Improving 21st Century Cures Act: Personalized Medicine and COVID-19

Foley & Lardner LLP

Foley & Lardner LLPOn April 27, 2020, Representatives Fred Upton (R-Michigan) and Diana DeGette (D-Colorado) released a “concept paper” to build on the success of the 21st Century Cures Act (Pub. L. 114-255) and improve the country’s surveillance and testing capabilities urgently needed to respond COVID-19 and future pandemics. 

Representatives DeGette and Upton originally introduced the first 21st Century Cures Act in the House on May 19, 2015. The House passed the bill with strong bipartisan support and it was signed into law by President Obama on December 13, 2016.

The Representatives’ April concept paper covers six key areas with initiatives across multiple agencies.

I.  Public Health

  • National Testing and Response Strategy for Current and Future Pandemics – the policy states that the President, “acting through the Secretary of Health and Human Service, shall be required to implement a national testing, data sharing infrastructure, vaccine, therapeutic, and medical supply readiness strategy to mitigate current and future pandemics.” Paper at page 1. 
  • COVID-19 Rare Disease Support Program – financial assistance would be provided to patients suffering from rare diseases and their families to assist them and navigate disruption of health care services caused by pandemics. 
  • Pandemic Preparedness Program for Patients – recognizing that patients face provider and resource shortages during the current battle with COVID-19, there is a need to help patients be prepared when a pandemic or other public health care emergency surfaces. This policy would establish a federal grant program for organizations to help support access to, and the cost of, health care for this and future pandemics.
  • Improving U.S. Pandemic Preparedness and Response through Support of Antimicrobial Resistance Product Commercialization – resources would be provided to support access to antibiotics, including federal support for pre-market and post-market costs for antibiotics.
  • Vaccine and Immunization Programs – support would be provided to strengthen the capacity of the Immunization Information System that in turn would provide effective preventative interventions. The policy would also improve education on the importance of vaccines and strengthen and support the capacity of the Immunization Information System (IIS) within the Centers for Disease Control and Prevention. 

II.  Caregiver Integration

  • Educational Programs and Training for Caregivers - recognizing that millions of American receive health care in their home from an informal caregiver, such as a close family member or friend, this policy supports grants for educational programs and training for caregivers to learn skills necessary to provide good care. 

III.  Patient Engagement in Health Care Decision-Making

  • Increasing Health Literacy to Promote Better Outcomes for Patients - this policy would promote systems and programs to assist Centers for Medicare & Medicaid Services (CMS) to promote greater health literacy of individuals.

IV.  Clinical Trials

  • Diversity in Clinical Trials – this policy would ensure that “Medicaid covers the routine costs of clinical trial participation for enrollees with life-threating conditions.” Paper at page 6. The policy aims to improve diversity in clinical trials.
  • Trial Sites at Care Sites – this policy would require CMS, in collaboration with FDA and NIH, to improve access to already covered medical services at clinical trial sites. This policy aims to remove barriers to medical services some Medicare patients encounter at a clinical trial site because they are not involved in a clinical trial.


  • Coordinated FDA Approach on Digital – the FDA Commissioner would be required to work with CDER, CBER and CDRH to establish “collaborative regulatory alignment where advisable” to the goal of having common regulatory standards across agencies on the integration of digital technologies for improved health care. Paper at pages 7-8.
  • FDA Grant-Making Authority and Funding – funds would be allocated to FDA to “provide grants in the area of innovative clinical trial design and patient-focused drug development to further build the science in these areas.” Paper at page 8.
  • Increasing Use of Real-World Data/Evidence – to support the use of real-world data (RWD) and real-world evidence (RWE) in agencies beyond FDA. Noting the successful use of Breakthrough Therapy Designation (BTD) that has expedited the development and approval of drugs to treat some serious conditions, this policy aims to build on this past success and apply RWD and RWE beyond BTD. 
  • Improve FDA-CMS Communication Regarding Transformative New Therapies – this provision would establish an automatic communication requirement between FDA and CMS for products granted BTD to ensure timely access to innovative products.

VI.  CMS Modernization

  • To the goal of allowing new treatments and technologies to benefit patients, Representatives Upton DeGette recognize that modern and systemic approaches to coverage and reimbursement are needed. Their position Paper requests additional feedback to understand impediments to adoption of health care treatments and technologies such as current coverage and reimbursement rules for new medical products, cell and gene therapies, medical products for small patient populations, and genomic sequencing. 

VII.  Technical Provisions

  • Breakthrough and Regenerative Medicine Advanced Therapy (RMAT) – Breakthrough Therapy and RMAT designation programs at FDA were implemented to expedite the development and review of drugs that could treat patients with serious or life-threating conditions. However, FDA will only review designation requests that if there is an investigational new drug (IND) application in place. This policy would remove this requirement for sponsors who have “collected scientifically valid preliminary clinical evidence outside of the U.S. to receive the benefits of these designations for investigational new drugs that otherwise meet the BT and RMAT criteria. Paper at page 12.
  • Removal of Geo-Tracking and Biometrics within Electronic Visitation Verification (EVV) – “Section 12006 of the 21st Century Cures Act requires that all states mandate the use of EVV systems for Medicaid funded personal care services … and home health care services.” Page at page 12. This policy would remove geo-tracking and biometrics within EVV systems to account for changes in service location and address privacy concerns.” Paper at page 12.

Personalized Medicine and COVID-19

The current COVID-19 pandemic has brought to light health care policies and programs that work for our nation and exposes those where modernization and improvement are needed. Initially targeted toward improving personalized therapies in general, the immediate impact of the 21st Century Cures Act was seen in cancer treatment and regenerative medicine. However, personalized medicine’s focus on diagnostics and follow up has provided a framework for further application to infectious disease. Fast action is necessary, and DeGette and Upton are hoping to put the pandemic and clinical trial portions into the next round of COVID-19 funding bills.1 


1 Baumann “Cures 2.0 Aims to Speed Up Virus Response, Curb Future Outbreaks” see

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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