Knowledge Base Category -

Did You Know?

In response to the COVID-19 Public Health Emergency, the CMS has published several Interim Final Rules with comment period (IFC). Included in the April 6, 2020 IFC, (https://www.govinfo.gov/content/pkg/FR-2020-04-06/pdf/2020-06990.pdf), with respect to pulmonary rehabilitation, cardiac rehabilitation, and intensive cardiac rehabilitation services, CMS adopted a change, “to specify that direct supervision for these services includes virtual presence through audio/video real-time communications technology when use of such technology is indicated to reduce exposure risks for the beneficiary or health care provider.”

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

CMS again references this policy change in the CY 2022 OPPS Final Rule (https://public-inspection.federalregister.gov/2021-24011.pdf), noting, “the required direct physician supervision can be provided through virtual presence using audio/video real-time communications technology (excluding audio-only) subject to the clinical judgment of the supervising practitioner.”

Why This Matters?

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

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

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

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

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

CY 2019 Top 5 States by Procedure Volume

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

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

CY 2020 Top 5 States by Procedure Volume

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

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

What Can You Do?

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

It has been a while since we have published an article solely focused on COVID-19 issues. However, November has been a busy month related to COVID-19 vaccines, Medicare Contractor COVID-19 specific audits, telehealth, and a shift in treatment payment from Medicare Fee-for-Service to Medicare Advantage Plans for their enrollees. As we have reiterated so often since the beginning of the COVID-19 Public Health Emergency (PHE), MMP is thankful to all front-line workers who have and continue to provide care to patients diagnosed with COVID-19 and emotional support to their families.

October 29, 2021: FDA Authorizes COVID-19 Vaccine for Emergency Use for Children

The FDA announced (link) emergency use authorization for Pfizer-BioNTech COVID-19 Vaccines for children 5 to 11 years of age. The announcement includes key points for parents and caregivers. For example, “Safety: The vaccine’s safety was studied in approximately 3,100 children ages 5 through 11 who received the vaccine and no serious side effects have been detected in the ongoing study.”

CMS including the following information related to vaccinations for children in the Thursday, November 4th edition of MLN Connects (link):

CMS now covers the Pfizer-BioNTech COVID-19 Vaccine for children ages 5 – 11. Health care providers and other entities administering COVID-19 vaccines:

• Must provide vaccines regardless of the patient’s health coverage
• Cannot charge patients for the vaccine or administering it, including deductibles and coinsurance

More Information:

• CDC COVID-19 Vaccination Program Provider Requirements and Support (link)
• CMS COVID-19 Provider Toolkit (link)
• CMS Press Release (link)

October 29, 2021: Supplemental Medical Review Contractor (Noridian) Posts New Project: Audio Only Telehealth Services During the PHE

The CMS released this Final Rule and notes in a related Fact Sheet (link) this final rule “would accelerate the shift from paying for Medicare home health services based on volume to a system that pays for value.” CMS finalized making permanent current blanket waivers related to home health aide supervision and the use of telecommunications in conducting assessment visits that are currently in place due to the COVID-19 public health emergency. The CMS does note that “while we are finalizing the limited use of telecommunications technology when performing the 14-day supervisory visit requirement when a patient is receiving skilled services, we expect that in most instances, the HHAs would plan to conduct the 14-day supervisory assessment during an on-site, in person visit, and that the HHA would use interactive telecommunications systems option only for unplanned occurrences that would otherwise interrupt scheduled in-person visits.”

November 4, 2021: MA Plans to Begin Payment for COVID-19 Vaccine and Monoclonal Antibody Products

CMS announced (link) that effective for dates of service on or after January 1, 2022, Original Medicare will no longer being paying claims for COVID-19 vaccination and monoclonal antibody products for beneficiaries enrolled in a Medicare Advantage (MA) Plan. Providers will need to submit claims to the MA Plan. More information is available on the following CMS webpages:

• Medicare Billing for COVID-19 Vaccine Shot Administration (link)
• Monoclonal Antibody COVID-19 Infusion (link)

November 4, 2021: Supplemental Medical Review Contractor (Noridian) Project 01-043 DRG COVID 20% Add-On Payment Review Results Posted

The SMRC posted review results of claims related to the add-on payment for COVID-19 (link). Claims reviewed were for dates of service from April 1, 2020, through August 30, 2020, and the denial rate was 1%. Noteworthy is the fact that as of September 1, 2020, CMS requires that claims eligible for the 20 percent increase in the MS-DRG weighting factor have a positive COVID-19 lab test documented in the record. While the SMRC review results were low, I believe that this may remain a review focus by the SMRC or another Medicare review contractor for claims on or after September 1, 2020.

November 5, 2021: Medicare and Medicaid Programs; Omnibus COVID-19 health Care Staff Vaccination Interim Final Rule with Comment Period

November 5, 2021, The effective date for this Interim Final Rule with Comment Period (IFC) (link) is November 5, 2021. Along with the IFC, CMS has published the following related resources:

• CMS Press Release: (link)
• CMS Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule: (link)
• Slides and Video from National Stakeholder Call are available on the CMS Current Emergencies COVID-19 webpage: (link)

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

Even though, Halloween has come and gone, the shift in your Hospital Readmission Reduction Program penalty for the new CMS Fiscal Year may or may not be a treat.

Did You Know?

It has been a decade since CMS began reducing payments to hospitals for excessive readmissions. The payment reduction is capped at 3 percent (that is, a payment adjustment factor of 0.97). And while your penalty rate is based on unplanned readmissions for the following six conditions, the penalty is applied to all Medicare Fee-for-Service inpatient discharges:

• Acute myocardial infarction (MI),
• Chronic Obstructive Pulmonary Disease (COPD),
• Heart Failure (HF),
• Pneumonia,
• Coronary Artery Bypass Graft (CABG) surgery, and
• Elective primary total hip arthroplasty and/or total knee arthroplasty (THA/TKA).

The CMS unplanned hospital visits provider data was last updated September 22, 2021 and released on October 27, 2021 (link). Note, data for the first and second quarters of 2020 are not included in this release due to the impact of the COVID-19 pandemic. CMS has updated the Medicare Hospital Compare webpage (link) with the latest data release.

Why it Matters?

FY 2022 Readmission Reduction Penalties by the Numbers According to a Kaiser Health News article by Jordan Rau (link):

• 2,499 or 47% of all hospitals will be receiving reduced payments,
• The average penalty is a 0.64% reduction in payment,
• Congress’ Medicare Payment Advisory Commission (MedPAC) has noted that the average fines for a hospital in 2018 was $217,000.
• For FY 2022, 82% of hospitals will receive a penalty. This is nearly the same number of hospitals as last year.

What Can You Do?

I encourage you to read the Kaiser Health News article and access the accompanying Look-Up Tool (link) where you will find a trend of your hospitals Readmission Penalties from FY 2015 through 2022.

Just in case you “aren’t from around here”, the state of Alabama is very divided when it comes to college football. In general, you are either a devoted fan of the Alabama Crimson Tide or the Auburn Tigers. On a personal note, and having been told I was from up North (Tennessee), I root for the Tennessee Vols. Unlike the either or of college football, receiving the COVID-19 vaccine, your annual flu shot, and pneumococcal vaccinations are integral to your personal preventive healthcare playbook.

Did You Know?

According to the CDC, “pneumococcal disease is common in young children, but older adults are at greatest risk of serious illness and death.” Potential “defensive options” have been made available by the FDA approval of five different pneumococcal vaccines.

Prevnar® or PCV7 was the first pneumococcal conjugate vaccine licensed by the FDA in 2000. This vaccine provided protection against seven types of pneumococcal bacteria.

Prevnar 13® (pneumococcal conjugate vaccine or PCV13) is a registered trademark by Wyeth LLC and marketed by Pfizer Inc. This vaccine provides protection against infections caused by 6 more serotypes than PCV7. This vaccine is part of the routine childhood immunization schedule. Additionally, in 2011, it was licensed by the FDA for use in adults 50 years or older. The CDC recommends PCV13 for:

• All children younger than 2 years old, and
• People 2 years or older with certain medical conditions. The CDC advises adults 65 years and older to discuss the need for this vaccine with their health care provider.

Pneumovax23® (pneumococcal polysaccharide vaccine or PPSV23) is a Merck product This vaccine was approved by the FDA in 1983 and helps protect against 23 types of pneumococcal bacteria. The CDC recommends this vaccine for:

• All adults 65 years or older,
• People 2 through 64 years old with certain medical conditions (i.e., diabetes, heart disease or COPD), and
• Adults 19 through 64 years old who smoke cigarettes.

Prevnar 20™ (Pneumococcal 20-valent Conjugate Vaccine) On June 8, 2021, Pfizer announced (link) the FDA approval of the Prevnar 20™ vaccine for adults 18 years or older and noted that it is “the first approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia, including seven responsible for 40% of pneumococcal disease cases and deaths in the U.S.”

Vaxneuvance™ (Pneumococcal 15-valent Conjugate Vaccine) On July 16, 2021, Merck announced (link) the FDA approval of Vaxneuvance™, a new vaccine for the prevention of invasive pneumococcal disease in adults 18 years and older caused by 15 serotypes.

Why It Matters?

With the approval of new vaccines, Medicare has expanded their coverage.

Medicare Coverage of Pneumococcal Vaccines

You can find information about pneumococcal shot and administration in the Medicare Learning Network Educational Tool: Medicare Preventive Services (link). This resource was last updated in September 2021 and indicates that Medicare will cover all patients with no copayment, coinsurance, or deductible for the Prevnar 13® and Pneumovax23® vaccines.

Since September, CMS published the following information related to the Prevnar 20™ Vaccine in the Thursday, October 14, 2021 edition of MLN Connects (link):

“Medicare began covering Pneumococcal conjugate vaccine, 20 valent on October 1. CMS suggests submitting separate claims for this vaccine (HCPCS code 90677).

• Part A Medicare Administrative Contractors (MACs) will hold these claims until the April 2022 system update
• Part B MACs began processing these claims on October 4
• CMS will deny claims for vaccines provided July 1–September 30 (before it was covered by Medicare)”

The CMS has also released Transmittal 11092 (Change Request 12439) and related MLN Matters Article (link) providing claims processing instructions for the new Pneumococcal conjugate vaccine, 20 valent.

What Can You Do?

With the 2021 approval of two new pneumococcal vaccines, the CDC’s Advisory Committee on Immunization Practices (ACIP) has held meetings to discuss considerations for age-based and risk-based use of PCV 15/PCV 20 among adults. The most recent meeting was a couple of weeks ago now on October 20, 2021 (link).

As a healthcare provider, I recommend “scouting” for Medicare guidance related to coverage of the Vaxneuvance™ vaccine. As a healthcare consumer, talk with your physician to come up with the winning play for your vaccination needs.

Resources:

• CDC webpage - Pneumococcal Vaccinations: What Everyone Should Know:
  https://www.cdc.gov/vaccines/vpd/pneumo/public/index.html
• Prevnar 20 FDA webpage:
  https://www.fda.gov/vaccines-blood-biologics/vaccines/prevnar-20
• Vaxneuvance FDA webpage:
  https://www.fda.gov/vaccines-blood-biologics/vaccines/vaxneuvance

Medicare MLN Articles & Transmittals – Recurring Updates

January 2022 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Fields and Revisions to Prior Quarterly Pricing Files

• Article Release Date: October 1, 2021
• What You Need to Know: Billing staff need to be aware of these quarterly updates to Medicare ASP and Not Otherwise Classified (NOC) Part B drug pricing files.
• MLN MM12469: (link)

Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 28.0, Effective January 1, 2022

• Article Release Date: October 1, 2021
• What You Need to Know: Billing staff need to be aware of these quarterly updates to Medicare ASP and Not Otherwise Classified (NOC) Part B drug pricing files.
• MLN MM12469: (link)

Changes to the Laboratory National Coverage Determination (NCD) Edit Software for January 2022

• Article Release Date: October 1, 2021
• What You Need to Know: Billing staff need to be aware of these quarterly updates to Medicare ASP and Not Otherwise Classified (NOC) Part B drug pricing files.
• MLN MM12469: (link)

New/Modifications to the Place of Service (POS) Codes for Telehealth

• Article Release Date: October 14, 2021
• What You Need to Know: The POS Workgroup has revised the description of existing POS code 2 and added a new POS code 10.
• MLN MM12427: (link)

Claim Status Category and Claim Status Codes Update

• Article Release Date: October 14, 2021
• What You Need to Know: This article updates, as needed, the Claims Status and Claim Status Category Codes approved by the National Code Maintenance Committee.
• MLN MM12299: (link)

April 2022 Update to the Java Medicare Code Editor (MCE) for New Edit 20 – Unspecified Code Edit

• Article Release Date: October 22, 2021
• What You Need to Know: This article tells about system changes needed to update the MCE to accept a new MCE edit 20 (Unspecified Code Edit).
• MLN MM12471: (link)

Revised Medicare MLN Articles & Transmittals

Medicare Clarifies Recognition of Interstate License Compact Pathways

• Article Release Date: Initial article May 5, 2020 – Revision September 16, 2021
• What You Need to Know: The CMS revised this MLN article to clarify recognition of licenses through interstate license compact pathways as valid and full licenses for purposes of meeting federal license requirements.
• MLN SE20008: (link)

Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) Updates for Fiscal Year (FY) 2022

• Article Release Date: August 12, 2021 – Revised October 6, 2021
• What You Need to Know: This MLN article was revised to reflect revised CR 12417 which corrected the fixed dollar loss threshold amount to $16,040.
• MLN MM12417: (link)

National Coverage Determination (NCD 110.24): Chimeric Antigen Receptor (CAR) T-cell Therapy – This CR Rescinds and Fully Replaced CR 11783

• Article Release Date: May 24, 2021 – Revised October 6, 2021
• What You Need to Know: In this fourth iteration of this MLN article, information has been added on the use of the KX modifier on professional claims. Substantive changes are in dark red font.
• MLN MM12177: (link)

Medicare Coverage Updates

September 27, 2021: Final Decision Memo – Home Use of Oxygen and Home Oxygen to Treat Cluster Headaches

The CMS posted a final national coverage determination (NCD) and decision memo ((link) for two separate, but medically related NCDs.

• NCD 240.2.2: Home Oxygen Use to Treat Cluster Headaches (CH)
• CMS is removing this NCD from the Medicare NCD manual,
• Ending Coverage with Evidence Development (CED), and
• Allowing MACs to make coverage determinations regarding the use of home oxygen and oxygen equipment for CH.
• NCD 240.2: Home Use of Oxygen
• CMS is expanding patient access to oxygen and oxygen equipment in the home, and
• Permitting MACs to cover the use of home oxygen and oxygen equipment in order to treat CH and other acute conditions.

Medicare Educational Resources

MLN Booklet: Transitional Care Management Services Revised

This MLN Booklet (link) focuses on covered services, location, who may provide services, supervision, billing services, documenting services and service benefits specific to Transitional Care Management. With the most recent updates, the CMS has added codes health care professionals can bill concurrently with Transitional Care Management services and added language about auxiliary personnel providing services under supervision.

WPS GHA YouTube: CERT Errors – Transitional Care Management (TCM)

WPS has published a YouTube video (link) focused on two Comprehensive Error Rate Testing (CERT) errors on Transitional Care Management (TCM) services. The errors concern the patient record for the:

• Medical decision-making complexity
• Interactive contact

MLN Booklet: Medicare Mental Health (MLN1986542)

This MLN booklet (link) was updated this month and includes information on covered and non-covered services, eligible professionals, Medicare Advantage and Medicare drug plan coverage, and medical record documentation and coding guidance.

COVID-19 Updates

COVID-19 Booster Shots for Eligible Consumers

From late September to mid-October, there have been several updates related to COVID-19 booster shots, for example:

• September 24, 2021: CMS to Pay for COVID-19 Booster Shots: (link)
• FDA Bulletin Announcing Booster Shot Authorization: (link)
• September 28, 2021: CDC Call: What Clinicians Need to Know About the Latest CDC Recommendations for Pfizer-BioNTech COVID-19 Booster Vaccination: (link)
• October 7, 2021: CDC Guidance: Who is Eligible for a COVID-19 Booster Shot? (link)
• October 20, 2021: FDA Takes Additional Actions on the Use of a Booster Dose: (link)
• October 21, 2021: CDC Expands Eligibility for COVID-19 Booster Shots: (link)
• October 22, 2021: CMS Reminds Eligible Consumers They Have Coverage for COVID-19 Booster Shot as No Cost: (link)
• October 26, 2021: CDC Clinician Outreach Call – What Clinician’s Need to Know About COVID-19 Booster Recommendations: (link)

September 30, 2021: OCR Issues Guidance on HIPAA, COVID-19 Vaccinations, and the Workplace

HHS and the Office of Civil Rights (OCR) announced their release of guidance (link) to help the public understand when the HIPAA Privacy Rule applies to information about a person’s COVID-19 vaccination status. The “guidance addresses common workplace scenarios and answers questions about whether and how the HIPAA Privacy Rule applies.”

October 5, 2021: Getting Your CDC COVID-19 Vaccination Record Card

The CDC has updated their webpage Getting Your CDC COVID-19 Vaccination Record Card (link). Of note, the “CDC does not maintain vaccination records or determine how vaccination records are used, and CDC does not provide the white CDC-labeled COVID-19 Vaccination Record card to people. These cards are distributed to vaccination providers by state health departments.” The CDC advises you to contact your state health departments if you have additional questions about your vaccination records. This webpage includes a link to help you find information about your state health department.

October 15, 2021: COVID-19 Public Health Emergency (PHE) Extended

Xavier Becerra, Secretary of Health and Human Services, renewed the Public Health Emergency (PHE) due to the COVID-19 pandemic (link). This declaration will last for the duration of the emergency or 90 days and may be extended again by the Secretary. Continuation of the PHE means that 1135 Blanket Waivers for health care providers will remain in place too (link).

Other Updates

September 30, 2021: Requirements Related to Surprise Billing; Part II

The CMS announced the issuance of an interim final rule with comment period to further implement the No Surprises Act (link). In addition to this second interim final rule, CMS launched new online information at www.cms.gov/nosurprises. In this Fact Sheet, CMS reminds you that the rules will take effect on January 1, 2022 and that “more information on how the rule impacts various types of health plans, providers, and organizations supporting payment dispute processes is described in a related fact sheet (link).

October 10, 2021: MLN Connects – Drugs & Biologics

CMS noted in the October 10th edition of MLN Connects (link) that they have published the third quarter 2021 HCPCS Application Summaries and Coding Decisions for Drugs and Biologics. Of the fourteen requests to establish a new HCPCS Level II code, eight new codes were established with an effective date of January 1, 2022.

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.