The 21st Century Cures Act: A Q&A Session

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What is the CURES Act?

  1. What is the 21st Century Cures Act? 

The 21st Century Cures Act was signed on December 13, 2016, with the purpose to promote and fund the acceleration of research into preventing and curing serious illnesses; accelerate drug and medical device development; attempt to address the opioid abuse crisis; and try to improve mental health service delivery.  The act includes a number of provisions that push for greater interoperability, adoption of electronic health records (EHRs) and support for human services programs.

The goal is to make patients the center of their care through access, transparency, interoperability and more! 

The 21st Century CURES Act and Information Blocking

2. Information blocking- what is it?

Cures defines information blocking as business, technical and organizational practices that prevent or materially discourage the access, exchange or use of electronic health information (EHI) when an actor knows or should know, that these practices are likely to interfere with access.

3. Who are the actors?

Providers, Health IT Developers, Health Information Networks and Health Information Exchanges.  The definition of healthcare is expansive and exceeds those required to comply with promoting interoperability programs.

4. What makes an individual or entity an information blocker?

Elements of information blocking include an Actor regulated by the information blocking provision that involves electronic health information.  Their practice is also likely to interfere with use of an EHI.

5. What is an EHI?

Health & Human Services defines electronic health information, or EHI, to mean electronically protected health information as defined by HIPAA to the extent that the information would be included in a designated record set. De-identified data is excluded from the definition of EHI and may be exchanged without concern.

Exceptions to the 21st Century CURES Act

6. What are the exceptions to information blocking in the CURES act?

Preventing Harm Exception– it will not be information blocking for an actor to engage in practices that are reasonable and necessary to prevent harm to a patient or another person, provided certain conditions are met.

Privacy Exception– it will not be information blocking if an actor does not fulfill a request to access or use information in order to protect a patient’s privacy

Security Exception– it will not be information blocking for an actor to interfere with the access or use of information, provided certain conditions are met.

Infeasibility Exception– it will not be information blocking for an actor to not fulfill a request for information due to the infeasibility of the request.  Infeasibility can include uncontrolled events, segmentation or circumstances.

Health IT Performance Exception– it will not be information blocking for an actor to make health IT temporarily unavailable.

Content and Manner Exception– it will not be information blocking for an actor to limit the content of its response to a request to access information provided certain conditions are met.

Fee Exception– it will not be information blocking for an actor to charge fees, including fees that result in a decent profit margin.

Licensing Exception– it will not be information blocking for an actor to license interoperability elements for information to be accessed.

21st Century CURES Act: How to Prepare

7. What steps can I take now to be ready for the CURES Act?

Update all forms, privacy and security policies consistent with HIPAA, the 21st Century Act and state and local regulations

Provide training for all staff including the new forms and risks of information blocking

Create a “Request Review Team” to evaluate appropriateness of a claim

Know what to do if you’re accused of information blocking

Provide talking points to use with individuals regarding the difference between requests and provider obligation

Have a discussion with your attorney about their understanding of information blocking

Remember the reason- it’s the right thing to do!

New regulations and acts can be a lot of information to take in.  This information will help you and your organization be ready for the 21st Century CURES Act! Exym will be there with you every step of the way as we learn to navigate these new regulations.