Jaya White, Kiel Zillmer Write American Health Law Association Health Law Connections Magazine Article About Regulatory Compliance Challenges in Home Infusion Care Industry
Jaya White and Kiel Zillmer, both Quarles & Brady Health & Life Sciences attorneys, wrote an article for the American Health Law Association Health Law Connections magazine about how new infusion care models are moving faster than current rules, causing confusion for providers. It emphasizes that providers need to stay updated to avoid potential penalties.
An excerpt:
To be enrolled as a home infusion therapy provider under the Medicare Part B HIT benefit, the home infusion provider must become accredited with one of the Medicare-approved accreditation organizations, 8 which creates an additional step to receiving reimbursement for the infusion nursing and education services. As discussed in more detail below, while time-consuming and costly, accreditation with a Medicare-approved organization may help address certain state issues, which tie Medicaid enrollment to Medicare-certification.
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Depending upon the underlying ownership structure, the scope of services offered, and the professional licensure (if any) held by the owners of the business, the guidance document also makes clear that these IV therapy providers (and by potential extension, infusion therapy providers) may require licensure with the RIDOH, including as organized ambulatory care facilities (OACFs). Licensure as an OACF requires prior review by the Rhode Island Health Services Council, a 30-day public comment period, and approval by the licensing agency.
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Originally published by American Health Law Association Health Law Connections, March 1, 2026
Copyright 2026, American Health Law Association, Washington, DC. Reprint permission granted.