CMS Proposes Sweeping Changes Aimed at Reducing Regulatory Burdens

September 18, 2018

The Centers for Medicare and Medicaid Services (CMS) announced a proposed rule to relieve burden on healthcare providers by “removing unnecessary, obsolete or excessively burdensome Medicare compliance requirements for healthcare facilities.” CMS estimates that these proposed changes would collectively save healthcare providers an estimated $1.12 billion annually. There are two changes specific to ASCs and a third—regarding emergency preparedness requirements—that impacts many providers, including ASCs.

Transfer Agreements with Hospitals

CMS proposes to remove the requirements at 42 CFR 416.41(b)(3), “Standard: Hospitalization.” According to CMS, “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 ASC.” ASCA has been working with CMS to address this problem. As the rule indicates, the Emergency Medical Treatment and Labor Act (EMTALA) emergency response regulations would continue to address emergency transfer of a patient from an ASC to a nearby hospital.

Requirements for Comprehensive Medical History and Physical Assessment

CMS is also proposing 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.” The operating physician still must 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, all pre-surgical assessments must 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.

Emergency Preparedness

Several changes were proposed regarding the emergency preparedness requirements healthcare providers and suppliers must comply with, and the following apply to ASCs:

    • Review of Emergency Plan (EP) every two years (instead of annually)
    • Elimination of requirement that facilities document efforts to contact local, tribal, regional, State and Federal EP officials (Still need to try to coordinate with them, but facilities would simply no longer need to document their efforts)
    • Training requirement changed from every year to every two years (or when EP is significantly updated)
    • Outpatient providers only need one testing exercise per year instead of two
      • Providers must participate in either a community-based full-scale exercise (if available) or conduct an individual facility-based functional exercise every other year
      • In the opposite years, providers may conduct a testing exercise of their choice, which may include: a community-based full-scale exercise (if available), an individual facility-based functional exercise, a drill, or a tabletop exercise or workshop that includes a group discussion led by a facilitator
    • Providers are exempt from the next required exercise after an event requiring activation of EP plan (i.e., if your facility must deal with an emergency)

ASCA leadership, including the Government Affairs Committee, are in the initial stage of formulating the association’s formal response. If you have any comments or questions, please contact Kara Newbury.