CMS SOM App. L, Tag Q-0065

[§416.42(a)(1) Immediately before surgery --]

(i) A physician must examine the patient to evaluate the risk of the procedure to

be performed;

Interpretive Guidelines: §416.42(a)(1)(i)

The purpose of the exam immediately before surgery is to evaluate, based on the patient’s

current condition, whether the risks associated with the surgical procedure that will be

performed fall within an acceptable range for a patient having that procedure in an ASC,

given that the ASC does not provide services to patients requiring hospitalization. The

examination must be specific to each patient; it is not acceptable for an ASC to assume,

for example, that coverage of a specific procedure by Medicare or an insurance company

in an ASC setting is a sufficient basis to conclude that the risks of surgery are acceptable

generically for every ASC patient. The requirement for a physician to examine the

patient immediately before surgery is not to be confused with the separate requirement at

42 CFR 416.52(a)(1) for a history and physical (H&P) assessment, if required by ASC

policy. If an ASC’s policy requires an H&P be conducted prior to surgery, review of the

H&P is considered to be a component of a pre-surgical assessment as required under 42

CFR 416.52(a)(2) upon admission. In those cases, however, where a history and physical

assessment is required and performed in the ASC on the same day as the surgical

procedure, the assessment of the patient’s procedure/anesthesia risk must be conducted

separately from the H&P. See the interpretive guidelines for§§416.42(a)(1)(ii),

416.52(a)(1) & (2).

Survey Procedures: §416.42(a)(1)(i)

• Verify that there is evidence for every medical record in the survey sample of an

assessment by a physician of the patient’s risk for the planned surgery.

• Ask the ASC to provide you with its policies and procedures for assessment of

procedural risk.

• Ask the ASC’s leadership whether they can point to any cases where an

assessment resulted in a decision not to proceed with the surgery. If there are no

such cases, ask the ASC to explain how its patient selection criteria assure that

there is an acceptable level of procedural risk for every patient scheduled for

surgery in the ASC – for example, do they use patient admission criteria that

exclude higher risk patients? If so, ask to see those criteria.

• The survey sample should include cases where a patient died or needed to be

transferred to a hospital; discuss the pre-surgical assessment of the patient in those

cases, preferably with the physician who conducted the assessments, to explore

the basis on which the patient was found to be suitable for the surgery.