21st Century Cures Act: 4 Health Industry Impacts Summarized

By OmniMD
Twitter: @omnimd

The law has been called the “most important bill of the year“.

Here’s summarized some of the notable implications of the bill in four buckets:

1) Health IT 2) Mental health 3) FDA reform 4) Research and care funding

1. Funding
   • Over the course of 10 years, the Cures bill authorizes the National Institutes of Health to spend $4.8 billion toward funding the Cancer Moonshot ($1.8 billion) and the precision medicine and the BRAIN Initiative efforts ($3 billion).
   • The package allocates $1 billion to help curb the opioid epidemic in the U.S.
   • It should be noted while the Cures act authorizes the spending, the actual money must be appropriated by Congress. This means the NIH funds must get fresh approval every year.
2. Health IT
   • While the bill is largely known for helping to fund efforts such as precision medicine, the “cancer moonshot” and potentially being a gift to the pharma industry, the bill contains some health IT-related provisions.
3. Low-risk medical devices
   • The legislation clarifies low-risk medical devices will not be regulated as a medical device under the FDA.
   • This includes your FitBits, your smart shirts that can track your physical activity or your EHRs for that matter
   • This is important from a health IT developer perspective, as investors won’t face the uncertainty that the health app could be blocked by the FDA before gaining a return on investment.
   • “Giving certainty is really important for investing purposes, such a law will help get more innovative, low-risk technology in patients’ hands.
4. Interoperability
   • One way the bill takes aim to drive greater interoperability is by having the Office of the National Coordinator for Health IT (ONC) assist public-private and public-public partnerships to create a “trusted exchange framework, including a common agreement among health information networks nationally.”
   • ONC would also help set up a provider directory for those that have adopted the agreement and data exchange standards.
   • In addition, under the legislation, HHS will be tasked to “educate healthcare providers on ways of leveraging the capabilities of health information exchanges” and “clarify misunderstandings” on HIEs’ use.
5. Mental health
   • Dr. John P. Docherty, senior vice president and medical director from ODH, Inc., tells the passage “of this bill in the House marks the first mental health reform bill in more than 50 years. It would require providers to care for the whole person, not just the physical. This will likely transform routine physicals as well as other preventative care screenings and exams.”
   • The bill would authorize the creation of a new HHS assistant secretary of mental health in charge of mental health and substance misuse disorders as well as authorize grants for community treatment teams and assisted outpatient treatment for non-cooperative patients.
6. FDA
   • The Cures act authorizes the FDA to receive $500 million to help speedup product approval processes, which some critics say weakens safety andefficacy standards.

This article was originally published on OmniMD and is republished here with permission.