Health Law Advisor

Federal agencies in health care publish large amounts of data, and my posts typically analyze that data.  To provide more value to readers, I’ve started submitting FOIA requests for unpublished data to produce additional insights into how FDA works.  And what better first topic than data on FDA responses to FOIA requests.

Information is important, and thus so is access to it.  Our democracy needs to know what’s going on in our government, and businesses trying to navigate the FDA regulatory process likewise need to understand the regulatory process.  For both purposes, the FOIA process should be fair and efficient.

FDA has been releasing data on its FOIA process, specifically its FOIA logs, for a few years.  For data analysis purposes, those data are missing some important fields such as the date of the final decision.  Further, when it comes to looking at the data on the closed cases, the data only go back four years.  In my experience, the pandemic years were anomalous in so many ways that we can’t treat any data from the last three years as typical.  As a result, I wanted to go back 10 years.

On February 17, 2023, the Federal Trade Commission (“FTC”) announced the creation of the Office of Technology (the “OT”), which will be headed by Stephanie T. Nguyen as Chief Technology Officer. This development comes on the heels of increasing FTC scrutiny of technology companies. The OT will provide technical expertise and strengthen the FTC’s ability to enforce competition and consumer protection laws across a wide variety of technology-related topics, such as artificial intelligence (“AI”), automated decision systems, digital advertising, and the collection and sale of data. In addition to assisting with enforcement matters, the OT will be responsible for, among other things, policy and research initiatives, and advising the FTC’s Office of Congressional Relations and its Office of International Affairs. 

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.

• 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.

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?

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).

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. 

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. 

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.

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.