryos are created to determine what happens to the embryos if they separate. However, pre-fertilisation contracts are agreements about healthcare and personal relationships, and changing circumstances can make enforcing such agreements unjust. Finally, it is argued that New Zealand's Family Court system should be used to reach decisions that balance the interests of those involved in the dispute.

Does managed competition constrain hospitals' contract prices? Evidence from the Netherlands.

In the Dutch health care system, health insurers negotiate with hospitals about the pricing of hospital products in a managed competition framework. In this paper, we study these contract prices that became for the first time publicly available in 2016. The data show substantive price variation between hospitals for the same products, and within a hospital for the same product across insurers. About 27% of the contract prices for a hospital product are at least 20% higher or lower than the average contract price in the market. For about half of the products, the highest and the lowest contract prices across hospitals differ by a factor of three or more. Moreover, hospital product prices do not follow a consistent ranking across hospitals, suggesting substantial cross-subsidization between hospital products. Potential explanations for the large and seemingly random price variation are: (i) different cost pricing methods used by hospitals, (ii) uncertainty due to frequent changes in the hospital payment system, (iii) price adjustments related to negotiated lumpsum payments and (iv) differences in hospital and insurer market power. Several policy options are discussed to reduce variation and increase transparency of hospital prices.

Swinging For Fairness: Law Creates New Ballgame for Surprise Billing.

When Senate Bill 1264 was first introduced in February, insurers had the bases loaded, threatening to score a lopsided surprise-billing victory on one swing. With some deft pitching in the Texas Legislature, medicine worked its way out of the jam. The "baseball-style arbitration" measure by Sen. Kelly Hancock (R-North Richland Hills) isn't perfect, and like a hitter who's getting busted inside, physicians will have adjustments to make. But the improved SB 1264 passed with a framework that's fairer to everyone involved.

Influence of out-of-network payment standards on insurer-provider bargaining: California's experience.

OBJECTIVES: To examine the early effects of California's recent policy addressing surprise medical billing (AB-72) on the dynamics among physician, hospital, and insurer stakeholders and to identify the influences of the policy's novel out-of-network (OON) payment standard on provider-payer bargaining. This study can inform current policy formation, given that current federal proposals include a payment standard like that in AB-72. STUDY DESIGN: Case study of the implementation of AB-72 and stakeholders' perspectives, experiences, and responses in the first 6 to 12 months after policy implementation. METHODS: Semistructured interviews were conducted with 28 individuals representing policy experts, representatives of advocacy organizations and state-level professional associations, and current executives of physician practice groups, hospitals, and health benefits companies. Related documentation was collected and analyzed, including bill text, rulemaking guidance, testimony before the California Senate Committee on Health, and advocacy letters. Qualitative analysis techniques, such as process tracing and explanation building, were employed to identify key themes. RESULTS: AB-72 is effectively protecting patients from surprise medical bills. However, stakeholders report that an OON payment standard set at payer-specific local average commercial negotiated rates has changed the negotiation dynamics between hospital-based physicians and payers. Interviewees report that leverage has shifted in favor of payers, and payers have an incentive to lower or cancel contracts with rates higher than their average as a means of suppressing OON prices. Physicians reported that this experience of decreased leverage is exacerbating provider consolidation. CONCLUSIONS: California's experience demonstrates that OON payment standards can influence the payer-provider bargaining landscape, affecting network breadth and negotiated rates.

Algunas consideraciones sobre el contrato de vientres de alquiler a la vista de la legislación española sobre adopción / Some considerations about the contract of surrogate mother in view of the spnanish legislation on adoption

El derecho español, artículo 177 del Código Civil, y el Convenio Europeo de adopción de menores requieren para la validez del consentimiento de la madre el transcurso, tras el parto, de seis semanas, en garantía de su libertad, consciencia y adecuada información. En contraste en los contratos de vientres de alquiler la mujer contratada en la gestación debe dar su consentimiento irrevocable de entrega del niño al nacer, ex ante del proceso, desprotegiéndola: impidiendo la revocación de su (aparente) voluntad inicial al concluir la gestación y conocer a su hijo ya nacido. Además de la ilicitud del objeto de este contrato, pese a la existencia de derecho que lo positivice, debe considerarse el consentimiento prestado nulo de pleno derecho

Spanish law, article 177 of the Civil Code, and the European Convention on the minors’ adoption require for the validity of the mother ́s consent, the passing of six weeks after the birth, as a guarantee of her freedom, consciousness and adequate information. In contrast, in the agreements of surrogate mother, the woman contracted for the pregnancy must give her irrevocable consent to give the child at birth, ex ante the process, leaving her unprotected: preventing the revocation of her (apparent) initial choice at the end of the pregnancy and knowing her child already born. In addition to the illegality of the object of this contract, despite the existence of a law that makes it positive, the consent given must be considered null and void

[Some considerations about the contract of surrogate mother in view of the spnanish legislation on adoption]. / Algunas consideraciones sobre el contrato de vientres de alquiler a la vista de la legislación española sobre adopción.

Spanish law, article 177 of the Civil Code, and the European Convention on the minors' adoption require for the validity of the mother's consent, the passing of six weeks after the birth, as a guarantee of her freedom, consciousness and adequate information. In contrast, in the agreements of surrogate mother, the woman contracted for the pregnancy must give her irrevocable consent to give the child at birth, ex ante the process, leaving her unprotected: preventing the revocation of her (apparent) initial choice at the end of the pregnancy and knowing her child already born. In addition to the illegality of the object of this contract, despite the existence of a law that makes it positive, the consent given must be considered null and void.