The 21st Century Cures Act: A Model for Change

Pat Stricker, RN, MEd
Senior Vice President
TCS Healthcare Technologies

As the Greek philosopher, Heraclitus, once said, "Change is the only constant in life." Those of us, who have been in healthcare for many years and have seen a myriad of changes, can certainly agree that "change is a constant in healthcare."

Change has never been more prominent than in today’s healthcare. We’ve spent the past six years making significant changes in all sectors of healthcare to implement the Affordable Care Act (ACA). Yet now, the ACA may be repealed, meaning we would need to discard our accomplishments and start over from the beginning. This has a lot of people upset and could cost the industry immeasurable losses. Hopefully this won’t happen. It seems it would be better to keep the things that work (processes, policies, guidelines, technology, payment structures, quality initiatives, etc.) and use them as a foundation to build another system.

Our two political parties have very different views about how we should proceed with our national healthcare system. They are so divided it has been difficult to get significant legislation passed over the past few years. However, that changed last week with the passage of the 21^st CenturyCures Act (H.R. 34 – 114^th Congress). This landmark bill was passed with overwhelming bi-partisan support (House 392-26 and Senate 94-5), which is something we haven’t seen in a long time. It was signed into law this week (December 13) by President Obama. Senate Majority Leader Mitch McConnell (R-Ky.) called it one of the most important bills Congress will pass this year. Under this provision, the Secretary of Health and Human Services (HHS) will have up to one year to develop a strategy and recommendations to meet the goals.

A summary of the bill states that it was designed to "modernize the health-care innovation infrastructure, incorporate a patient perspective into the drug and device approval process, support advances in personalized medicine, streamline clinical trials, and provide more resources to support cutting-edge research and help young scientists." It also seeks to speed and improve the discovery, development, and delivery of life-saving and life-improving therapies, and provide faster cures. Some of the provisions of the bill are:

• The National Institutes of Health (NIH) and the Federal Drug Administration (FDA) Innovation projects (Precision Medicine, the Beau Biden’s Cancer Moonshot Program, the BRAIN research project, and Stem Cell Regenerative Medicine);
• State responses to opioid abuse;
• Support of young and emerging scientists;
• Modernization, improvements, and increased access to clinical trials;
• Clarification of regulations for certain classifications of medical software;
• Development of patient-focused drugs, antimicrobials, and drugs for rare diseases;
• Advancements in new drug therapies, and education and access to them;
• Improving the documentation, interoperability and usability of EHRs;
• Facilitating collaborative research;
• Innovations in medical devices and apps, developing standards for use, and improving the review process;
• Innovation in Medical Countermeasures (develop guidelines, strategic plan, and identify promising technologies);
• Vaccine Access, Certainty, and Innovation;
• Savings, Payment, and Reimbursement;
• Health Information Technology (HIT) Improvements (Interoperability, Information blocking, Access to electronic health information, Leveraging EHRs to empower patients and improve patient care, Protection of patient data, and Telehealth services in Medicare;
• Permitting small employers, who do not offer a group health plan to any of their employees, to create their own Health Reimbursement Arrangement (HRA); and
• Investing in 21^st Century science and next generation investigators.

The entire bill includes twenty-five Titles (sections). Eight sections relate to the items above, with four others relating to Medicare changes. Two other Acts passed earlier this year by the House were also included in this bill: the Helping Families in Mental Health Crisis Act of 2016 (H.R. 2646) (5 sections) and the Family First Prevention Services Act of 2016 (H.R. 5456) (8 sections). For more details about the provisions of the 21^st Century Cures Act (H.R. 34), click here or review the summary provided by the House Rules Committee. You can also review the entire bill (all 996 pages!).

As you can see, the bill includes a large variety of health care items. As a nurse who works in the technology field, I am excited about the focus on the HIT initiatives, especially the goals to: Prioritize interoperability of systems and utilize the existing implementation standards, rather than recreate them; Focus on Telehealth services, which is a booming initiative right now; and Leverage EHRs to empower patients, improve patient care, and make documentation less burdensome.

The Bill also identifies five specific categories of medical software and apps that will not be regulated by the FDA because their use does not create a high level of patient risk. However, the FDA has the authority to regulate software in these categories if any safety concerns identified.

• Electronic health records;
• Administrative and operational, e.g. appointment software;
  
• Wellness apps, e.g. those used for tracking exercise;
  
• Software that transfers, stores, or displays medical device data, e.g. lab data; and
  
• Clinical decision support software.
  

Having clarity on these will help vendors move forward with more distinct and less costly development projects.

As a case manager, I am excited about the clinical aspects of this Bill. It provides $6.3 billion in biomedical research funding. $4.8 billion will go to the NIH over the next 10 years to help fund new innovative cures, treatments, and research initiatives for neuroscience, regenerative medicine, precision medicine, and cancer. Examples of these include President Obama’s BRAIN and Precision Medicine Initiatives ($1.4 billion) and Vice President Joe Biden’s Cancer Moonshot ($1.8 billion). [NOTE:The Cancer Moonshot program has been renamed the "Beau Biden Cancer Moonshot and NIH Innovation Projects" in honor of his son who died of cancer. The goal of the initiative is to make a decade’s worth of progress in five years in the prevention, diagnosis and treatment of cancer. Vice President Biden states this initiative is not meant to "start another war on cancer, but to win the war Nixon declared on cancer in 1971"].

An additional $500 million will go to the FDA over the next 10 years to make drugs and medical devices available to patients more quickly, while maintaining the same standard for safety and effectiveness. Another $1 billion will be given to States over the next 2 years for grants for opioid abuse prevention, treatment, monitoring, and training programs.

Having the focus on these healthcare initiatives should help us in our case manager role, as more new diagnostic procedures, drugs, and treatments become available. Clinical trials for medications, treatments, procedures, and medical devices should also be more available with easier, quicker access for patients who need them.

While the Cures Act was passed with overwhelming bi-partisan support, there were some legislators who did not vote for it because they felt that the less restrictive access requirements and the abbreviated time frames for the clinical trials may create less stringent oversight resulting in safety concerns and adverse outcomes. They are worried that the new products and programs will have fewer standards and be less effective. Others are worried about the cost of these programs. Some are upset because the bill cuts $3.5 billion from the Prevention and Public Health Fund that was established to promote the prevention of Alzheimer’s disease, hospital-acquired infections, and chronic illnesses and other ailments. While some of these programs will be included in the initiatives, the overall focus and amount of money allotted may be less now than it was before.

While everything identified in the bill may not get accomplished and there may be some problems, the overall goals of the Cures Act (modernize health care, encourage greater innovation, support research, and streamline the system) are exciting, challenging, and worth working towards. Health care is a complicated, complex, fast-moving industry, so we need to be able to keep pace. According to the U.S. House of Representatives Energy & Commerce Committee, "health research is moving quickly, but the federal drug and device approval apparatus is in many ways the relic of another era." We need to change that. New comprehensive laws like the 21^st Century Cures Act will continue to assure that the U.S. maintains its distinction as a world leader in healthcare innovation and infrastructure.

Pat Stricker, RN, MEd, is senior vice president of Clinical Services at TCS Healthcare Technologies. She can be reached at pstricker@tcshealthcare.com.