On Tuesday, December 13, 2016, President Obama signed the bipartisan 21st Century Cures Act into law, to “expedite the discovery, development, and delivery of new treatments and cures and maintain America’s global status as the leader in biomedical innovation”, according to the government fact sheet.
The law’s 5 broad goals have seen the most press, funding to the fight against the opioid epidemic and expanding on President Obama’s Precision Medicine Initiative to name a few, but the law includes other provisions which have important implications in electronic healthcare. I recently attended the monthly Electronic Heath Record Association meeting where we went over parts of the 21st Century Cures Act that focused on the electronic exchange of health information. These provisions provide the foundation for the meaningful use with electronic health technology in years to come.
Interoperability at the Forefront of Healthcare
The shift towards a patient-focused, value-based healthcare system is predated on the ability for health organizations to exchange information openly and freely. Patient health outcomes, and in turn our healthcare system, cannot be improved if the data is hidden or hoarded. In line with outcome-focused legislation like MACRA, the 21st Century Cures Act formally defines the standards for interoperable technology as:
- Secure transfer: The technology allows the secure transfer of all electronically accessible health information to and from any and all health information technology for authorized use under applicable State or Federal law.
- Complete access to health information: The technology allows for complete access, exchange, and use of all electronically accessible health information for authorized use under applicable State or Federal law without special effort by the requestor of such health information.
- No information blocking: The technology is not configured, set up, or implemented to information block
The Act puts special focus on the 3rd bullet point of information blocking, which many see as a huge detriment to interoperability. The Act defines information blocking (paraphrased), “with respect to the access, use, and exchange of qualified electronic health records and other health information technology, business, technical, and organizational practices, including practices described in paragraph, that prevent or materially discourage the access, exchange, or use of electronic health information”, and gives the HHS special authority to fine information blockers up to $1 million per violation.
More than ever are we seeing a push towards a data-based approach to improving health outcomes, and what’s interesting to me is the strict language on the penalization of information blocking. The government is taking a hands-on approach to health data exchange in the industry.
Telehealth once again in the Spotlight
Though telehealth is defined in MACRA, the 21st Century Cures Act promotes the adoption of telehealth in clear and concise language (with its own provision). The Act orders the Centers for Medicare & Medicaid Services (CMS) to provide information on how telehealth can improve the lives of Medicare beneficiaries, which telehealth services can improve care, and what barriers there are to telehealth.
The law notes that any expansion of telehealth services under the Medicare Program should:
- Recognize that telemedicine is the delivery of safe, effective, quality health care services, by a health care provider, using technology as the mode of care delivery
- Meet or exceed the conditions of coverage and payment with respect to the Medicare Program under title XVIII unless specifically address in subsequent statute, of such Act if the service were furnished in person, including standards of care
- Involve clinically appropriate means to furnish such services (Sec. 3021)
Telehealth is extremely promising, and has many benefits for providers. In particular, I believe that telehealth has the potential to solve many of the challenges we face with rural health. If you were unsure on the prognosis of telehealth in healthcare, you can be sure that with this legislation, telehealth isn’t going anywhere.
Final Thoughts, Electronic Health Records (EHRs) at the Center of Information Exchange
To sum up the law in regards to the aforementioned provisions, it is a united effort by legislators to promote the sharing of health information for the betterment of American citizens. And to facilitate this push, it falls to EHRs to take the first step. EHRs are both the repository of data and the means for information exchange in healthcare. They are the platform that must be first in promoting interoperability among the health industry, and must be sufficiently capable of handling new healths platforms like telehealth.
The 21st Century Cures Act acknowledges opportunities and challenges with EHRs, as they will require certified EHRs to be able to capable of sending and receiving data to clinical registries that are certified to ONC standards (Sec. 4006). This is particularly important because it requires both parties to adhere to the same standards.
What we have in the 21st Century Cures Act is a grand, bipartisan push to promote health innovation in America. Interoperability, once a buzzword of vague definition, is now formally defined with stringent standards. Telehealth, which was once at the fringes of healthcare, has specific provisions on its implementation in healthcare as a promising solution, and EHRs will be a platform for innovation and growth. We live in exciting times where paradigm shifts seem to happen overnight. Stay tuned for more information on the 21st Century Cures Act.