Knowledge Base Article

The Calendar Year (CY) 2021 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule (CMS-1736-FC) was released on December 2, 2020 and is scheduled to be published in the Federal Register on December 29th. A Wednesday@One article released earlier this month highlighted changes to the Inpatient Only Procedure List and the Hospital Outpatient Department Prior Authorization Program.

This week’s article details finalized changes for supervision of outpatient therapeutic services and the Ambulatory Surgical Center (ASC) Covered Procedures List.

Changes in the Level of Supervision of Outpatient Therapeutic Services in Hospitals and Critical Access Hospitals (CAHs)

In the 2020 OPPS Final Rule, CMS finalized their proposed policy to change the “generally applicable minimum required level of supervision for hospital outpatient therapeutic services from direct supervision to general supervision for services furnished by all hospitals and CAHs.” General supervision means that the procedure is furnished under the physician’s overall direction and control, but that the physician’s presence is not required during the performance of the procedure.

This policy became effective January 1, 2020 and will remain in place for future years unless modified by later notice and comment rulemaking.

In the 2021 OPPS Proposed Rule, CMS noted that a March 31, 2020 interim final rule with comment period (IFC) was issued with the intent to give providers “needed flexibilities to respond effectively to the serious public health threats posed by the spread of the COVID-19.”

Specific to the level of supervision the following policies were adopted in the IFC to be effective for the duration of the Public Health Emergency (PHE) due to COVID-19:

• A policy to reduce the minimum default level of supervision for non-surgical extended duration therapeutic services (NSEDTS) to general supervision for the entire service, including the initiation portion of the service, for which CMS previously required direct supervision on initiation of the service.
• A policy indicating that the requirement for direct supervision of pulmonary, cardiac and intensive cardiac rehabilitation services includes virtual presence of the physician through audio/video real-time communications technology when use of such technology is indicated to reduce exposure risks for the beneficiary or health care provider.

CMS decided that these policies are appropriate outside of the PHE and proposed to adopt them for CY 2021 and beyond.

NSEDTS Level of Supervision

In the final rule, CMS finalized their proposal without modification to reduce the minimum default level of supervision for NSEDTS to general supervision. They do “note that the requirement for general supervision for an entire NSEDTS does not preclude these hospitals from providing direct supervision for any part of a NSEDTS when the practitioners administering the medical procedures decide that it is appropriate to do so. Many outpatient therapeutic services, including NSEDTS, may involve a level of complexity and risk such that direct supervision would be warranted even though only general supervision is required.”

In response to a comment from Med PAC, CMS intends to “monitor NSEDTS for safety or service quality issues that may arise from the change to general supervision as the minimum default level of supervision for the initiation period of these services.”

Direct Supervision of Pulmonary, Cardiac, and Intensive Cardiac Rehabilitation Services Using Interactive Telecommunication Technology

Several commenters expressed concerns regarding the proposed change to direct supervision for these three rehabilitation services.

Ultimately, CMS finalized their “proposed policy to permit direct supervision of these services using virtual presence only until the later of the end of the calendar year in which the PHE ends or December 31, 2021. Specifically, the required direct physician supervision can be provided through virtual presence using audio/video real-time communications technology (excluding audio-only) subject to the clinical judgement of the supervising practitioner, as discussed in IFC-1 (85 FR 19246).

When the policy to permit direct supervision through virtual presence ends, we will resume our current policy to require direct physician supervision of pulmonary rehabilitation, cardiac rehabilitation, and intensive cardiac rehabilitation services, and that the supervising practitioner must be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the procedure. This does not mean that the supervising practitioner must be present in the room when the procedure is performed.”

CMS also clarified “that, to the extent our policy allows direct supervision through virtual presence using audio/video real-time communications technology during the PHE, the requirement could be met by the supervising practitioner being immediately available to engage via audio/video technology (excluding audio-only), and would not require real-time presence or observation of the service via interactive audio and video technology throughout the performance of the procedure.”

Proposed Additions to the Ambulatory Surgical Center (ASC) Covered Procedures

In general procedures on the ASC covered procedure list (ASC-CPL) are those procedures that are not “expected to pose a significant safety risk to a Medicare beneficiary when performed in an ASC, and for which standard medical practice dictates that the beneficiary would not typically be expected to require active medical monitoring and care at midnight following the procedure.”

CMS proposed to continue to apply the revised definition of “surgery” adopted in the CY 2019 OPPS/ASC Final Rule that includes procedures that are “surgery-like” procedures that are assigned outside the CPT surgical range, for CY 2021 and subsequent years.

CMS Outlook for the Future of the ASC-CPL

CMS reiterated many thoughts/beliefs about the future of ASCs included in the proposed rule. Following are some of the statements found in the final rule:

• CMS believes “that significant advancements in medical practice, surgical techniques, medical technology, and other factors have allowed certain ASCs to safely perform procedures that were once too complex, including those involving major blood vessels and other general exclusion criteria.”
• CMS acknowledges “that ASCs and hospitals have different health and safety requirements. Despite this fact, ASCs often undergo accreditation as a condition of state licensure and share some similar licensure and compliance requirements with hospitals as well as meet Medicare conditions for coverage (see 42 CFR 416.40 through 416.54).”
• CMS reminds the reader that “in recent years, we have added procedures to the ASC-CPL that were largely considered hospital inpatient procedures in the past, such as total knee arthroplasty (TKA) and certain coronary intervention procedures.”
• “Many procedures that are currently only payable as hospital outpatient services under Medicare fee-for-service are safely performed in the ASC setting for other payors.”
• CMS recognizes “that non-Medicare patients tend to be younger and have fewer comorbidities than the Medicare population.” However, “careful patient selection can identify Medicare beneficiaries who are suitable candidates for these services in the ASC setting.”
• “Medicare Advantage plans are not obligated to adopt the ASC-CPL as it exists in Medicare fee-for-service and…many MA enrollees have had services performed in the ASC setting that are not currently payable under Medicare fee-for-service.”
• “The COVID-19 pandemic has highlighted the need for more healthcare access points throughout the country…Looking ahead to after the pandemic, it will be more important than ever to ensure that the health care system has as many access points and patient choices for all Medicare beneficiaries as possible. Because the pandemic has forced many ASCs to close, thereby decreasing Medicare beneficiary access to care in that setting, we believe allowing greater flexibility for physicians and patients to choose ASCs as the site of care, particularly during the pandemic, would help to alleviate both access to care concerns for elective procedures as well as access to emergency care concerns for hospital outpatient departments.”
• “In the CY 2021 OPPS/ASC proposed rule, we sought to continue to promote site neutrality, where possible, between the hospital outpatient department and ASC settings, and expand the ASC CPL to include as many procedures that can be performed in the HOPD as reasonably possible to advance that goal.”

CMS finalized without modification the addition of the eleven proposed procedures to the ASC-CPL. These procedures are listed in Table 59 of the final rule.

Table 59: Final Additions to the List of ASC Covered Surgical Procedures for CY 2021

Specific to the addition of total hip arthroplasty (THA) to the ASC-CPL, CMS notes in the final rule that they “are aware that beneficiaries may incur greater cost-sharing for THA procedures in an ASC setting under our proposal, but note that this is not an occurrence that is unique to THA.” Section 4011 of the 21st Century Cures Act added the requirement that the Secretary make a searchable website available to the public, “with respect to an appropriate number of items and services, the estimated payment amount for the item or service under the OPPS and the ASC payment system and the estimated beneficiary liability applicable to the item or service.” CMS implemented this provision by providing an Outpatient Procedure Price Lookup tool available at https://www.medicare.gov/procedure-price-lookup. “This web page allows beneficiaries to compare their potential cost-sharing liability for procedures performed in the hospital outpatient setting versus the ASC setting.” CMS that this tool will include cost-sharing liability for THA in the outpatient hospital and ASC settings in the future.

At the end of the day, whether a procedure is performed in the Inpatient, Outpatient or ASC setting, documentation is crucial to accurately reflect the complexity of the patient, support the medical necessity for services provided and support the setting in which the services are performed.