Both houses of Congress easily passed the 21st Century Cures Act by large non-partisan majorities and President Obama signed it into law this past December. The ambitious law aims to accelerate how the healthcare system operates and includes a number of other details that will affect hospital teams, providers, medical device makers, and patients. In three words, the new Bill will emphasize discovery, development and delivery within our healthcare system beginning in 2017.
An article in Modern Healthcare explained the major components of the Bill: “The legislation contains $4.8 billion in funding for the National Institutes of Health for programs like Obama’s precision medicine initiative and Biden’s cancer research “moonshot” program.” According to an overview at WhiteHouse.gov, “Precision Medicine is an innovative approach that takes into account individual differences in people’s genes, environments, and lifestyles. “ Advances in Precision Medicine have led to several new treatments that are tailored to specific characteristics of a person’s genetic makeup, or even the genetic profile of an individual’s tumor.
This Act looks to bring a little bit of something for everyone in healthcare with an emphasis on efficiency in deploying new solutions. MassDevice.com has identified that the Act’s “Breakthrough Devices program” can more quickly help “bring technology to the market for conditions with no cleared or approved alternatives.“
Delving deeper into the Act, the Journal of AHIMA (American Healthcare Information Management Assoc), reports that:
“The act, which is largely devoted to regulations surrounding medical device and prescription drug approval, has numerous implications for health information management (HIM) and health IT professionals. “
Some key points AIHMA listed include:
- Section “Title IV: Delivery” deals with improving nationwide interoperability. This section tackles issues such as information blocking, patient matching, and improving patient access to their electronic health information.
- Penalties levied against entities found to be engaging in information blocking can run as high as $1 million per instance.
- Non-physicians, such as nurses or scribes, now will have the ability to document in the patient record.
We took a look at the text of the 21st Century Cures Act itself at Congress.gov and found some additional features of note for our hospital and physician group clients. The Act will:
- Give Medicare payment incentives for the transition from traditional X-Ray imaging to digital radiography and other medicare imaging payment provisions. This will include 20% penalties for using older film-based X-Ray systems.
- Expedite the development and availability of treatments for serious or life-threatening bacterial or fungal infections in patients with unmet needs, while maintaining safety and effectiveness standards for such treatments.
- Give guidance from Secretary of Health and Human Services on facilitating the responsible dissemination of truthful and non-misleading scientific and medical information not included in the approved labeling of drugs and devices.
CIO.com sums up the 21st Century Cures Act as a mission to “accelerate the discovery, development and delivery of 21st-century cures”; which it’s article then defines like this:
- Discovery ensures that the NIH (National Institutes of Health, which the Bill reauthorizes) is provided with a total of $4.8 billion in new funding.
- Development addresses modernizing clinical trials (analyzing the safety and efficacy of data), utilization of biomarkers (to assess how a therapy is working), and empowering the FDA to utilize flexible approaches to reviewing medical devices.
- Delivery helps to put newly tested and approved drugs into the hands of patients, at the right time. Where interoperability of electronic health records systems for “seamless patient experience” is the essence of delivery.
Whew. That’s quite an ambitious mission to speed up the healthcare system. The SSI Group applauds the Act’s goals and believes it will rely upon Smart technology infrastructure to make it all happen.