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Course Details

Course Information
  • smart_display Format

    On-Demand

  • signal_cellular_alt Difficulty Level

    Intermediate

  • work Practice Area

    Health

Date & Time
  • event Date

    Thursday, October 12, 2023

  • schedule Time

    1:00 p.m. ET./10:00 a.m. PT

  • timer Program Length

    90 minutes

Credit Information

  • This 90-minute webinar is eligible in most states for 1.5 CLE credits.

$297.00
CLE
ALL

This CLE webinar will discuss the recently published rule that empowers the Department of Health and Human Services Office of Inspector General (HHS-OIG) to impose civil monetary penalties (CMPs) of up to $1 million per violation for unlawful acts of information blocking beginning Sept. 1, 2023. The panel will describe who is subject to the new rule, OIG's enforcement priorities, interagency cooperation, and how CMPs may be assessed. The panel will also provide key considerations and best practices for compliance.

Faculty

Carolyn V. Metnick
Partner
Sheppard Mullin Richter & Hampton Llp - San Diego

Ms. Metnick is a partner in the Corporate Practice Group in the firm's Chicago office and a member of the Healthcare and Privacy & Cybersecurity Teams. She represents a range of healthcare industry clients, including hospitals and health systems, physician organizations and digital health companies. Ms. Metnick advises on healthcare regulatory and transactional matters with a focus on health information privacy and security. She is the founder and leader of Sheppard Mullin Healthy AI, which is an initiative focused on legal issues relates to the use of AI in healthcare. Ms. Metnick counsels healthcare clients on issues relating to AI, including governance, contractual matters, and data related issues. She advises clients on a range of privacy and security laws, including HIPAA and other federal and state privacy laws. Ms. Metnick also counsels businesses in data breach investigations and compliance with federal and state breach notification laws. She is a Certified Information Privacy Professional/United States (CIPP/ US) and a Certified Information Privacy Professional/Europe (CIPP/E).

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Pat G. Ouellette
Attorney
Mintz Levin Cohn Ferris Glovsky & Popeo PC

Mr. Ouellette focuses his practice on representing healthcare organizations and is a Certified Information Privacy Professional–US (CIPP–US). He advises clients on a broad spectrum of healthcare regulatory, clinical trial, data privacy, PBM, healthcare technology, and transactional matters. Mr. Ouellette has experience drafting and negotiating healthcare services agreements and with technology transactions as well as counseling clients on state licensure rules, compliance with fraud and abuse laws, privacy and data protection issues, and the Interoperability and Information Blocking Rules under the 21st Century Cures Act.

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Description

On July 3, 2023, HHS-OIG issued a final rule (CMP Rule) that empowers the agency to impose CMPs of up to $1 million per violation for unlawful acts of information blocking in violation of the 21st Century Cures Act. Enforcement begins Sept. 1, 2023.

Under the CMP Rule, any health information network and exchange (HIN/HIE), health IT developer, or healthcare provider that meets the statutory definition of one of these actors, who knows, or should know, that it engaged in a practice that is likely to interfere with access, exchange, or use of electronic health information (unless an exception applies) may be subject to a costly CMP. This means that penalties may be imposed whether or not any actual interference occurs as long as the party has the requisite intent.

OIG's enforcement will be complaint-driven and involve coordination with other regulatory agencies where information blocking violations raise issues within the other agencies' purview. Therefore, counsel should ensure their clients' business practices are compliant across their organizations.

Although the CMP Rule does not apply to healthcare providers generally, counsel should determine whether their healthcare provider clients meet the statutory definition of a developer or HIN/HIE subject to CMPs. Additionally, counsel should be aware of an upcoming HHS proposed rule that would make healthcare providers subject to “appropriate disincentives” set forth by HHS.

Listen as our expert panel discusses the final CMP Rule including who qualifies as information blocking actors and how OIG will prioritize and enforce complaints. The panel will also address interagency cooperation and how it may impact regulated entities, as well as provide best practices for assisting clients with organizational compliance.

Outline

  1. Overview of 21st Century Cures Act
    1. Definition of information blocking
    2. Exceptions
    3. Information blocking actors
  2. The final CMP Rule
    1. Purpose
    2. Information blocking actors
    3. Complaint enforcement
      1. Prioritizing investigations
      2. Interagency coordination
        1. ONC
        2. OCR
        3. FTC
        4. Others
    4. Assessing CMPs
    5. Why healthcare providers should pay attention
  3. Future rulemaking related to information blocking
  4. Best practices for compliance

Benefits

The panel will review these and other important issues:

  • Who is subject to the CMP Rule?
  • How does the CMP Rule affect healthcare providers?
  • What will be the effect of interagency cooperation?
  • How can counsel help clients prepare for compliance across their organizations?
  • What is the status of ongoing rulemaking related to information blocking?