Let’s Talk Compliance: Trends Affecting the Health Care & Life Sciences Sector
On January 23-24, PYA and Foley & Lardner LLP presented the seventh annual Let’s Talk Compliance virtual conference. The event was moderated by Foley Health Care Partner Jana Kolarik and PYA Principal Angie Caldwell. Panelists included attorneys from Foley’s Health Care & Life Sciences Sector as well as PYA’s healthcare consulting, compliance, and cybersecurity experts. Each day featured two sessions that covered relevant and trending topics in healthcare and life sciences compliance.
Day 1: Thursday, January 23, 2025
Session 1: The OIG’s General Compliance Program Guidance: “Auld Lang Syne”
Presenters: Shannon Sumner, Judith Waltz
As in the lyrics of “Auld Lang Syne,” the beginning of a new year leads us to reflect nostalgically. For compliance experts, that means considering what the compliance industry learned from implementing the new and refreshed Office of Inspector General (OIG) General Compliance Program Guidance (GCPG) in 2024 while we set the stage for 2025.
Learning objectives for this session included the following:
- Discussed GCPG implementation best practices identified from serving clients in 2024
- Shared key concepts with which clients are still struggling and steps they are taking to comply with the GCPG’s expectations
- Provided an overview of the latest industry segment-specific guidance for Skilled Nursing Facilities
- Summarized significant settlements and cases that pressure-tested organizations’ compliance programs in 2024
Presentation Slides | View On-Demand
Session 2: Trends in Healthcare Privacy and Security: Cybersecurity, Patient Rights, and Reproductive Rights
Presenters: Barry Mathis, Jennifer Hennessy
This presentation covered updates and strategies for healthcare cybersecurity defenses and incident response, Health and Human Services’ (HHS) continued enforcement of patient rights in accessing their own health information, and HIPAA’s amendments to protect reproductive healthcare information.
Learning objectives for this session included the following:
- Discussed trends in healthcare cybersecurity, including expected updates to the HIPAA Security Rule, HHS’ Security Risk Analysis enforcement initiative, and recent HHS ransomware settlements
- Provided a refresher on HIPAA’s right for individuals to access their own information, in light of HHS’ continued HIPAA Right of Access enforcement initiative
- Discussed the status of HIPAA’s recent amendments to provide additional protections for reproductive healthcare information under the incoming Trump administration
- Shared effective strategies for cyber event response, focusing on containment, mitigation, and recovery, with lessons learned from recent cyber incidents in healthcare
- Explored the role of artificial intelligence in enhancing cybersecurity defenses, including its applications in threat detection, anomaly analysis, and predictive security measures
- Explained how to manage cyber risks with third-party vendors, emphasizing the importance of vendor risk assessments, contract provisions, and ongoing monitoring to ensure compliance and safeguard sensitive information
Presentation Slides | View On-Demand
Day 2: Friday, January 24, 2025
Session 3: A New Era for Interacting with Federal Agencies
Presenters: Martie Ross, Matt Krueger
The end of Chevron deference and President Trump’s reelection mean federal agencies like the Centers for Medicare & Medicaid Services, Health Resources and Services Administration, and the Food and Drug Administration will operate under fundamentally different rules than in the past. This presentation explained the changes and identified what organizations need to know.
Learning objectives for this session included the following:
- Provided key background on the Chevron doctrine, which required courts to defer to agencies’ interpretations of statutes, and the Supreme Court’s overturning of it in Loper Bright
- Identified important changes resulting from Chevron’s end and the election of President Trump, including more cautious rulemaking, more frequent challenges to agency actions, and more restrictions on subregulatory guidance
- Identified risks and opportunities for healthcare companies that are subject to agencies’ rules, actions, and guidance
Presentation Slides | View On-Demand
Session 4: Antitrust Issues in Provider Mergers and Acquisitions
Presenters: Michael Ramey, Benjamin Dryden
This presentation covered the key antitrust issues that arise in mergers and acquisitions involving healthcare providers, including hot issues in federal and state antitrust enforcement, practical tips for staying compliant in due diligence and integration planning, and major changes to the requirements for reporting transactions under the Hart-Scott-Rodino Act.
Learning objectives for this session included the following:
- Understanding key antitrust requirements and risks that arise in healthcare mergers and acquisitions
- Understanding recent reforms to the federal Merger Guidelines
- Unpacking key changes to the rules for reporting transactions under the Hart-Scott-Rodino Act and what they mean for the healthcare sector
- Addressing state regulatory requirements and their impact on healthcare mergers and acquisitions
- Addressing potential antitrust enforcement trends and priorities for the second Trump administration
Presentation Slides | View On-Demand
Speakers
Angie Caldwell, Principal, PYA
Jana Kolarik, Partner, Foley & Lardner
Benjamin Dryden, Partner, Foley & Lardner
Jennifer Hennessy, Partner, Foley & Lardner
Matt Krueger, Partner, Foley & Lardner
Barry Mathis, Principal, PYA
Michael Ramey, Principal, PYA
Martie Ross, Principal, PYA
Shannon Sumner, Principal, PYA
Judith Waltz, Partner, Foley & Lardner
Learn more:
Check out the PYA and Foley & Lardner compliance initiatives.
If you would like assistance with any matter involving compliance, valuation, or strategy and integration, one of our executives would be happy to assist.
About Educational Credits
CHC: The Compliance Certification Board (CCB)® has approved this event for up to 4.8 Non-Live CCB CEUs, based on a 50-minute hour, each. Continuing Education Units are awarded based on individual attendance records. Granting of prior approval in no way constitutes endorsement by CCB of this event content or of the event sponsor.
CPE: Participants of the live event were eligible for up to 4 CPE credits in Specialized Knowledge. Program Level: Intermediate. Delivery Method: Group Internet Based. Advanced Preparation: None. Prerequisites: None. No fee. PYA, P.C. is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of continuing professional education on the National Registry of CPE Sponsors. State boards of accountancy have final authority on the acceptance of individual courses for CPE credit. Complaints regarding registered sponsors may be submitted to the National Registry of CPE Sponsors through its website: www.NASBARegistry.orgCLE:
Applications for accreditation will be submitted to CO, FL, NY, and WI for up to 1 credit hour (50-minute hour) and CA, IL, TX, UT, and VA for up to 1 credit hour (60-minute hour) per session. Uniform Certificates of Attendance will be provided to attendees seeking credit in other jurisdictions.
Foley & Lardner LLP is an approved MCLE provider in California, Colorado, Illinois, New York, Texas, and Utah.
For purposes of New York CLE credit, this program is appropriate for both newly admitted and experienced attorneys. Certificates of attendance will be distributed to eligible participants approximately eight weeks after the program via email.
