'To Our Readers' Archive

To Our Readers:

Although we no longer live on the academic calendar, September still feels like the start of a new year. In our case, as we turn this next page, we are pleased and honored to be able to draw attention to five recent, additional new accolades. For the first time. Dan Shay was been named to The Best Lawyers in America® (2024). The firm has been recognized, using terms such as “visionary”, and “trailblazing”, in three more separate awards. In addition to other continuing individual recognitions of Alice, these firm honors include articles written about us, describing how the firm developed into a nano-national powerhouse.The articles are all somewhat different. We appreciate these significant acknowledgements.

On the substantive side of the street, at Latest Issues we draw attention to the OIG’s General Compliance Guidance and how it can be used in practical terms. To those skeptics who have doubted our guidance to NOT pay independent contractors sales commissions, we note an OIG settlement for exactly that reason. In contrast, we single out an OIG Advisory Opinion in which the OIG favorably reviewed (!) a program where a financial consulting firm paid gift cards to its physician customers who referred other potential customers, with even more money to be paid if the marketing targets became customers. Also, effective Jan 1, 2025, Pennsylvania will impose a ban on post-termination non-competes of more than a year, joining other states with such prohibitions. Dan also provides a basic understanding of artificial intelligence in healthcare, while Alice offers a deep dive into some Stark law conundrums elucidating in specific terms why it is one of the worst pieces of legislation ever issued in this sector.

For many years, Dan Shay has done presentations to residents and fellows contemplating their first jobs, which presentations have been offered by the Philadelphia County Medical; Society. We have provided a link to the PowerPoint.

We have also both been engaged as expert witnesses, on separate topics, in a complex false claims act case, working for the defense. Please get in touch if you would like to learn more about that. We are interested in exploring more such opportunities.

We have updated our website generally. We welcome comments and suggestions.

To Our Readers:

As we have done traditionally for many years, we are making available on our website www.gosfield.com pre-publication manuscripts of our articles to be published in the HEALTH LAW HANDBOOK in early fall, 2024.  Dan Shay takes on the role of artificial intelligence in healthcare. In “Does ChatGPT Dream of Electric Sheep? Legal Implications of Artificial Intelligence in Health Care” he explains the terminology of AI, which has a lingo of its own, and then discusses how it actually works, including its very real limitations.There are many misconceptions abounding here. AI is NOT fancy Google. He addresses current applications of AI in health care and speculates on future uses. He then examines state and federal regulatory controls, presents some of the very small amount of caselaw on point, and considers HIPAA and fraud and abuse implications from using AI. This is a must read for people who have wondered what is realistic about AI in health care and how it can create legal liabilities.

In “The Stark Statute: Parsed, Probed and Panned” I take on an in depth untangling of confounding issues under the Stark statute, from whether it even works, to such basics as the definitions of referral, a consultation, and a group practice, none of which is actually straightforward. I then move on to the quagmires of supervision where the law sweeps into its ambit the issues of personal supervision, direct supervision and incident to—used without reference to their long-standing presence in Medicare prior to Stark.  Shifting to pure financial issues, I address the distinctions between fair market value vs. commercially reasonable vs. the fair market value exception. Additional nuance arises with respect to the differences among indirect compensation arrangements vs. under arrangements vs. stand in the shoes concepts, as well as shared facilities by contrast with timeshare arrangements. I also consider permitted directed referrals vs value-based arrangements. I end with a consideration of the dilemma created by how the drafters addressed Medicaid. I have chosen these specific issues, which are hardly all that can be said about this travesty of a statute, because the law is both vague and ambiguous on these points.

The 2024 edition of the HEATLH LAW HANDBOOK, will be the 35th, each year a completely new book to which other lawyers contribute articles as well.. Our goal in these writings is to elucidate and enhance comprehension of challenging legal issues. We hope you enjoy our articles. As always, please contact us with questions or concerns.

To Our Readers:

The doldrums of summer are over, but developments in health law have soldiered on even during the otherwise calmer summer months.  In our current website update, we have included four new accolades, two new publications by Dan, one on physician views of employment agreements and the other on HIPAA enforcement.  At Latest Issues we have added four new issues including the dangers of regulatory research which includes artificial intelligence such as Chat GPT, the risk of commercial false claims enforcement, the realities of HIPAA enforcement as conveyed by the government itself, and the continuing need for vigilance in the billing company/revenue cycle management relationship.  There are dangers abounding in all these contexts, many of which are under-appreciated.

We will be offering one of our teleconferences soon on “Quality Fraud: What’s That?”  Look for our announcement in your in-box.

We try to keep our volume of communications low and our style brisk and informative.  We welcome your comments.

To Our Readers:

It has been six months since our last update, but the challenges of health law have continued to grow.  While our website  update includes 4 new Latest Issues and 4 new Publications, the highlight is probably our making available pre-publication manuscripts of our 2023 HEALTH LAW HANDBOOK articles on little discussed but significant topics. Both have implications for all providers’ compliance programs which should be updated to address these issues. Dan has written on "HIPAA Enforcement On the Books and In Practice". He elucidates both what HIPAA enforcement is really about on the ground (with some surprises) and what it means to develop policies to avoid enforcement. For those who want a handy guide to applying the lessons to be learned there, we also offer a DFS List with 5 practical suggestions. Alice takes on the fraud and abuse risks that lurk in clinical misbehaviors from under-use, over-use and lack of medical necessity, to failure to comply with clinically-based payment requirements. In Quality Fraud: Gathering The Threads she illuminates how the new value-based environment changes the risks from clinical performance as well as from quality reporting to create new types of false claims. She explains the guidance the government has offered on point, and gives practical guidance of her own.

We have added yet another accolade to our growing list  but these most welcome recognitions do not come without our efforts. To explain why we think we are different, we have posted “What is excellence in health law?” to explicitly explain the principles we deploy in our work that we think sets our little nano-firm apart. We think these are measures all health lawyers should implement, but we’re happy to be acknowledged today for our distinctions in this regard.

We try not to burden our readers with too much in their in-boxes, but we think what is here you will find useful, in some ways intriguing, and in the last analysis – worth the read.  We welcome your comments.

To Our Readers:

As we all wonder how the coronavirus will impact us in the fall and winter, health care continues to be a vital and essential aspect of our economy. We have updated our website with a number of new resources to assist our readers.  We have added 5 new Latest Issues. At Publications we have two new articles: one by Alice on physician compensation models and challenges and the other by Dan on switching EHRs, an increasingly prevalent development among our clients. We are offering two of our past teleconferences for sale: one by Alice on physician compensation and the other by Dan on the No Surprises Act. All our teleconferences are supported by meaningful, substantive multi-page handouts. We have added a video where Alice clarifies and elucidates the distinctions between the Stark law and the Anti-kickback statute – a real challenge for non-lawyers, but critical to understand for compliance purposes.  And finally, but certainly not least, we have a new Agg Note which unravels the Gordian knots of “incident to” billing. Once merely two paragraphs in the Carriers Manual, this fundamental principle of Medicare billing now has 9 regulatory conditions.  It is fertile ground for false claims actions as well as Stark law compliance. It is a topic replete with myths and mystery.  Alice clarifies it all.

We try not to clog your in-box with multiple communications. But, when we update our website, it is to provide new resources to assist our readers with understanding the substance of the issues on which we work. We believe that a well-informed client is in the best position to maintain the integrity and safety of their practice. Our job is to help you do that.

We welcome your comments.

To Our Readers:

As we do every year, we are making available pre-publication copies of our articles for the 2022 HEALTH LAW HANDBOOK. These are major pieces which address significant legal issues in matters of interest to us and our clients. This year, Dan Shay has written on how the health care system is acknowledging that diet and nutrition are social determinants of health which profoundly affect patients with certain chronic conditions.  New payments are available to support their needs, but other issues arise in delivering these newly covered services.  He explores these issues and offers practical guidance. Alice picks up, once again, the issue of physician compensation, especially in light of multiple new revenue sources that pay for physician services,  many of which are quantitatively unpredictable.  Against that background, she explains the new issues raised by the Stark regulations addressing productivity, profit-sharing and value based enterprise payments.  We have also posted an article by Dan in Compliance Today on split/shared visits .

While our primary constituency is physician groups and physicians, these articles are relevant to all physician employers as well as health systems on their own.  We provide analysis, information, and practical guidance in using these resources.  We welcome your comments and questions.

To Our Readers:

As we are all hoping to emerge soon from the two year pandemic cocoon, we have continued to work with our clients who have been stalwart performers in difficult circumstances. We value our relationships with such an important sector of the American economy. In our latest website update, in a first for this firm, we are offering TWO new AGG Notes at once, both written by Dan Shay, one addressing the final split/shared visit rules which have changed and the other on the No Surprises Act, which offers new challenges of transparency for all providers and no balance billing for out of network providers. Both merit more discussion than just a blurb on Latest Issues.

We have posted 6 new Latest Issues (1) a first case to interpret the commission payment issues under EKRA; (2) another case on the murkiness of asking for and giving legal advice in a context where the law is unsettled; (3) a negative Advisory Opinion from the OIG on significantly egregious facts; and (4) the effect of caselaw which says that MACs can rely on LCDs which have not been subject to notice and comment. Then, in two additional listings, we have provided context for why the issues addressed in our two AGG Notes are important. We have also culled the Latest Issues list to both remove obsolete entries and update links, but we have retained material going back to the early 2000s because it provides useful context for today's pitfalls. We also have posted four publications, and two additional accolades including our being named Health Law Firm of The Year 2021 -- USA. While these times are testing everyone's mettle and patience, the circumstantial impacts weigh more heavily in health care. We look forward to assisting our clients in confronting their legal context, today and tomorrow.

Please let us know your thoughts about our information.

With our best wishes for a better 2022. Stay safe.

To Our Readers:

In this Update, we have added to our Latest Issues with (1) implications of Part D drugs under Stark (2) CMS removal of the Medicare billing rule on split/shared visits, and (3) the relatively unknown physician option to “withdraw” from Medicare as distinct from opting out or non-participating. At Publications, we've added Dan's article “Business Associate Agreements 101,”.

Finally, we are pleased to announce an upcoming teleconference on October 19, 2021: "HIPAA In the Social Media Context."

HIPAA in The Social Media Context
Tuesday October 19, 2021
(1-1:45 EST, 12-12:45 CST; 11-11:45 MST, 10-10:45AM PST)

The Health Insurance Portability and Accountability Act (HIPAA) and its regulations have existed for over 20 years, but remain confusing for many health care providers. Updates have been issued over the years, but the health care industry and the world have changed dramatically in that time. Social media has become an ever-present aspect of modern life, for patients, physicians, and office staff alike. Myths and misconceptions have arisen with respect to HIPAA in the online context, for all parties, both professionally and personally. This thirty minute session with fifteen minutes of Q & A and a detailed, substantive handout will clarify the HIPAA rules and dispel misunderstandings, with a particular focus on their practical application to the social media and online setting, and policies health care providers can implement to reduce their risk of HIPAA violations.

Click here to sign up. Credit Card only. No exceptions.
$275 no matter how many people listen on your line.
(One line per enrollment. This is not a webinar. A computer is not necessary.)

If you can’t join us on the 19th but would be interested in an MP3 recording to download, including the presentation with Q & A and the handout for the same $275, please click here (for recorded session)

• HIPAA Privacy and Security Basics in the Electronic Context
• When to Use an Authorization vs. a Records Access Request
• Online Reputation Management and HIPAA Risks
• Online Breaches: Real-world HIPAA “Horror Stories”
• Policy Recommendations for HIPAA and Social Media

As always, we welcome your comments and suggestions.

 To Our Readers:

As we are now fully into spring, and more Americans are getting vaccinated, the pace of change in health care has not lagged at all. Through our infrequent emails and other resources, we try to keep our readers informed of significant developments. We also think it is important to focus, from time to time, on issues that get relatively little attention in the legal literature or the industry literature. Toward that end, we are making available to our readers pre-publication copies of our HEALTH LAW HANDBOOK articles for 2021. Dan has written on "The Lure of Foreign Shores: Outsourcing Overseas Health Care Functions." There are myths and legends about how offshore services may be used, reimbursed and compensated. Dan unravels these mysteries and addresses the challenges in contracting for over seas assistance in terms of personnel, IT or other services, whether from HIPAA, reimbursement rules or basic liability concerns. He offers practical guidance and contract language. In Alice's article on "Billing Company Contracts: Accountability and Pitfalls," she considers the many more types of players who offer these services from stand alone companies, to private equity funded management entities to health systems and more. She challenges the traditional payment model and offers an alternative. She then dissects the contracts themselves with specific guidance. She elucidates both the Medicare reassignment rules and the OIG Model Compliance Guidance to these companies and offers examples of how things can go wrong. We have placed these articles in context in our most recent Latest Issues.

As we work on the new edition of MEDICARE AND MEDICAID FRAUD AND ABUSE, published by WestGroup, we are making the most massive content changes since we started authoring this book in 2003. Why? Because more than 400 pages in the Federal Register extensively revised both the anti-kickback safe harbor regulations and the Stark regulations. We have eased that challenge for lawyers and non-lawyers with five crisp, focused, half hour recorded teleconferences with substantive handouts. They can be purchased online singly or in any combinations. We urge you to take advantage of what was an enormous amount of work for us, to save you the time.

As always, we welcome your comments and suggestions.

To Our Readers:

As the administration is on the verge of change, despite the crippling pandemic, the regulatory pace has been fast and furious. Most notoriously, the Stark and antikickback (AKS) regulations, initially said to be delayed until August 2021, were published as a post-Thanksgiving gift on December 2 along with the Medicare Physician Fee Schedule for 2021 which won't even be in the Federal Register until 12/27/20. In typescript, the Stark and AKS materials were together 625pp. In the Federal Register, which usually shortens documents by a lot, Stark alone is 191 pages of preface and changes and the AKS preface and regulations alone consume 212pp!! This is one of the most massive regulatory publications probably since the advent of the prospective payment system and DRGs for hospitals. We know our colleagues in larger firms are already offering webinars on the changes. We, however, are going for depth and practicality over speed. We will be digesting these materials and offering crisp, segmented resources addressing them, focused around our constituencies of physician practices and those who do business with them, later in January or early February. Stay tuned!

In the meantime, health law goes on. We have posted 5 Latest Issues addressing some E&M documentation issues, EKRA enforcement, COVID and telehealth, and more. We offer a new DFS List addressing practical approaches to the information blocking rules. We have posted 3 new articles at Publications. On a different note, Alice has been recognized by Marquis Who's Who, Continental Who's Who and the International Association of Who's Who, who are unrelated and compete with one another! Each has highlighted a different aspect of her career. Check them out among our other Accolades.

As we all await the arrival of vaccines and also approach the coming holidays with much hope for a better 2021, we offer our best greetings to you all, both for the season and for your continued good health.

To Our Readers:

With the start of a new year and a new decade, we have updated our website with a range of new items: First, Dan Shay’s HEALTH LAW HANDBOOK article “Navigating Spaghetti Junction: The Intersection of Medicare’s Diagnostic Testing Rules” parses the confounding and sometimes conflicting sets of regulations governing Medicare diagnostic testing including basic reimbursement rules, but also Stark, incident to, anti-markup and more.  Alice’s HANDBOOK article “Paying Physicians for Cancer Care” (1) looks at the special problems in paying physicians for drugs rather than what they actually do for patients, (2) examines past efforts at payment reform, (3) explicates CMS’s current and developing oncology payment programs, and (4) presents a new program design which Alice participated in creating. This was work of a group of experts who joined, on a pro bono basis, to provide guidance to CMS regarding how to change the oncology payment program. We wrote a white paper, a Health Affairs blog-post, and created a podcast interview with me and two of the other participants.

We also post 9 additional publications by Dan covering such issues as pitfalls in medical marijuana, maintaining Medicare enrollment, legal risks in social media and more. In addition, Alice has added an article on heightened peril in physician audits. All are contextualized in our 10 new Latest Issues discussions. Along with an interview of Alice by David Glusman of Marcum on her views on upcoming federal regulatory concerns which is available to read. Finally, we have 5 upcoming speeches.

The practice of health law is challenging in a dynamic environment. We continue our focus on representing physicians and those who want to do business with them. We hope our resources and observations on the website create more informed readers who are in a better position to help themselves. Toward that end, keep your eye out for our announcement of an upcoming teleconference of issues worthy of a revisit on avoiding trouble in Medicare diagnostic testing for a new decade.

Happy new year!

To Our Readers,

We are thrilled to announce that our tiny little nano-law firm of two attorneys has just been named by Best Lawyers a Best Law Firm in the US for the tenth consecutive year-- every year that US News has generated this list. We are especially pleased since the selection is based on peer votes only. We are honored that our peers regard us as highly as they do. We enjoy our work and working with each other, and value excellence in our performance. We have been working together since 2003 so to be acknowledged for our joint efforts is especially satisfying.

To Our Readers,

As we approach the summer, health law issues remain dynamic. Our most recent website update includes 4 Latest Issues including our most recent accolade, 3 upcoming speeches, and 1 new publication. We also have a new DFS List offering 4 fundamental checkpoints for maintaining effective enrollment in Medicare, while avoiding deactivation or revocation of billing number. Dan offers these from time to time to provide quick check-ups on specific areas of potential problems. Check out his new one and the three preceding ones. These are practical guidance to avoid pitfalls lurking in a range of regulatory programs. There is also a new AGG Note on how the Department of Justice evaluates compliance programs. The guidance there should require almost everyone to update and revamp their compliance programs in accordance with our analyzed list of 10 areas of focus. Finally, for those who like that sort of thing ……we have new photos!!!!  There are four photos of us that rotate on the home page, and there is an additional photo of each of us at About Us.

Not to burden our readers’ in-boxes, we try to provide information relatively infrequently; but we hope what we present is seen as brisk, yet useful. Please check out what’s new and what’s old; and feel free to comment or get in touch.

To Our Readers,

With the advent of 2019 we have updated our website (www.gosfield.com) with 8 new Latest Issues including the new anti-kickback issues in the world of drug treatment, two cases showing how courts differ in whether they will enjoin the government’s recoupment of overpayments while appeals are pending, and a case where an IT provider could be sued under consumer protection laws for botching the transfer of data from NextGen to Allscripts. We have our two major articles for the Health Law Handbook: Dan Shay’s on the challenges of maintaining enrollment with Medicare as a compliance issue, with a review of caselaw which puts a real premium on getting this right every time; and Alice’s on physicians “End Running The Payers” with whom they are fed up, choosing direct contracting, both with employers and patients, as well as concierge care and opting out of Medicare. She reviews 13 direct primary care contracts for their implications. We have a new  AGG Note “Time Becomes Money” on both the substance and implications of the 2019 Fee Schedule including visit codes, add on codes, documentation changes , and advanced diagnostic testing controls. Unlike many other commentators, we discuss why the way CMS has issued these policies will have significance for false claims liability.

Finally, we are planning  our upcoming teleconference schedule and would be interested in feedback regarding those we think would be of interest. Please click here for a less than a one minute survey or see below to respond to whether you would have an interest in a crisp, half hour plus 15 minutes of Q & A and a substantive handout on the topics listed or whether there are other topics you would rather hear about.

As health law continues its dynamism, and rules change along with liabilities for their violations, we look forward to continuing to work with our clients to be successful and avoid pitfalls.

Happy New Year!

Click to open survey.

To Our Readers,

As the summer is about to begin, we are updating our website (www.gosfield.com) with the kinds of things we typically address and one thing that is quite different.  We have created a new document which we are calling “Our Attorney-Client Compact™” which we think is so different that we are seeking a trademark for the name. The Compact is an explicit statement of the expectations clients should have regarding our interactions with them, but it also speaks to those aspects of our attorney-client relationship where the client can enhance, by their own behaviors, the efficiency and quality of our interactions with them. We welcome comments on it. We are sending it to all our new clients along with our fee agreement. We strongly encourage all our existing clients who are receiving this notice to read it.

We have also posted a new DFS List addressing medical records ownership and the practical and legal issues that arise there. We have posted 4 new publications. Amazingly, the thirtieth edition of the Health Law Handbook is now available. In it, Alice acknowledges by name, every single one of the 347 individual authors who have contributed to it (excluding herself) over the last thirty years. You can read the Foreword and the Acknowledgments along with the Table of Contents here. In addition, we have added 6 new, upcoming presentations. Don’t forget to check out our Compliance Plan Development Protocols for both Fraud and Abuse and HIPAA as well as our recorded teleconferences.

Health care remains as dynamic as ever and the challenges our clients face are changing as the system changes. We continue to be enthusiastic about helping them accomplish their goals.

To Our Readers,

The last year was tumultuous in many ways. While the continuing dynamism in health care reflects overall policy buffets across our society, people still get sick, need to be kept well, and health care must go on. So do we! 

In our latest update to our website (www.gosfield.com) we have added 21 additional speeches presented or to be presented by each of us. We have added a new button under “Listen” which includes “Public Media” and offers three radio interviews with Alice on the Women’s Radio Network about her career and advice for younger attorneys, as well as a YouTube video of her interview about her role in  the development of the AHLA in connection with the 50th Anniversary of the American Health Lawyers Association, which she served as President from 1992-93 and continues her involvement by  speaking for them. Dan is making his way in the rising leadership there as well.

Speaking of anniversaries, we have also posted, before their publication, our major articles to be published in June in the astonishingly 30th edition of the HEALTH LAW HANDBOOK. Alice has written on “Lessons Learned from Leasing” offering a blueprint for transactions where a physician practice enters into an omnibus contract with a health system or hospital to align with it more closely without being employed. Dan has written on the challenging problems of “Switching EHRs”. These are in addition to 14 more publications on a range of topics of interest to our constituency, including social media, opting out of Medicare, employment contracts, the rising tide of audits and more.  Seven we are just posting now, and seven others were posted without announcement since January 2017.

At “Latest Issues” we have added 5 new entries addressing matters including Stark compensation, a court case on the importance of proper contract documentation of Stark transactions, why our major Handbook articles are so important, and the availability of new tools to make bundled payment easier and more accessible to all.

We have updated both of our profiles at “About Us”.

We don’t send out quarterly newsletters, We don’t offer a blog. We use our website updates as a tool to help our readers understand what we think is important, to provide them with resources to cope with the challenges they face,  and to garner attention for our work.  We hope you find it interesting and useful.  We welcome comments and suggestions.

To Our Readers:

Compliance program effectiveness has been highlighted by the OIG and HCCA in a recently published Resource Guide to measuring compliance plan effectiveness. It is, however, 54 pages long and contains more than 400 recommendations. While no one is expected to use all of them, we found that unwieldy for our constituency. We have created a new 10 page document which draws on the Guide and speaks to the issues relevant to physician practices and smaller entrepreneurial businesses. In addition, the implications of the Guide have led us to revise our Medical Practice Fraud and Abuse Compliance Plan Development and Maintenance Protocol. We have created our measurement document both as a stand alone piece and as part of the revised Protocol.

ANYONE WHO BOUGHT THE PROTOCOL IN 2016 OR AFTER MAY REQUEST THE REVISED ONE OR THE MEASUREMENT DOCUMENT FOR FREE. To review our updated Protocol, the new document, and our HIPAA Compliance Plan Development Protocol, click here.  We offer discounts to our clients, as well as to those who buy both protocols.

We hope you find these materials useful.

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Gosfield & Associates
2309 Delancey Pl, Philadelphia, PA, United States
Philadelphia, PA 19103

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To Our Readers,

Since our last update in January, the long awaited voluntary repayment rule was published. It is a showstopper! Every compliance plan needs to be updated to take those rules into account. At publications we have two new articles on the subject. We offered a teleconference on point which can be purchased as a recording with the handout. In addition, the implications of those rules are so significant that we completely revamped and revised our Fraud and Abuse Compliance Plan Development Protocol which is available for sale atwhere you can review the table of contents of this very practical guide to developing and managing a compliance plan.

We also have a new AGG Note addressing Stark liberalizations – an unexpected development which was published with the last Fee Schedule, but requires no immediate action. Still the changes offer some greater flexibility in applying the regulations which govern the single worst piece of legislation among the many we confront regularly.

We, like our clients, are preparing for MIPS – the new Medicare payment model for which final regulations will undoubtedly be published with the Fee Schedule in November, 2016. We expect there will be significant challenges presented there if CMS’ approach to all the other new forms of payment are any indication. We also think there is much work physicians can do among themselves in terms of clinically integrating better in their own practices to enhance their chances of success going forward. We enjoy helping our clients engage on all these issues. Finally, with the ‘new’ website, we are archiving these notes To Our Readers, to provide some ongoing context for our updates.

We hope you will visit the website at www.gosfield.com and romp around. There is a lot of free information there.

As always, if you have comments or questions, don’t hesitate to get in touch.

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Gosfield & Associates
2309 Delancey Pl, Philadelphia, PA, United States
Philadelphia, PA 19103