By James E. Grue, OD,
and Ronald P. Snyder, OD, FAAO
Sept. 2, 2020
Part one of a two-part article on the 21st Century Cures Act
There is a new law with the potential to significantly impact patients–and doctor mindset: The 21st Century Cures Act. Here is what you should know about this new piece of legislation.
No More Information Blocking
The 21st Century Cures Act was enacted, and is being implemented, for one main reason–to stop information blocking. With all of the technology currently available in healthcare, it is still difficult for patients to have their health information where they need it and when they need it. The 21st Century Cures Act remedies the portability of health information by mandates and includes significant penalties for both the electronic health record (EHR) vendors and providers who block information.
The Act describes the required technical capabilities for EHRs and providers to enable the access, transmission and use of data. The Act specifies that the penalties can be as high as $1 million per patient violation, so there is serious enforcement behind it.
The Act, which went into effect on June 30, 2020, requires EHR vendors to attest that they are certified EHR vendors and that that they will not participate in any information-blocking activities. Financial penalties will first start with the EHR vendors, followed shortly thereafter with penalties to providers.
What Does this Mean for You as a Provider?
It means the patient is in complete control of their health information. If your patient requests that their data be sent elsewhere, you must have the capability to provide them with electronic access to their data, the ability to transmit the data, and the data must be usable without any additional effort on the receiving end. Your EHR vendor must provide that capability in your certified EHR, in the form of an Application Programming Interface (API).
The API allows any data that you have recorded during your exam to be accessed and exported. This transfer needs to be done effortlessly. Directions to use the API will be openly available on your EHR vendor’s web site. Over the next year, you will be hearing more details on exactly how this will work. It is imperative that you begin transforming the way you think, as your role will significantly change as patients begin to request that you send their exam results anywhere they wish.
There are research programs already in place in which patients may want to participate by sharing their health information data. One such program is Sync for Science (S4S). Click HERE to review the article, “Empowering Patients to Advance Precision Medicine, One EHR at a Time,” which appeared in Health IT Buzz, “The Latest in Health Information Technology from ONC.” Here is a a synopsis of the article:
Electronic health record (EHR) systems store incredibly rich data about individual patients, but historically, individuals have been unable to access this information easily and share it for research. However, use of patients’ data could accelerate scientific discovery and progress toward precision medicine. Permitting patients to connect and share their data with researchers—while maintaining the security and privacy of those data—is just one of the many benefits to the research community of the ONC‘s Cures Act Final Rule released in March 2020.
Sync for Science (S4S) is a collaboration among ONC, the National Institutes of Health’s All of Us Research Program (All of Us), and the Harvard Medical School Department of Biomedical Informatics. It is one demonstration that shows how patient participation can help accelerate research and discovery. With just a few clicks, S4S allows researchers to receive EHR data from a third-party application used by a patient based on open data standards. Information technology companies such as Apple, Google, and Microsoft are now using the same application programming interface (API) standards leveraged in S4S to enable sharing of health data for a variety of purposes, including research.
Where Else Might Patients Want to Send Their Data?
Sync for Science (S4S) is just one research organization with which a patient may want to share their data. There are many real-world testing studies that will look at clinical outcomes, but now organizations like S4S can do much more complex studies. For example, if a patient with Retinitis Pigmentosa decides they want to be part of the Sync for Science (S4S) collaborative study on RP, all they have to do is tell S4S that they want to be included in the study and they want their information from your office to be included in the study.
Other Articles to Explore
The patient may also request that their data be sent to a PCP, as well as to other specialists. These research organizations now have the ability to perform extremely large-scale data-type studies that are expected to dramatically improve the clinical outcomes, and in this case, help move medicine into “precision medicine.”
As this article was being written, the Secretary of Health for Pennsylvania was on TV informing parents of the red eye and conjunctivitis symptoms being reported by the CDC for the new COVID-19 related Multi-system Inflammatory Syndrome in Children. We can expect multiple entities to study this condition to try to determine if conjunctivitis could be a first presenting sign. Many parents will want to participate in this type of study, especially if they have a child who was recently seen for a red eye.
With all the attention that myopia control is getting, there will be numerous studies that patients will be invited to participate in regarding the effectiveness of the myopia control approach you use.
The important fact is that you may not even be involved in the parent’s decision to enroll their child in a study. It is completely between the parent or patient, and whatever other organization with which they want to share their information. All you have to do is make sure that your office or your EHR does not block the information sharing if you want to avoid financial penalties. Your role in this new world of interoperability is not only to collect and record the data that you deem important for the care of your patients, but also to be prepared to deliver that data to wherever necessary. It also becomes critical that you know your own clinical outcomes, as very soon the patient may know more about the clinical outcomes they are getting from your care than you do.
The possibilities are almost endless. It is reasonable to think that some patients with AMD will want to participate in an AMD study. Patients with glaucoma, dry eye, diabetes, blepharitis and other conditions will soon have numerous opportunities to participate in research projects. Most patients will ask your opinion or tell you about their plan to enroll in a study, but some may not even discuss it with you.
Part two of this article will address the implications that these changes will have on your patients knowing the clinical outcomes they are getting from the care you are providing them. It will also discuss the importance of payers being able to use your clinical data to determine whether they want you on provider panels and, if so, how much they will pay you to participate.
James E. Grue, OD, is a health-care reform speaker and consultant. To contact him: JimGrue@HealthCareRegistries.com