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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.

I have recently noticed a resurgence of a favorite commercial from my childhood featuring a little boy, Mr. Turtle, Mr. Owl, and a tootsie roll pop (link). Although it’s a given that we will never know how many licks it takes to get to the center of a Tootsie Roll pop, it’s no mystery as to why the OIG believes CMS has paid millions in overpayments for neurostimulator implantation surgeries. Let’s unwrap this OIG report (link) and get to the center of it.

Why This Audit was Conducted

CMS analysis revealed that claims for spinal neurostimulator implantation surgeries increased by nearly 175 percent between 2007 and 2018. “CMS researched possible causes for the increased volume of these procedures that would indicate the services are increasingly necessary, but CMS did not find any plausible reason for the increase in services and concluded that a financial motivation was the most likely cause for the increase.”

Strategic Health Solutions, the first Supplemental Medical Review Contractor (SMRC), was tasked with reviewing post-payment claims of Medicare Part B spinal neurostimulator implantation surgeries. They reviewed claims with dates of service from January through September of 2014 and identified a 72% error rate.

Without a “plausible reason for the increase in services” and the SMRC review’s high error rate, the OIG conducted this review to “determine whether health care providers complied with Medicare requirements when they billed for neurostimulator implantation surgeries.”

What are Neurostimulators?

• What is it? A battery-powered electronic device enclosed in a small metal container that is surgically implanted under a patient’s skin and connected to wires called leads
• Types of Neurostimulators: Spinal cord, deep brain, and vagus nerve stimulator (VNS) devices.
• Conditions that can be treated with neurostimulator: chronic pain, Parkinson’s disease, essential tremor, dystonia, obsessive-compulsive disorder, seizures, and epilepsy.

Medicare Coverage Requirements for Neurostimulators

As noted above, there are several conditions where treatment with a neurostimulator implant may be warranted. Medicare has several National Coverage Determinations (NCDs) related to neurostimulators that detail the indications and limitations of coverage, including:

• NCD 160.2: Treatment of Motor Function Disorders with Electrical Nerve Stimulation,
• NCD 160.7: Electrical Nerve Stimulators,
• NCD 160.18 – Vagus Nerve Stimulation, and
• NCD 160.24 – Deep Brain Stimulation for Essential Tremor and Parkinson’s Disease.

OIG Claims Selection by the Numbers

• 2016-2017: The audit period for this review,
• $1.4 billion: The Medicare payments made to providers during the audit period,
• 58,213: The number of beneficiaries who had at least one neurostimulator implantation during the audit period.
• HCPCS Codes 61885, 61886, or 63685: The codes used to identify beneficiaries who had undergone a neurostimulator implantation surgery.
• 124 claims: The stratified random sample of claims reviewed in this audit.
• $1,000: All claims reviewed were for paid amounts greater than $1,000.
• $3.4 million: The amount paid to 102 providers for the 124 claims in the audit sample.
• Audit sample claim specific indication for neurostimulator:
• 87 claims were for treatment of chronic pain,
• 4 claims were for treatment of seizures, and
• 13 claims were for essential tremors and Parkinson’s disease.
• Note, the remaining two claims involved a neurostimulator implant with an investigational device exemption.

Audit Error Rates

The OIG found that 40% of health care provided did not comply with Medicare requirements. Based in this finding, they estimated that:

• Providers received $636 million in unallowable Medicare payments, and
• Medicare beneficiaries paid $54 million in related unnecessary coinsurance amounts.

An independent contractor reviewed the medical records and determined that 48 (49%) of the 106 claims did not contain documentation supporting compliance with the applicable NCD indications. The OIG report lists types of missing/incomplete documentation by NCD, for example:

• NCD 160.7:
• No documentation of other failed treatment modalities or that other treatment prior to a neurostimulator was felt to be unsuitable or contraindicated, and
• No documentation of the multidisciplinary screening includes a psychological evaluation.

OIG Audit Conclusions & Recommendations

The “tootsie-roll center” of this audit are the OIG’s audit conclusions and recommendations. Both lay the groundwork for steps for providers moving forward. The OIG concluded that:

• Medical records lacked documentation to support the NCD coverage requirements for neurostimulator implants,
• There were limited instances when providers “stated that they did not fully understand these Medicare coverage requirements,”
• These claims did not require prior authorization, nor were they subject to pre-payment reviews, and
• There is no edit in the CMS software to initiate such a review.
• It was not until after the completion of this audit that CMS published the CY 2021 OPPS Final Rule that added prior authorization of spinal neurostimulators to the Prior Authorization for Certain Hospital Outpatient Department Services program effective for services on or after July 1, 2021(link). The OIG notes that this final rule does not include claims for neurostimulator implantation for Parkinson’s disease or seizure disorders.
• Note, in May of 2021, the CMS limited the prior authorization requirement to CPT code 63650 (implantation of spinal neurostimulator electrodes, accessed through the skin).

Based on their conclusions, the OIG recommended that CMS instruct the Medicare Administrative Contractors:

• Recover overpayments,
• Advise applicable providers to exercise reasonable diligence to identify, report, and return over-payments in accordance with the 60-day rule,
• Conduct provider outreach and education regarding Medicare coverage requirements, and
• Require prior authorization for procedures for Parkinson’s disease and seizures.

CMS agreed with all recommendations but indicated that neurostimulator implantation for Parkinson’s disease and seizure disorders are currently on the Medicare Inpatient Only (IPO) Procedure List and their prior authorization authority does not extend to inpatient services. The OIG noted that “CMS’s inability to implement this control for inpatient claims…leaves this area vulnerable to future overpayments.”

Steps Moving Forward

I encourage you to:

• Become familiar with the Medicare coverage requirements at the National and Local MAC level,
• Identify the documentation deficiencies by NCD detailed in this OIG report,
• Work with your Physician’s offices to ensure all documentation needed to support the medical necessity of the procedure is in the medical record, and
• Learn about current MAC specific provider outreach and education activities in a related article in this week’s newsletter.

This week is National Case Management Week. Given the ongoing COVID-19 public health emergency (PHE), now more than ever it is important to celebrate the hard work and dedication of Case Managers. The American Case Management Association (ACMA) and the Case Management Society of America (CMSA) both recognize this week as an opportunity to spotlight the great things about case managers and the case management industry.

American Case Management Association (ACMA)

The ACMA’s official definition of Case Management, as approved by their membership in April 2020, as follows:

"Case Management in health care delivery systems is a collaborative practice including patients, caregivers, nurses, social workers, physicians, payers, support staff, other practitioners and the community. The Case Management process facilitates communication and care coordination along a continuum through effective transitional care management. Recognizing the patient’s right to self-determination, the significance of the social determinants of health and the complexities of care, the goals of Case Management include the achievement of optimal health, access to services, and appropriate utilization of resources."

For 2021, the ACMA Case Management Week theme is Case Management: Transitions through Care, Compassion, Community. MMP believes it takes all three qualities to carry out the definition of Case Management and would like to celebrate the hard work and dedication of all the Case Managers that we have the opportunity to work with.

Did You Know?

Chances are you; a family member, close friend or acquaintance has been impacted by breast cancer. October is Breast Cancer Awareness Month. According to a World Health Organization (WHO) Breast Cancer Fact Sheet (link):

• In 2020, globally 2.3 million women were diagnosed with breast cancer and there were 685,000 deaths,
• At the end of 2020, there were 7.8 million women alive who were diagnosed with breast cancer in the last 5 years, making it the world’s most prevalent cancer,
• There are more lost disability-adjusted life years (DALYs) by women to breast cancer globally than any other type of cancer,
• Breast cancer occurs in every country of the world in women at any age after puberty but with increasing rates later in life,
• Approximately 0.5-1% of breast cancers occur in men,
• Improvements in survival began in the 1980’s in countries with early detection programs combined with different modes of treatment to eradicate invasive disease.

Why Should You Care?

Even though family history increases the risk of breast cancer, most women diagnosed with breast cancer have no known family history of the disease. Early detection of breast cancer allows for a higher chance of cure. Mammography is used to detect breast cancer and is one of many Preventative Services covered by Medicare.

“A WHO survey conducted in 2020 indicated that treatment for cancer had been disrupted in more than 40% of countries surveyed.” A related RealTime Medicare (RTMD) infographic, in this week’s newsletter, highlights the impact of the COVID-19 pandemic on the volume of Medicare Fee-for-Service beneficiaries undergoing screening mammography in RTMD’s footprint.

NCD 220.4 Mammograms

The CMS National Coverage Determination (NCD) 220.4 Mammograms (link) distinguishes the difference between diagnostic and screening mammography.

Diagnostic Mammography

A radiologic procedure furnished to a man or woman with signs and symptoms of breast disease, or a personal history of breast cancer, or a personal history of biopsy - proven benign breast disease and includes a physician's interpretation of the results of the procedure. CMS covers this service if ordered by a Doctor of Medicine or Osteopathy in addition to the following conditions:

• A patient has distinct signs and symptoms for which a mammogram is indicated,
• A patient has a history of breast cancer, or
• A patient is asymptomatic but, based on the patient’s history and other factors the physician considers significant, the physician’s judgment is that a mammogram is appropriate.

Screening Mammography

A radiologic procedure furnished to a woman without signs or symptoms of breast disease, for the purpose of early detection of breast cancer, and includes a physician’s interpretation of the results of the procedure. A screening mammography has limitations as it must be, at a minimum a two-view exposure (cranio-caudal and a medial lateral oblique view) of each breast. Routine screening includes:

• Asymptomatic women 50 years and older, and
• Asymptomatic women 40 years and older whose mothers or sisters have had the disease, is considered medically appropriate, but would not be covered for Medicare purposes.

Guidance for coding and billing for screening mammography is available in the MLN Educational Tool: Medicare Preventive Services (link).

What Should You Do?

Take the initiative to discuss having a screening mammogram with your health care provider. You can also check out the CDC’s webpage Find a Screening Program Near You (link) that highlights the CDC’s national Breast and Cervical Center Early Detection Program (MBCCEDP). This year marks the 30th Anniversary for this program that has provided women who have low incomes, uninsured, and underinsured women across the United States.

“Oh, what a tangled web we weave…when first we practice to deceive.”

- Sir Walter Scott

“Oh, what a tangled web we weave…. when first we practice to protect.” Changing just one word in this quote from “deceive” to “protect” makes it become an apt description of the numerous medical review contractors that are part of the CMS Medical Review and Education Program (link).

This premise is supported by CMS’ stated purpose for this interconnected web of medical review contractors as being to “identify errors through claims analysis and/or medical review activities. Contractors use this information to help ensure they provide proper Medicare payments (and recover any improper payments if the claim was already paid.) Contractors also provide education to help ensure future compliance.”

The Medicare Quarterly Provider Compliance Newsletter is one tool used for provider education. This quarterly newsletter’s aim is to provide guidance to address billing errors identified by Medicare Administrative Contractors (MACs) and other contractors such as Recovery Auditors, the Comprehensive Error Rate Testing (CERT) Review Contractor, and the Supplemental Medical Review Contractor (SMRC). Other governmental organizations, such as the Office of Inspector General (OIG), also conduct reviews and identify issues. The CMS recently announced the release of the July 2021 edition of this newsletter (link).

July 2021 Newsletter Topics:

• the Comprehensive Error Rate Testing (CERT) program review of glucose testing supplies,
• Recovery Auditor Issue 0181: Bone Marrow or Stem Cell Transplant: Medical Necessity and Documentation Requirements
• Recovery Auditor Issue 0081: Negative Pressure Wound Therapy: Medical Necessity and Documentation Requirements.

As I read through the newsletter, I noted that the CERT findings include background information, examples of improper payments and resources. Likewise, the Recovery Auditor review of negative pressure wound therapy includes a problem description, background information, recommendations to prevent denials and improper payments and resources. However, the Recovery Auditor review of bone marrow or stem cell transplant is lacking examples of improper payments and/or recommendations to prevent denials and improper payments. This lack of information led me to the CMS RAC webpage in search of additional information related to the RAC issue 0181. Much to my surprise this issue is no longer on the list of approved RAC issues and is no longer on the individual RACs list of approved issues.

Inpatient Bone Marrow and Stem Cell Transplant Procedures Medical Review Timeline

February 2016: OIG Review

The OIG noted in a February 2016 report (link) that Medicare had paid hospitals $185.9 million for inpatient claims related to bone marrow and stem cell transplant procedures. The OIG identified two hospitals that did not always comply with the Medicare billing requirements for inpatient claims for stem cell transplants that resulted in approximately $4 million in overpayments. In general, lengths of stay (LOS) for these claims ranged from 10 to 21 days. However, the LOS for claims reviewed were one to two days. Based on findings from the two hospitals, the OIG conducted a nationwide review of 143 claims and found that 133 (93%) of the claims did not comply with Medicare billing requirements. The two reasons cited by the OIG for noncompliance included:

• Hospitals incorrectly billing Medicare Part A for stays that should have been billed as outpatient, or outpatient with observation services, and
• Hospitals billing an incorrect Medicare Severity-Diagnosis Related Group (MS-DRG).

January 2019: New Review Project for SMRC

In response to the OIG report, the CMS tasked the SMRC (Noridian) with reviewing inpatient bone marrow and stem cell transplant procedures to determine compliance with statutory, regulatory, and sub-regulatory guidance. The SMRC reviewed claims billed on dates of service from January 1, 2017, through December 31, 2017. Specific MS-DRGs requested included:

• MS-DRG 014: Allogenic bone marrow transplant,
• MS-DRG 016: Autologous bone marrow transplant with a complication or comorbidity (CC), and
• MS-DRG 017: Autologous bone marrow transplant without a CC or major CC (MCC).

For this project, Noridian included the following list of specific documentation requirements in each Additional Documentation Request (ADR) sent to providers:

1. Documentation to support the beneficiary was expected to require an inpatient level of care for at least 2-Midnights
2. Documentation to support an inpatient level of care was expected and provided. Documentation should include, but is not limited to: Medication Administration Records (MAR), History & Physical, Physician Progress Notes, Nursing Notes, Discharge Summary, Procedure Notes
3. Inpatient admission order from attending physician
4. Physician or Non-Physician Practitioner (NPP) order for the stem cell transplant for the dates of service
5. Medical documentation that supports the beneficiary met criteria for one of the following covered services:
1. Allogenic Hematopoietic Stem Cell Transplantation (HSCT)
2. Autologous Stem Cell Transplantation (AuSCT)
6. Documentation to support enrollment in an approved Clinical Research Study, if applicable
7. Full detailed itemization of services, including diagnosis codes
8. Legible handwritten physician and/or clinician signatures
1. Signature logs and Signature Attestation Statement should be submitted when physician and/or clinician signatures are illegible
9. Valid electronic physician and/or clinician signatures
10. Advance Beneficiary Notice of Noncoverage (ABN), if applicable

Results of this review were posted to the SMRC website in October 2019. The error rate for the SMRC Project 01-006 (link) was 86%. Common reasons for denial cited by the SMRC included:

• Documentation received did not support medical necessity of an inpatient stay,
• No response by a provider to the documentation request,
• Signature requirements not being met, and
• Incorrect coding.

March 2020: RAC Approved Issue 0181: Complex Review of Hospital Inpatient Bone Marrow or Stem Cell Transplants

Six months later, further proof of the interconnected web of medical review contractors concept, a review of bone marrow and stem cell transplants became a RAC approved issue. Each of the 4 RAC Regions added Issue 0181 to their list of Issues in March of 2020 (link). Even Though RAC Issue 0181 is no longer listed on the RAC websites, if your hospital performs these procedures, I encourage you to perform a review of these inpatient records for documentation supporting medical necessity of the procedure and the inpatient stay.

Moving Forward

In July of this year, each of the RACs posted the following notice: “The Centers for Medicare & Medicaid Services (CMS) is required to protect the Medicare Trust Fund against inappropriate payments which pose a risk to the Trust Fund. Therefore, we are resuming Medicare Fee-for-Service medical review activities. The COVID-19 Public Health Emergency (PHE) continues to be monitored very closely.”

It is important to be aware of who your review contractors are, what issues they are focused on, and respond to ADRs in a timely manner. If you are unsure of who your review contractors are you can find out by using the CMS Review Contractor Directory – Interactive Map (link).

In case you are not a long-time reader of our newsletter, fall is my favorite time of year. Even though the official start of fall is still a week away, with morning lows in the mid 50’s recently, I have already had my first cup of apple spice tea, first cup of pumpkin spice coffee, and made my first batch of chili in the slow cooker. I have also put out my fall pumpkin themed door mat as we enter the months of celebrating fall, Halloween, Thanksgiving, Christmas.

In the world of Medicare, fall is also a time for new beginnings and celebrations. The new CMS Fiscal Year (FY) starts on October 1st and more importantly this week is all about celebrating the 11th annual Clinical Documentation Integrity (CDI) Week. In keeping with my culinary firsts of the fall, this year’s CDI Week theme is CDI Kitchen: Recipes for a Successful Program. According to a related Association for Clinical Documentation Integrity Specialists (ACDIS) Fact Sheet (link), “the growth of the CDI specialist profession has mirrored the healthcare industry’s increased focus on compliance with regulations, managed care profiles, payment for services rendered, quality of care improvement measurements, and liability exposure. All these factors increasingly depend on the integrity of complete and specific clinical documentation in the medical record.”

MMP would like to wish all the hard-working CDI Professionals that we have the privilege to work with a happy CDI week. To help you prepare for the new CMS fiscal year, while celebrating this week, following are links to key ingredients for a successful start to the CMS FY 2022.

2022 ICD-10-CM Official Guidelines

• Available on CDC website at: https://www.cdc.gov/nchs/icd/icd10cm.htm
• Available on CMS website at: https://www.cms.gov/medicare/icd-10/2022-icd-10-cm

You can read about changes for FY 2022 in a related MMP article (link).

2022 ICD-10-PCS Official Guidelines

• Available on CMS website at: https://www.cms.gov/medicare/icd-10/2021-icd-10-pcs

2022 CMS IPPS Final Rule

• CMS FY 2022 IPPS Final Rule Home Page: https://www.cms.gov/medicare/acute-inpatient-pps/fy-2022-ipps-final-rule-home-page
• Tables 6A-6K are also available on this page in excel format and includes among other things:
• New Diagnosis and Procedure codes,
• “Additions to” and “deletions from” the MCC and CC lists, and
• The complete MCC and CC lists.

FY 2022 ICD-10-CM/PCS Codes, MCCs and CCs

There are 165 new diagnosis codes. Of note, including in this list are:

• 11 new Social Determinants of Health (SDOH) ICD-10-CM codes, and
• 4 new COVID-19 related codes including U09.9 (Post COVID-19 condition, unspecified), Z1152 (Encounter for screening for COVID-19), Z20.822 (Contact with and *suspected) exposure to COVID-19), and Z86.16 (Personal history of COVID-19).

There are 212 new ICD-10-PCS procedure codes, including several new codes related to COVID-19 vaccines and monoclonal antibody treatments for COVID-19.

There are nine additions to the MCC list, including J12.82 (Pneumonia due to coronavirus disease 2019) which was implemented January 1, 2021. There are eleven additions to the CC list, which also include two codes implemented January 1, 2021 (M35.81 (multisystem inflammatory syndrome) and M35.89 (Other specific systemic involvement of connective tissue)).

Again, happy CDI week from our team to yours.