REGULATORY REVIEW


CMS Updates State Operations Manual Familiarize yourself with recent revisions to the Interpretive Guidelines BY KARA NEWBURY


In January, the Centers for Medicare & Medicaid Ser- vices (CMS) amended the State Operations Manual: Appendix L, which pro-


vides guidance to surveyors on how to interpret the ASC Conditions for Cov- erage (CfCs) when surveying facilities. In the industry, this manual is referred to as the “Interpretive Guidelines.” A few of the changes to the Inter-


pretive Guidelines were prompted after the May 2014 adoption of a final rule, titled Medicare and Medicaid Pro- grams; Regulatory Provisions To Pro- mote Program Efficiency, Transpar- ency, and Burden Reduction; Part II. This rule included changes to the radi- ologist on staff language in the CfCs. Whenever the CfCs are amended, CMS must also update the Interpretive Guidelines; CMS also took this oppor- tunity to make technical corrections and update and clarify other portions of the existing guidance. The interpretive guidelines became


effective immediately upon release of the Surveyor memo.


Major Changes Radiologist on Staff §416.49(b) The only CfC section impacted by the burden reduction rule mentioned above was the removal of the require- ment that ASCs have a radiologist on their medical staff. ASCA has long advocated for this change, noting that requiring ASCs to have a radiologist on staff does not make sense given that radiologic services in an ASC are gen- erally limited to intra-operative guid- ance that does not require interpreta- tion by a radiologist. The revised CfC language now indicates: (b)(1) Radiologic services may only


be provided when integral to procedures offered by the ASC and must meet the


22 ASC FOCUS MAY 2015


requirements specified in §482.26(b), (c)(2), and (d)(2) of this chapter. (2) If radiologic services are uti-


lized, the governing body must appoint an individual qualified in accordance with state law and ASC policies who is responsible for assuring all radiologic services are provided in accordance with the requirements of this section. The new CfC language requires an


ASC providing radiologic services to comply with only the following pro- visions of the hospital Conditions of Participation (CoP) for radiologic ser- vices: §482.26(b) (Safety for patients and personnel), (c)(2) (Only qualified personnel may use radiologic equip- ment and administer procedures) and (d)(2) (Maintenance for at least 5 years of certain records of radiologic ser- vices). The prior regulation required the ASC to comply with the entire hos- pital radiologic services CoP. The revised interpretive guidelines clarify that any radiological services provided as an integral part of the ASC’s surgical services must be speci- fied in writing and approved by the gov- erning body. If radiologic services are provided, the ASC’s governing body must appoint an individual with appro-


Track the Latest Regulatory and Legislative News for ASCs


Visit ASCA’s web site every week to stay up to date on the latest government affairs news affecting the ASC industry. Every week, ASCA’s Government Affairs Update newsletter is posted online for ASCA members to read. The weekly newsletter tracks and analyzes the latest legislative and regulatory developments concerning ASCs.


www.ascassociation.org/ GovtAffairsUpdate


priate qualifications in accordance with state and federal laws. CMS clari- fies that the person appointed to over- see radiologic services could be some- one already working in the ASC.


Hospital Transfers §416.41(b) The immediate hospital transfer guid- ance clarifies that


the ASC’s writ-


ten policies for an “effective trans- fer” of patients in case of emergency must include communicating with the receiving hospital. While it is still acceptable if the ASC contacts an ambulance service via 911 to arrange emergency transport (unless state law requires additional arrangements), the ASC is still responsible for communi- cating with the receiving hospital to facilitate the transfer.


CMS added language clarifying that the local hospital with which the ASC has a transfer agreement need not be the closest hospital to the facility. If the closest hospital could not accommodate the patient population or the predominant medi- cal emergencies associated with the type of surgeries performed by the ASC, another hospital that is able to do so would meet the “local” defini- tion. “For example, if there is a long- term care hospital within five miles of the ASC, and a short-term acute care hospital providing emergency services within 15 miles of the ASC, the ASC would be expected to trans- fer patients to the short-term acute care hospital.” An example, however, is given in


the interpretive guidelines that if an appropriate hospital is eight miles from the ASC, and another hospital with similar capabilities is located 20 miles from the ASC, the farther hos- pital would not be considered a local hospital for ASC emergency transfer


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