We previously outlined the requirements of the Hospital Price Transparency Rule (the “Rule”), which goes into effect January 1, 2021. See The Price Transparency Rule Goes Into Effect January 1, 2021 – Is Your Hospital Ready?  Since releasing that blog post, the U.S. Court of Appeals for the District of Columbia Circuit issued its decision, ruling against the American Hospital Association and other hospital groups and upholding the District Court’s grant of summary judgement for the Department of Health and Human Services (“HHS”).  Among its allegations, the American Hospital Association had contended that the Rule exceeded HHS’ statutory authority, violated the First Amendment, and was arbitrary and capricious under the Administrative Procedure Act.
Continue Reading Court of Appeals Upholds Hospital Price Transparency Rule

The FDA could approve two COVID-19 vaccines within a matter of days. However, drug makers have tried to keep expectations in check about how much vaccine they can deliver immediately and over the next few months as they grapple with supply chain and manufacturing challenges. In Safety Law Matters, we write about limited and

In this episode, Husch Blackwell’s Meg Pekarske is joined by colleague Stephanie Kaiser for a rich conversation on what it means for a hospice board to carry out its fiduciary duties and how this relates to the role and responsibilities of hospice executives. Through counseling and training boards across the country, Stephanie has gained unique insights on the inner workings of boards, and breaks down what good governance looks like in action. Stephanie debunks common misconceptions on what defines a “good” board and provides practical tips on how hospice executives can and should engage and inform their boards. We also discuss when boards and individual members are liable and how to guard against such claims.
Continue Reading Working Together: Tips for Ensuring A Compliant Relationship Between You and Your Hospice Board

Part IV: Healthcare Regulatory Issues that Arise in Private Equity Transactions

This is the fourth article in our series on “Closing a Private Equity Transaction.” In Part I, the benefits of preparing for a transaction were explained, along with how best to prepare. In Part II, the letter of intent was discussed, and key terms were identified and explained. In Part III, we walked through what to expect during the due diligence process. Here, we identify the various healthcare regulatory issues that arise in private equity transactions.

The Healthcare industry is heavily regulated at both the federal and state levels, and regulatory issues will be the greatest area of concern for a buyer. The buyer will review the information disclosed through the due diligence process to confirm both pre- and post-closing regulatory compliance.

No business is perfect, and it’s not uncommon for areas of past non-compliance to be uncovered. A buyer needs to understand what they will be potentially inheriting in terms of risk. This gives the parties a chance to correct deficiencies, which may include a self-disclosure or refund, and make improvements going forward.
Continue Reading Ultimate Guide to Closing a Private Equity Transaction

Part III: Due Diligence

This is the third article in our series on “Closing a Private Equity Transaction.” In Part I, the benefits of preparing for a transaction were explained, along with how best to prepare. In Part II, the letter of intent (LOI) was discussed, and key terms were identified and explained. Next, we walk through the due diligence process, which begins immediately after the parties execute the LOI.

Due diligence is used by both the buyer and seller to confirm the decision to proceed with an ultimate closing. Typically, the buyer’s examination of the seller’s business will be comprehensive and include information covering the past three to five years. This is necessary in order for buyer to understand what it will be purchasing, in terms of profitability, operations, business relationships, and potential liabilities. 
Continue Reading Ultimate Guide to Closing a Private Equity Transaction

On Tuesday, June 18, 2019, our team of legal professionals and industry experts hosted a Compliance Considerations for Pharmacy Sale or Acquisition Webinar that took a look at the regulatory pitfalls and problems that can arise in a pharmacy transaction.

The free on-demand recording will provide real-life examples of what to do – and not

If you happen to miss our NHIA Talk Infusion Webinar on Compliance and Risk Considerations for Compounding Pharmacies, please click on the link to enjoy a free on-demand recording.

Our program guides you through the current landscape and common compliance concerns in compounding. We will help you understand the focus of FDA and state

The United States Department of Justice (“DOJ”) has intervened in a False Claims Act (“FCA”) case against a Florida compounding pharmacy, Diabetic Care Rx, LLC d/b/a Patient Care America (“PCA”), and, in an unexpected move, named PCA’s private equity sponsor and controlling shareholder, Riordan, Lewis & Haden, Inc. (“RLH”), as a co-defendant. The DOJ complaint accuses PCA, RLH and two PCA officers/directors (who were also RLH partners) of overseeing a kickback scheme which DOJ alleges induced referrals that resulted in TRICARE paying over $68 million for medically unnecessary compound drug prescriptions. DOJ alleges the illegal scheme was designed by RLH.

Continue Reading DOJ Adds Private Equity Firm to False Claims Act Complaint

As most healthcare providers know, HIPAA requires that covered entities or business associates  conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information (“ePHI”) held by the covered entity or business associate.[1] Providers who receive Meaningful Use incentive payments from the Centers for Medicare and Medicaid Services (“CMS”) for implementing electronic health record (“EHR”) systems into their practices or operations are also likely aware of the fact that one of the many requirements for these incentive payments is to conduct a HIPAA security risk analysis annually. Now, perhaps more than ever before, both CMS and the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) is demonstrating the importance of ensuring that these risk analyses are performed, or providers can face dire consequences. Below are the top reasons to conduct a thorough HIPAA security risk analysis.
Continue Reading Top 5 Reasons to Conduct a Thorough HIPAA Security Risk Analysis

Image copyright Catherine Lane 2015My New Year’s resolutions will likely be broken early and often in 2016. My consequences are mostly non-monetary: a few more pounds, a little less savings, and not winning the triathlon in my age group. Your consequences, as a HIPAA-covered entity or business associate, for not complying with the Privacy and Security Rules could be much greater, and could put you into serious debt to the HHS Office of Civil Rights (OCR). Therefore, we propose that you resolve now to become fully HIPAA compliant in 2016.

OCR delivered an early holiday gift, wrapped in the Director’s Sept. 23, 2015, report to the Office of Inspector General. In that report, she disclosed that OCR will launch Phase 2 of its HIPAA audit program in early 2016, focusing on noncompliance issues for both covered entities and business associates.

So, grab that cup of hot cocoa and peruse this review of 2014-2015 HIPAA enforcement actions, which should help identify noncompliance issues on which OCR will focus in 2016.
Continue Reading HIPAA compliance: another year older, but hopefully not deeper in debt