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In this episode of the Diagnosing Health Care Podcast:  What are the various factors impacting stakeholders in the direct access testing industry?

By the end of this four-part series on direct access laboratory testing, listeners will have gained insight into how to navigate the complex regulatory and legal regimes that govern the process of making lab tests available directly to patients and understand the aspects that will dictate how their operations should be structured.

Continue Reading <em>Podcast:</em> Direct Access Laboratory Testing: Navigating the Regulatory Landscape – <em>Diagnosing Health Care</em>
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  • Lowest Total Recoveries Since 2008
  • Record-Shattering Number of New Cases Filed
  • Health Care and Life Sciences Cases Continue to Dominate

On February 7, 2023, the U.S. Department of Justice (DOJ) released its annual False Claims Act (FCA) enforcement statistics for fiscal year (FY) 2022, which ended on September 30, 2022.[1] While total recoveries exceeded $2.2 billion, this is a drop of more than 50 percent from the $5.7 billion recovered in FY 2021, marking the lowest annual reported recovery in 14 years. The total recoveries in fraud cases brought with respect to the health care and life sciences industries fell to the lowest level since 2009.

Continue Reading DOJ’s FY 2022 False Claims Act Recoveries: A Mixed Bag
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In this episode of the Diagnosing Health Care Podcast:   The U.S. Food and Drug Administration (FDA) recently issued a final guidance document clarifying how the agency intends to regulate clinical decision support (CDS) software.

How has this document caused confusion for industry? How can companies respond?

Continue Reading <em>Podcast:</em> Unpacking FDA’s Final Clinical Decision Support Guidance – <em>Diagnosing Health Care</em>
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In a quiet yet shocking announcement on February 3, 2023, the Antitrust Division of the U.S. Department of Justice (DOJ) withdrew three major antitrust policy statements (collectively, the “Statements”) that have served for years as mainstays of health care antitrust enforcement guidance. Specifically, DOJ withdrew the following statements: Department of Justice and FTC Antitrust Enforcement Policy Statements in the Health Care Area (September 15, 1993); Statements of Antitrust Enforcement Policy in Health Care (August 1, 1996); and Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in Medicare Shared Savings Program (October 20, 2011).

Continue Reading DOJ Withdraws Long-Standing Support for Antitrust Enforcement Policy Statements in Health Care
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The California Privacy Protection Agency Board (the “Board”) held a public meeting on February 3, 2023, adopting and approving the current set of draft rules (the “Draft Rules”), which implement and clarify the California Consumer Privacy Act of 2018 (“CCPA”) as amended by the California Privacy Rights Act of 2020 (“CPRA”). The Draft Rules cover many CCPA requirements, including restrictions on the collection and use of personal information, transparency obligations, consumer rights and responding to consumer requests, and service provider contract requirements. At the meeting, the Board also addressed additional proposed rulemaking processes concerning cybersecurity audits, risk assessments, and automated decision-making. 

Continue Reading California Privacy Protection Agency Board Adopts and Approves CCPA Regulations and Discusses Preliminary Rulemaking for Cybersecurity Audits, Risk Assessments, and Automated Decision-Making
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On February 1, 2023, the FTC announced a proposed $1.5 million settlement with GoodRx Holdings, based on alleged violations of the Federal Trade Commission Act (“FTC Act”) and Health Breach Notification Rule (“HBNR”) for using advertising technologies on its websites and mobile app that resulted in the unauthorized disclosure of consumers’ personal and health information to advertisers and other third parties. On the same day, the U.S. Department of Justice, acting on behalf of the FTC, filed a Complaint and Proposed Stipulated Order detailing the FTC’s allegations and the terms of the proposed settlement. 

Continue Reading FTC Brings Enforcement Action Under FTC Act and Health Breach Notification Rule Based on GoodRx’s Use of Advertising Tracking Technology on Its Websites and Mobile Application
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On February 1, 2023, the Centers for Medicare & Medicaid Services (CMS) published a final rule outlining its audit methodology and related policies for its Medicare Advantage (MA) Risk Adjustment Data Validation (RADV) program. The final rule codifies long-awaited regulations first proposed by CMS in 2018.

Continue Reading CMS’s Final Rule on Medicare Advantage Risk Adjustment Data Validation
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In this episode of the Diagnosing Health Care Podcast:   Changes are on the horizon for provisions of the Program of All-Inclusive Care for the Elderly (PACE) that haven’t been updated in over a decade.

What exactly is PACE and how will new proposed rule modifications affect PACE plans moving forward?

On this episode, hear from special guest Wendy Edwards, Director of Internal Operations at BluePeak Advisors.

Continue Reading <em>Podcast:</em> The PACE Program – What Changes May Be Coming Soon? – <em>Diagnosing Health Care</em>
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Introduction

Let’s say FDA proposed a guidance document that would change the definition of “low cholesterol” for health claims.  Now let’s say that when FDA finalized the guidance, instead of addressing that topic, FDA banned Beluga caviar.  If you are interested in Beluga caviar, would you think you had adequate opportunity to comment?  Would you care if FDA argued that Beluga caviar was high in cholesterol so the two documents were related? Continue Reading Unpacking Averages: Using NLP to Assess FDA’s Compliance with Notice and Comment in Guidance Development

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The Food and Drug Administration (FDA) recently issued both draft and final guidance regarding food allergen labeling requirements.  The draft guidance document, Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5), updates the previous (fourth) edition with new and revised guidance concerning food allergen labeling. FDA also issued a final guidance document with the same title in order to preserve questions and answers that were unchanged from the previous (fourth) edition, which was published in 2004 and last updated in 2006.

Continue Reading FDA Issues Final and Draft Guidance Documents Regarding Food Allergen Labeling