Congress Considers Payment for Non-opioids in the NOPAIN Act
The Non-Opioids Prevent Addiction in the Nation Act (NOPAIN Act) has been introduced in the Senate. If passed, this bill would temporarily establish Medicare reimbursement for a period of five years for certain drugs, biologics, and devices used for pain management that are able to replace or reduce opioid consumption, as shown through clinical trials or data. The bill would also require CMS to submit a report to Congress identifying the limitations, gaps, barriers to access, or deficits in Medicare coverage or reimbursement for restorative therapies, behavioral approaches, and complementary and integrative health services that are identified in the Pain Management Best Practices Inter-Agency Task Force Report.

The NOPAIN Act was introduced on March 4th by Senators Rob Portman, Jeanne Shaheen, Shelley Moore Capito, and Joe Manchin, and has been referred to the Committee on Finance.

Deadline for Responding to CDC and FDA Draft Guidance is April 11
CDC continues to accept public comments on CDC Clinical Practice Guideline for Prescribing Opioids—United States, 2022. AACIPM is currently working with a writing group made up of varied stakeholder organizations and experts to develop a collective response. If you are a leader of an organization or policy group interested in learning more about this effort, contact Amy Goldstein, Director, AACIPM.

FDA continues to accept feedback from the public on their draft Development of Non-Opioid Analgesics for Acute Pain. The guidance provides recommendations about three specific topics: development of non-opioid analgesic products for acute pain, labeling claims, and expedited programs as they pertain to this purpose.

Public comments are due for both dockets no later than April 11, 2022.

Appropriations Update: FY 2022 Budget Finalized, Increases Health Funding
After numerous congressional delays, President Joe Biden signed the Consolidated Appropriations Act, 2022 (H.R. 2471) into law on March 15, 2022. The law completes all funding bills for federal agencies for FY 2022, including finalization of the NIH Budget.

The bill impacts healthcare in a number of ways, including, but not limited to:

  • $45 billion for NIH in FY 2022, an increase of $2.03 billion over FY 2021.
  • $50 million for health disparities research at National Institute on Minority Health and Health Disparities.
  • $16.2 million to the Office of the Chief Officer for Scientific Workforce Diversity, an increase of $10 million over FY 2021 levels, to continue to lead efforts to combat racism and improve diversity in the biomedical research workforce.
  • $541 million for the All of Us precision medicine initiative.
  • $350 million for the Agency for Healthcare Research and Quality (AHRQ), an increase of $12.4 million above the FY 2021 spending level.
  • $799 million for the Health Resources and Services Agency (HRSA) Title VII Health Professions and Title VIII Nursing Workforce Development Programs, a 5% increase above FY 2021 levels.
  • $8 million for the CDC Social Determinants of Health Pilot Program.

With the budget now finalized, federal agencies are poised to release a large number of funding opportunities that were pending, subject to the final appropriations bill. NIH has already cleared a number of important pain-related research concepts for funding, and it is strongly recommended that stakeholders explore these possible funding opportunities prior to seeing official notices posted for them.

NIH and NIDA Continue to Fund Various Pain-related Projects
Funding opportunities related to pain management, integrative care, and other related topics continue to abound.

The NIH HEAL Initiative currently has open funding opportunities related to:

  • Availability of Administrative Supplements to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in Clinical Studies (Application Due 04/29)
  • Research Supplements to Promote Diversity in Health-Related Research (Admin Supp – Clinical Trial Not Allowed) (Application Due 05/15)
  • Discovery and Functional Evaluation of Human Pain-Associated Genes and Cells (LOI Due 6/07)
  • Discovery of Biomarkers and Biomarker Signatures to Facilitate Clinical Trials for Pain Therapeutics (LOI Due 05/24)
  • Discovery and Validation of Novel Targets for Safe and Effective Pain Treatment (LOI Due 5/02)

NIDA is currently aiming to fund:

  • Public Health Research on Cannabis, including impact of polysubstance use on health outcomes, including interactions (substitution/complementation) of cannabis product use with alcohol, tobacco, and prescription and nonprescription opioids. (Begins accepting applications June 5, 2022)