Introduction to CMS Hospital-at-Home Rule
COVID did a lot of things. One new initiative launched by the Centers for Medicare & Medicaid Services (CMS) was to allow hospitals to enroll acute care patients at home. Launched on November 25, 2020, during the COVID-19 public health emergency, the Acute Hospital Care at Home (AHCAH) initiative was designed to provide hospitals with the flexibility to deliver acute care in home settings, alleviating pressure on hospital facilities and improving patient outcomes.
To receive approval to participate in AHCAH, hospitals must submit an individual waiver request to CMS. The request specifically asks CMS to waive 42 CFR 482.23(b) & (b)(1) of the Medicare Conditions of Participation, which require nursing services to be provided on premises 24 hours a day, seven days a week, as well as the immediate availability of a registered nurse for the care of any patient.
There are over 400 hospitals in 39 states that are approved to provide AHCAH services to patients. In October of 2024, CMS reported that patients had lower mortality rates, and lower readmission rates.
The AHCAH initiative was extended multiple times, most recently by the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026, through January 30, 2026. CMS will no longer accept waiver requests for participation in the AHCAH initiative after January 1, 2026. Perhaps with a long-term extension of the AHCAH, this will change. One thing I hope Congress will consider is the use of controlled substances in conjunction with the AHCAH.
The problem with these CMS rules and dispensing controlled substances
What the AHCAH program does NOT account for is the use of controlled substances. An inpatient at a hospital would receive controlled substances through a doctor’s order, which would be charted and administered by another practitioner. This is allowed because the hospital is a DEA-registered location where controlled substances are allowed to be dispensed by a practitioner. 21 CFR 1301.12(a).
The AHCAH allows patients to be enrolled as inpatients of a hospital at their home. The problem is that these locations are not DEA-registered locations where controlled substances can be dispensed or administered from hospital stock.
The DEA has said there are only two ways to administer controlled substances to a patient enrolled in AHCAH. The first is the DEA’s “the black bag exception.” Noted in the Becker Decision, practitioners are allowed to travel with controlled substances outside of their registered locations on an “as needed and random basis.” DEA has said that if dispensing at locations is scheduled and frequent, then the “black bag exception” no longer applies, and the practitioner must register at those locations. This is impractical for most AHCAH patients, who would most likely not allow their residences to be registered. This brings us to option two, delivering a prescription to the AHCAH patient. A DEA-registered pharmacy is allowed to deliver a controlled substance prescription to a patient or another member of their household. Some states allow DEA-registered hospitals to dispense prescription drugs, or the hospital system may have a separate on-site registered retail pharmacy where the dispensing can occur. Usually, hospitals do not dispense prescriptions because it is outside the scope of hospital practice.
Action Needed
Congress should consider changing regulations related to controlled substances with any extension of the AHCAH.
Need Help?
If you need any advice on the CSA and its implementing regulations, email me at sarah.boblenz@sbrinksconsulting.com. I would be happy to help you.
#deaconsulting #deacompliance #brinksdeaconsulting #CMShospitalathome
Disclaimer: Brinks DEA Consulting and its employees are not attorneys and do not provide legal advice. The guidance offered is based solely on their extensive experience in DEA compliance and investigations. If you need help finding a specialized attorney in DEA regulations, reach out to us—we’re happy to assist.