CMS SOM App. L, Tag Q-0261

(1) The ASC must develop and maintain a policy that identifies those patients who

require a medical history and physical examination prior to surgery. The policy

must—

(i) Include the timeframe for medical history and physical examination to be

completed prior to surgery.

(ii) Address, but is not limited to, the following factors: Patient age,

diagnosis, the type and number of procedures scheduled to be performed on

the same surgery date, known comorbidities, and the planned anesthesia

level.

(iii) Be based on any applicable nationally recognized standards of

practice and guidelines, and any applicable State and local health and

safety laws.

Interpretive Guidelines §416.52(a)(1)

The purpose of a medical H&P is to determine whether there is anything in the patient's

overall condition that would affect the planned surgery, such as a medication allergy, or a

new or existing co-morbid condition that requires additional interventions to reduce risk

to the patient, or which may even indicate that an ASC setting might not be the

appropriate setting for the patient’s surgery.

ASCs must develop and maintain a policy that identifies those patients who require an

H&P prior to surgery. No specific list of surgical procedures or patient types is specified

in the CfCs. Instead, the ASC is expected to determine which patients require an H&P,

including the timeframe for completion, and develop policies to ensure those patients

receive the H&P prior to surgery. Policies must address certain patient characteristics

that may necessitate the need for examination and testing prior to surgery. These factors

include, but are not limited to:

• patient age (considering the need for H&P’s based on pediatric, adult, or geriatric

age differences),

• diagnosis,

• the type and number of procedures scheduled to be performed on the same

surgery date,

• known comorbidities (e.g. cardiac or pulmonary disease), and

• the planned anesthesia level (e.g. minimal sedation vs general anesthesia).

The ASC’s H&P policy must include the timeframe for the examination to be completed

prior to surgery. There is no “one size fits all” approach to the timeframe for H&P

completion. Although no longer required by the regulation, the ASC is not precluded

from retaining, in ASC policies, the previous timeframe requirement that H&Ps be

completed and documented for each ASC patient no more than 30 calendar days prior to

date of surgery. The current regulation allows ASCs to self-impose restrictions, and

allows all affected ASC providers to retain current restrictions for some categories of

surgery. It is also important to note that State law may have specific timeframe

requirements for ASCs to consider.

Policy development must be based on nationally recognized standards of practice and

guidelines, as well as any applicable State and local health and safety laws.

Consideration should also be given to information on H&P recommendations from

specialty societies and medical literature. For example, the American College of

Surgeons, the American Society of Anesthesiologists, the American College of

Cardiology, and the American Academy of Ophthalmology have best practice guidelines

or recommendations for preoperative care.

ASCs are encouraged to review the scope of procedures performed within their ASC

along with national standards, and then engage the governing body and medical staff to

determine which patients require an H&P prior to surgery. Additionally, the ASC should

conduct periodic assessments of its policies and procedures in order to ensure that

patients receive the appropriate pre-surgical assessments taking into consideration the

types of patients the ASC serves and the types of procedures performed in the ASC.

ASCs should also consider their policy and process for cases where the patient is referred

to the ASC for surgery on the same day as the referral. The policy should state how the

ASC will handle those situations that require a same day H&P per policy. The H&P may

be performed on the same day as the surgical procedure, and may be performed in the

ASC, as long as it is conducted by qualified personnel and the results of the H&P are

placed in the patient’s medical record prior to the surgical procedure (see §416.52(a)(4)).

It is not acceptable to conduct the H&P after the patient has been prepped and brought

into the operating or procedure room.

Survey Procedures: §416.52(a)(1)

• Review the ASC’s policies and procedures regarding H&Ps to determine if they are

consistent with the regulatory requirement.

• Is there documentation that the ASC has developed the H&P policies based on

nationally recognized standards of practice and guidelines, and any applicable State

and local health and safety laws?

• Determine through a sample of medical record reviews whether the ASC is following

its own policy.

• For H&Ps performed in the ASC on the day of the surgery, verify that the H&P is

performed and placed in the patient’s medical record prior to the surgical procedure.