Knowledge Base Category -

Did You Know?

In response to the COVID-19 Public Health Emergency, the CMS has published several Interim Final Rules with comment period (IFC). Included in the April 6, 2020 IFC, (https://www.govinfo.gov/content/pkg/FR-2020-04-06/pdf/2020-06990.pdf), with respect to pulmonary rehabilitation, cardiac rehabilitation, and intensive cardiac rehabilitation services, CMS adopted a change, “to specify that direct supervision for these services includes virtual presence 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.”

The CY 2021 OPPS Final Rule finalized maintaining this policy change being until the end of the PHE or December 31, 2021, whichever is later. The PHE was renewed on October 15, 2021, meaning this change will remain in place at least through January 13, 2022.

CMS again references this policy change in the CY 2022 OPPS Final Rule (https://public-inspection.federalregister.gov/2021-24011.pdf), noting, “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 judgment of the supervising practitioner.”

Why This Matters?

With the recent release of the CY 2022 OPPS/ASC final rule, MMP has had clients ask if CMS will make this option for audio/video real-time physician supervision for these rehabilitation services permanent. Specific to this question, I have listed a few comments by the CMS in the CY 2022 OPPS/ASC final rule:

• Commentors are in favor of adoption of direct supervision via two-way, audio/video communication technology on a permanent basis, or if the decision is made to end this flexibility, they encourage CMS to maintain this policy for a period following the COIVD-19 PHE, such as the end of 2022.
• Most commentors were in favor of developing a service-level modifier to allow CMS to track and collect data.
• Based on public comments, and feedback since the policy was implemented, CMS is convinced “that we need more information on the issues involved with direct supervision through virtual presence before implementing this policy permanently.”

Whether or not this policy becomes permanent, facilities providing cardiac rehabilitation services need to be aware of and compliant with coverage requirements for a couple of reasons. First, this continues to be an area of focus for Medicare review contractors. Second, given that according to the CDC ( https://www.cdc.gov/heartdisease/facts.htm), heart disease costs the United States about $363 billion each year from 2016 to 2017, cardiac rehabilitation is big business. You can read more about how cardiac rehabilitation can help heal your heart on the CDC website (https://www.cdc.gov/heartdisease/cardiac_rehabilitation.htm).

So, just how big of a business is cardiac rehabilitation? To answer this question, I turned to RealTime Medicare Data (RTMD). Specifically, volume and paid claims data below represent Medicare Fee-for-Service outpatient hospital claims in the entire RTMD footprint for calendar years 2019 and 2020 for cardiac rehabilitation CPT codes 93798 (outpatient cardiac rehab with continuous ECG monitoring) and 93979 (outpatient cardiac rehab without continuous ECG monitoring).

CY 2019	Procedure Volume	% Of Procedure Volume	Sum of Paid Claims
CPT 93798	3,718,721	94.00%	$307,007,481.00
CPT 93797	239,673	6.00%	$19,584,844.68
Combined	3,958,394	100.00%	$326,592,325.68

CY 2019 Top 5 States by Procedure Volume

• Florida (292,461)
• Texas (287,575)
• California (229,235)
• Illinois (186,899), and
• Pennsylvania (164,897)

CY 2020	Procedure Volume	% Of Procedure Volume	Sum of Paid Claims
CPT 93798	2,290,837	94.00%	$178,236,580.99
CPT 93797	150,097	6.00%	$11,486,994.57
Combined	2,440,934	100.00%	$189,723,575.56

CY 2020 Top 5 States by Procedure Volume

• Florida (182,865),
• Texas (180,179),
• California (131,190),
• Illinois (120,897), and
• Pennsylvania (105,882)

Even though the COVID-19 PHE had an impact on procedure volume and sum of paid claims, collectively across the country, Medicare payment for cardiac rehabilitation is big business.

What Can You Do?

• Be aware of documentation needed to support medical necessity of the services provided,
• Submit medical record requests to the Medicare Contractor in a timely manner, and
• Read a related article in this week’s newsletter to learn who is currently targeting Cardiac Rehabilitation and what coverage documents and education resources are available by CMS and Medicare Contractors.

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. In a related Fact Sheet (link), they note that this Final Rule “includes policies that align with several key goals of the Administration, including addressing the health equity gap, fighting the COVID-19 Public Health Emergency (PHE), encouraging transparency in the health system, and promoting safe, effective, and patient-centered care.”

CMS estimates “that the OPPS expenditures, including beneficiary cost-sharing, for CY 2022 would be approximately $82.1 billion, which is approximately $5.9 billion higher than estimated OPPS expenditures in CY 2021.”

Changes to the Ambulatory Surgical Center (ASC) Covered Procedure List (CPL)

In the CY 2022 OPPS Proposed Rule, CMS also did an about face for the ASC CPL. Of the 267 procedures added to the list in CY 2021, CMS proposed to remove 258 procedures as they do not believe they meet the proposed revisions to the CY 2022 ASC CPL criteria.

CMS noted in the Proposed Rule, “Based on our internal review of preliminary claims submitted to Medicare, we do not believe that ASCs have been furnishing the majority of the 267 procedures finalized in 2021. Because of this, we believe it is unlikely that ASCs have made practice changes in reliance on the policy we adopted in CY 2021. Therefore, we do not anticipate that ASCs would be significantly affected by the removal of these 258 procedures from the ASC CPL.”

After reviewing recommendations made by commentors, CMS finalized the removal of 255 of the 258 codes proposed from the ASC CPL. Table 62 in the Final Rule includes the complete list of 255 procedures.

Revisions to the CY 2022 ASC CPL Criteria

In CY 2021, CMS revised their policy for adding surgical procedures to the ASC CPL. For CY 2022, they have finalized their proposal to revise the requirements for covered surgical procedures to reinstate the general standards and exclusion criteria established prior to CY 2021.

Inpatient, outpatient or ASC, documentation is crucial to accurately reflect the complexity of the patient, support the medical necessity for services provided and support the setting in which services are performed.

Hospital Price Transparency Increase in Civil Monetary Penalties

CMS noted in the Proposed Rule from initial months of experience with enforcing the hospital price transparency requirements that they expressed “concern by what appears to be a trend towards a high rate of hospital noncompliance identified by CMS through sampling and reviews to date.” One approach to address this trend was their proposal to impose potentially higher penalties and “to scale the CMP to ensure the penalty amount would be more relevant to the characteristics of the noncompliant hospital.”

CMS agrees with commenters in the Final Rule “that application of a scaling approach using bed count would be an effective way to ensure compliance, consistency and fairness in application of penalties across noncompliant hospitals” and finalized their proposal as follows:

• Hospitals with a bed count ≤ 30 will have a minimum Civil Monetary Penalty (CMP) of $300 per day or $109,500 for a full CY of noncompliance,
• Hospitals with at least thirty-one beds up to and including 550 beds will have a penalty of $10 per bed per day or a range from $113,150 to $2,007,500 penalty for a full CY of noncompliance depending on bed size, and
• Hospitals with greater than 550 beds will have a daily dollar penalty of $5,500 or $2,007,500 for a full CY of noncompliance.

Learn about changes to the Inpatient Only (IPO) by clicking here.

Resource

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

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

CMS Resumes Targeted Probe & Educate Program

In response to the COVID-19 Public Health Emergency (PHE), CMS suspended medical review activities on March 30, 2020. In August 2020, Recovery Auditors, Comprehensive Error Rate Testing Program, and Medicare Administrative Contractor post-payment reviews were resumed. At that time, the Targeted Probe and Educate (TPE) program remained on hold.

On May 8, 2019, CMS put a temporary hold on SSRs and HWDRG reviews as they planned to procure a new contractor to review both types of reviews on a national basis. The expectation was to award the contract by the 3rd quarter of calendar year 2019.

According to a CMS TPE Q&A document (link), when performing medical review as a part of this program, Medicare Administrative Contractors (MACs):

• Focus on specific providers/suppliers who, through data analysis, have been identified as varying significantly from their peers,
• Typically review 20-40 claims per provider/supplier, per item or service (round),
• Provide individualized education based on review results after a round, and
• Perform up to three rounds of reviews per item or service.

The CMS announced in the Thursday August 12, 2021, edition of MLN Connects (link) that the TPE Program is restarting “to help educate providers and reduce future denials and appeals.”

Livanta to Begin Short Stay Reviews and Higher Weighted DRG Reviews

Kepro and Livanta are the two Beneficiary and Family Centered Care Quality Improvement Organizations (BFCC-QIOs) that serve all regions across the nation. The BFCC-QIO scope of work, among other things includes performing certain types of medical record reviews. Two specific reviews are Short Stay Reviews (SSRs) and Higher Weight Diagnosis-Related Group (HWDRG) review.

It wasn’t until April of 2021, that Livanta announced they had been awarded this contract. On August 11, 2021, Livanta released a Provider Bulletin (link) to announce the official start of claims reviews. The bulletin includes information on the following topics:

• What Hospitals Can Expect,
• Hospital Inpatient Claim Review Types,
• HWDRG Review Process,
• SSR Process, and
• Questions and Education.

The review process for each type of medical review includes the timing of when they will begin requesting records. For HWDRG reviews, they expected to send the first medical record request the week of August 16th. For SSRs, Livanta anticipated sending the first individual medical record requests on or about the week of September 20, 2021. Note, record requests will be sent to your Medical Record point of contact via fax when possible or U.S. mail if fax is not possible. A hospital sample will consist of 30 claims reviewed within a rolling 3-month period and records must be submitted electronically.

I encourage you to visit Livanta’s webpage (link), read the Provider Bulletin and share this information with appropriate staff at your facility.

“The primary objective of the IPPS and the LTCH PPS is to create incentives for hospitals to operate efficiently and minimize unnecessary costs, while at the same time ensuring that payments are sufficient to adequately compensate hospitals for their legitimate costs in delivering necessary care to Medicare beneficiaries.”

- Source: Appendix A: Economic Analysis of FY 2022 IPPS Final Rule

CMS released the display copy of the Fiscal Year (FY) 2022 Inpatient Prospective Payment System (IPPS) Final Rule (CMS-1752-F) on Monday August 2, 2021. This article focuses on New Technology Add-On Payments (NTAP) for FY 2022.

New Technology Add-On Payment Pathways

There are now several pathways for a new services or technology to be approved for New Technology Add-On Payments (NTAPs) including:

• Traditional Pathway: To meet this pathway, the medical service or technology must be new, must be costly such that the DRG rate otherwise applicable to discharges involving the NTAP is inadequate, and must demonstrate a substantial clinical improvement over existing services or technologies.
• Certain Antimicrobial Products Alternative Pathway: In FY 2021 the alternative pathway for Qualified Infectious Disease Products (QIDPs) was expanded to include products approved under the Limited Population for Antibacterial and Antifungal Drugs (LPAD) pathway. In the Final Rule, CMS finalized policy to refer more broadly to “certain antimicrobial products” rather than specifying FDA programs for antimicrobials (i.e., QIDPs and LPADs). Products approved through this pathway will be considered new and not substantially similar to an existing technology and will not need to demonstrate that it meets the substantial clinical improvement criterion. However, the technology will need to meet the cost criterion.
• Certain Transformative New Devices Alternative Pathway: Beginning in FY 2021, “if a medical device is part of FDA’s Breakthrough Devices Program and received FDA marketing authorization, it will be considered new and not substantially similar to an existing technology for purposes of the new technology add-on payment under the IPPS.” However, the new device must meet the cost criterion and must receive marketing authorization for the indication covered by the Breakthrough Device Program designation.

For the alternative pathways, a technology is not required to have a specified FDA designation at the time the application for NTAP is made. Instead, “CMS will review the application based on the information provided under by the applicant under the alternative pathway specified by the applicant. However, to receive approval for the new technology add-on payment under that alternative pathway, the technology must have the applicable designation and meet all other requirements in the regulations in § 412.87(c) and (d), as applicable.”

Additional Payment for NTAP’s

Payment for an NTAP is based on the cost to hospitals for the new medical service or technology. As set forth in § 412.88(b)(2), unless the discharge qualifies for an outlier payment, the additional Medicare payment will be limited to the following:

• For “Traditional Pathway” and “Certain Transformative New Devices”, Medicare will make an add-on payment equal to the lesser of: (1) 65 percent of the costs of the new medical service or technology; or (2) 65 percent of the amount by which the costs of the case exceed the standard DRG payment.
• For Certain Antimicrobial NTAPs (QIDPs and LPADs), Medicare will make an add-on payment equal to the lesser of: (1) 75 percent of the costs of the new medical service or technology; or (2) 75 percent of the amount by which the costs of the case exceed the standard DRG payment.

Coding NTAPs

Section X is the New Technology section that was added to ICD-10-PCS effective October 1, 2015. CMS has indicated that Section X was created in response to public comments received regarding New Technology proposals presented at ICD-10 Coordination and Maintenance Committee Meetings, and general issues facing classification of new technology procedures. The public had opposed many requests to add new codes to the existing ICD-10-PCS sections for the use of specific drugs, devices, or supplies in an inpatient setting, even when the code related to an application for New Technology add-on payments.

NTAPs for FY 2022 by the Numbers

NTAPs are not budget neutral and generally this add-on payment is limited to the 2-to-3-year period after the date a technology becomes available. Due to the COVID-19 Public Health Emergency (PHE) impacting hospital volumes, CMS finalized using FY 2019 data for rate setting. They also finalized a one-year extension of NTAPs for technologies that would have otherwise been discontinued beginning October 1, 2021.

CMS estimates the payment amounts for new technology add-on payments in the Final Rule based on the applicant’s estimates. This amount and the estimated number of patients is highlighted in Appendix A of the Final Rule. Appendix A begins on page 2,174 of the display version of the Final Rule.

• A total of 42 services or technologies have been approved for NTAPs,
• The estimated total amount to be paid to hospitals is $1,424,341,317.63, and
• The estimated number of patients is 468,206.
• The estimated number one NTAP by volume and payment is Veklury® (remdesivir) with an estimated 174,996 cases and estimated total payment of $354,891,888.00. This drug is used in the treatment of COVID-19 patients.

NTAPs FY Trend: Number of Services or Technologies Approved for NTAP

• FY 2020: 18
• FY 2021: 24
• FY 2022: 40

NTAPs FY Trend: Estimated Number of Patients to Receive a New Technology during an Inpatient Stay

• FY 2020: 71,659
• FY 2021: 259,201
• FY 2022: 468,206

New COVID-19 Treatment Add-on Payments (NCTAPs)

As new therapies were approved in response to the COVID-19 PHE, New COVID-19 Treatments Add-on Payment (NCTAP) were created. CMS finalized the following related to NCTAPs in the FY 2022 IPPS Final Rule:

• The NCTAP for eligible COVID-19 products will extend through the end of the fiscal year in which the PHE ends, and
• A hospital will be eligible to receive the NCTAP and the traditional NTAP for qualifying patient stays, through the end of the fiscal year in which the PHE ends, with the NTAP reducing the amount of the NCTAP.

You can learn more about NCTAP’s on the related CMS COVID-19 NCTAP specific webpage (link).

Moving Forward

Identifying and coding new technologies is an opportunity not to be missed for those hospitals providing these services. That said, some questions come to mind for you to think about:

• Is your hospital providing any of these medical services or technology?
• Who needs to be aware of what the new technologies are? (i.e. Physicians, Pharmacy, Coding Professionals, Clinical Documentation Integrity Specialists, Case Managers)
• What process do you have in place to alert your Coding Staff of the need to code the new technologies?

Resources:

CMS August 2, 2021, Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/fiscal-year-fy-2022-medicare-hospital-inpatient-prospective-payment-system-ipps-and-long-term-care-0

FY 2022 IPPS CMS webpage: https://www.cms.gov/medicare/acute-inpatient-pps/fy-2022-ipps-final-rule-home-page

In general, my day-to-day focus as it relates to Medicare Fee-for-Service guidance, is the acute hospital inpatient and outpatient setting. Last week, CMS issued Christmas in July gifts, in the form of 4 final FY 2022 payment rules. While not my day-to-day focus, highlights, and links to information about the final rules are important enough to share with you, our readers, who may be impacted.

FY 2022 Skilled Nursing Facility (SNF) Prospective Payment System (CMS-1746-F)

Major provisions in this final rule are highlighted in a related CMS Fact Sheet (link) and includes:

• FY 2022 Updates to the SNF Payment Rates,
• Methodology for Recalibrating the Patient Driven Patient Model (PDPM) Parity Adjustment,
• Rebase and Revise the SNF Market Basket by using the 2018-based SNF market basket to update the PPS payment rates, instead of the 2014-based SNF market basket,
• Section 134 of the Consolidated Appropriations Act, 2021 – New Blood Clotting Factor Exclusion from SNF Consolidated Billing,
• Changes in the PDPM ICD-10 Code Mappings,
• SNF Quality Reporting Program (SNF QRP) update, and
• SNF Value-Based Purchasing (SNF VBP) Program.

FY 2022 Hospice Payment Rate Update Final Rule (CMS-1745-F)

Major provisions highlighted in a related CMS Fact Sheet (link) includes:

• FY 2022 Routine Annual Rate Setting Changes,
• Other Medicare Hospice Payment Policies,
• Changes to the Hospice Conditions of Participation (CoPs) in response to the COVID-19 Public Health Emergency (PHE),
• Hospice Quality Reporting Program, and
• Home Health Quality Reporting Program.

FY 2022 Inpatient Rehabilitation Facility (IRF) Prospective Payment System (PPS) Final Rule (CMS-1748-F)

Major provisions in this final rule in a related CMS Fact Sheet (link) includes:

• Updates to IRF Payment Rates,
• IRF Quality Reporting Program (IRF QRP) Updates, and
• Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Policy Issues.

FY 2022 Inpatient Psychiatric Facility (IPF) Prospective Payment System Final Rule (CMS-1750-F)

Major provisions highlighted in a related CMS Fact Sheet (link) includes:

• FY 2022 Updates to the IPF Payment Rates,
• Updates to the IPF Teaching Policy, and
• IPF Quality Reporting Program (IPF QRP) Updates.

Question

In last week’s article about the OPPS and ASC Proposed Rule you indicated that CMS has proposed to remove 258 procedures that were added to the ASC covered procedure list in CY 2021. What procedures are remaining on the ASC list?

Answer

In the CY 2021 Final Rule, the finalized additions to the ASC Covered Procedure List were separated into two tables:

• Table 59 listed procedures added under the standard review process, and
• Table 60 listed procedures added under the second alternative proposal considered for CY 2021.

The procedures proposed for removal from the ASC list for CY 2022 are from Table 60. The procedures listed in Table 59 were not proposed for removal from the ASC list and includes the following CPT/HCPCS codes:

• 0266T: Implantation or replacement of carotid sinus baroreflex activation device; total system (includes generator placement, unilateral or bilateral lead placement, intra-operative interrogation, programming, and repositioning, when performed),
• 0268T: Implantation or replacement of carotid sinus baroreflex activation device; pulse generator only (includes intra-operative interrogation, programming, and repositioning, when performed),
• 0404T: Transcervical uterine fibroid(s) ablation with ultrasound guidance, radiofrequency,
• 21365: Open treatment of complicated (e.g., comminuted or involving cranial nerve foramina) fracture(s) of malar area, including zygomatic arch and malar tripod; with internal fixation and multiple surgical approaches,
• 27130: Arthroplasty, acetabular and proximal femoral prosthetic replacement (total hip arthroplasty), with or without autograft or allograft,
• 27412: Autologous chondrocyte implantation, knee,
• 57282: Colpopexy, vaginal; extra-peritoneal approach (sacrospinous, iliococcygeus),
• 57283: Colpopexy, vaginal; intra-peritoneal approach (uteroscacral, levator myorrhaphy),
• 57425: Laparoscopy, surgical, colpopexy (suspension of vaginal apex),
• C9764: Revascularization, endovascular, open or percutaneous, and vessel(s); with intravascular lithotripsy, includes angioplasty within the same vessel(s), when performed, and
• C9766: Revascularization, endovascular, open or percutaneous, any vessel(s); with intravascular lithotripsy and atherectomy, includes angioplasty within the same vessel(s), when performed.

Resources:

• CY 2021 OPPS Final Rule and ASC Payment System Final Rule [CMS-1736-FC]: https://www.cms.gov/medicaremedicare-fee-service-paymenthospitaloutpatientppshospital-outpatient-regulations-and-notices/cms-1736-fc
• CY 2022 OPPS and ASC Payment System Proposed Rule {CMS-1753-O]
  Note, see table 45 for procedures proposed for removal from the ASC Covered Procedures List. (link)
• Related MMP Article: CY 2022 OPps and ASC Proposed Rule – Inpatient Only List and ASC Covered Procedure List (link)

The Calendar Year (CY) 2022 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule (link) was released on July 19, 2021.

CMS estimates “that total payments to OPPS providers (including beneficiary cost-sharing and estimated changes in enrollment, utilization, and case-mix) for calendar year (CY) 2022 would be approximately $82.704 billion, an increase of approximately $10.757 billion compared to estimated CY 2021 OPPS payments.”

CMS, in general, plans to use 2019 claims data for rate setting due to the COVID-19 PHE. Examples of specific decreases or increases in claims in CY 2020 cited by CMS includes:

• An approximate 20 percent decrease in the overall volume of outpatient hospital claims,
• An approximate 30 percent decrease in volume in the APCs for hospital emergency department and clinic visits,
• For HCPCS code Q3013 (Telehealth originating site facility fee) in the hospital outpatient claims, the approximate 35,000 services billed in CY 2019 increased to 1.8 million services in the CY 2020.

Inpatient Only Procedure List

Historically, CMS used the following five criteria 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 a complete one-eighty, CMS has proposed to halt the elimination of the IPO list and, “after clinical review of the services removed from the IPO list in CY 2021,” add the 298 services removed in CY 2021 back to the IPO list beginning in CY 2022. CMS has also proposed to codify the five longstanding criteria for potential removal from the IPO list.

CMS noted that “many commenters, including hospital associations and hospital systems, professional associations, and medical specialty societies, vociferously opposed eliminating the IPO list. These commenters primarily cited patient safety concerns, stating that the IPO list serves as an important programmatic safeguard and maintains a common standard of medical judgment in the Medicare program.”

CMS requests public comments on several questions related to the IPO list. For example, “what information or support would be helpful for providers and physicians in their considerations of site-of-service selections?

Proposed Medical Review of Certain Inpatient Hospital Admissions under Medicare Part A for CY 2022 and Subsequent Years

Once a surgical procedure has been removed from the IPO List, documentation in the record must support the need for the inpatient admission. CMS reminds providers that “removal of a service from the IPO list has never meant that a beneficiary cannot receive the service as a hospital inpatient – as always, the physician should use his or her complex medical judgment to determine the appropriate setting on a case-by-case basis.”

For CY 2020, CMS finalized a two-year exemption from site-of-service claim denials, Beneficiary and Family Centered Care Quality Improvement Organization (BFCC-QIO) referrals to RACs, and RAC reviews for “patient status” (that is, site-of-service) for procedures that are removed from the IPO list under the OPPS beginning on January 1, 2020.

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-Midngiht rule, and RAC reviews for “patient status” (that is, site-of-service).” This exemption was to remain in place until Medicare claims data indicated a procedure was being performed more than 50 percent of the time in the outpatient setting.

On Monday, July 19th, WPS posted the following notice about spinal neurostimulators prior authorization requests:

For CY 2022, CMS has proposed 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 provided based on a National or Local Coverage Determinations (NCDs and LCDs) when applicable.

Proposed Changes to the Ambulatory Surgical Center (ASC) Covered Procedure List (CPL)

CMS is also doing an about face for the ASC CPL. Of the 267 procedures added to the list in CY 2021, CMS has proposed to remove 258 procedures as they do not believe they meet the proposed revisions to the CY 2022 ASC CPL criteria.

CMS notes, “Based on our internal review of preliminary claims submitted to Medicare, we do not believe that ASCs have been furnishing the majority of the 267 procedures finalized in 2021. Because of this, we believe it is unlikely that ASCs have made practice changes in reliance on the policy we adopted in CY 2021. Therefore, we do not anticipate that ASCs would be significantly affected by the removal of these 258 procedures from the ASC CPL.”

A complete list of the 258 procedures can be found in table 45 of the proposed rule.

Proposed Revisions to the CY 2022 ASC CPL Criteria

In CY 2021, CMS revised their policy for adding surgical procedures to the ASC CPL. For CY 2022, they have proposed to revise the requirements for covered surgical procedures to reinstate the specifications established prior to CY 2021. One key proposal would once again define covered surgical procedures as surgical procedures specified by the Secretary and published in the Federal Register and/or via the Internet on the CMS website that are separately paid under the OPPS, that would not be 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.

Inpatient, outpatient or ASC, 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.

While this article highlights a couple of topics in the proposed rule, I encourage you to review the entire document for other key proposals such as the proposed increase in civil monetary penalties (CMP) for hospital noncompliance with the Price Transparency requirements. You can also read more about what is being proposed in a related CMS Fact Sheet (link).