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1st Talk Compliance

1st Talk Compliance

著者: First Healthcare Compliance
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  • Telehealth Extensions & 2026 Compliance Priorities: A Compliance Cliffs Update
    2026/02/04
    In this episode of 1st Talk Compliance, Kevin Chmura is joined by Robyn Johns, as they discuss recent updates to their November live webinar, Compliance Cliffs: Navigating Telehealth Waivers and Reimbursement Changes. Learn how the policy landscape has shifted in recent months—especially around telehealth flexibilities, controlled substance prescribing, and the 2026 CMS payment rules. Kevin Chmura Welcome to 1st Talk Compliance. I’m Kevin Chmura, CEO of Panacea Healthcare Solutions. Today we’re bringing you a timely update on our November live webinar, Compliance Cliffs: Navigating Telehealth Waivers and Reimbursement Changes. Since that webinar, several policy changes have moved quickly, especially in telehealth flexibilities. Controlled substance prescribing and 2026 CMS payment rules. Before we jump in, just a quick note. 1st Talk Compliance is brought to you by 1st Healthcare Compliance, a part of Panacea Healthcare Solutions. We help healthcare organizations strengthen their compliance programs with practical education tools and compliance management support. So teams can reduce risk, keep pace with regulatory change and operate with confidence. Now I’m pleased to welcome back Robyn Johns from Med USA. Robyn, thanks for coming back. Robyn Johns Thanks, Kevin. I’m happy to be here. Kevin Chmura Great. So, let’s jump in. So, in November on the webinar, we spent a lot of time on what people were calling the telehealth cliff, which was creating a tremendous amount of uncertainty on whether flexibilities would expire. Can you catch us up on what the status is now? Robyn Johns Yeah. The major update is that the spending package released on January 20th includes extensions of the telehealth flexibilities all the way through December 31st of 2027. Kevin Chmura So that’s a pretty meaningful runway. That’s great, but I guess doesn’t eliminate compliance obligations, but it is reducing near-term uncertainty which give everybody some time to standardize workflows. So, it’s in the news, but maybe you could tell. So, what’s in the spending package at a high level and what should healthcare leaders like us be paying attention to? Robyn Johns Right. So, it was the one from the 20th was a $1.2 trillion spending package released by the House Appropriations Committee and it was just passed yesterday on the 22nd in two separate votes by the full House. So, those bills included the remaining six of the twelve appropriations necessary to avert a government shutdown. So that’s good news for everyone. If we can get them across the finish line, they funded many of the federal government agencies such as HHS, Labor, Defense, HUD, and also Homeland Security. That was a contentious one. That’s why they had to do two separate votes. It funds them through fiscal year 2026, which ends on September 30th of this year. Kevin Chmura So, OK, so we have a funding package with multiple healthcare policy riders. Not, I guess not too surprising in today’s day and age. So, besides the telehealth through 2027, what else is included in there that compliance and operational leaders should know about? Robyn Johns So the writers also include PBM reform and it extends hospital at home actually through 2030, which is another one that hit a lot of facilities hard with the government shutdown. It extends Medicare dependent hospital and low volume hospital programs, which is really beneficial for our rural providers and it delays the Medicaid disproportionate share cut again until fiscal year 2028. Notably, for a lot of people, it does not include an extension of the ACA subsidies, which were such a sticking point in the government shutdown last fall. Kevin Chmura Yeah, that that that last point is operationally really important and coverage instability often turns into eligibility churn and puts real pair mix pressures on the you know same patients, different coverage, right.? And that’s just you know probably increases downstream compliance and documentation stress. Yeah that’s a that’s a tough one. So what’s the timing of congressional action now? Robyn Johns So with the House passing all of the bills, they now send the full appropriations package to the Senate. The Senate will take all of that up when they return from recess on Monday the 26th, and will hopefully pass them all ahead of the January 30th deadline. And hopefully without any significant changes which might require them to go back to the house because the house will be on recess next week. Kevin Chmura Wow. So split schedule, it’s why we should keep ourselves in a monitoring posture. I guess we should always be monitoring, but things are moving pretty quickly right now and you sort of get into that world of what is expected is not what’s in effect. Which is always, always a tough place to operate, but hey, that’s healthcare, isn’t it? So, given the extension to 2027, in your opinion, what ...
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    20 分
  • Update to the HIPAA Privacy Rule to Support Reproductive Healthcare Privacy Compliance
    2025/07/14
    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 分
  • The Role of Compliance Programs in Mitigating False Claims Act Liability
    2025/06/11
    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 分
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