US · guidance
CMS SOM App. A, Tag A-0022
§482.11(b) The hospital must be--
(1) Licensed; or
(2) Approved as meeting standards for licensing established by the agency of the State or
locality responsible for licensing hospitals.
Interpretive Guidelines §482.11(b)
Hospitals applying for initial Medicare certification as a hospital or hospitals currently participating in
Medicare must, among other things, meet the statutory definition of a hospital under section 1861(e) of
the Act. Section 1861(e)(7) of the Act further requires that a hospital located in a state which provides
for the licensing of hospitals, the hospital must be licensed in accordance with state law or approved as
meeting standards for licensing as established by the agency of the State or locality responsible for the
licensing of hospitals.
While a facility may have a license from a state to operate as a hospital or may have been approved by a
state as a hospital under state or local standards and authorities, that facility may still not meet the
Medicare definition of a hospital as per the Act. The criteria used by a state to determine that a hospital
meets the requirements for state licensure as a hospital is not the same criteria used to define a hospital
for the purpose of participation in Medicare, and each state has its own criteria and standards for
licensure.
The definition of a hospital and the issue of whether the facility is Primarily Engaged are issues not
applicable to a Critical Access Hospital (CAH).
Survey Procedures §482.11(b)
• Prior to the survey, determine whether the hospital has a current license by the state or local
authority in which it operates, or, if it is located within a
State that does not license hospitals, verify that the responsible State agency has approved the
hospital as meeting the State’s established standards for the licensing of hospitals.
History
Rev.172, Issued: 11-17-17, Effective: 11-17-17, Implementation: 11-17-17
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
2e9442d68c415d11d20d7f2ac0924120ca138a0754c463dd4a09f34ccccdf788
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