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FDA Announces Plan to Ban Shock Devices; Other HHS Regulatory Plans of Note

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FDA Announces Plan to Ban Shock Devices; Other HHS Regulatory Plans of Note

December 17, 2018

ANCOR is thrilled to announce that in a major win for the I/DD community last week, the Food and Drug Administration (FDA) announced it was “is finalizing a ban on electrical stimulation devices used to treat self-injurious or aggressive behavior.  FDA has determined that these devices present substantial and unreasonable risks of illness or injury that cannot be corrected or eliminated by labeling or a change in labeling.  In the proposed rule, FDA sought comments on its proposal to ban these devices and on associated issues.”

ANCOR has been advocating for the ban of electric shock devices for multiple years, which involved working with Senator Murphy (D-CT)  to get him to join the push for a ban and also this spring when we joined 200 organizations in asking the FDA to finalize its proposal to ban the devices. We will keep ANCOR members informed once the proposal is published and open to public comment.

The FDA announcement was made as part of the federal Fall Unified Agenda of Regulatory and Deregulatory Actions, which “reports on the actions administrative agencies plan to issue in the near and long term.” As part of this agenda, ANCOR notes that the Department of Health and Human Services’ statement of regulatory priorities includes:

  • Moving away from the fee-for-service model, stating that “Over the years, it has become increasingly apparent that the United States' fee-for-service payment system does not incentivize innovative therapies and intelligent treatment plans for patients.” ANCOR recently shared that the head of the Centers for Medicare and Medicaid Innovation (CMMI) stated interest in moving away from fee-for-service. Also note that this portion of the HHS statement includes language about revising HIPAA. See "HHS Announces Intention to Revisit HIPPA" for further discussion.
  • Protecting the exercise of conscience rights, which ANCOR has flagged to its members in the past over the course of this year because of the potential application to Direct Support Professionals.
  • Promoting flexibility for states, stating that “HHS intends to enhance regulatory flexibility so that its state and community partners are able to better tailor their programs to meet the needs of the people they serve.” ANCOR is flagging this because of its applicability to many issues of importance to the I/DD community, including the implementation of Electronic Visit Verification (EVV), which remains a priority policy issue for ANCOR.