Health Law Expressions

HortySpringer attorneys Henry Casale and Hala Mouzaffar review how the “But For” test is changing the landscape of false claims cases brought in qui tam lawsuits. Listen now to this episode of The Kickback Chronicles to see what you can learn from the misfortune of others.

On this week's episode, HortySpringer attorneys Henry Casale and Hala Mouzaffar dive into a case of alleged bribery to induce providers to prescribe a specific pharmaceutical drug that resulted in a new test for Anti-Kickback claims in the Second Circuit.Listen now to this episode of the “Kickback Chronicles” to see what you can learn from the misfortune of others.

In this episode, HortySpringer attorneys Henry Casale and Hala Mouzaffar change gears and discuss how a surgery center could have prevented disaster with its credentialing and peer review processes. 

Unless you have been in a coma or hiding in the Witness Protection Program, you probably are aware that there is an election coming up in a few weeks. It is our right as Americans to vote and participate in the political process. But nonprofit organizations like hospitals and health systems that are tax exempt under Section 501(c)(3) of the Internal Revenue Code are prohibited from participating in political campaigns and may only have limited involvement in lobbying or attempting to influence public policy. HortySpringer partners Henry Casale and Dan Mulholland will review these rules and also discuss guidance from the IRS in terms of what your organization can and can't do this election season. Please join us for this important and timely podcast.

Exciting news for those in the PSO world! The United States Court of Appeals for the Eleventh Circuit issued an opinion (In re Baycare Medical Group, 101 F.4th 1287 (11th Cir. 2024)) on May 14, 2024 that expands the scope of information, known as “Patient Safety Work Product,” protected by the Patient Safety and Quality Improvement Act (“PSQIA”). The Court rejects the “sole purpose” test articulated by other courts and the Department of Health and Human Services (“HHS”), finding that the test and HHS's guidance “contradicts” the PSQIA's final regulations. The “sole purpose” test was extremely limiting in what providers could categorize as Patient Safety Work Product because the information had to be generated solely for reporting to a PSO.  Now, with the Eleventh Circuit's rejection of the test, it allows additional types of information to qualify as Patient Safety Work Product.  Join Horty, Springer and Mattern partners Dan Mulholland and Charlie Chulack for a discussion of the PSQIA, the “sole purpose” test, the In re Baycare Medical Group case, and how the opinion will affect PSOs, and providers that contract with PSOs, during the podcast “Patient Safety Organizations – New Court Case Provides New Opportunities.”

HortySpringer attorneys Henry Casale and Hala Mouzaffar take a look at three clinics in rural Alabama to see how a physician's disregard of warnings that her clinics were committing fraud led to the fall of the clinics, the physician, and the physician's wife.  Listen now to this episode of the The Kickback Chronicles to see what you can learn from the misfortune of others. 

On this week's episode, HortySpringer attorneys Henry Casale and Hala Mouzaffar dive into the case of a seasoned professional who found himself in the middle of not one, not two, but three different fraudulent healthcare schemes. Listen now to this episode of the “Kickback Chronicles” to see what you can learn from the misfortune of others. 

It has been a longstanding practice within Hospitals across the U.S. for medical students and other practitioners-in-training to perform pelvic and other sensitive examinations on patients, most of whom are under anesthesia, without their explicit consent. Join Hala and Mary as they discuss the growing movement to better police this practice and how, as a result of mounting public scrutiny, it has caught the attention of CMS. 

On this week's episode, HortySpringer attorneys Henry Casale and Hala Mouzaffar take a look at how some not-so-routine drug testing landed two providers in hot water. Listen now to this episode of the “Kickback Chronicles” to see what you can learn from the misfortune of others.

When hospitals and health systems are pursuing a merger or affiliation, there is a natural tendency to move things along quickly. While it is ok to conduct due diligence, explore potential efficiencies and plan for what might be possible if the affiliation takes place, the parties need to refrain from acting like they are already affiliated, implementing plans or sharing competitively sensitive information such as payor contracts until the deal is done. To do so could constitute unlawful “gun jumping” in violation of federal antitrust rules, possibly subject the parties to fines and other penalties or even derail the transaction. This podcast will summarize the gun jumping rules with suggestions about how to keep out of trouble.

On this week's episode, HortySpringer attorneys Henry Casale and Hala Mouzaffar turn their attention to a small town in Tennessee to look at a provider that helped exacerbate the opioid crisis in his community for fame and fortune.  Listen now to this episode of the “Kickback Chronicles” to see what you can learn from the misfortune of others.

Two recent lawsuits decided by Utah courts draw attention to the importance of strong, broad release language protecting physician leaders who volunteer to participate in credentialing, peer review, and other medical staff activities. In both cases, the physicians challenging peer review activity argued that the release language set forth in the Medical Staff Bylaws should not be applied to block their claims. One aggrieved physician claimed that the release language only applied to formal review and not collegial intervention efforts. The other claimed that the release language should not apply because the leadership allegedly violated the Bylaws while conducting peer review. In the end, good release language saved both hospitals and their leaders from more protracted litigation. When it comes to release language, bigger is better. Learn more about these cases and releases on this short podcast.

On this week's episode, HortySpringer attorneys Henry Casale and Hala Mouzaffar take their first look at for-profit hospitals to discuss a unique case involving a hospital, its investors, and an attempt to avoid repaying Medicare.  Listen now to this episode of The Kickback Chronicles to see what you can learn from the misfortune of others. 

CMS recently clarified that physicians can give orders via test in hospitals and critical access hospitals.  But the texts have to be through a secure system, and computerized physician order entry is still preferred. Join HortySpringer attorneys Dan Mulholland and Mary Paterni as they discuss this new CMS guidance and also talk about the dangers of texting in general.

On this episode, HortySpringer attorneys Henry Casale and Hala Mouzaffar take a look at cases happening in their own backyard to show that healthcare fraud can happen anywhere.  Listen now to this episode of the “Kickback Chronicles” to see what you can learn from the misfortune of others.

The Office of Inspector General recently published its General Compliance Program Guidance. The GCPG is a reference guide for the health care compliance community and other health care stakeholders. It is chock-full of information about relevant Federal laws, compliance program infrastructure, OIG resources, and other information useful to understanding health care compliance.  While the GCPG is voluntary guidance and not binding on any individual or entity, it is an important roadmap to how the Government views the industry and how it intends to enforce the law. Join HortySpringer partners Henry Casale and Dan Mulholland for this new podcast as they break down this new guidance and suggest what you need to do in light of it.

On this week's episode of The Kickback Chronicles, HortySpringer attorneys Henry Casale and Hala Mouzaffar look back at cases they have discussed over the last year to see where the defendants are today, what sentences they actually received, and if any old habits die hard.  Listen now to this episode  to see what you can learn from the misfortune of others.

On this week's episode of The Kickback Chronicles, HortySpringer attorneys Henry Casale and Hala Mouzaffar discuss a series of fraudulent schemes that spanned the West Coast. They take a deeper dive into how “one of the nation's busiest” physicians got caught in a scheme riddled with fraud and abuse.  Listen now to see what you can learn from the misfortune of others.

In the Congressional Appropriations Act passed in December 2022, Congress adopted a new Stark exception and Anti-Kickback safe harbor for wellness programs for physicians and other clinicians. Specifically, the new law provides that counseling, mental health services, suicide and substance abuse prevention programs offered by hospitals and other providers with a formal medical staff will not violate the Stark law or Anti-Kickback Statute so long as the are set out in a board-approved policy that meets five specific elements described in the statute.Join HortySpringer Partners Henry Casale and Dan Mulholland on this new Health Law Expressions podcast episode as they explain the new law and what you should do to take advantage of it.  

The Kickback Chronicles, Episode 18On this week's episode, HortySpringer attorneys Henry Casale and Hala Mouzaffar discuss what happens when a Chief Compliance Officer stops performing in accordance with his job description and instead becomes the center of a fraudulent scheme.  Listen now to this episode of The Kickback Chronicles to see what you can learn from the misfortune of others.

The U.S. Supreme Court recently held that in order to violate the False Claims Act,  a defendant's knowledge and subjective beliefs matter—not to what an objectively reasonable person may have known or believed.  That case – U.S. ex rel Schutte v. Supervalu, Inc. – dispels the notion that defendants can skate on an FCA claims by coming up with after-the-fact justifications.  Understanding this case and its implications is a must for any compliance officer or in house or external counsel in the health care field.  Join HortySpringer partners Henry Casale and Dan Mulholland as they explain this case and what it will mean for health care providers in this new podcast episode.   

 The Kickback Chronicles, Episode 17On this week's episode of The Kickback Chronicles, HortySpringer attorneys Henry Casale and Hala Mouzaffar examine a pharmacogenetic testing scheme spanning several states and take a closer look at the spider web of arrangements that frauded Medicare out of $28 million.  Listen now to this episode of The Kickback Chronicles to see what you can learn from the misfortune of others.

 The Kickback Chronicles, Episode 16On this week's episode of The Kickback Chronicles, HortySpringer attorneys Henry Casale and Hala Mouzaffar examine one of their favorite archetypes: the repeat offender. They examine how a former PA already convicted for practicing without a license re-emerged years later to repeat her crimes.  Listen now to this episode of The Kickback Chronicles to see what you can learn from the misfortune of others.

 The Kickback Chronicles, Episode 15On this week's episode of The Kickback Chronicles, HortySpringer attorneys Henry Casale and Hala Mouzaffar examine a massive scheme involving a compound pharmacy and TRICARE. They take an especially close look at the lengths this group went to after they were caught to cover their trail and falsify documents—all in a fruitless effort to vindicate themselves of any wrongdoing.  Listen now to this episode to see what you can learn from the misfortune of others.

 The Kickback Chronicles, Episode 14On this week's episode of The Kickback Chronicles, HortySpringer attorneys Henry Casale and Hala Mouzaffar examine a scheme involving ophthalmology surgery equipment. In a scheme seemingly drenched in kickbacks, find out why the company and its owner decided to roll the dice and take their case to trial.  

 The Kickback Chronicles, Episode 13On this week's episode of The Kickback Chronicles series, HortySpringer attorneys Henry Casale and Hala Mouzaffar see how encompassing pharmaceutical fraud can be by taking a closer look at three recent cases, each involving prescriptions, each entirely unique from the others, and each more expensive than the last.  Listen now to this episode of the “Kickback Chronicles” to see what you can learn from the misfortune of others.

The Kickback Chronicles, Episode 12On this week's episode, HortySpringer attorneys Henry Casale and Hala Mouzaffar look at a North Carolina Medicaid fraud scheme in which Medicaid recipients were required to submit medical unnecessary urine specimens that were billed to the North Carolina Medicaid program in order to participate in subsidized housing programs, after school programs, and mental health and other clinics. Listen now to this episode of the “Kickback Chronicles” to see what you can learn from the misfortune of others.

 The Kickback Chronicles, Episode 11On this week's episode, HortySpringer attorneys Henry Casale and Hala Mouzaffar review the recent sentencing of two individuals connected with over prescribing Subsys, one of the drugs at the center of the opioid crisis.  Listen now to this episode of the “Kickback Chronicles” to see what you can learn from the misfortune of others.

The Joint Commission announced in mid-December that, effective immediately, hospitals could begin reappointing and renewing clinical privileges for practitioners every three years, rather than every two years.  This is nothing new for those hospitals accredited by the DNV, but with this announcement, many hospitals accredited by TJC are considering moving to a three-year appointment period.  Before making this decision, there are several factors that you should evaluate.  For example, what changes will you need to make to your Medical Staff governance documents, does state law permit you to reappoint practitioners every three years (some do not), and are there changes to your peer review process that you will need to make to ensure that patients are protected if a longer appointment term is adopted.  Join Horty, Springer and Mattern attorneys Susan Lapenta and Charles Chulack for this podcast episode that provides the answers to these questions and more!

On this week's episode, HortySpringer attorneys Henry Casale and Hala Mouzaffar turn their focus to telemedicine fraud in the pharmaceutical industry. With help from an industry expert, they take a closer look at some common themes to look for and avoid in the pharmaceutical world. Listen now to this episode of the “Kickback Chronicles” to see what you can learn from the misfortune of others. 

On this week's episode, HortySpringer attorneys Henry Casale and Hala Mouzaffar dive into the world of telemedicine. The expansion of access to telemedicine services during the COVID-19 pandemic has opened the door to a whole new type of fraud.  Join us as we take a closer look at how the OIG will be identifying and evaluating these types of cases as well as some of the most recent victims of the OIG's crackdown on telemedicine.    Listen now to this episode of the “Kickback Chronicles” to see what you can learn from the misfortune of others.

On this week's episode, HortySpringer attorneys Henry Casale and Hala Mouzaffar take a closer look at a recent case involving an alleged kickback scheme between an engaged couple on separate ends of a financial relationship. In what first appeared to be a shut and close case, now remains unfinished. Learn how just two words changed everything.   Listen now to this episode of the “Kickback Chronicles” to see what you can learn from the misfortune of others.

On this week's episode of The Kickback Chronicles, HortySpringer attorneys Henry Casale and Hala Mouzaffar take a closer look at a recent case involving a woman who just couldn't get enough of the Department of Justice. While awaiting sentencing for a guilty plea of health care fraud, this week's schemer got herself involved in yet another Medicaid billing scheme. Listen now to this episode to see what you can learn from the misfortune of others.

On this week's episode, HortySpringer attorneys Henry Casale and Hala Mouzaffar flip the script and examine the government's investigation tactics when examining fraud cases. As they walk through the process using a recent case, you will get a sense of the resources the government has at its fingertips and just what lengths it will go to prove fraud beyond a reasonable doubt.  Listen now to this episode of the “Kickback Chronicles” to see what you can learn from the misfortune of others.

On this week's episode, HortySpringer attorneys Henry Casale and Hala Mouzaffar look into the world of fraudulent COVID-19 Vaccination Cards by taking a deeper dive into two recent cases involving forged and fraudulent vaccination cards.  Although fraudulent vaccination cards were the root of these crimes, you'll be shocked to learn the series of events that led up to charges being filed and the subsequent guilty pleas entered.  Listen now to this episode of the “Kickback Chronicles” to see what you can learn from the misfortune of others.

On this week's episode, HortySpringer attorneys Henry Casale and Hala Mouzaffar look at the recent guilty plea of the owner and operator of a marketing company that conducted business with medical testing companies. What began as a scheme to defraud Medicare out of funds related to genetic testing, turned into a bigger opportunity at the onset of the COVID-19 pandemic. This case will show the government's crackdown on fraud in connection with COVID-19 and leave you wondering if this is just the tip of the iceberg.  Listen now to this episode of the “Kickback Chronicles” to see what you can learn from the misfortune of others.

Hospitals often review and revise their medical staff bylaws and policies to keep up with new developments, but many rarely or ever pay attention to their hospital corporate bylaws.  Corporate bylaws are required to contain provisions required by CMS, the IRS, state licensure agencies, and accrediting bodies, but if they haven't been updated in a while they may not meet these requirements. Corporate bylaws should also compliment and supplement medical staff documents, but if they are inconsistent with medical staff documents it can spell trouble if there is ever a dispute over credentialing or privileging.  HortySpringer partners Lauren Massucci and Dan Mulholland will explore this topic in their current podcast and tell you what you should be looking for when you dust your corporate bylaws off to see what's in them. 

On this week's episode, HortySpringer attorneys Henry Casale and Hala Mouzaffar look at the recent conviction of the 3 owners of multiple orthotic brace supply companies across Texas. Together they set out to defraud Medicare out of nearly $6.5 million by violating the Anti-Kickback Statute. This case will leave you wondering how you even conceal these payments, and what is the price these owners stand to pay?Listen now to this episode to see what you can learn from the misfortune of others.

On this week's episode, HortySpringer attorneys Henry Casale and Hala Mouzaffar take a closer look at the recent conviction of 3 individuals involved in a substance use disorder treatment facility's scheme to defraud the California Medicaid program out of nearly $18 million over the course of 4 years. This case will have you asking: How many people can be convicted for a company-wide scheme?What causes so many people to participate in a fraudulent scheme?And who has to pay back all that money? Listen now to this episode of the “Kickback Chronicles” to see what you can learn from the misfortune of others.

Over the years, the Department of Justice has increasingly cracked down on fraudulent billing and kickbacks provided to healthcare providers. Despite nearly $2 billion in recovery of illegal funds every year, providers continue to disregard these laws thinking their actions will go undetected.  On this inaugural episode, HortySpringer attorneys Henry Casale and Hala Mouzaffar dive into a recent case involving a mobile x-ray provider, where a jury had to consider:•  Can you bill dead patients and get away with it?•  Does it matter that Medicare paid for fraudulent claims for years?•  What are the repercussions of these kind of violations? Listen now to this episode of the “Kickback Chronicles” to see what you can learn from the misfortune of others.

On November 5, 2021, CMS issued an interim final rule requiring hospitals and other facilities subject to Medicare Conditions of Participation to adopt a process or plan for vaccinating all eligible staff by December 6, 2021. Staff must be fully vaccinated by January 4, 2022. This not only applies to employees but also medical staff members, trainees, independent contractors, and others. HortySpringer attorneys Dan Mulholland and Nick Calabrese break down the new regulation for you and tell you what you need to do NOW to get ready for compliance. Aside from explaining the new rule, the podcast discusses: ·  What happens if you don't comply? ·  Can you ask for a waiver from CMS? ·  How should you handle requests for medical and religious exemptions? ·  How do you enforce your policy if independent members of the medical staff don't comply? ·  The lawsuit filed by 10 states on November 10 seeking to enjoin the regulations.Listen now to this episode to learn the latest about what is clearly the hottest topic in health care today!  

This podcast summarizes the requirements in OSHA's new COVID-19 Emergency Temporary Standard (“ETS”) for employers in the healthcare setting. While the ETS is long and detailed, some healthcare settings are exempt from its requirements. Join HortySpringer attorneys Dan Mulholland and Philip Zarone to learn what healthcare employers must do to comply and where they can turn for additional information.    

Houston, do we have a problem?Join HortySpringer attorneys Dan Mulholland and Nicholas Calabrese as they explore the rules and risks of mandatory vaccination programs for hospital employees, including a discussion of the Houston Methodist Hospital vaccination program case.

The OIG and the Courts have long taken the position that a person who pays an alleged kickback can be sent to prison if the government can prove that merely “one purpose” of the payment of the kickback is to induce the referral of business that is paid for, in whole or in part, by a federal healthcare program.  But what about the recipient of the kickback?  What must the government prove in order to convict the recipient of the kickback?  In a case of first impression, a federal circuit court's answer to this question is nothing—the recipient's intent is irrelevant. Join HortySpringer attorneys Dan Mulholland and Henry Casale to find out why the court ruled the way that it did and why this decision will make it even easier for the government to enforce this criminal statute that it was before the decision.  

Have you discovered that one of your physician contracts is out of compliance with the Stark Law? You may be able to fix it. CMS has now developed a new way to correct noncompliance with the Stark Law without having to make a formal self-disclosure. The recently revised Stark Regulations, at 42 CFR §411.357(h) of the new regulations, sets forth a special rule for correcting technical deficiencies and even reconciling compensation that might be in excess of fair market value. Tune into this episode where Dan Mulholland and Joshua Hodges explain how this new rule can work for you.

On May 19, 2020, President Trump issued an Executive Order on Regulatory Relief to Support Economic Recovery. The purpose of the Executive Order was to remove regulatory barriers to economic recovery from the effects of coronavirus lock downs throughout the country. The Order primarily directs federal agencies to address the current economic emergency by rescinding, modifying, waiving, or providing exemptions from regulations and other requirements that may inhibit economic recovery. But it goes farther than that. Among other things, it directs agencies to not just temporarily but permanently rescind regulations, accelerate pre-enforcement ruling procedures, decline enforcement against persons and entities that have attempted in reasonable good faith to comply with applicable statutory and regulatory standards and consider extenuating circumstances a rationale for declining enforcement. It then goes on to articulate the principles of fairness in administrative enforcement and adjudication and directs agencies to revise their procedures and practices in light of them. Perhaps the most important principle listed in the Order is that the Government should bear the burden of proving an alleged violation of law - the subject of enforcement should not bear the burden of proving compliance. The Order contains the standard caveat that it is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the Government or anyone else. But given that agencies are expected to follow it, it can be a useful tool to use in discussions or negotiations with the Government in a wide range of situations.Join Henry Casale and Dan Mulholland for a new Health Law Expressions Podcast where they explain this Executive Order in more detail and suggest ways to use it to your advantage now and in the future.

Under normal circumstances, physician burnout has been described as a “public health crisis” resulting in high turnover rates, inefficiency, increased medical errors, and exit from the profession. Some surveys show that nearly half of all physicians experience burnout in some form. While burnout has been attributed to numerous factors, including the demands of electronic health records and a reduction in physician autonomy, it is almost certainly going to increase and be exacerbated as a result of the current pandemic. Physicians in COVID-19 hotspots can be treating an overwhelming amount of critically ill patients and confronting death rates unlike anything they have ever seen. There have been several anecdotal reports on the effect that the COVID-19 crisis is having on physician well-being and it has been significant. During this podcast, Horty, Springer & Mattern partners Rachel Remaley and Charles Chulack discuss burnout, its contributing (and aggravating) factors, and strategies to improve physician well-being and satisfaction.

If your organization has received a loan from the new Paycheck Protection Program, congratulations! But like any government program, be careful! There are always strings attached. Recent controversy about large organizations getting assistance has caused regulators to warn that if you keep the money but are later found to not need it, you could be in big trouble. To help you understand what may be at stake, tune into this timely podcast, where HortySpringer attorneys Phil Zarone and Dan Mulholland describe what you must do to document that you may not be able to cover payroll, rent or utilities without the loan and the consequences of the certification that you made to get it. They also discuss the option of repaying the loan by May 7 if you don’t need it, which can limit your exposure later on.

Many federal agencies have weighed in with various waivers, policy statements and guidance regarding arrangements between and among health care providers and their patients to address the COVID-19 pandemic. These include several blanket waivers by CMS of sanctions under the Stark Law and an OIG Policy Statement declining to impose administrative sanctions under the Federal anti-kickback statute. These actions are helpful, but should not be a blanket license to ignore these laws. In this special podcast, HortySpringer partners Dan Mulholland and Henry Casale review the recent guidance, explain what you can and can’t do and look ahead to the potential for a tsunami of False Claims Act litigation once the pandemic subsides.

In today’s deal happy world, we’re seeing joint ventures make a comeback. Joint ventures come in all shapes and sizes; some are with physicians, some with other business partners, and some are with people you’ve never met before. Join faculty Dan Mulholland and Henry Casale as they discuss these ventures and the questions you should ask and get answered before you commit.

Horty Springer and Mattern partners Dan Mulholland and Henry Casale discuss a False Claims Act case that was based on the Stark Law in which the Third Circuit Court of Appeals interpreted the Stark Law to question whether most RVU compensation models were permitted by the Stark Law. However, as proof that not even the federal courts understand the Stark Law, the Third Circuit vacated its September 17th decision and reissued its opinion on December 20. The new Opinion corrected some of the more egregious errors that were included in the September Opinion. However, it still leaves a number of questions about Stark unanswered.