SECTION 1: PUBLIC HEALTH AND COVID-19 RESPONSE

Pandemic Planning
Cures 2.0 contains several provisions that would establish collaborative
practices based on lessons learned during the COVID-19 pandemic. The legislation would require the secretary of Health and Human Services (HHS) to conduct a nationwide study to further understand the implications of long COVID, a condition that causes patients to experience a range of symptoms related to COVID-19 for weeks, and even months, after contracting the virus. It also would require the secretary to develop a nationwide testing and vaccine distribution strategy, including consideration for how to help patients with rare diseases mitigate public health emergencies, to be used in future pandemics following a series of national meetings with key stakeholders. It would also propose $25 million annually for the CDC to fund a public education campaign on the importance of vaccines for fiscal years 2022-24.

Antimicrobials
It would require HHS to establish a Committee on Critical Need Antimicrobials made up of representatives from NIAID, CDC, BARDA, FDA, CMS, VA and DoD that would develop regulations for approving “critical need antimicrobial drugs” – a new FDA designation – as well as other recommendations and include education strategies for providers and patients on appropriate use of antimicrobial drugs.

SECTION 2: PATIENTS AND CAREGIVERS

Caregivers
Cures 2.0 authorizes grants for caregiver education and training programs to improve the skills of the home care team to better complement clinical visits.

Health Literacy
It would require HHS to work with CMS to improve health literacy to ensure patients from multicultural and multilingual backgrounds can understand their illness, covered benefits and the treatment options at their disposal.

Diversity in Clinical Trials
Cures 2.0 has several provisions to address transparency and barriers currently inhibiting diversity in clinical trials that include:

• HHS Secretary Report: It would require HHS to provide a report to Congress and the FDA containing the prevalence of demographic subgroups (sex, age, race and ethnicity) in clinical trials and whether subgroup-specific safety and effectiveness measures have been implemented. The report must be made available to the public and include an action plan with HHS recommendations to improve the representation of demographic subgroups in clinical trials.
• Government Accountability Office (GAO) Report: It would direct GAO to review how HHS currently addresses participation barriers faced by populations underrepresented when conducting or supporting clinical trials.
• Improving Recruitment Efforts in Clinical Trials: The bill would require HHS to implement a public awareness campaign to improve the recruitment of minorities in clinical trials. The campaign must increase awareness and understanding of upcoming and current clinical trials and how to enroll in the trials as well as increase the availability of enrollment resources.

SECTION 3: FOOD AND DRUG ADMINISTRATION

Communication and Digital Health
With the goal of having common regulatory standards across agencies on the integration of digital technologies for improved health care, it would establish an automatic communication requirement between FDA and CMS for products granted BTD to ensure timely access to innovative products. HHS would be required to submit a report to Congress on how to improve interagency collaboration and alignment on digital health technologies.

Novel Trial Design Grants
It would authorize a new $25 million grant program for incorporating novel clinical trial designs into clinical protocols and applications for drugs, prioritizing the use of digital health technologies and real-world evidence in drug development.

Cell and Gene Therapy
HHS would have to inform Congress about the current state of cell and gene therapy regulations and potential regulatory challenges for the FDA in the future.

Real World Evidence
It would create the Real World Evidence Task Force to coordinate HHS programs and provide recommendations on ways to encourage patient engagement in using this evidence.

InterCenter Institutes
Cures 2.0 would create at least two new institutes within FDA with one focusing on the most burdensome diseases that represent a leading cause of mortality or disability or affecting at least 50 million Americans and the other focusing on diseases impacting fewer than 200,000 people in the U.S. or for which over 90% of such diseases have no therapy approved by FDA or over 50% of patients are children.

Breakthrough Therapies
It would clarify when sponsors of drugs and regenerative medicine can be granted investigational drugs and apply for BTD during the FDA approval process. The FDA would also be required to publish guidance to provide clarity on the development and submission of chemistry, manufacturing, and controls (CMC) data relating to breakthrough therapies, fast track products, accelerated approval, and regenerative advanced therapies. Finally, other evidence—real world evidence—is allowed to be used and can derive from clinical evidence or patient registries to fulfill post-approval study requirements to confirm the predicted clinical benefit of a therapy.

SECTION 4: CENTERS FOR MEDICARE AND MEDICAID SERVICE

Telehealth, Medicare Restrictions and Coverage
The bill includes the Telehealth Improvement for Kids’ Essential Services (TIKES) Act, which would assist states in effectively integrating telehealth into their Medicaid program and CHIP. It also includes the Telehealth Modernization Act, which would permanently remove Medicare's geographic and originating site restrictions and extend the waivers implemented during the pandemic. This means a patient must no longer live in a rural area and be physically in a doctor's office or clinic to use telehealth services. It would also allow HHS to permanently expand the types of services that can be reimbursed under Medicare and the types of health care providers that can offer telehealth services. In addition, HHS must provide a report on the current capabilities and deficiencies of CMS’s computer systems.

Breakthrough Devices
Cures 2.0 would require that when FDA designates a breakthrough device, during the transitional coverage period (that starts on the date of approval and ends after four years) a breakthrough device is deemed to be reasonable and necessary and approved for pass-through payment. Within three months of this FDA approval, HHS must assign a unique temporary or permanent code for coverage. After the four year period, HHS must establish a process for the coverage of these breakthrough devices. HHS must provide a report to Congress on this program.

Genomics
Cures 2.0 would increase access to genetic screening and counseling by covering genomic precision medicine consultation but only when provided by a qualified licensed pharmacist with appropriate training. It would create a pediatric DNA sequencing clinical services demonstration project spanning up to five states (with preference for states that do not cover DNA sequencing clinical services) to provide genomic testing for children with rare diseases. Project participants must provide information and data on how such services improve the diagnosing of rare diseases, explanation of how and the extent to which coverage of genomic testing may improve clinical outcomes, and a report to the Health Resources and Services Administration (HRSA) on the extent to which DNA sequencing reduces health disparities. Further, a pilot grant program would be created within the CMS Innovation Center to test the delivery of personalized-medicine consultations. Finally, it prohibits the use of geographic tracking features and biometrics within Medicare electronic visit verification (EVV) system.

SECTION 5: RESEARCH

ARPA-H
It would establish President Biden’s ARPA-H initiative with $6.5 billion. Its mission would be to speed transformational innovation in health research and application and advance the implementation of health breakthroughs. The new ARPA-H would be largely modeled after the military’s Defense Advanced Research Projects Agency, or DARPA. ARPA-H would aim to accelerate new medical breakthroughs with the intent to cure cancer, Alzheimer’s and other devastating diseases. Specifically, ARPA-H would:

• Take on work that requires large scale, sustained coordination
• Expand capacity in fields such as technologies, data resources, and disease models
• Establish new paradigms by supporting high risk endeavors
• Use solutions, such as financial incentives, to overcome market failures
• Complement research undertaken by the NIH and the private sector.

To support additional research, it would provide $25 billion for universities, research institutions, and public laboratories throughout the country to continue their work on thousands of federally funded research projects.