On May 14, 2021, CMS published FAQs addressing questions that have been raised regarding the Interoperability and Patient Access final rule published May 2020.  CMS is careful to note that the FAQs “do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract, as directed by a program.”  CMS has provided links and other guidance, including regarding technical standards, best practices, and privacy and security resources, and has directly addressed questions raised by trade associations and others.

We summarize some of the key points addressed in the FAQs.  We encourage you to review the full CMS response where questions arise in your implementation.
Continue Reading CMS Issues First FAQs on the CMS Interoperability and Patient Access Rule

Last week, the Center for Medicare & Medicaid Services (CMS) finalized long-awaited regulations on Interoperability and Patient Access (the “CMS Rule”) to require Medicare Advantage plans, Medicaid and Children’s Health Insurance Program (CHIP) managed care plans, state agencies, and Qualified Health Plan (QHP) issuers on federally-facilitated exchanges (“CMS Payers”) to provide patients easy access to their claims and encounter information, as well as certain clinical information, through third-party applications of their choice. On the same day, the Office of the National Coordinator for Health Information Technology finalized its rules on Interoperability, Information Blocking, and the ONC Health IT Certification Program (the “ONC Rule”) related to the 21st Century Cures Act (Cures Act). The CMS Rule and ONC Rule have far-reaching impacts.

As individuals and organizations covered by the rules are considering how they may facilitate their access to health information to support patients, health care providers, and others, it is important to understand when provisions in the rules will be effective and timing and what acts may constitute violations of these rules.  To help clients get familiar with these deadlines, we are providing this summary chart of compliance requirements and applicable deadlines to help your organization prepare for upcoming enforcement of the ONC Rule and the CMS Rule.  For legal advice tailored to the specific needs of your organization, please reach out to Jodi Daniel, head of the firm’s Digital Health Practice at jdaniel@crowell.com.

As you read the chart, you should keep the following in mind:


Continue Reading Compliance Reference Chart for ONC and CMS Interoperability Rules

Building on momentum from Administrator Seema Verma’s announcement of the MyHealtheData initiative at HIMSS 2018, CMS has published more clues as to future action to liberate health information for patients.

In the CY 2019 call letter to Medicare Advantage organizations and Part D programs, CMS describes the Blue Button 2.0 project and its use of