Contracts, Antitrust and Other Issues

The call for generating more value in the delivery of and payment for health care has encompassed a long-standing criticism of the fee for service payment model that has traditionally applied to physicians. How to compensate physicians, whether as a physician group or health system employer, is an on-going bulwark to those efforts.  In "Coping with Merging Streams: Legal Issues in Physician Compensation", Alice reviews multiple new forms of revenue from payment for physician services including – 6 forms of commercial payment along with the challenges of the new evaluation and management codes, 5 federal programs and another 4 vehicles often associated with different payment.  She considers their relative effects and the compliance issues each generates, as well as contractual pitfalls they present. Then she examines the practical impact these programs have had on the physicians they are intended to motivate, taking into account as well the widespread consolidation of physicians with health systems. Against that background, including the advent of the value-based enterprise exceptions and safe harbors, she explicates issues in physician compensation presented by the 2022 Stark rules on physician productivity and profit-sharing within a group.  She includes the need to account for external audits and voluntary repayments and offers contract guidance. The complexity of these sources of revenue combined with the restrictions of Stark present a major challenge in physician compensation relationships and agreements.

In settlements and whistleblower cases around the country, the problems that can be created by a billing company (or as it is referred To in hospital world as ‘revenue cycle management’) have increased recently. Alice has addressed the major problems lurking here in the past in her article on billing company accountabilities. As we have reviewed more and more of these contracts for our clients, and have received more and more complaints about problems created in these relationships, we think it important to reassert issues that must be addressed in the contract for billing and collection services: (1) standards of performance, particularly with respect to timeliness of claims submission, collection rate, and aging of accounts receivable; (2) the obligation to bring billing concerns to management before going anywhere else; (3) getting a representation that the company and its personnel have not been whistleblowers in the past. There are plenty of other issues but those three are critical and frequently absent.

Many of the issues we, and other lawyers, address for our clients entail unsettled law or areas where the risks range from pearl gray to charcoal grey without being illegal per se.  In an 11th Circuit opinion in 2021, in Reynolds v. Mintz, Levin, a disgruntled laboratory's bankruptcy trustee sued a prominent health law firm for legal malpractice because the firm did not affirmatively instruct the client to stop paying physicians processing and handling fees. When the client sought advice regarding a competitor's behavior in paying high fees, Mintz Levin offered several options including reporting the competitor to the government, while advising regarding the risk in doing so, given their own practice of paying such fees.  The lab went bankrupt, but was also sued for $25 million by a whistleblower for the payment of the handling fees. The court found that the law was unsettled at the time the law firm's advice was given; so there was no obligation on the law firm to advise the client to stop what it was doing. What this means for many of our clients seeking guidance is that there is often no settled law on point; and the business decision belongs to the client. Not us.  Unlike informed consent in medicine where there is often data regarding risk of complications, we often have zero data available and must rely only on our own judgment.  One of the values in using a health law focused firm like us is that our judgment comes from long-standing reviews of a wide variety of transactions.  That said, there is, still, often no clear answer.  Welcome to health care!

In the face of ever-increasing documentation and reporting requirements, reduced reimbursement, and the general hassle of managing EHRs, some physicians are reevaluating their relationships with Medicare. Towards this end, they may be exploring whether to switch from “participating” to “non-participating” status (where the physician may elect to accept assignment on claims or charge the patient a fee up to the applicable limiting charge), or to opt out of Medicare (entering into private contracts with patients wherein the physician’s services will not be reimbursed at all by Medicare, and they may charge what they please). In investigating these options, however, physicians may encounter additional information regarding how to “withdraw” from Medicare, which may lead to some confusion. Which status is the right status: non-participating, opted out, or withdrawn? And what is the difference between withdrawing from Medicare and the other statuses? Withdrawal from Medicare is appropriate when a physician is voluntarily terminating involvement in Medicare altogether, such as when the physician retires, or closes a practice location and wishes to terminate permanently the billing privileges for that location. It is not meant to be the same thing as switching to non-participating status, nor for opting out and entering into private contracts with patients.
The alignment between hospitals and physicians which is sought to produce better value –- improved outcomes at lower cost with a better patient experience of care --  takes a range of forms. These include new phenomena like accountable care organizations (ACOs), clinically integrated networks (CINs)-- a non-specific characterization of a range of provider networks-- bundled payment, gainsharing, pay for performance, and probably the most widely deployed: hospital employment of physicians.  As Alice reports, the latter has proven not only a profound failure – losing hospitals by many estimates $100,000 and more per physician, it has also now been shown to cost the Medicare program much more money on just four outpatient procedures alone.  A different model of leasing the physician practice to the health system or hospital has been little examined, analyzed or reviewed.  Alice has created a fair number of these transactions around the country, with different specialties.  She first presented a teleconference and wrote an initial article on the subject in 2012.  In 2017 she published another article, and presented a longer teleconference addressing both what makes this approach potentially better than hospital employment and the fundamental elements of the relationships.  Now, going far further,  in an in-depth presentation of a specific guide on how to structure such an arrangement in her article “Lessons Learned from Leasing: A Blueprint for Physician-Hospital Alignment", she presents the lessons she has learned from multiple transactions that have now been in effect long enough to have involved second negotiations.  These transactions can garner all the alignment the parties want allowing the physician group to retain its cohesion, while producing more value when they are founded on clinical integration principles. If they go wrong, the termination is far easier since it is merely the termination of a contract. These leasing arrangements deserve far more attention than they have received to date.

When things go wrong with software and IT providers, it is often almost impossible to find relief because of the way their contracts are written, Amazingly, a New Jersey health-care provider was allowed to proceed with its lawsuit against two health-care information technology firms that represented they could convert patient files from NextGen to Allscripts, computer software programs physicians use to track all aspects of patient care. Nearly 200,000 patient charts were corrupted when the conversion attempt failed. The plaintiff sued under the New Jersey Consumer Fraud Act and the defendants argued the Act didn’t apply. The court had none of it. They found the defendants apparently offered a guarantee of results, and professed to have expertise in the conversions when they had never done it before. The court found the risk of harm was obvious, the nature of the data was of public significance and that the case could proceed. It offers tantalizing possibilities in contracting with IT and software vendors.

Because of COVID-19, CMS issued an emergency waiver of certain telehealth requirements, and made additional changes in coverage and reimbursement for a range of telehealth services. Physicians can be paid for the performance of certain telephone visits for both new and established patients; telehealth services no longer need to be provided only in rural settings only; additional telehealth visits may be performed more frequently than previously; nursing home residents may be “visited” using telehealth instead of requiring in-person visits; and direct supervision for services may be provided virtually using real-time audio-video technology. These and other changes are shifting how care is provided to patients for the duration of the federal COVID-19 emergency declaration (still in effect, as of November, 2020). In a video interview, Dan discusses how COVID-19 and increased usage of telemedicine has changed how health care practitioners are caring for their patients now, as well as what may come in the future, in a video interview with Infection Control Today. As he has observed, with health care providers forced to meet with patients remotely, the health care industry is learning just how effective and efficient telemedicine can be. As a result, it is likely that telemedicine will become more widely covered and, hopefully, reimbursed at equal rates in comparison with in-person visits. Watch the 15 minute interview for more of Dan’s thoughts on this issue.

The use of off shore services and personnel to contribute to the delivery of health care has a long standing presence in health care. Yet, state law, federal reimbursement principles and other federal laws create barriers to the use of overseas personnel, resources, information technology and more in the delivery of health care.  Issues of whether supervision can be rendered from afar, licensure requirements, HIPAA restrictions and Medicare reimbursement prohibitions create a challenging context to make these arrangements work.  Dan Shay explores all of this and offers practical contractual language to use in any of these undertakings in his article "The Lure of Foreign Shores: Outsourcing of Overseas Health Care Functions" in the 2021 edition of the Health Law Handbook.

The role of the billing function in physician practices is critical-- so critical that many groups do not trust themselves to do it effectively. They outsource this role. Hospitals are increasingly doing the same thing. The billing function is also essential in emerging transactions such as leasing a practice to a health system, private equity management contracts, MSOs and more.  In her article "Billing Company Contracts: Accountability and Pitfalls" Alice elucidates who does this work, explores and challenges the traditional compensation model for these tasks and offers an alternative approach.  She addresses performance metrics to be considered, and then dissects the allocation of responsibilities to be set forth in these agreements. She further assesses the implications of the Medicare reassignment rules, the OIG's Model Compliance Guidance and its import, and then presents information on what happens when things go wrong.  This little addressed area of the law merits significantly more attention than it has gotten to date.

With the advent of the value demand in health care, the concept of ‘managed care’ seems almost quaint Yet, provider participation agreements continue to be presented to providers to form networks and participate in plans.  But, increasingly, the contract may not be with a health plan itself, but with some intermediate entity.  In “The Modern Managed Care Contract” Alice describes what remains and what is new in the reforming system of network configurations with health plans and the contracts that forge those relationships.
As the healthcare landscape changes, the role and content of physician employment contracts has changed, too.  The new environment requires protections for employers and employees. In two publications, we address new provisions and potential pitfalls that lurk in the employment context.  In "The Modern Employment Agreement" Alice and Dan present typical provisions that meet today's new requirements, such as with respect to compliance, HIPAA, and post-payment audits, addressing what older style agreements have included as well.  In "Avoiding landmines when signing a hospital contract" Alice elucidates some of the special problems that can occur when physicians become employed by the hospital, a health system or its affiliated medical group.  None of this is your father's handshake of yore.

Young physicians coming out of training will confront a range of challenges for which most are unprepared. One of the first real challenges young physicians confront is their first employment agreement. From compensation, to term and termination, restrictive covenants and “tail insurance,” many issues are unfamiliar to them. Then there is the matter of how to approach negotiation of any of the provisions. Dan brings his special interest in working with young physicians to bear in “The First Employment Agreement: Common Clauses and Practical Tips for Residents.” The article is oriented towards physicians just leaving training, but it includes advice that even veteran physicians may find helpful.

Although the federal government has not changed its stance, many states have begun to liberalize their laws regarding the use of marijuana, especially in a medical context. This has sparked curiosity among physicians about whether and how to provide medical marijuana. The legal landscape varies from state to state, though, with some states permitting recreational use of cannabis, while others only permit such use for medical purposes and then only for specific conditions. In “Peering Through the Haze of Medical Marijuana Laws,” Dan examines state laws regarding certifying patients for medical cannabis use, as well as the implications of staff usage in states that permit either recreational or medicinal use of marijuana.

The drumbeat for insurers to move to value-based payments cannot be ignored. However, both experience and expertise at the health plans which are touting their programs are widely variable. A recent survey reports that 82% of health plans consider the development of new payment models a major priority. They are, however, all over the ballpark in what they are doing. Many of the national plans now claim to have many ACO projects in the works, although these vary widely as well. Almost all of the new value payment propositions that are not mere pay-for-performance turn on some concepts of bundling budgets or bundling payments. Typically, providers are paid in the ordinary course, with a gainsharing bonus available based upon reconciliation at some pre-determined point in time. The contracts that create these arrangements are the most critical foundation of potential success. As Medicare moved into this arena with the Bundled Payment for Care Initiative (BPCI) they engaged consultants to provide contracting advice. Mitre and Brookings acknowledge in the Foreword to their material their extensive reliance on Alice's input and review of their document. The Manual is oriented around the Medicare program, but essentially highlights what is necessary to make one of these bundled payment contracts work.

The rapid rise in the employment of physicians by health systems has been repeatedly noted. A recent survey by yet another recruitment company found that 70% of health care leaders say physicians are approaching them for employment. Yet, the data has also consistently shown that this is a money losing proposition for the hospitals in many ways, in part because once employed, the hospitals do not facilitate the physicians' clinical integration or undertake any effort to actually improve value [See also issues: #1: 61, 55, 48]. In "Four Top Complaints of Employed Doctors", newly employed physicians complain about (1) being "bossed around by less educated administrators;" (2) not being able to make decisions about staff and personnel; (3) having less authority over billing and charge coding; and (4) being forced to use new equipment and technology. In addition to the efficiencies of many of the organizations now employing physicians, the consolidation in the industry is raising other concerns with respect to provider power and negotiating with plans. It is not hard to imagine that many of the employment strategies will unravel. Whether physicians have prepared well in their negotiations with the hospital in the first place for life after a failed transaction is something that needs to be dealt with in the first place. More to the point, in many instances, health systems and hospitals can get precisely the same impact that they seek from employment without the troubles while physicians can function more effectively in their own environments. We have repeatedly stated this ("Alignment Without Servitude: Leasing the Practice to the Hospital"), and have facilitated many practices in a wide variety of affiliation strategies with hospitals and health systems that fall short of employment and "avoid marriage." [See also issues: #1: 54, 52, 47]

Bundled payment has been touted as the next, new aligned incentive payment model. Although rarely defined in the many discussions about it, bundled payment by definition combines two different providers, typically traditionally paid differently, into one budget or, in more radical versions, subject to a single prospective payment. Today's bundled payment models usually include an episode based payment. The Medicare ACO program anticipates a bundled payment model in its requirement that participating entities have the ability to allocate dollars to the disparate participants. In fact, though, in that program hospitals, physicians and others will be paid on a business as usual basis, and then, at the end of three years, if they have saved money over a benchmark there will be one payment to share. PROMETHEUS Payment offers a different model. If providers want to be paid separately, they are at risk together in a single budget, but PROMETHEUS Payment has a software program that can allocate savings appropriately to the diverse participating providers, based on good clinical practice guidelines which form the basis for the case rate. The incentives are the same, but the payment methods differ. Many commercial bundled payment and ACO programs follow the Medicare model. Herein lies the rub. Unless there are clear rules at the outset, providers may end up in the rancorous fights that characterized the few instances in the 1990s when PHOs received dollars, usually held by the hospital. CMMI asked Alice to present a technical assistance webinar for potential participants in their Medicare Bundled Payment Initiative on contractual and governance issues among providers in administering bundled payment models, and in "Avoiding Food Fights: The Value of Good Drafting to ACO Physician Participants" she elucidates the types of policy decisions that should be made today and documented governance documents and contracts among providers to avoid the problems of tomorrow. The third of our Three Tuesday Teleconferences addresses many of these issues with an opportunity for participants to ask questions.

Clinical integration has increasingly been discussed as the vehicle to accomplish what is necessary to be accountable for care.  But even among those commentators who have gotten beyond the antitrust notions of clinical integration, few really describe the focus of change that can create a truly clinically integrated environment, nor how those changes can make a difference. For some time now, we have touted clinical integration as a way to reorganize clinical and administrative processes of care, particularly among physicians and the other clinicians who work with them, but also in relationship to hospitals. (See issues: #70, #67, #60) Now, Alice and Jim Reinertsen MD, have created a Clinical Integration Self Assessment tool which elucidates 17 distinct attributes of clinically integrated programs, whether within a physician group, by a hospital with its newly employed physicians, within the organized medical staff, or in a newly coalescing ACO-like entity.  All ought to take into account the range of issues identified, but in slightly different ways.  We are also explicitly calling for those who may use the tool, to revise, refine and add to it.

In her article in Medical Economics “Making Clinical Integration Work” Alice focuses on how clinical integration is meaningful to small physician practices.  In their brief piece for the Health Forum, “Clinical Integration: Getting From Here to There” Alice and Jim Reinertsen focus on the hospital-physician nexus of clinical integration.  Clinical integration of various kinds is going to be the sine qua non of health care delivery which will succeed in an environment of heightened quality expectations, the need for better patient safety, diminishing reimbursement, and pressure for contained costs.

Hospital employment of physicians is occurring all over the country.  Much of it is comes from completely misguided expectations.  There are delusions and fantasies on both sides of these transactions.  Physicians hurl themselves on the bosom of the hospital in the belief this will give them financial security while they will be left alone to practice, business as usual.  Hospitals, for their part, think this will give them control over physicians, but they rarely do anything with them, particularly the specialists who have recently joined their fold.  Many of the finances of these deals cannot work going forward as hospitals confront decreased reimbursement from Medicare and fewer admissions in a quality driven environment.  We have confronted these issues before in articles addressing non-acquisition financial strategies between hospitals and physicians and on the right questions to ask and answer before leaping into these arrangements. We fully expect there to be unwinds of many of those transactions which are without content, given physician gripes about employment. That said, these arrangements can work. But the mere existence of a W-2 between the health system or hospital and the physician is not a viable, sustainable approach. Strategic goals, clear targets and benchmarks of behavior from both sides of the table are the only reasonable way for these transactions to add any real value in the changing system.

Clinical integration has been a vaguely understood topic since the antitrust regulators introduced the concept in 1996. Alice continues her focus on this issue in a new article which includes how clinical integration within groups may be an important first step before clinical integration with competitors or with hospitals. In “Clinical Integration Is Back”  she observes that the furtherance of clinical collaboration across the continuum of care will be essential to improve healthcare delivery. A broader understanding of clinical integration techniques can enhance physician performance and quality results both with hospitals and on their own.

As the concept of “Accountable Care Organizations” and moving to “The Clinic Model” have captured the fancies of a number of small and large hospital systems around the country, Alice with Jim Reinertsen, MD explores the real questions that should be asked and answered before health systems and physicians leap into these often ill-defined strategies. In their piece “Informed Consent to the Ties That Bind” , Alice and Jim describe specific points of evaluation, and offer good and bad answers to the tough questions. They raise issues that few of the consultants pushing these strategies are willing to address.

While specialists are seeking employment by health systems, health systems are forming multi-specialty groups and the billiard balls are repositioning themselves throughout the country, the illusion that health system employment of physicians will solve alignment problems going forward is unfortunately far too simplistic for the current state of affairs. In her new HEALTH LAW HANDBOOK chapter, “Avoiding Marriage: Hospital and Physician Non-Acquisition Financial Strategies”  Alice examines these issues in greater depth than was presented in her teleconference. She explores the phenomenon of enthusiasm for full merger business strategies and offers a range of other techniques by which physicians and hospitals may bond more tightly while physicians remain independent---all with particular emphasis on improving healthcare value and quality.

Pay for performance programs show no signs of abating in popularity, yet their impact remains equivocal. Whether quality would be better if physicians within groups also paid themselves based on quality performance is unknown. If the incentives of P4P are to have impact, how are those monies distributed to the individual physicians once the group gets paid? There is virtually nothing in the literature on point. In “Physician Compensation for Quality: Behind The Group’s Green Door,” Alice looks at the data on P4P programs, the basics of traditional compensation within groups and then presents the findings from a unique survey which was sent out on her behalf by the AMGA producing responses from 14 groups around the country who are variably paying for quality as part of physician compensation. Some report significant improvement in quality performance too. Alice then looks at the payment reform models on the horizon and concludes that traditional notions of productivity, on which most current group compensation models turn, will not reward what the new systems, and most particularly the PROMETHEUS Payment® model (www.prometheuspayment.org) is designed to generate. She examines whether the Stark rules on compensation will be a barrier to changed, creative approaches, concludes that it will not, and then looks at what employment contracts will have to accommodate to make physician compensation for quality within groups real and of value to both patients and physicians.

The PROMETHEUS Payment® model is designed explicitly to reward clinical collaboration among otherwise independent providers. Since 30% of any provider’s scores will turn on the performance of all the other providers treating the patient for that condition, and scores determine the totality of the payment a provider can receive, there is a real reason to pay attention to the web of referral relationships – from whom you take referrals, to whom and where you refer. Even when the optimal moment for referral occurs would be an important point for agreement among clinicians – whether primary care to specialty, vice versa or among specialists. In fact, much of what PROMETHEUS Payment® would reward, providers should be doing anyway. In her article “A New Payment Model for Quality: Why Care Now?” Alice articulates some of the steps providers should be taking anyway to improve their care and their efficiency.

In a blog interview conducted by a surgeon who has been a client, Alice is questioned about how she became a health lawyer, her views on P4P, why she didn't become a physician and more. For a real change of pace go to http://insidesurgery.com/.

As health plans and health systems have consolidated and fraud and abuse enforcement has intensified throughout healthcare, the natural business tendencies in any other industry for business partners to find ways to benefit each other economically in win-win strategies has been stifled in health care. Anxiety over fraud and abuse and antitrust risks, has gotten in the way of hospitals and physicians on one hand and health plans and physicians on the other working together for their mutual economic benefit with the purpose of improving quality. In a new chapter in the Health Law Handbook, Alice makes the argument that until the three principal drivers of the care that patients receive in this country take common ownership of the quality mission and stop thinking of themselves as disparate, adversarial stakeholders, quality will never advance to the levels we would like. "In Common Cause for Quality" she articulates a perspective on how to consider a business case for quality, sets forth the quality demands on hospitals and health plans which cannot be met without full cooperation of physicians and debunks the myths that the law impedes collaboration which benefits any party economically. She then enumerates 10 specific strategies by which hospitals and health plans can advance the physician's business case for quality through activities with direct beneficial financial impact on those physicians. She also presents 6 additional strategies through which physicians can and will have to help hospitals to optimize their quality efforts.

In "Enhancing Oncology's Business Case: How the Hospital Can Help" she presents a crisper version of these arguments in terms of how oncologists can safely look to their hospitals to help them with their own quality demands.

In an article in Community Oncology, Alice makes the argument that because of the perverse impact of the Medicare drug payment model on oncology practices, they have neglected to focus on their own business case for some time. When much of your income is driven by profits made on the provision of pharmaceuticals to patients, a reduction in that payment can result in significant practice dislocation. For oncologists, the moment may well be optimal to really consider clinical integration. In “Better Quality, Better Margins: Seizing the Moment” Alice elucidates these connections in relationship to the application of UFT-A principles.

Clinical integration has been held out by the FTC in every physician network settlement into which they have entered in the last few years. "You can't do this, but if you were clinically integrated you could." Some have questioned whether clinical integration is really available as an option to facilitate providers bargaining with payors. Brown and Toland in California was the subject of an FTC enforcement action in 2003 for their PPO bargaining activities. When they eventually settled, they agreed not to undertake any PPO bargaining unless the FTC prior approved what they were doing as sufficient clinical integration. The FTC has now reviewed Brown and Toland's ( B & T) approach and has said it represents enough clinical integration to permit negotiations, but they will still be subject to review for conformity with the integration principles. B & T says that the elements of integration they have adopted are a utilization review program, disease management and case management activities and an electronic medical record. This is meaningful because until this point there has been only one advisory opinion which addressed acceptable elements of clinical integration and now the B & T program is different. The FTC says it will review their actual implementation; but this action stands for the proposition that clinical integration is alive and well. It also means clinical integration does not require a uniform approach consistent in every respect with the hypothetical facts set forth when its permissibility was first published by the FTC in 1996. We think that UFT-A offers an option which will, by its implementation, create appropriate clinical integration to qualify for joint bargaining.

With the reemphasis on 'transparency' in health care quality policy, more and more quality information about providers will be made available. The commercial value of provider data is also increasing. Providers enter into many contractual relationships where data about them may be in play, even if that is not the focus of the relationship. For example, a managed care contract, a practice management company relationship, obtaining an electronic medical record from a software vendor, or hiring a billing company are all relationships where significant provider data will be at issue. In "Commerce in Provider Data: What, Why and Provider Contractual Controls" Daniel Shay looks at what is proprietary to a provider, considers who is reporting data and why, and offering actual contract language as well as case law, addresses contractual protections providers should think about in entering into relationships with a range of other entities.

One of the major thorns in the side of physicians confronting managed care payors has been their antitrust risk if they bargain for fees collectively. We have posited that ‘clinical integration’, which the antitrust regulators have said can permit otherwise collusive bargaining among competing physicians, is part of the business case for quality. In each of the physician and hospital network settlements in the last months, the FTC has noted that the physician groups were not sufficiently integrated financially or clinically. In the settlement with Brown and Toland, the FTC imposed a new requirement that if they chose to bargain based on clinical integration they would have to submit their approach to the FTC before implementation. Given the dearth of regulatory guidance on point, and only one advisory opinion to date, it is with great pleasure that we are able to make available an important article from our 2004 HEALTH LAW HANDBOOK by Bob Leibenluft who was the head of the health care division of the FTC when the clinical integration opportunity was made available. In “Clinical Integration: Assessing the Antitrust Issues” Bob and his colleague Tracy Weir, acknowledge that the antitrust regulators have not seen much real clinical integration. We think that is probably true since much of what we are familiar with as purported to demonstrate clinical integration, in fact, does not go far enough. Still his article supports our case that doing what we suggest in our ‘unified field theory’ work would likely meet the regulators’ criteria.

The last five years have heard a relentless call for information technology dissemination to improve quality and lower costs in health care. Electronic health records (EHR) have been touted as the first and most important step to a real technology revolution. For physicians, though, the cost of EHR implementation has often proven prohibitive. The Stark and anti-kickback protections for donated medical records was expected to jumpstart this effort. Not so fast. In his consideration of downstreamed EHR licenses Dan Shay takes his primer on EHR license agreements a step further in explicating the special complications of tri-partite license agreements. What happens on termination is at least as important as what is entailed in implementation.

For quality to advance in this country, it is becoming increasingly clear that universal electronic medical records will be necessary. Proposed regulations to permit hospitals to provide record systems to their physicians have been published under Stark. Many physician practices are looking to obtain these programs. Whatever the source of an electronic health record system, it is certain there will have to be a license agreement by which the practice obtains access to the software, unless they build their own. In "A Primer on Electronic Health Records License Agreements", Daniel Shay reviews the context for these contracts, elucidates their common features, based on reviews of real-life documents, and points out pitfalls that physician practices should avoid in obtaining access to these vital practice accessories. In a practical, easily applied application of the deeper issues addressed in the primer, Daniel has also offered guidance on “Top Ten Questions To Ask When Looking At An EHR License Agreement.”

Lawyers offer special expertise which health care providers need in order to function in their highly regulated contexts. In addition, the special liability problems faced by those providers who do not meet the standard of care, merit careful attention to risk management. But increasingly, we see hospitals who are held captive by attorneys who needlessly scare them about compliance and liability risk. There are increasing tensions in this regard in the new world of quality transparency. We see lawyers advising physicians in so restrictive a way as to impinge on their ability to function as business entities. We see lawyers who over-estimate the nature of compliance problems and recommend potentially more risky efforts to fix them. After 35 years of working in this area, Alice can say, without limitation, that older lawyers offer more seasoned and reasoned advice than younger ones. Young lawyers get hysterical and rigid about things which do not merit such anxiety. In addition, too many lawyers of all ages over-control the situation where, mostly, the risks are purely the client’s to take.

On the other hand, it is not well understood that lawyers advising health care providers, and particularly boards of trustees, have personal liability, not only for what they do, but increasingly for what their clients do. This cannot help but influence the way they give advice. Still further, the context for the relationship between attorney and client can also color the way advice is given. What is the lawyer’s liability and how do we take that into account? Does a member of the law firm sit on the board of the hospital? How important are we as a client to the firm advising us? How does that affect what we are hearing from them? How did the in-house counsel pick the attorney she is recommending for a technical issue? What kinds of information should clients ask to assess the advice they are getting? Finally, are there certain kinds of issues on which the lawyer should be taken more seriously than others? These matters are never discussed openly – at the board, between the client and attorney, or by attorneys themselves. Alice is taking this issue on in a new webinar that addresses “When Should You Listen to Your Lawyer?” Aimed at hospital trustees, the issues she poses are relevant to all clients in the health care industry.

As the healthcare industry has become more complex and more regulated, the role of health lawyers has become even more important. But, Alice has taken this issue further in a direct and hard hitting article for trustees on how to assess their lawyer’s judgment. In “How To Listen To Your Lawyer”, she offers practical guidance for lay trustees of hospitals, but her insight and advice is applicable to healthcare executives, managers, and physicians who don’t really understand what to make of their lawyer’s advice, especially when the lawyer says “You can’t do that.”

Alice Gosfield has been a Key Author for West Group since 1989. In addition to the HEALTH LAW HANDBOOK, which is a new book every year, she also has revised and revamped MEDICARE AND MEDICAID FRAUD AND ABUSE which is updated every year. It includes a chapter on investigations by Kevin Raphael. Now, in an interview with the publishers, she describes her entry into health law, her views of its future, and her current work on the PROMETHEUS Payment® model.

Physicians and their practice managers frequently consider contracts to be overly burdensome, too detailed, and too expensive to create. Paradoxically, though, they similarly want assurances that when they do create a contract that it will be “iron-clad”. These are naïve misunderstandings of the enormous power and value that contracts have in the modern business environment. As physicians relate to others in a wide variety of ways, whether in employment, joint ventures, vendor relationships or otherwise, contracts define their business context. By the same token, a contract is only as good as the will of the parties to abide by it, so a clear and common understanding of the goals and intentions is essential. In “Understanding Contracts: The Glue of Modern Business Relationships”, elucidates with specific reference to typical physician relationships, those fundamental aspects of contracts that are often referred to as “boilerplate” or appear in the back of the document and are assumed not to be important. This is must reading for anyone who signs a contract no matter the purpose.