In this episode of 1st Talk Compliance, Kevin Chmura is joined by Rachel Rose, JD, MBA, as they discuss recent changes to the HIPAA Privacy Rule to Support Reproductive Health Care and Privacy in relation to recent court rulings. This rule, which went into effect in April of 2024, still has certain components which practices need to know about and adhere to heading into 2026.

Learn about how these rulings are, and will, impact this important rule, and what HIPAA regulated organizations need to know concerning these updates. In addition, hear about what might be coming in the future of not only reproductive health regulations, but also various other areas of healthcare with regards to privacy.



Kevin Chmura

Hello and welcome to today's episode of First Talk Compliance. I'm your host, Kevin Chmura, CEO of First Healthcare Compliance and Panacea Healthcare Solutions. And I'm excited to bring you an important discussion about a major legal development that impacts all HIPAA regulated entities. By way of background, on June 18th, 2025, the U.S. District Court for the Northern District of Texas issued a nationwide order striking down the HIPAA Privacy Rule Amendments designed to strengthen reproductive health care privacy.

The amendments had been mandatory since December 2024, and this court decision has created a new compliance challenge for covered entities and business associates. To help us understand what happened, why it matters, and what organizations should do now, we're joined by our expert guest. Rachel V. Rose, J.D. MBA, who's a leading authority on HIPAA healthcare privacy law.

If you listen to our podcast, you've heard Rachel many times. In fact, we've discussed this particular topic, or issues around it, pretty recently. So it's great to have her back. So, Rachel, welcome back. Thank you for coming to share your expertise with us today.

 

Rachel V. Rose

Kevin, it's always my pleasure and thank you for having me back.

 

Kevin Chmura

Yeah, your content is always heavily consumed because it's very important. So we thank you for being here. So, maybe probably best way to just start off is if I can ask you to just briefly explain what the U.S. District Court's order did, why it's significant and who it applies to?

 

Rachel V. Rose

Absolutely. So on June 18th of this year, the United States District Court for the Northern District of Texas and specifically the Amarillo Division in the case caption Carmen Purl et all the United States Department of Health and Human Services et all. And for those who are interested, that case number is 224 dash CV, Dash 228, Dash Z and ta Z.

It correlates to the judge at any time you see initials or an initial after a case number, it's the judge. And I'll just simply refer to this case as the Purl case. Purl. Basically, what the court did was to issue an order vacating the April 16th, 2024 HIPAA Privacy Rule to support reproductive health care and privacy.

And for simplicity's sake, I'll just call that the HIPAA reproductive privacy rule. And basically what it did was to leave intact the requirements regarding the updates to the notice of privacy practices which are due in early 2026. And to focus on that, there really hasn't been any guidance yet from HHS. But every covered entity and business associate and subcontractor need to be aware that the notice of privacy practices updates, which really incorporate the HIPAA provisions along with a 42 CFR part two regulations, are still in play, and the part two regulations specifically relate to the substance use disorder regulation.

So that's something that again, covered entities, business associates and subcontractors should put on their calendar and look for updates from First ...

In this episode of 1st Talk Compliance, Kevin Chmura is joined by Rachel Rose, JD, MBA, as they discuss the False Claims Act in detail. The FCA, one of five federal laws built to combat fraud, waste, and abuse, is the government’s primary fraud fighting tool, with the healthcare industry paying the largest contributor in recoveries for over a decade.

Learn not only about how to avoid running afoul of this law, but also some details of cases in which it was violated, and the repercussions those who did so faced. In addition, find out how a proper compliance program can protect your practice in various ways, including staying up to date on cybersecurity training.



Kevin Chmura

Rachel, welcome to the podcast. Thanks for joining us.

 

Rachel V. Rose

Thank you, Kevin, for having me back for another round of a very major healthcare compliance topic.

 

Kevin Chmura

It very much is, yeah. This one generates some revenue for the government. So this is one that I think especially in today's environment, people should be paying a lot of attention to. So as I said in the intro, we're here to talk about the False Claims Act. It's one of the most important fraud, waste and abuse laws that applies to physicians and health care practitioners of all kinds.

The healthcare industry has consistently been one of the, if not the highest contributor to funds received under the False Claims Act. And it's essential to be familiar with the law and maintain compliance programs to mitigate that risk. Rachel, I know you spend a fair amount of time in your practice in and around the False Claims Act defending and representing customers and providers.

So you're perfect to cover this topic for us. Wondering, though, if you could give us a brief synopsis of the False Claims Act and why is it unique?

 

Rachel V. Rose

Absolutely. So as you mentioned, my practice focuses a lot on the False Claims Act, and I am fortunate to do a lot of compliance work not only around the False Claims Act, but HHS. OIG has identified five important federal fraud, waste and abuse laws. The False Claims Act, the Anti-Kickback Statute, the Stark Law, the Exclusion Authorities, and the Civil Monetary Penalties.

And Kevin, as you mentioned, the False Claims Act is really the federal government's primary fraud fighting tool. And in 2024, there were more than $2.9 billion in recoveries and, moreso healthcare represented over two thirds of that amount. That healthcare trend, as you mentioned, being the largest contributor, has gone on for at least the last decade.

And what the False Claims Act does that makes it unique are really, I would say, five main things. But first, the False Claims Act goes back to 1863, and it is also known as the Lincoln Law. Its primary purpose, even back during the Civil War, was to root out fraud that was being perpetrated on the government. So how would that be done?

Congress thought about it and said, well, the government could do it on its own if they caught wind of something, or they could insert a provision which gave an individual known as a relator, also known as a whistleblower, the potential to bring fraud to the government's attention and receive a portion of the recovery. It's very important to note that a relator and I represented several relators successfully, sometimes with co-counsel, sometimes with not, so I get to see the False Claims Act from the whistleblower standpoint as well. But this notion of being able to represent a whistleblower is the first distinguishing factor. And that's because most other civil cases, a person can represent themselves on a pro say basis, meaning they don't need a lawyer. There was a provision in the False Claims Act which in fact requires an in...

In this episode of 1st Talk Compliance, guest Raymond Ribble, CEO and Founder at SPHER, Inc., discussed guidelines and procedures to help protect your organization from actions of malicious employees.

In this episode of 1st Talk Compliance, guest Raymond Ribble, CEO and Founder at SPHER, Inc., discussed guidelines and procedures to help protect your organization from actions of malicious employees.

In this episode of 1st Talk Compliance, we dive into an increasingly crucial topic in healthcare: price transparency and its ever-growing impact on the industry. Kevin Chmura, CEO at Panacea Healthcare Solutions, joins us to share expert insights on strategic pricing and compliance, emphasizing the transformative benefits for healthcare providers. Learn how to proactively engage with CMS regulations and set your organization apart as an ethical leader in the realm of price transparency.

Grace Walsh speaks with Kevin Chmura, CEO at Panacea Healthcare Solutions, to explore an extremely timely topic: price transparency and its far-reaching impact on how healthcare providers interact with consumers, with each other, and with the market at large. Tune in as Kevin shares some important insights about how price transparency has opened the door to a whole new world of data analysis and strategic business strategies for healthcare providers, and covers what we might expect to see for the future of price transparency. We’ll also include some key resources for listeners hoping to boost their knowledge of CMS price transparency regulations and learn how they can leverage price transparency data to empower their own strategic initiatives.

In this episode of 1st Talk Compliance, Kevin Chmura and BreAnn Meadows discuss the challenges healthcare providers face due to payers increasingly denying claims for supplies that are missing HCPCS codes. The issue stems from recent payer policy changes, with supplies that were previously chargeable now being rejected if they lack a corresponding HCPCS code. The conversation tackles the complexities providers face in managing their chargemaster (CDM), maintaining accurate HCPCS coding, and addressing claim denials, which can result in lost revenue.

Tune in to equip yourself with actionable strategies to avoid claim denials, as Bre underscores the importance of adopting a strategic, focused approach to managing your CDM, adapting to evolving payer practices, and staying proactive in compliance efforts.

The Centers for Medicare and Medicaid Services (CMS) recently released additional guidance on the Two-Midnight rule that carries important implications for hospitals seeking to apply the rule correctly and consistently. In this episode of 1st Talk Compliance, host Kevin Chmura is joined by Stacy Pereira, Executive Director of Coding and Clinical Services in Panacea’s KA Consulting Division, to continue the discussion surrounding the Two-Midnight rule and the challenges it poses.

If you enjoyed Panacea’s recent webinar on the topic, or you’re simply looking for more information on how the rule might impact you, tune in for a deep dive into the potential challenges involved for hospitals seeking to apply the rule correctly, possible financial impacts of the rule’s enforcement, and pitfalls of over- or underusing observation status.

In case you missed our webinar on the Two-Midnight rule, you can watch it on-demand here.

In a landmark episode of 1st Talk Compliance, Kevin Chmura, CEO of Panacea Healthcare Solutions and host of the show, is joined by George Kelley, president of Panacea’s KA Consulting Services division.

For over 40 years, KA Consulting Services has delivered unmatched revenue cycle solutions, helping hospitals and health systems nationwide enhance reimbursement, improve compliance, and streamline Medicaid eligibility. Known for its eligibility services, clinical coding and auditing services, and revenue integrity solutions, KA Consulting has earned a reputation for providing solutions that go the extra mile to obtain appropriate reimbursement and to improve compliance. We are thrilled to welcome them as a division of Panacea Healthcare Solutions, further enhancing our commitment to delivering industry-leading healthcare financial, revenue integrity, and clinical solutions nationwide.

Tune in to get the inside scoop on this latest development as Kevin and George delve into KA’s background and our shared history and discuss how our newly combined expertise complements each other’s teams.

The False Claims Act—alongside the Anti-Kickback Statute and Stark Law—represents one of the five core fraud, waste, and abuse laws identified by the HHS Office of the Inspector General. Out of the billions of dollars reclaimed through False Claims Act recoveries in 2023, the majority was attributed to the healthcare industry. This concerning trend highlights the importance of maintaining robust compliance programs and prioritizing education surrounding these regulations.

In this episode of 1st Talk Compliance, Rachel Rose, JD, MBA discusses recent key developments in the False Claims Act landscape and shares tips on how healthcare providers can enhance their compliance strategies and mitigate regulatory risks. Tune in to gain a comprehensive understanding of the False Claims Act and its role in the healthcare sector, hear updates on several recent significant fraud, waste, and abuse cases, and receive actionable insights into bolstering your organization’s compliance initiatives.

Previously on First Talk Compliance, we spoke with Kevin Chmura, CEO of Panacea Healthcare Solutions, about how the advent of price transparency has caused the business of healthcare to evolve and opened up fresh possibilities for healthcare providers to gain a competitive advantage.

In this episode, we continue that conversation by inviting on two additional experts from Panacea—Govind Goyal, President of Financial Services, and Henry Gutierrez, Senior Vice President, Financial Consulting Services—to dive deeper into the recent changes to price transparency requirements and expand upon the many ways healthcare providers can adapt to succeed in this new consumer-driven arena. From navigating compliance regulations to leveraging data for a competitive advantage, tune into Part 2 of “The Sky’s the Limit – How Price Transparency Can Empower Healthcare Providers” to gain insight into the evolving landscape of price transparency and what lies ahead.

Private equity has become increasingly entrenched in the healthcare sector, offering various financing options for providers to consider. However, like all types of financing, private equity introduces its own unique set of benefits and drawbacks and carries important legal implications. It’s essential to understand all the factors at play in order to maximize financial impact and preserve operational efficiencies while avoiding sacrificing compliance and quality of care.

Tune in to hear Grace Walsh in conversation with Rachel Rose, JD, MBA, to explore this timely topic. In addition to providing a detailed overview of private equity in healthcare and its various pros and cons, Rachel shares valuable updates on enforcement actions by the U.S. Department of Justice and Congressional inquiries.

Grace Walsh speaks with Kevin Chmura, CEO at Panacea Healthcare Solutions, to explore an extremely timely topic: price transparency and its far-reaching impact on how healthcare providers interact with consumers, with each other, and with the market at large. Tune in as Kevin shares some important insights about how price transparency has opened the door to a whole new world of data analysis and strategic business strategies for healthcare providers, and covers what we might expect to see for the future of price transparency. We’ll also include some key resources for listeners hoping to boost their knowledge of CMS price transparency regulations and learn how they can leverage price transparency data to empower their own strategic initiatives.

Grace Walsh is joined by Govi Goyal, President of Panacea's Financial Services Division, and Brian Prokop, Senior Vice President of Financial Consulting Services at Panacea, to discuss the importance of undertaking a strategic pricing initiative for your organization. In our current healthcare climate, it's more crucial than ever to maintain defensible and rational healthcare pricing while remaining competitive and optimizing net revenue. As Govi and Brian can tell you, it's a tricky balance to strike. Tune in as they share their tried-and-true approaches to developing defensible pricing strategies and learn how these measures can position hospitals for success in the era of price transparency.

Grace Walsh is joined by Becky Jacobsen, Vice President of CDM, Coding & Audit Services at Panacea Healthcare Solutions, to explore the key updates to evaluation and management (E/M) guidelines for 2024. On the surface, this year's changes may appear fairly straightforward, but dig a little deeper and you’ll find that the updates have important implications for correct coding procedures. From payers, providers, and coders to those who work in auditing or IT template development, it is essential to keep up a comprehensive grasp on E/M coding guidelines. Tune in as Becky breaks down a few of the most significant guideline updates, clarifies some common areas of confusion, and shares her insider tips as an expert in the field of coding compliance auditing and education.

Grace Walsh is joined by Becky Jacobsen, Vice President of CDM, Coding & Audit Services at Panacea Healthcare Solutions, to explore the key updates to evaluation and management (E/M) guidelines for 2024. On the surface, this year's changes may appear fairly straightforward, but dig a little deeper and you’ll find that the updates have important implications for correct coding procedures. From payers, providers, and coders to those who work in auditing or IT template development, it is essential to keep up a comprehensive grasp on E/M coding guidelines. Tune in as Becky breaks down a few of the most significant guideline updates, clarifies some common areas of confusion, and shares her insider tips as an expert in the field of coding compliance auditing and education.

In this episode of 1st Talk Compliance, we dive into an increasingly crucial topic in healthcare: price transparency and its ever-growing impact on the industry. Kevin Chmura, CEO at Panacea Healthcare Solutions, joins us to share expert insights on strategic pricing and compliance, emphasizing the transformative benefits for healthcare providers. Learn how to proactively engage with CMS regulations and set your organization apart as an ethical leader in the realm of price transparency.

Rachel V. Rose, JD, MBA, principal with Rachel V. Rose – Attorney at Law, P.L.L.C., Houston, TX will be presenting this informative webinar. Cybersecurity risk management and the potential for enforcement actions is not diminishing. An area of increasing interest by the Federal Trade Commission, the United States Department of Justice, and Congress is third parties taking sensitive data (especially by social media and search engine giants), including protected health information, without obtaining affirmative patient/consumer consent and benefiting financially. The U. S. Department of Health and Human Services, the agency tasked with enforcing HIPAA, also plays a critical role. The purpose of this presentation is to address different federal government initiatives, recent enforcement actions and incidents, and risk mitigation.

1st Talk Compliance features guest Govi Goyal, President, Financial Services, at Panacea Healthcare Solutions, on the topic of Evolution of Price Transparency and How to Stay Ahead of CMS Requirements. Govi joins our host Catherine Short to discuss how the new CMS Price Transparency Rule and No Surprises Act are closely related. By providing Good Faith Estimates for healthcare services, hospitals can comply with both regulations. This helps patients understand their expected costs upfront and avoid surprise medical bills. Panacea's CMS Price Transparency and Hospital Zero-Base Pricing software solutions can assist hospitals in providing accurate Good Faith Estimates to their patients and stay compliant with the latest regulations. 

1st Talk Compliance features attorneys Sean McKenna, Lauren Nelson, and Vincent Aiello of Spencer Fane LLP, on the topic of Healthcare Assets: How to Preserve and Protect. We will discuss the interplay between enforcement and liability proceedings with asset protection, explore how government and private litigation matters can impact healthcare companies, clinicians, and executives, and provide tips and preventative strategies to preserve income and assets prior to such action to ensure business continuity and succession planning.