4 Critical Regulatory and Reimbursement Trends to Watch

3. Federal Health R&D Budget Priorities Getting Set Now. SHOW US THE MONEY!

In 2018 R&D spending by the federal government rose 12/8%—the largest annual increase in recent memory—to $176.8 billion. That’s serious money.

For the next federal budget, will R&D spending continue its upward trajectory and where will the money be spent?

This past September 3, 2019, the White House’s Office of Management and Budget (OMB) and the Office of Science and Technology Policy (OSTP) answered the second of those questions releasing the Administration’s FY 2021 research and development budgetary priorities.

For medicine, here are the key priorities.

1. 1. Artificial Intelligence, Quantum Information Science, and Computing: Departments and agencies should prioritize basic and applied research investments that are consistent with the 2019 Executive Order on Maintaining American Leadership in Artificial Intelligence. In terms of computing, departments and agencies should work together to explore new applications in and support R&D for high performance future computing paradigms, fabrication, devices, and architectures.
   2. Biomedicine: Departments and agencies should prioritize R&D investments aimed at combatting the opioid crisis, rapid detection and containment of infectious diseases, anti-microbial resistance, chronic disease prevention and treatment, gene therapy, neuroscience, medical countermeasures and public health preparedness, eradicating HIV/AIDS once and for all, and enhancing the independence, safety, and wellness of aging Americans and individuals with disabilities.
   3. Bioeconomy: The American Bioeconomy represents the infrastructure, innovation, products, technology, and data derived from biologically related processes and science that drive economic growth, promote health, and increase public benefit. The increasing economic value and public benefits derived from the research, innovation, and applications in the biological and agricultural sciences need to be better measured, promoted, and safeguarded. Departments and agencies should prioritize evidence-based standards and research to rapidly establish microorganism, plant, and animal safety and efficacy for products developed using gene editing, to better accelerate biotechnology product adoption and socially responsible use.
   4. Advance Science and Technology and ensure maximum return on taxpayer investment in R&D, the laboratory, the factory, the field, and any other setting where R&D is performed must welcome all individuals without prejudice and enable them to work safely, efficiently, ethically, and with respect, consistent with the American values of free inquiry, competition, openness, and fairness. Four high-priority areas related to research environments require significant attention: • Reducing administrative burdens on federally funded research; 13 • Improving rigor and integrity in research; • Creating safe and inclusive research environments; and • Protecting American research assets.

4. CMS to Require All ACA Plans to Publish Their Star Ratings

On August 15, 2019, Centers for Medicare and Medicaid Services (CMS) announced that the Trump Administration will now require Affordable Care Act (ACA) plans offered through a Health Insurance Exchange to display their quality star ratings on gov and the state-based exchange (SBE) websites. The star ratings, which score plans on a scale of 1 to 5, are based on a series of 38 quality measures categorized into 3 buckets: medical care, member experience, and plan administration. This nationwide policy is set to go into effect during the 2020 open enrollment period, which begins on November 1, 2019.