The Centers for Medicare and Medicaid Services (CMS) released proposed changes to the Conditions of Participation for ambulatory surgery centers (ASCs), hospitals, and other segments of the health care industry on Monday. CMS indicated that it has gathered feedback from stakeholders, and this proposal would address 55 percent of the issues. As a result, CMS may release more proposals in the future.

The proposal indicated that it is addressing several issues that the ASC Association brought to CMS’s attention. Click here to download the proposal.  Click here to read CMS’s fact sheet.

ASC Transfer Agreements with Hospitals
The proposal would eliminate the requirements for ASCs to have a written transfer agreement with hospitals or physicians performing services at ASCs to have privileges at transfer hospitals. CMS indicated that this policy has been “rendered obsolete by other patient protections.”

Per CMS (page 9 and page 27):

We propose to remove the requirements at 42 CFR 416.41(b)(3), “Standard: Hospitalization.” This would address the competition barriers that currently exist in some situations where hospitals providing outpatient surgical services refuse to sign written transfer agreements or grant admitting privileges to physicians performing surgery in an ambulatory surgical center (ASC). The Emergency Medical Treatment and Labor Act emergency response regulations would continue to address emergency transfer of a patient from an ASC to a nearby hospital.

New ASC Requirements for H&P
Per CMS (page 9 and page 27):

We propose to remove the current requirements at § 416.52(a) and replace them with requirements that defer, to a certain extent, to the ASC policy and operating physician’s clinical judgment to ensure that patients receive the appropriate pre-surgical assessments tailored to the patient and the type of surgery being performed. We still would require the operating physician to document any pre-existing medical conditions and appropriate test results, in the medical record, which would have to be considered before, during and after surgery. In addition, we have retained the requirement that all pre-surgical assessments include documentation regarding any allergies to drugs and biologicals, and that the medical history and physical examination (H&P), if completed, be placed in the patient’s medical record prior to the surgical procedure.

It is important to note the commentary by CMS on page 33:

Our proposed change would simply eliminate the requirement for a pre-operative H&P, while allowing patient-specific physician decisions and ASC-wide policy decisions to determine what examinations and tests are necessary for each patient. Such decisions could be informed by specialty societies, medical literature, past experience, or other factors. We believe the proposed changes will reduce burden and provide flexibility for patients while maintaining a balance of health and safety requirements for providers.

In reading the discussion that follows, it is important to understand that the requirement for making a patient assessment at the ASC, on the day of surgery and before surgery commences, remains unchanged. This assessment addresses any new surgical risks for the patient with procedure-specific or patient-specific questions (for example, has the patient had a fever in the last 24 hours or, for a patient with diabetes, have there been any recent changes to random blood glucose levels with at-home monitoring?). The questions focus on any recent changes or updates to the patient’s condition since the last H&P that might adversely impact the outcome of the procedure for the patient. This assessment must occur before proceeding with the procedure. Furthermore, we are not proposing to eliminate or discourage comprehensive pre-surgical H&Ps where warranted. To replace the current arbitrary 30-day rule applying to all patients, regardless of procedure or risk, we propose that each facility make an independent determination as to which procedures and which patient profiles would dictate requiring a …

New Hospital H&P for Outpatients
Per CMS (page 10):

We propose to allow hospitals the flexibility to establish a medical staff policy describing the circumstances under which such hospitals could utilize a pre-surgery/pre-procedure assessment for an outpatient, instead of a comprehensive medical history and physical examination (H&P). We believe that the burden on the hospital, the practitioner, and the patient could be greatly reduced by allowing this option. In order to exercise this option, a hospital would need to document the assessment in a patient’s medical record. The hospital’s policy would have to consider patient age, diagnoses, the type and number of surgeries and procedures scheduled to be performed, comorbidities, and the level of anesthesia required for the surgery or procedure; nationally recognized guidelines and standards of practice for assessment of specific…

CMS Asks for Additional Comments on ASCs
CMS placed a strong emphasis on ASCs in this summer’s calendar year (CY) 2019 Medicare payment proposal for ASCs and hospital outpatient departments when CMS pushed favorable proposals for ASCs. In this latest proposal, CMS hinted that it will introduce future initiatives that are favorable for ASCs:

We seek to reduce burdens for health care providers and patients, improve the quality of care, decrease costs, and ensure that patients and their providers and physicians are making the best health care choices possible. Therefore, we are soliciting public comments on additional regulatory reforms for burden reduction in future rulemaking. Specifically, we are seeking public comment on additional proposals or modifications to the proposals set forth in this rule that would further reduce burden on ASCs and create cost savings, while also preserving quality of care and patient health and safety. Consistent with our “Patients Over Paperwork” Initiative, we are particularly interested in any suggestions to improve existing requirements, within our statutory authority, where they make providing quality care difficult or less effective.

Unified and Integrated Quality Assessment System for Hospitals
CMS is proposing to allow multi-hospital systems to have a unified and integrated Quality Assessment and Performance Improvement system and a unified infection control program for all member hospitals.

Portable X-Ray Services
CMS made new proposals related to portable x-ray services, which are primarily used for chest and extremity studies in nursing homes, long-term care facilities, and homebound scenarios. CMS is proposing to remove certain training requirements for radiological technicians.