Knowledge Base Article

The CMS released the Calendar Year (CY) 2022 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule on November 2, 2021. This article focuses on changes to the Inpatient Only (IPO) List and medical review of claims. Click here for an article reviewing changes to the ASC covered procedure list and hospital price transparency civil monetary penalties.

CMS reminds providers that “The removal of a service from the IPO list does not require the service to be performed only on an outpatient basis…we reiterate that services that are removed from the IPO list can be and are performed on individuals who are admitted as inpatients (as well as individuals who are registered hospital outpatients) when the patient’s condition warrants inpatient admission (65 FR 18456). It is a misinterpretation of CMS payment policy for providers to create policies or guidelines that establish the hospital outpatient setting as the baseline or default site of service for a procedure based on its removal from the IPO list. As stated in previous rulemaking, services that are no longer included on the IPO list are payable in either the inpatient or hospital outpatient setting subject to the general coverage rules requiring that any procedure be reasonable and necessary, and payment should be made pursuant to the otherwise applicable payment policies (84 FR 61354; 82 FR 59384; 81 FR 79697).”

Criteria used prior to CY 2021 to assess for removal of a procedure from the Inpatient Only (IPO) list:

• Most outpatient departments are equipped to provide the services to the Medicare population.
• The simplest procedure described by the code may be furnished in most outpatient departments.
• The procedure is related to codes that we have already removed from the IPO list.
• A determination is made that the procedure is being furnished in numerous hospitals on an outpatient basis.
• A determination is made that the procedure can be appropriately and safely furnished in an ASC and is on the list of approved ASC services or has been proposed by us for addition to the ASC list.

In CY 2021, CMS removed 298 musculoskeletal-related services from the IPO List and finalized the elimination of the list over three years. For CY 2022, CMS has done a one-eighty and finalized the following changes:

• The IPO list is not being eliminated,
• A reference of phasing out the IPO list through a 3-year transition has been removed,
• The five longstanding criteria for determining whether a service or procedure should be removed from the IPO list is being codified in regulation text, and
• Most of the procedures removed from the IPO list in CY 2021 are being added back to the list.

Commenters believed a few codes should not be added back to the IPO list and CMS agreed. CPT codes not being added back to the IPO list includes:

• CPT 22630: Arthrodesis, posterior interbody technique, including laminectomy and/or discectomy to prepare interspace (other than for decompression), single interspace; lumbar,
• CPT 23472: Arthroplasty, glenohumeral joint; total shoulder (glenoid and proximal humeral replacement (for example, total shoulder),
• CPT 27702: Arthroplasty, ankle; with implant (total ankle) and corresponding anesthesia codes:
• CPT 01638: Anesthesia for open or surgical arthroscopic procedures on humeral head and neck, sternoclavicular joint, acromioclavicular joint, and shoulder joint; total shoulder replacement, and
• CPT 01486: Anesthesia for open procedures on bones of lower leg, ankle, and foot; total ankle replacement

AccuCinch Device: New Inpatient Only Procedure

For the July 2021 update, the AMA’s CPT Editorial Panel established CPT code 0643T (Transcatheter left ventricular restoration device implantation including right and left heart catheterization and left ventriculography when performed, arterial approach) to describe the AccuCinch device implantation procedure.

CMS proposed to assign this code to status indicator (SI) “E1” (Items, codes, and services not covered by any Medicare outpatient benefit category; statutorily excluded; not reasonable and necessary) to indicate the service is not covered by Medicare.

A commenter requested the code be reassigned the inpatient-only SI “C,” believing “this is the more appropriate assignment for the ventricular restoration therapy based on the complex patient population enrolled in the US clinical trial. The commenter explained that the investigational device, the AccuCinch® Ventricular Restoration System, is currently under evaluation in the CORCINCH-HF pivotal trial (NCT04331769).”

CMS noting that “Based on the interventional structural heart (SH) technique involved in the procedure, use of an experimental device, and close monitoring of the patient that is required during the intra- and post-op period consistent with the resources available in the hospital inpatient setting, we believe the AccuCinch procedure should be designated as an inpatient-only procedure. We note that the CORCINCH-HF pivotal trial (NCT04331769) was approved by Medicare and meet’s CMS’ standards for coverage as an Investigation Device Exemption (IDE) study effective November 11, 2020.”

CMS finalized change the SI “E1” to “C” for CPT code 0643T.

Information about this procedure is available on the Ancora Heart, Inc. website at https://www.ancoraheart.com/ and information about the clinical trial at https://clinicaltrials.gov/ct2/show/NCT04331769.

Table 48 of the Final Rule lists changes made to the IPO list for CY 2022. Addendum E to this Final Rule includes all inpatient only procedure codes for CY 2022.

Medical Review of Certain Inpatient Hospital Admissions

For CY 2021, CMS finalized “that procedures removed from the IPO list after January 1, 2021, were indefinitely exempted from site-of-service claims denials under Medicare Part A, eligibility for BFCC-QIO referrals to RACs for noncompliance with the 2-Midnight rule, and RAC reviews for “patient status” (that is, site-of-service).” This exemption was to remain in place until Medicare claims data showed a procedure was performed more than 50 percent of the time in the outpatient setting.

For CY 2022, CMS finalized the proposal to “rescind the indefinite exemption and instead apply a 2-year exemption from two midnight medical review activities for services removed from the IPO list on or after January 1, 2021.”

As a provider, keep in mind this exemption is specific to site-of-service claim denials and does not include exemption from medical necessity reviews of services based on a National or Local Coverage Determinations (NCDs and LCDs) when applicable. Once a surgical procedure has been removed from the IPO List, documentation in the record must support the need for the inpatient admission.

Resources

CY 2022 OPPS Final Rule

• CMS Press Release: https://www.cms.gov/newsroom/press-releases/cms-oppsasc-final-rule-increases-price-transparency-patient-safety-and-access-quality-care
• CMS Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/cy-2022-medicare-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center-0