Knowledge Base Category -

Fiscal Year 2021 Estimated Improper Payment Rates

In mid-November 2021, the Comprehensive Error Rate Testing (CERT) program published the Fiscal Year (FY) 2021 Annual CERT Report. A related Press Release, (link) noted that “CMS’ aggressive corrective actions led to an estimated $20.72 billion in reduction of Medicare Fee-for-Service (FFS) improper payments over seven years.”

While CMS cites an impressive reduction in improper payments over seven years, there was only a slight change from 2020 to 2021.

• Improper Payment Rate
• o FY 2020: 6.27%
• o FY 2021: 6.26%
• Improper Payment Amount
• o FY 2020: $25.74 billion
• o FY 2021: $25.03 billion

As I have noted in past articles, CMS noted in the Press Release that “while fraud and abuse may lead to improper payments, it is important to note that the vast majority of improper payments do not constitute fraud, and improper payment estimates are not fraud rate estimates.”

Fiscal Year 2021 Supplemental Improper Payment Data

The 2021 Supplemental Improper Payment Data Report (link) was published on December 12, 2021. This report highlights common causes of improper payments and includes tables allowing you to drill down into the review findings.

COVID-19 Impact

• From March 27, 2020, until August 10, 2020, CERT program activities were suspended,
• CMS reduced the claim sample size for FY 2021 (claims submitted July 1, 2019, through June 30, 2020), and
• Claims with dates of service within the COVID-19 PHE were reviewed in accordance with all applicable CMS waivers and flexibilities.

“0 or 1 day” Length of Stay Claims

Since implementation of the Two-Midnight Rule, the supplemental data report has included a table comparing improper payments rates for Part A hospital claims by length of stay (LOS). The improper payment rate for “0 or 1 Day” stay claims was highest in 2014 at 37.18% and in 2021 hit an all-time low of 16.8%. However, with the project improper payment rate being $1.5 billion, it is not surprising that Two-Midnight Stays are currently on the OIG Work Plan (link) and Livanta as the National Medicare Claim Review Contractor (link), is focusing their review efforts solely on Short Stay Reviews (SSRs) and Higher Weighted DRG (HWDRG) reviews.

Top 20 Service Types with Highest Improper Payments: Part A Hospital IPPS Table D4 of this report includes the top 20 DRG types with the highest improper payment rate. The table also details the percentage of error by each of the CERT’s major error categories:

• No documentation,
• Insufficient documentation,
• Medical Necessity,
• Incorrect Coding, and
• Other.

Overall, 58.9% of the errors in this table were due to the error category medical necessity. The CERT places a claim into this category when the CERT contractor reviewers receive adequate documentation from the medical records submitted to make an informed decision that the services billed were not medically necessary based upon Medicare coverage and payment policies. One hundred percent of the errors for the following four DRG Types was attributed to medical necessity:

• DRG 069: Transient Ischemia,
• DRGs 308, 309, 310: Cardiac Arrhythmia & Conduction Disorders,
• DRG 312: Syncope, and
• DRG 313: Chest Pain.

Moving Forward

For the Septicemia DRGs 871 and 872, 37.2% of the errors was attributed to “no documentation.” Unfortunately, denied claims due to no documentation is also a frequent issue reported by the Medicare Administrative Contractors (MACs) and the Supplemental Medical Review Contractor (SMRC).

Moving forward, here are ideas and resources to help in your efforts to prevent claims errors:

• Visit the CERT Provider Website (link) to find information about the CERT, how to submit records, sample request letters and much more.
• Become familiar with National and Local Coverage Determinations and Local Coverage Articles that detail indications and limitations of specific services. For example, DRGs 469 and 470 (Major Hip and Knee Joint Replacement or Reattachment of Lower Extremity) had the highest projected improper payment in Table D4 at $724,055,597. The CERT attributed 19.5% of the error to insufficient documentation and 80.3% to medical necessity. CMS has published an MLN Booklet titled Major Joint Replacement (Hip or Knee) (link) that provides guidance on what to document to avoid denied claims.
• Become familiar with and utilize your hospital’s Program for Evaluating Payment Patterns Electronic Report (PEPPER).
• And finally, take the time to review the CERT’s Supplemental Improper Payment Data report annually.

MMP’s Protection Assessment Report (P.A.R.) combines current Medicare Fee-for-Service review targets (i.e. MAC, RAC, OIG, etc.) with hospital specific paid claims data made possible through a collaboration with RealTime Medicare Data (RTMD). Monthly, our newsletter spotlights current review activities. This month we highlight recent CMS and Medicare Administrative Contractor (MAC) eNews reminders for Providers.

P.A.R. PRO TIPS: eNews Reminders for Providers

November 29, 2021: WPS J8 eNews: Prior Authorization for Hospital Outpatient Department Services Tips and Reminders

After noting they continue to find errors, including omissions, on prior authorization requests that may result in processing delays, WPS offered the following tips and reminders related to the CME Prior Authorization for Hospital Outpatient Department Services Program (link) in their daily eNews:

Vein Ablation

• Prior authorization requests should clearly identify which extremity and vein(s) the request is for, and
• Documentation should include conservative measures and the length of time the conservative measures were tried.

Implantation of Spinal Neurostimulators

• The Unique Tracking Number (UTN) assigned to an affirmed implantation of spinal neurostimulators trial is the same UTN that shall be used for the permanent implantation,
• A new UTN for the permanent implantation is only required if more than 120 days have passed since the trial UTN was issued or if the trial and permanent Provider Transaction Numbers (PTANs) are different, and
• Documentation should include a psychiatric evaluation and support of tried and failed conservative treatment.

WPS provides a more detailed article on their website about this program (link)

December 1, 2021: Palmetto GBA eNews: Aftercare, Musculoskeletal System and Connective Tissue Diagnosis Related Groups (DRGs)

“This article (link) includes a description of the DRG codes for Aftercare, Musculoskeletal System and Connective Tissue and a list of Principal Diagnosis Tips. Please review this information and share it with your staff.” For example, Palmetto advises that ICD-10-CM Diagnosis code M48.4 (Fatigue fracture of vertebra, should not be used for acute traumatic fracture.

Comprehensive Error Rate Testing (CERT) Question & Answer Fact Sheet

A second article of interest (link) in Palmetto’s December 1st eNews answers who, what and how questions about the CERT. For example:

• Question: “Are healthcare providers required to comply with CERT’s request for medical records?
• Answer: Yes, the CERT is a federally mandated program. Non-submission of medical records will result in a denial of all services billed on the claim.”

December 2, 2021: CMS MLN Connects eNews: Skilled Nursing Care & Skilled Therapy Services to Maintain Function or Prevent or Slow Decline

CMS included the following reminder to providers in the December 2nd edition of MLN Connects (link):

“Medicare covers skilled nursing care and skilled therapy services under skilled nursing facility, home health, and outpatient therapy benefits when a beneficiary needs skilled care to maintain function or to prevent or slow decline, as long as:

• The beneficiary requires skilled care for the services to be provided safely and effectively
• An individualized assessment of the patient's condition demonstrates that the specialized judgment, knowledge, and skills of a qualified therapist are needed for a safe and effective maintenance program

Visit the Jimmo Settlement Agreement webpage for more information.”

December 2, 2021: Palmetto GBA eNews: Responding to CERT Documentation Request

As a follow-up to the previously mentioned CERT FAQ document, Palmetto published an article (link) detailing why you are required to respond to CERT requests, what you need to send, and where to send the documentation to.

December 7, 2021: Novitas Solutions JL eNews: Prior Authorization: Cervical fusion with disc removal

Novitas noted in their eNews that the A/B MAC Prior Authorization Collaboration Workgroup has published an article (link) about cervical fusions with disc removal and reminds providers that this procedure is part of the prior authorization program for certain hospital outpatient department services.

December 10, 2021: Protecting Medicare and American Farmers from Sequester Cuts Act

President Biden signed this Act into law on December 10th (link) and while this is not a Pro Tip, passage of this Act does impact hospitals. Among other items in the Act, it amends the CARES Act to extend the 2 percent sequestration suspension until March 31, 2022. Beginning April 1, 2022, and ending June 30, 2022, the sequestration payment reduction will be 1.0 percent. The full 2 percent Medicare sequester cut will begin again on July 1, 2022.

Question:

Are there any updates for rehabilitative therapy services’ threshold amounts for the coming year?

Answer:

Yes. MLN MM12470 (link) details updates to the annual per-beneficiary incurred expenses amounts now call the KX modifier thresholds and related policy for CY 2022. These thresholds were previously known as “therapy caps.” For CY 2022, the KX modifier threshold amounts are:

1. $2,150 for Physical Therapy (PT) and Speech-Language Pathology (SLP) services combined, and
2. $2,150 for Occupational Therapy (OT) services.

Providers can track a patient’s year-to-date therapy amounts on Medicare eligibility screens. The KX modifier must be appended to therapy services’ line-items on the claim for medically necessary therapy services above the threshold amounts. The medical necessity of services beyond the threshold amount must be justified by appropriate documentation in the medical record. Services provided beyond the threshold that are not billed with the KX modifier will be denied with Claim Adjustment Reason Code 119 - Benefit maximum for this time period or occurrence has been reached

There is also a therapy threshold related to the targeted medical review process, now known as the Medical Record (MR) threshold amount. This threshold remains at $3,000 for PT and SLP combined and a separate $3,000 for OT until CY 2028. Not all therapy services exceeding the $3,000 thresholds will be reviewed. CMS will analyze data to select claims exceeding this threshold for review.

In response to the ongoing COVID-10 public health emergency, CDC’s National Center for Health Statistics (NCHS) will be implementing new ICD-10 diagnosis and procedures codes. The three new ICD-10-CM diagnosis codes are for reporting an individual’s vaccination status.

New Diagnosis Codes

• Z28.310: Unvaccinated for COVID-19
• Z28.311: Partially vaccinated for COVID-19
• Z28.39: Other underimmunization status

There are also seven new ICD-10-PCS procedure codes to describe the introduction or infusion or therapeutics, including vaccines for COVID-19 treatment. In the CMS announcement related to the procedure codes, providers are reminded that “for hospitalized patients, Medicare pays for the COVID-19 vaccines and their administration separately from the Diagnosis-Related Group rate. As such, Medicare expects that the appropriate CPT codes will be used when a Medicare beneficiary is administered a vaccine while a hospital patient.”

New Procedure Codes

• XW013V7: Introduction of COVID-19 vaccine dose 3 into subcutaneous tissue, percutaneous approach, new technology group 7
• XW013W7: Introduction of COVID-19 vaccine booster into subcutaneous tissue, percutaneous approach, new technology group 7
• XW023V7: Introduction of COVID-19 Vaccine dose 3 into muscle, percutaneous approach, new technology group 7,
• XW023W7: Introduction of COVID-19 Vaccine booster into muscle, percutaneous approach, new technology group 7,
• XW0DXR7: Introduction of fostamatinib into mouth and pharynx, external approach, new technology group 7,
• XW0G7R7: Introduction of fostamatinib into upper GI, via natural or artificial opening, new technology group 7, and
• XW0H7R7: Introduction of fostamatinib into lower GI, via natural or artificial opening, new technology group 7.

All ten new codes will become effective April 1, 2022.

Resource: CMS’ MS-DRG Classifications and Software webpage (link), see ICD-10 MS-DRGs V39.1 Effective April 1, 2022 Zip file under “Latest News”

Did You Know?

• Lung cancer is the third most common cancer and the leading cause of cancer deaths in the United States,
• In 2021, the National Cancer Institute (NCI) estimated that the number of new lung cancer cases is over 235,000, with a median age at diagnosis of 71 years; and
• Cancer of the lung and bronchus accounted for over 130,000 deaths in 2021 (more than the total number of estimated deaths from colon, breast and prostate cancer combined), with a median age at death of 72 years.
Source: CMS Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) Proposed Decision Memorandum (CAG-00439R)

According to the CDC’s Lung Cancer Awareness webpage (link):

• Lung Cancer is the leading cause of cancer death among both men and women in the United States, and
• Different people have different symptoms for lung cancer. Most people do not have symptoms until the cancer is advanced.

Why Should You Care?

You can be your own advocate to lower your lung cancer risks:

• If you smoke, quit!
• Stay away from secondhand smoke,
• Get your house tested for Radon,
• If appropriate, get screened for Lung Cancer with LDCT.

Lung cancer screening with LDCT is a covered Medicare Preventive Service and is covered annually with no copayment, coinsurance, or deductible when you meet the Medicare coverage requirements (link).

On November 17, 2021, the CMS posted proposed National Coverage Determination (NCD) and Decision Memorandum (CAG-00439R) (link) for NCD 210.14 Screening for Lung Cancer with Low Dose Computed Tomography (LDCT).

Beneficiary Eligibility criteria:
Proposed changes to the eligibility criteria include expanding the age eligibility from 55 to 50 years and decreasing the tobacco smoking history in pack-years from thirty pack-years to twenty pack years.

Counseling and Shared Decision-Making Visit
Before a beneficiary’s first LDCT screening, the beneficiary must receive a counseling and shared decision-making visit meeting all criteria outlined in the Proposed Decision Memo.

CMS is proposing “to remove the specificity regarding the type of provider who must furnish the counseling and shared decision-making…we do not believe there is an evidentiary reason to continue to limit the shared decision-making visit to physician and non-physician practitioners. We note that this expansion can allow for this service to be furnished “incident to” a physician’s professional service. Removing the specification for the type of practitioner should expand the individuals that can conduct shared decision-making to other health care practitioners, such as health educators and others beyond physicians or non-physician practitioners. This proposed change may broaden access to LDCT screening.”

Reading Radiologist Eligibility Criteria :
CMS notes that the proposed Decision Memo “reduces the eligibility criteria for the reading radiologist and removes the radiology imaging facility eligibility criteria (including removes the requirement that facilities participate in a registry).”

What Can You Do?

As a healthcare provider, be familiar with the Medicare coverage requirements and as a healthcare consumer, you can visit the CDC’s Lung Cancer Awareness webpage (link) to learn about ways to lower your lung cancer risk, take a lung cancer screening quiz, and identify if you are an appropriate candidate for screening with LDCT.

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.

MMP’s Protection Assessment Report (P.A.R.) combines current Medicare Fee-for-Service review targets (i.e. MAC, RAC, OIG, etc.) with hospital specific paid claims data made possible through a collaboration with RealTime Medicare Data (RTMD). Monthly, our newsletter spotlights current review activities. This month’s focus is on cardiac rehabilitation.

Did You Know?

Cardiac Rehabilitation (CR) and Intensive Cardiac rehabilitation (ICR) Defined

• CR means a physician-supervised program that furnishes physician prescribed exercise; cardiac risk factor modification, including education, counseling, and behavioral intervention; psychosocial assessment; and outcomes assessment.
• ICR program means a physician-supervised program that furnishes CR and has shown, in peer-reviewed published research, that it improves patients’ cardiovascular disease through specific outcome measurements described in 42 CFR 410.49(c).

Timeline to Medicare Coverage of CR and ICR

• 2008: The Medicare Improvements for Patients and Providers Act of 2008 amended the Act to establish coverage for CR, ICR and pulmonary rehabilitation.
• 2010: The CMS implemented provisions for the three rehabilitation services in the CY 2010 Physician Fee Schedule (PFS) final rule.
• 2014: National Coverage Determination (NCD) 20.10.1 expanded CR coverage to beneficiaries with stable, chronic heart failure
• 2018: Bipartisan Budget Act (BBA of 2018) expanded covered indications for ICR to include beneficiaries with stable, chronic heart failure.
• 2020: CY 2020 PFS final rule updated 42 CFR 410.49 to codify the expansion of coverage.
• March 2021: CMS updated sub-regulatory guidance regarding coverage requirements for outpatient CR to reflect the regulatory text more closely and published an MLN Fact Sheet.

Medicare Review Contractor Activities

Recovery Auditors: On January 8, 2019, CMS approved Issue 0135 (Cardiac Rehabilitation: Medical Necessity and Documentation Requirements). By March of 2019, all four RAC regions had added this issue to their list of complex medical record reviews for outpatient hospital claims.

Medicare Administrative Contractors (MACs): In 2021, three MACs have been performing post-payment reviews of CR and includes

• CGS (J15) has published review results for claims from Ohio with dates of service from January through March 2021. The claims error rate was 64.7%.
• NGS (J6) has published review results of claims with dates of service from January 1, 2019, through February 29, 2020. The claims error rate was 51.18%.
• NGS (JK) posted notice of a service specific post payment review of cardiac rehab on May 26, 2021. The primary focus is to determine whether the medical necessity of the services billed is at the correct code per Medicare guidelines.

Office of Inspector General (OIG): In May 2021, the OIG Published a report titled CMS Needs to Strengthen Regulatory Requirements for Medicare Part B Outpatient Cardiac and Pulmonary Rehabilitation Services to Ensure Providers Fully Meet Coverage Requirements (link).

The OIG reviewed the third highest-paid provider in the country in combined Medicare reimbursement for outpatient cardiac and pulmonary rehabilitation services. The audit period was from April 2016 through March 2018 and covered just over $2.7M in Medicare payments representing 26,408 beneficiary days of rehabilitation services.

As the audit progressed, the focus shifted from the provider to CMS. This occurred due to the OIG noting that “we found that although the provider generally complied with Medicare coverage requirements, it did not meet the intent of the requirements. Therefore, we determined that the larger issue was whether CMS’s regulatory requirements were sufficient to ensure providers complied with the intent of the Medicare coverage requirements.”

Based on their findings, the OIG believes that Medicare payments made by CMS to all providers for outpatient cardiac and pulmonary rehabilitation services during the audit period may not have met requirements. They recommended that CMS revise its regulations to provide sufficient guidance to ensure that providers meet coverage requirements for these services.

In their response, CMS noted that in March 2021 they updated sub-regulatory guidance within the Medicare Benefit Policy Manual and Medicare Claims Processing Manual regarding coverage requirements to reflect the regulatory text more closely. CMS also noted they will take the OIG recommendation into consideration when determining next steps regarding the regulations for these rehabilitation services.

P.A.R. Pro Tips: Cardiac Rehabilitation Provider Outreach and Education Efforts )

Both CMS and the MACs have made available several resource documents related to outpatient cardiac rehabilitation services.

CMS

• March 2021 MLN Fact Sheet: Overview of the Conditions of Coverage for Medicare Part B Outpatient Cardiac Rehabilitation Services (link).
• March 24, 2021, Transmittals updating Pulmonary Rehabilitation (PR), Cardiac Rehabilitation (CR) and Intensive Cardiac Rehabilitation (ICR) Program Manual Sections
• R10573CP (link)
• R10573BP (link)

CGS (J15 MAC)

• CGS Article: Cardiac Rehabilitation: Coverage and Documentation requirements (link)
• Cardiac Rehab with Continuous ECG Monitoring ADR checklist (link)

NGS (J6 and JK MAC))

• NGS Article: Reminder for Billing Cardiac Rehabilitation Session and Session Limitations (link)

Noridian (JE and JF MAC)

• Noridian has published outpatient CR local coverage article (LCA) for JE (A54068) and JF (A54070).
• Noridian has a dedicated webpage on their website titled Cardiac and Pulmonary Rehabilitation Programs (link).

Novitas Solutions (JH and JL MAC)

• Novitas has published LCA A55758.
• Noridian recently published a September 15, 2021 Ask the Contractor (ACT) Q&A document (link). Question four is about cardiac the KX modifier and Cardiac Rehab.

Palmetto GBA (JJ and JM MAC) )

• Palmetto GBA has published LCA A53775.
• On October 28, 2021, Palmetto GBA published a CR: Coverage Criteria & Documentation Requirements Module (link).

What Can You Do?

• Become familiar with indications for CR/ICR & Medicare documentation requirements,
• Submit medical record requests to the Medicare Contractor in a timely manner, and
• Read a related article in this week’s newsletter to learn the temporary direct supervision policy change due to the COVID-19 PHE and paid claims amounts paid to providers by CMS in CY’s 2019 and 2020 for CR/ICR services.

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

MMP’s Protection Assessment Report (P.A.R.) combines current Medicare Fee-for-Service review targets (i.e. MAC, RAC, OIG, etc.) with hospital specific paid claims data made possible through a collaboration with RealTime Medicare Data (RTMD). Monthly, our newsletter spotlights current review activities in this P.A.R. Pro Tips article. This month’s focus is on neurostimulator implantation surgeries.

Did You Know?

Effective for services on or after July 1, 2021, implanted spinal neurostimulator procedures was one of two new procedures added to the list of procedures included in the Prior Authorization for Certain Hospital Outpatient Department (OPD) Services program ( https://www.cms.gov/research-statistics-data-systems/medicare-fee-service-compliance-programs/prior-authorization-and-pre-claim-review-initiatives/prior-authorization-certain-hospital-outpatient-department-opd-services">link).

On October 5, 2021, the Office of Inspector General released the report Medicare Overpaid More Than $636 Million for Neurostimulator Implantation Surgeries (link). The OIG made several recommendations to CMS in response to the review findings. One recommendation being that MACs conduct provider outreach and education.

Pro Tip: MAC Neurostimulation Implantation Surgery Provider Outreach and Education Efforts

In response to neurostimulation implantation being added to the Prior Authorization for Certain OPD Services program and to recommendations made by the OIG in their report, the MACs have been conducting provider outreach and education. This article highlights resources available by the different MACs. You can read more about the OIG report in a related article in this week’s newsletter.

CGS (Jurisdiction 15)

The CGS OPD Prior Authorization webpage (link) includes medical record documentation needed to meet coverage criteria for all procedures in this program including implanted spinal neurostimulators.

First Coast Service Options, Inc. (Jurisdiction N)

First Coast published the article Implantation of spinal neurostimulator in their October 13, 2021, First Coast eNews article (link).

You can also find general documentation requirements and links to Local Coverage Determination (LCD) and Local Coverage Article (LCA) for Spinal Cord Stimulation for Chronic Pain on their PA Program general documentation requirements webpage (link).

National Government Services (J6 and JK MAC)

In July, NGS posted a news article (link) to their website highlighting information about prior authorization for implanted spinal neurostimulators including:

• The applicable HCPCS code,
• Documentation Requirements, and
• Links to related content.

You will find a link to the required coversheet to request prior authorization for performing an implanted spinal neurostimulator procedure and National Coverage Determination (NCD) 160.7 Electrical Nerve Stimulators on the NGS Prior Authorization Documentation webpage (link) includes a

Noridian (JE and JF MAC)

Both Noridian JE (link) and Noridian JF (link) have an article posted under Medical Review on their website, that provides general documentation requirements and links to their LCD and LCA for Spinal Cord Stimulators for Chronic Pain.

Novitas Solutions Jurisdiction (JH and JL MAC)

Novitas recently published the article Prior Authorization: Implantation of Spinal Neurostimulator in (link), highlighting the components of the spinal cord neurostimulator system, documentation requirements, best practice documentation feedback/tips and links to related content including their LCD and LCA titled Spinal Cord Stimulation.

In July 2021, Novitas updated their Prior Authorization Program for certain hospital outpatient department services general documentation requirements article to include guidance for implanted spinal neurostimulators (trial or permanent) and cervical fusion with disc removal (link).

Finally, in case you missed it, you can view a September 8, 2021 webinar (link) recording focused on reviewing the two new services requiring PA effective dates of service on and after July 1, 2021.

Palmetto GBA (JJ and JM MAC)

On October 12, 2021, Palmetto GBA updated their article titled Implantation of Spinal Neurostimulator. You can find this article on their Outpatient Department Prior Authorization (PA) webpage (link). Additional resources available on the Palmetto website includes:

• A Documentation Checklist (link) highlighting the documentation requirements for trial or permanent implanted spinal neurostimulators,
• An on-demand webinar video (link) highlighting the two services added to Outpatient PA program effective July 1, 2021 (implanted spinal neurostimulators and cervical fusion with disc removal), and an
• Links LCD (L37632) and LCA (A56876) for Spinal Cord Stimulators for Chronic Pain (link).

WPS (J5 and J8 MAC)

WPS has published an article (link) highlighting the July 1, 2021 addition of implanted spinal neurostimulators to the hospital outpatient department Prior Authorization Program.

On August 18, 2021, WPS posted a YouTube video (link) detailing the process for submitting a prior authorization request for implanted spinal neurostimulators.

WPS also has a live event scheduled for October 26, 2021, titled Prior Authorization – Understanding Implanted Spinal Neurostimulators in the Hospital Outpatient Department (http://wpsghalearningcenter.com/catalog/Teleconferences/J8%20Teleconferences/all">link). They note in the announcement that this teleconference will answer questions on:

• Inpatient Psychiatric Facility (IPF),
• Inpatient Rehabilitation Services,
• Routine Foot Care, and
• Wound care in a Critical Access Hospital (CAH).

What Can You Do?

Take advantage of resources made available by your MAC related to implanted spinal neurostimulators.