HANDS Act

This bill requires Medicare, Medicaid, and TRICARE to cover opioid overdose reversal drugs at no cost to patients when furnished preventively at hospitals, critical access hospitals, rural emergency hospitals, emergency departments, or ambulatory surgical centers. It also directs the FDA to issue guidance on hospital-based distribution of these drugs.

Sec. 3, No-cost coverage of preventive opioid overdose reversal drugs: Under Medicare, the bill adds preventive opioid overdose reversal drugs as a covered benefit starting January 1, 2024, defined as drugs furnished by a clinician to an inpatient or emergency department patient determined to be at risk for opioid overdose, given at discharge with administration instructions. Medicare must pay 100% of the cost, and no deductible or cost-sharing applies. Medicare Advantage plans must also cover these drugs without cost-sharing. Under Medicaid, states must include these drugs in their state plans and alternative benefit plans starting January 1, 2024, without any deductions, cost-sharing, or similar charges. The drugs are added to the list of medical assistance, subject to drug rebate requirements, and deemed prescribed drugs for rebate purposes. Cost-sharing is prohibited for these drugs under both regular and alternative Medicaid cost-sharing rules. Under TRICARE, eligible covered beneficiaries cannot be required to pay cost-sharing for a preventive opioid overdose reversal drug starting January 1, 2024, using the same definition as in the Social Security Act.

Sec. 4, Regulatory guidance: Within one year of enactment, the FDA Commissioner must issue guidance for state boards of pharmacy, nursing, and medicine on enhancing safe and effective hospital-based dispensing and distribution of opioid overdose reversal drugs and eliminating barriers to such dispensing and distribution.