CMS Finalizes Sweeping Changes Aimed at Reducing Regulatory Burdens

September 25, 2019

The Centers for Medicare & Medicaid Services (CMS) today announced a final rule to relieve burden on healthcare providers by “removing unnecessary, obsolete or excessively burdensome Medicare compliance requirements for healthcare providers and suppliers.” CMS estimates that these changes will collectively save healthcare providers an estimated $843 million in the first year and slightly more in future years. There are two changes specific to ASCs and a third—regarding emergency preparedness requirements—that impacts many providers, including ASCs.

ASCA Members can access resources breaking down the burden reduction rule here. This includes a spreadsheet directly showing changes to ASC Conditions for Coverage (CfCs), as well as one pagers breaking down states with existing requirements for medical history and physical assessments (H&Ps) and transfer agreements. Changes will take effect November 29, 2019.

Transfer Agreements with Hospitals

Proposed Rule: CMS proposed to remove the requirements at 42 CFR 416.41(b)(3), “Standard: Hospitalization” for an ASC to have a written transfer agreement or hospital admitting privileges for all physicians who practice within the ASC. According to CMS, this was meant, in part, “to 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 for years to address this problem. As the rule indicates, the Emergency Medical Treatment & Labor Act (EMTALA) emergency response regulations would continue to address emergency transfer of a patient from an ASC to a nearby hospital. CMS indicated that it received split feedback in favor of and opposed to this proposed change.

Final Rule: CMS is finalizing revisions to § 416.41(b)(3) to require ASCs to periodically provide the local hospital with written notice of its operation and patient population served. For example, the notice would include details such as hours of operation and the procedures that are performed in the ASC. According to CMS, providing written notice, rather than securing a transfer agreement, will alleviate the administrative burden of negotiating or being denied negotiating opportunities associated with the written transfer agreement between the ASC and hospital. 

Requirements for Comprehensive Medical History and Physical Assessment

Proposed Rule: CMS proposed 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 would still have 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, all pre-surgical assessments would still be required to include documentation regarding any allergies to drugs and biologicals. The H&P, if completed, would be placed in the patient’s medical record prior to the surgical procedure.

Final Rule: CMS is finalizing the proposal to revise the requirement at § 416.47(b)(2) to state “Significant medical history and results of physical examination, as applicable.” They are finalizing the proposal to eliminate the requirement at § 416.52(a) for each patient to have a medical history and physical assessment completed by a physician not more than 30 days before the scheduled surgery and replace it with the requirement for ASCs to develop and maintain a policy that identifies those patients who require a medical history and physical examination prior to surgery. 

The facility’s policy must include the timeframe for the H&P to be completed prior to surgery. The policy must also address, but not be 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. Upon admission, each patient must have a pre-surgical assessment completed by a physician or other qualified practitioner, in accordance with applicable state health and safety laws, who will be performing the surgery. 

CMS is also revising § 416.52(a)(1)(iii) to clarify that the ASC policy must be based on nationally recognized standards of practice and guidelines, and applicable state and local health and safety laws.   

Emergency Preparedness

Several changes that were proposed regarding the emergency preparedness requirements healthcare providers and suppliers must comply with were also finalized. 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 (ASCs still need to try to coordinate with them, but facilities 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 need only one testing exercise per year instead of two
    • Providers must either participate in 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)

According to ASCA Chief Executive Officer Bill Prentice, “This rule will make it easier for ambulatory surgery centers to remain efficient and affordable providers of outpatient surgery without compromising their commitment to patient safety.”

This rule becomes effective on Friday, November 29. It is important to note that if your state law or accrediting body requirements are more restrictive than the new CMS Conditions for Coverage, those other requirements would take precedence. As staff continue to analyze the full extent of the rule, ASCA will provide more education to its members. For questions regarding this rule, please contact Kara Newbury.

Posted 9.25.2019