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1st Talk Compliance

1st Talk Compliance

De: First Healthcare Compliance
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  • Update to the HIPAA Privacy Rule to Support Reproductive Healthcare Privacy Compliance

    Update to the HIPAA Privacy Rule to Support Reproductive Healthcare Privacy Compliance
    Jul 14 2025
    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 v. United States Department of Health and Human Services et all. And for those who are interested, that case number is 224-CV-228-Z. And the 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, P-U-R-L. 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 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 Healthcare Compliance, whenever HHS releases some more guidance related to what should be included. As many know who have been in healthcare a long time. Oftentimes HHS and SAMHSA, the Substance Abuse and Mental Health Services Administration, which oversees 42 CFR part two, will issue guidance or form types of agreements or other relevant compliance items. One great example is the Business Associate Agreement. So that’s the part that should be calendar and people should make sure that they are staying abreast of. Now that brings us to what was vacated. And so basically, procedurally, the court granted the plaintiff’s motion for summary judgment. And for those non-lawyers, summary judgment is available when there is no issue of a material fact. In essence, it is judgment as a matter of law, and in doing so, denied the defendants, which in this case is the United States Department of Health and Human Services motion, to dismiss for lack of jurisdiction. And the specific section that was vacated pursuant to five U.S.C. Section 7062, except for the modifications that I mentioned to C.F.R. Section 164.520 with the notice of privacy practices are the provisions associated with what were 45 C.F.R. section 1604 520b, 1, 2...
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    33 m
  • The Role of Compliance Programs in Mitigating False Claims Act Liability

    The Role of Compliance Programs in Mitigating False Claims Act Liability
    Jun 11 2025
    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 individual to be represented by a lawyer. So unless the relator is a lawyer, then the individual needs to obtain counsel in order to file a False Claims Act case. That’s the first thing. Secondly, only the government can choose to open a criminal investigation. So even though certain laws like the federal Anti-Kickback Statute can have criminal penalties or civil penalties associated with them, only the federal government, or if a state has a similar type of law, the state can actually move and bring a parallel criminal investigation in potential proceeding. So that notion that only the government can bring in a criminal case is not unique to the False Claims Act. But what is unique is that a private party can bring a type of case, and that’s how the government learns of something to then potentially open a parallel criminal action. The process for the relator’s counsel is also very different. Normally, if I want to file a lawsuit in federal district court, I have to make sure that either a federal question is involved under 1331, or I need to meet the amount in controversy and diversity of the party’s requirement under 1332. While first, the False Claims Act is a federal statute, so it falls under 1331. So that’s ...
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    36 m
  • HIPAA Privacy Rule to Support Reproductive Healthcare Privacy Compliance

    HIPAA Privacy Rule to Support Reproductive Healthcare Privacy Compliance
    May 12 2025
     In this episode of 1st Talk Compliance, Kevin Chmura is joined by Rachel Rose, JD, MBA, to discuss the HIPAA Privacy Rule to Support Reproductive Healthcare Privacy, passed in 2024. With the reproductive healthcare landscape being very dynamic, this new rule has already passed one compliance date, with a second important date coming in February 2026. Tune in to learn about this new rule, and what it means in terms of reproductive health, patient privacy, and the legality between different states. In addition, learn some best practices for implementing the requirements of this rule into your practice. On June 18, 2025, The U.S. District Court for the Northern District of Texas – Amarillo Division (Carmen Purl, et al v. United States Department of Health and Human Services, et al., Case No. 2:24-cv-228-Z (N.D. Tex.)), issued an order vacating the HIPAA Privacy Rule to Support Reproductive Health Care Privacy, published on April 26, 2024, which amended the HIPAA Privacy Rule (Reproductive Health Rule). The decision left intact amendments to the HIPAA rule regarding certain Notice of Privacy Practice provisions pertaining to substance use disorder regulations, which need to be adhered to by early 2026. Kevin Chmura Rachel, thank you for joining us. Appreciate you joining us and looking forward to a timely discussion. Rachel V. Rose Thank you, Kevin, for having me, as well as to Panacea and First Healthcare Compliance, it’s always my pleasure to coordinate and converse with you on our favorite healthcare compliance topics. Kevin Chmura And it’s always great having you helping us with this and your expertise is invaluable. And you helped us and were the contributor, really writer, of an e-book on this particular subject that will be released very soon. Really this podcast is somewhat of a companion piece to that. And so what we’re talking about today is the HIPAA privacy rule to support reproductive health care privacy, passed in 2024. Reproductive health is a prominent and evolving topic within the healthcare policy landscape. It really, major changes have come down in recent years, and so there’s just a ton. So we thought it would be great to publish a book to get everybody up to speed and, but moreover, this podcast is an opportunity for people to hear directly from the person who helped us develop that. And that is Rachel. So, Rachel, I wonder, can you just start off by giving us a synopsis of the 2024 Final Rule, maybe some key terms we should be thinking about? Rachel V. Rose Sure. As you mentioned, Kevin, the reproductive healthcare landscape is very dynamic and the rule itself was issued on April 22nd of 2024 with an effective date of June 25th of 2024. And basically what an effective date does is to start the clock running as to when certain requirements need to be implemented. In this particular rule, which I will refer to as the HIPAA Reproductive Rule, has two prongs of compliance dates. The first already passed and that had to be done by December 23rd, 2024. And for your clients who were with First Healthcare Compliance or Panacea at the time, they were able to access FAQs. And the first prong of the requirements really addressed every applicable item that I’ll run through, with the exception of the notice of privacy practices. Now, for anyone who’s been in the healthcare sector for a long time, and for anyone who goes to the doctor, a dentist or even a pharmacy to pick something up, we all know we have to sign the HIPAA authorization form, and then covered entities are required to post their notice of privacy practices. So the updated privacy practices, which need to include some of the reproductive health requirements among other items, does not need to be done until February 16 of 2026. So this is similar to the staggering of the compliance dates which we saw with the Final OmnibusRrule, which was published in the Federal Register, it’s hard to believe, but going on over 12 years ago and that was January 25th of 2013. Now specifically, the HIPAA reproductive rule really prohibits the disclosure of protected health information related to in these terms I need you to focus on: lawful reproductive health care in certain circumstances. And the reason it’s important is because legal means that whatever service or good is being sought, it has to be legal within the jurisdiction where the individual is receiving that care or that good, so to speak. And so if we want to take certain types of surgeries or certain types of procedures that in a viable fetus’s life, then you need to be in a jurisdiction or a state where that is permissible. So the terms are the meaning of a person. What is a person? If you read the Final Rule, it means a natural person, meaning a human being that is born alive, a trust or estate, a partnership, corporation, professional association or corporation, or other entity, public or private. And this definition is common. It was adopted by...
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    20 m
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