; or (II) in the event that any of such regulations have not taken effect by such end date, the moratorium under subparagraph (11) shall be extended until such regulations are final and effective. (iii) Limitation The authority to promulgate regulations under this paragraph is limited to setting forth the details necessary and appropriate to carry out the requirements of subparagraph (B) efficiently, effectively, and in conformity with such subparagraph. (B) Standards and requirements (i) Hospital Child Site Standards (I) In general Hospitals described in subparagraphs (L) and (M) of paragraph (4) may register off-campus outpatient facilities associated with the hospital (also known as child sites ) to participate in the drug discount program under this section (beginning after the moratorium under paragraph (11) ends), if— (aa) the site is listed on the hospital’s most recently filed Medicare cost report on a line that is reimbursable under the Medicare program (or, if the hospital is a children’s hospital that does not file a Medicare cost report, the hospital submits to the Secretary a signed statement certifying that the facility would be correctly included on a reimbursable line of a Medicare cost report if the hospital filed a cost report); (bb) such cost report demonstrates that the services provided at the facility have associated costs and charges for hospital outpatient department services under title XVIII of the Social Security Act (or, if the hospital is a children’s hospital that does not file a Medicare cost report, the hospital submits to the Secretary a signed statement certifying that the services provided at the facility include or consist solely of outpatient services); (cc) the facility is wholly owned by the covered entity