ParaRev Weekly eJournal June 29, 2022

ej o u r n a l june29, 2022

End-Stage Renal Disease PPS Proposed Rule Fact Sheet For 2023

OPPSEdit Issue Modifier1 PT On Colonoscopy Codes

PARA Weekly eJournal: June 29, 2022

PALMETTO OPPS EDIT ISSUE: MODIFIER PT ON COLONOSCOPY CODES

A Par aRev client recently reported an unexpected edit when submitting claims to Palmetto GBA, the Medicare Administrative Contractor (MAC) Jurisdiction JM (West Virginia, Virginia, North Carolina, and South Carolina) for colonoscopy claims reporting the PT modifier.

Palmetto has acknowledged a system error which applied to claims reporting only one diagnostic colonoscopy code, such as 45380 (COLONOSCOPY, FLEXIBLE; WITH BIOPSY, SINGLE OR MULTIPLE) with modifier PT appended. The system error triggered Edit 120, which states: ?Incorrect reporting of modifier PT ? A claim is submitted with only one procedure from the designated surgical ranges (10000-69999 or 0000T-9999T) and reported with modifier PT for a single date of service. This edit is returned at the line level.?

The same system issue might have occurred in other MAC jurisdictions, since the April 1, 2022 update to the Integrated Outpatient Code Editor (IOCE) from CMS at the national level appears to be at the root of the problem. The April 1, 2022 IOCE update added the following sentence to adjudication instructions under section 5.10 --Preventive Services and Deductible/Coinsurance Waiver Processing: ?Note: Given that multiple procedures within the surgical ranges defined (10000-69999 or 0000T-9999T) are expected, if the claim submitted has only a single line, within those surgical ranges, reported with modifier PT for a single date of service, edit 120 is applied.?

The IOCE sentence from the April 2022 update is problematic. Although multiple codes reporting different colonoscopy procedures may be reported when more than one diagnostic or therapeutic procedure is performed in the same operative session, multiple codes are not always expected for colonoscopy claims.

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PARA Weekly eJournal: June 29, 2022

PALMETTO OPPS EDIT ISSUE: MODIFIER PT ON COLONOSCOPY CODES

The July 1 update appears to have corrected the language by deleting the ?Note? sentence and replacing it with the following paragraphs: https://www.cms.gov/Medicare/Coding/OutpatientCodeEdit/OCEQtrReleaseSpecs

For claims submitted prior to January 1, 2022, the deductible is waived for colorectal cancer screening services that become diagnostic or therapeutic, and for any other OPPS surgical procedures (SI = J1, T, or Q1, Q2, Q3 that resolve to J1 or T) present for the same service date. The presence of HCPCS modifier PT (Colorectal cancer screening test converted to diagnostic test or other procedure) is used to identify when there is a diagnostic or therapeutic procedure or service reported, that was converted from a colorectal cancer screening. If modifier PT is present for either a single day claim or a single date of service on a multiple day claim, there must also be a Colorectal procedure present for the same service date.

In the instance that modifier PT is present and there is no Colorectal procedure reported for the same service date, edit 120 (RTP) is returned at the line level.(See the Data_HCPCS table, within the data files, for procedures identified as Colorectal). The IOCE sets the PAF to 4 on the Colorectal procedure and the OPPS payable procedure line(s) except when any other PAF is already applied to the same line. Additionally, if a line reporting modifier PT is packaged (SI = N) with charges = $0.00, PAF 4 is not returned. Note: For Critical Access Hospital Non-OPPS claims with bill type 085x, the logic for setting the PAF is not applicable however, editing for the correct reporting of modifier PT does apply.

Effective January 1, 2022 (v23.0), Section 122 of the Consolidated Appropriations Act (CAA) includes not only a waiver of the deductible, but also requires a gradual reduction to the beneficiary coinsurance payment to be implemented over the next eight years for colorectal cancer screening services that are converted to diagnostic procedures or services.

To accommodate the OPPS Pricer in providing the deductible waiver and gradual reduction in coinsurance, the IOCE no longer sets the PAF to 4, the IOCE now returns PAF 25 (Deductible not applicable and coinsurance reduced) on the Colorectal procedure and the OPPS payable procedure line(s) except when any other PAF is already applied to the same line, or when a line reporting modifier PT is packaged (SI=N) with charges = $0.00, PAF 25 is not returned.

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PARA Weekly eJournal: June 29, 2022

PALMETTO OPPS EDIT ISSUE: MODIFIER PT ON COLONOSCOPY CODES

Palmetto graciously acknowledged that the edit is incorrect, and advised the facility that they are working to resolve the problem.Following is an excerpt from the email the hospital received from Palmetto in response to their written inquiry: ?? The edit W7120 has been recognized as a system error and is currently under review. There is no provider action necessary and any corrections or updates will be done internally. Please allow more time for correction.? ?

The PT modifier is used to identify a colonoscopy that began as a screening colonoscopy, but was converted to a diagnostic or therapeutic colonoscopy due to the discovery of cancer or precancerous conditions (such as polyps) during the screening procedure.

Although screening colonoscopies are covered by Medicare in full, without patient liability, if evidence of colon cancer or precancerous conditions are discovered during the procedure, the service cannot be reported using the screening colonoscopy HCPCS (i.e. G0121 -- COLORECTAL CANCER SCREENING; COLONOSCOPY ON INDIVIDUAL NOT MEETING CRITERIA FOR HIGH RISK).

The findings during the colonoscopy procedure require it to be reported with diagnostic HCPCS codes, such as 45380 (COLONOSCOPY, FLEXIBLE; WITH BIOPSY, SINGLE OR MULTIPLE.)Diagnostic colonoscopy codes are not covered in full ? these codes are adjudicated by Medicare to assign both deductible and coinsurance to patient liability.

The PT modifier attempts to alleviate some of the dissatisfaction generated when patients are assigned unexpected financial liability following the screening procedure.When modifier PT is appended to a diagnostic colonoscopy code, Medicare will waive the deductible that would otherwise apply ? although Medicare will not waive the coinsurance ? not just yet.Beginning in 2023, Medicare will gradually reduce the coinsurance obligation for diagnostic or therapeutic colonoscopy procedures when modifier PT is appended ? culminating in no patient liability for such procedures after 1/1/2030.

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PARA Weekly eJournal: June 29, 2022

CY2023 ESRD PPS PROPOSED RULE FACT SHEET

On June21, 2022, t heCent er s f or Medicar e & Medicaid Ser v ices (CMS) issued a pr oposed r ul et hat pr oposes t o updat e pay ment r at es and pol icies under t he End- St ageRenal Disease(ESRD) Pr ospect iv e Pay ment Syst em (PPS) f or r enal dialysis ser v ices f ur nished t o Medicar e benef iciar ies on or af t er Januar y 1, 2023.

This rule also proposes an update to the Acute Kidney Injury (AKI) dialysis payment rate for renal dialysis services furnished by ESRD facilities for calendar year (CY) 2023.

In addition, the rule proposes to update requirements for the ESRD Quality Incentive Program (QIP), and includes requests for information on topics that are relevant to the ESRD QIP. CMS is proposing refinements to the ESRD Treatment Choices Model in this proposed rule.

In order to explore options regarding payment under the ESRD PPS, the CY 2023 ESRD PPS proposed rule includes requests for information regarding (1) a potential add-on payment adjustment for certain new renal dialysis drugs and biological products, and (2) health equity issues under the ESRD PPS, with a focus on pediatric dialysis payment.

The rule also includes a proposed change to the definition of ?oral-only drug? beginning January 1, 2025, along with a proposal to clarify the descriptions of the ESRD PPS functional categories.

These proposals, if finalized, would help ensure that CMS policies are appropriately supporting innovation for new drugs that are truly innovative and not simply variations of existing drugs, and the requests for information will help CMS collect information on ways to align resource use with payment and ensure that Medicare beneficiaries with ESRD have continued access to technologies that can improve health outcomes and quality of life.

This rule also proposes a change to the ESRD PPS methodology for calculating the outlier threshold for adult patients, a proposed rebasing and revising of the ESRD Bundled (ESRDB) market basket, a proposed update to the labor-related share, a proposed increase to the wage index floor, and a proposed permanent 5% cap on decreases to the ESRD PPS wage index.

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PARA Weekly eJournal: June 29, 2022

CY2023 ESRD PPS PROPOSED RULE FACT SHEET

The ESRD PPS provides a bundled, per-treatment payment to ESRD facilities that includes all renal dialysis services furnished for outpatient maintenance dialysis, including drugs and biological products (with the exception of oral-only ESRD drugs until 2025).

Additionally, the bundled payment includes all other renal dialysis items and services that were formerly separately payable under previous payment methodologies. The bundled payment rate is case-mix adjusted for a number of factors relating to patient characteristics. There are also facility-level adjustments for ESRD facilities that have a low patient volume, for facilities in rural areas, and for the wage index.

When applicable, the bundled payment rate also includes a training add-on payment adjustment for home and self-dialysis modalities, an outlier payment for high-cost patients, and add-on payment adjustments for certain drugs, equipment and supplies.

Pr oposed Updat es t o t h e ESRD PPS f or CY 2023 Under the ESRD PPS for CY 2023, Medicare expects to pay $8.2 billion to approximately 7,800 ESRD facilities for furnishing renal dialysis services. The proposed CY 2023 ESRD PPS base rate is $264.09, which would be an increase of $6.19 to the current base rate of $257.90.

CMS projects that the updates for CY 2023 would increase the total payments to all ESRD facilities by 3.1% compared with CY 2022. For hospital-based ESRD facilities, CMS projects an increase in total payments of 3.7%, and for freestanding facilities, CMS projects an increase in total payments of 3.1%.

Rebasin g an d r evision of t h e En d-St age Ren al Disease Bu n dled (ESRDB) m ar k et bask et f or CY 2023: CMS is proposing to rebase and revise the ESRDB market basket to a 2020 base year using data from the Medicare Cost Report and other publicly available data. In addition, we are proposing to update the labor-related share, as it is based on the labor-related cost share weights in the ESRDB market basket. The proposed CY 2023 labor-related share is 55.2% based on theproposed 2020-based ESRDB market basket weights.

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PARA Weekly eJournal: June 29, 2022

CY2023 ESRD PPS PROPOSED RULE FACT SHEET

Pr oposed Wage In dex Ch an ges: The ESRD PPS uses the latest core-based statistical area (CBSA) delineations and the latest available ?pre-reclassified? hospital wage data collected under the Hospital Inpatient Prospective Payment System. The wage index is applied to the labor-related share of the payment rate to account for differing wage levels in areas in which ESRD facilities are located.

Beginning CY 2023, CMS is proposing to increase the wage index floor from 0.5 to 0.6.

Additionally, CMS is proposing to apply a permanent 5% cap on decreases in the ESRD PPS wage index beginning CY 2023. Specifically, CMS is proposing that an ESRD facility?s wage index for CY 2023 would not be less than 95% of its final wage index for CY 2022, and that for subsequent years, a facility?s wage index would not be less than 95% of its wage index calculated in the prior calendar year.

Pr oposed Updat es t o t h e Ou t lier Policy: CMS annually updates the outlier policy using the most current data. CMS is proposing to update the outlier services fixed-dollar loss (FDL) amounts for CY 2023, using 2021 claims data.

Additionally, CMS is proposing refinements to its methodology for calculating the FDL amount for adults in order to more effectively target 1.0% of total ESRD PPS payments.

Based on the latest available data, the proposed FDL amount for pediatric beneficiaries would decrease from $26.02 to $21.51, and the Medicare allowable payment (MAP) amount would decrease from$27.15 to $25.62, as compared to CY 2022 values. For adult beneficiaries, based on the latest data and proposed methodology, the proposed FDL amount would decrease from $75.39 to $40.75, and the MAP amount would decrease from $42.75 to $36.85.

Pr oposed Ch an ge t o Def in it ion of Or al-on ly Dr u g: CMS is proposing to include the word ?functional? in the definition of oral-only drug at § 413.234(a), effective January 1, 2025. Specifically, under the proposed definition, an oral-only drug would be a drug or biological product with no injectable functional equivalent or other form of administration other than an oral form.

Pr oposed Clar if icat ion t o t h e ESRD PPS Fu n ct ion al Cat egor y Descr ipt ion s: CMS is proposing revisions to clarify the descriptions of the ESRD PPS functional categories to ensure they reflect current policies.

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PARA Weekly eJournal: June 29, 2022

CY2023 ESRD PPS PROPOSED RULE FACT SHEET

Tr an sit ion al Add-on Paym en t Adju st m en t f or New an d In n ovat ive Equ ipm en t an d Su pplies(TPNIES) Applicat ion s: Three products, a monitoring system for peritoneal dialysis, a post-dialysis compression sleeve, and a dialyzer, are under consideration for the TPNIES for CY 2023. CMS is requesting public comment on whether the products meet the eligibility criteria.

Proposed Changes to the Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury: As required by section 1834(r) of the Social Security Act (the Act), CMS is proposing to update the AKI dialysis payment rate for CY 2023 to equal the CY 2023 ESRD PPS base rate and to apply the CY 2023 wage index. The proposed CY 2023 payment rate is $264.09.

Pr oposed Ch an ges t o t h e En d-St age Ren al Disease Qu alit y In cen t ive Pr ogr am (ESRD QIP) The End-Stage Renal Disease Quality Incentive Program (ESRD QIP) is authorized by section 1881(h) of the Act. Under the program, CMS assesses the total performance of each facility on quality measures specified for a payment year, applies an appropriate payment reduction to each facility that does not meet a minimum total performance score (TPS), and publicly reports the results.

Pr oposals f or Paym en t Year 2023: - CMS is proposing to continue to collect and publicly report all ESRD QIP measures while pausing the use of certain measures data for scoring and payment adjustment purposes in the PY 2023 ESRD QIP because CMS has determined that circumstances caused by the Public Health Emergency (PHE) for the coronavirus disease 2019 (COVID-19) pandemic have significantly affected the validity and reliability of the measures and resulting performance scores.

This policy is intended to ensure that these programs do not penalize facilities based on circumstances caused by the PHE for COVID-19 that the measures were not designed to accommodate. Specifically, CMS is proposing to pause the Standardized Hospitalization Ratio (SHR) clinical measure, the Standardized Readmission Ratio (SRR) clinical measure, the In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) clinical measure, the Long-Term Catheter Rate clinical measure, the Percentage of Prevalent Patients Waitlisted (PPPW) clinical measure, and the Kt/V Dialysis Adequacy Comprehensive clinical measure.

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PARA Weekly eJournal: June 29, 2022

CY2023 ESRD PPS PROPOSED RULE FACT SHEET

Although they are not affecting payments, these measures will still be collected and made public. Although the paused measures would not be scored for PY 2023, CMS would still provide confidential feedback reports to facilities on their measure rates on all measures to ensure that they are made aware of the changes in performance rates that have been observed. CMS would also publicly report suppressed measure data with appropriate caveats noting the limitations of the data due to the PHE for COVID-19.

- CMS is proposing to update the PY 2023 performance standards to use CY 2019 datato avoid using paused CY 2020 data for scoring purposes for that payment year. Currently, CY 2021 is the performance period and CY 2020 is the baseline period for the PY 2023 ESRD QIP. Under the nationwide Extraordinary Circumstance Exception that CMS granted in response to the PHE, first and second quarter data for CY 2020 are excluded from scoring for purposes of the ESRD QIP. CMS is concerned that it would be difficult to assess performance standards for PY 2023 using a baseline period based on partial year data.

Therefore, CMS is proposing to use pre-pandemic data from CY 2019 as the baseline period for the PY 2023 ESRD QIP.

Pr oposals f or Paym en t Year 2024: - CMS is proposing technical updates to begin expressing the Standardized Hospitalization Ratio (SHR) clinical measure and Standardized Readmission Ratio (SRR) clinical measure results as rates beginning with the PY 2024 ESRD QIP. CMS believes that converting these measures?results to be expressed as rates will help providers and patients better understand a facility?s performance on the measures, and would be more intuitive for a facility to track its performance from year to year.

Pr oposals f or Paym en t Year s 2025 an d 2026: - CMS is proposing to modify the technical measure specifications for the SHR and the SRR clinical measures to include a covariate adjustment for patient history of COVID-19 in the 12 months prior to measure eligibility.

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PARA Weekly eJournal: June 29, 2022

CY2023 ESRD PPS PROPOSED RULE FACT SHEET

- CMS is proposing the adoption of the COVID-19 Healthcare Personnel (HCP) Vaccination reporting measure in the PY 2025 ESRD QIP measure set as a reporting measure. This measure will assess the percentage of healthcare personnel employed at the facility who receive a complete COVID-19 vaccination course. CMS is proposing quarterly reporting deadlines for the ESRD QIP and a 12-month performance period. If finalized, facilities would report the measure through the Centers for Disease Control and Prevention?s National Healthcare Safety Network (NHSN) web-based surveillance system beginning in CY 2023.

- CMS is proposing to convert the STrR reporting measure to a clinical measure beginning in PY 2025. CMS believes that previous validity concerns have been adequately examined and addressed, and the proposed STrR clinical measure would more closely align with National Quality Forum (NQF) measure specifications.

In addition to CMS?s proposal to convert the STrR reporting measure to a clinical measure, CMS is also proposing to update the scoring methodology for the STrR clinical measure so that facilities that meet previously finalized minimum data and eligibility requirements would receive a score on the STrR clinical measure based on the actual clinical values reported by the facility, rather than the successful reporting of the data. Consistent with the technical updates to the SHR clinical measure and the SRR clinical measure, this proposal would also modify the clinical measure results to be expressed as a rate beginning in PY 2025.

- CMS is proposing to convert the Hypercalcemia clinical measure to a reporting measure beginning in PY 2025. CMS is proposing to convert the Hypercalcemia clinical measure to a reporting measure, while exploring possible replacement measures that would be more clinically meaningful for purposes of quality improvement.

CMS is also proposing to update the scoring methodology so that facilities that meet previously finalized minimum data and eligibility requirements would receive a score on the Hypercalcemia reporting measure based on the successful reporting of the data, rather than the actual clinical values reported by the facility.

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PARA Weekly eJournal: June 29, 2022

CY2023 ESRD PPS PROPOSED RULE FACT SHEET

- CMS is proposing to create a new domain for reporting measures and re-weight current measure domains beginning with PY 2025. Currently, ESRD QIP measures are weighted and distributed across four measure domains: Patient & Family Engagement, Care Coordination, Clinical Care, and Safety.

Based on changes to the measure set since PY 2021, CMS has reassessed the impact of the ESRD QIP measure domains and domain weights on TPSs, and believes it is necessary to increase incentives for improving performance by increasing the weights on measures where there is the most room for improvement, especially on patient clinical outcomes.

Therefore, CMS is proposing to create a new Reporting Measure Domain, which would include the four current reporting measures in the ESRD QIP measure set, as well as the proposed COVID-19 HCP Vaccination reporting measure and the proposed Hypercalcemia reporting measure. CMS is also proposing to update the domain weights and individual measure weights in the Care Coordination Domain, Clinical Care Domain, and Safety Domain accordingly to accommodate the new Reporting Measure Domain and individual reporting measures therein.

As the ESRD QIP measure set has evolved over the years, CMS believes this would help to address concerns regarding the impact of individual measure performance on a facility?s TPS, while also further incentivizing improvement on clinical measures.

Requ est s f or In f or m at ion : In this proposed rule, CMS also requests information on the following topics relevant to the ESRD QIP: - Qu alit y In dicat or s f or Hom e Dialysis Pat ien t s: - CMS is seeking public comments on potential indicators of quality for patients who receive dialysis at home in order to support the use of home dialysis for ESRD patients where it is appropriate. While home-based dialysis may not meet the needs of every patient, home dialysis has clear benefits for those who are suitable candidates.

Often, it may be more convenient for many ESRD patients, and survivability rates for home dialysis are comparable to those of transplant recipients and in-center hemodialysis.Although some measures in the ESRD QIP apply to home dialysis facilities, certain measures do not apply to facilities that have high rates of home dialysis.

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PARA Weekly eJournal: June 29, 2022

CY2023 ESRD PPS PROPOSED RULE FACT SHEET

Therefore, many of these facilities are eligible for fewer ESRD QIP measures than facilities that provide in-center hemodialysis only. As increasing numbers of ESRD patients use home dialysis therapies, CMS is interested in learning more about potential indicators of quality of care for home dialysis patients that are not currently being captured by the ESRD QIP. - Pr in ciples f or M easu r in g Healt h car e Qu alit y Dispar it ies: -

Consistent with Executive Order 13985 on Advancing Racial Equity and Support for Underserved Communities through the Federal Government, CMS?Equity Plan for Improving Quality in Medicare, and CMS?strategic pillar to advance equity, CMS is committed to addressing persistent inequities in health outcomes in the U.S. through improving data collection to better measure and analyze disparities across programs and policies.

As disparity initiatives expand, it is important to model efforts off of existing best practices. In the proposed rule, CMS is seeking comment, via a request for information, on considerations that CMS can take into account when advancing the use of measurement and stratification as tools to address healthcare disparities and advance healthcare equity. CMS is seeking comment on key considerations in five specific areas that could inform our approach: identification of goals and approaches for measuring healthcare disparities and using measure stratification across CMS quality programs; guiding principles for selecting and prioritizing measures for disparity reporting across CMS quality programs; principles for social risk factor and demographic data selection and use; identification of meaningful performance differences; and guiding principles for reporting disparity results.

CMS also seeks comment on additional disparity measurement or stratification guidelines suitable for overarching consideration across quality programs.

- Pot en t ial Fu t u r e In clu sion of Tw o Social Dr iver s of Healt h M easu r es: - CMS is requesting information through public comment on two potential social drivers of health screening measures. The Screening for Social Drivers of Health measure would assess whether facilities screen all patients that are 18 years or older for food insecurity, housing instability, transportation needs, utility difficulties, and interpersonal safety.

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PARA Weekly eJournal: June 29, 2022

CY2023 ESRD PPS PROPOSED RULE FACT SHEET

The Screen Positive Rate for Social Drivers of Health measure would be complimentary to the Screening for Social Drivers of Health measure. This measure would facilitate estimation of the impact of individual-level social risk factors and community-level conditions in which patients live when evaluating quality of care. Reporting the screen positive rate for each domain would inform actionable planning within the ESRD QIP program and at the facility level.

- Pr oposed Ch an ges t o t h e ESRD Tr eat m en t Ch oices M odel The ESRD Treatment Choices (ETC) Model is a mandatory payment model tested under the authority of section 1115A of the Act. Under the ETC Model, participating ESRD facilities and clinicians who manage dialysis patients (Managing Clinicians) receive positive or negative adjustments on certain claims for dialysis and dialysis-related services based on the home dialysis rate and transplant rate among their attributed beneficiaries. The ETC Model began January 1, 2021, and payment adjustments under the Model will end June 30, 2027.

- Th e ETC M odel in clu des t w o paym en t adju st m en t s: - The Home Dialysis Payment Adjustment (HDPA) is an upward adjustment on home dialysis and home dialysis-related claims with claim service dates between January 1, 2021 and December 31, 2023, the initial three years of the ETC Model.

- The Performance Payment Adjustment (PPA) creates upward or downward performance-based adjustment on dialysis and dialysis-related claims with claim service dates between July 1, 2022 and June 30, 2027. The PPA amount will depend on the ETC Participant?s performance on the ETC Model?s home dialysis rate and transplant rate among the beneficiaries attributed to the ETC Participant.

In the CY 2023 ESRD PPS proposed rule, CMS is proposing refinements to the ETC Model, including a change to the improvement scoring methodology, and a change to the requirements related to flexibilities regarding kidney disease patient education services under the ETC Model.

CMS also discusses its intent to publish certain performance data.

Learn more about the ETC Model h er e.

The proposed rule can be downloaded from the Federal Register at: h t t ps:/ / w w w.f eder alr egist er .gov/ pu blic-in spect ion / 2022-13449/ m edicar e-pr ogr am -en d-st age-r en al-disease -pr ospect ive-paym en t -syst em -paym en t -f or -r en al-dialysis

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PARA Weekly eJournal: June 29, 2022

CMS ISSUES REMINDER ON CARDIAC DEVICE CREDITS

In May 2022, Medicare released a new MLN which reminds hospitals of the special billing rules for cardiac device charges if the hospital obtains the device at full or partial credit due to a manufacturer warranty or recall. Readers may recall the November 2020 audit report released

by The Health and Human Services Office of Inspector General (OIG), which found Medicare overpaid hospitals for reimbursements for medical devices supplied at a reduced cost for specific patients. The full OIG audit report is available on the PARA Dat a Edit or Advisor tab:

The new MLN reminds hospitals of the proper modifiers, condition codes and value codes that must be used for billing when receiving cardiac devices at no cost or with credits from the device manufacturers for the replacements. Below lists key billing information for reporting cardiac devices at no costs or credits.

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PARA Weekly eJournal: June 29, 2022

HIMSS, THE GREAT RESIGNATION & OVERCOMING STAFFING CHALLENGES

The first quarter of 2022 was a whirlwind in our industry. There was an influx in national and regional shows (or family reunions, for some who have missed their industry colleagues), consistent conversations about staffing shortages, and the shroud of darkness that is ?The Great Resignation?which continues to cause complications in programs reliant upon staff across the Untied States.

At #HIMSS22, and every week since the national HIMSS show, we have had conversation around staff augmentation assistance, and the use of tech enabled services that allow facilities to breathe and feel confident in their ability to do more with less.

We had the opportunity to visit with 4 different subject matter experts in different segments of the industry about the impact they are feeling from the great resignation and how they are seeing it impact the revenue cycle. It was one of the more insightful episodes of Cof f ee w it h Cor r o, and worth a listen. One segment of the interview is with Grace Vinton (@HITeaWit h Gr ace on Twitter). She specifically discusses the compounding effects of the great resignation, the toll COVID has taken on our industry, physician burnout, and how all of this is happening during a push to remote work environments.

Ch eck it ou t :

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PARA Weekly eJournal: June 29, 2022

HIMSS, THE GREAT RESIGNATION & OVERCOMING STAFFING CHALLENGES

Also at HIMSS, Greg Goodale (VP of Marketing) and Jason Barnhouse (National Director of Enterprise Solutions) sat down with Colin Hung (HealthcareIT Today) to discuss how AI can help can bring relief to the staffing challenges we are facing.

Specifically, they discuss overcoming shortfalls that are occurring in revenue cycle management.

As I am sitting here writing this blog, I was tagged in a tweet that perfectly encompasses the importance of both rectifying the staffing issue, as well as knowing and trusting the positive impact that AI solutions can have on your workers, programs, facilities, and overall RCM processes.

Joe Desiderio stated here, h t t ps:/ / t w it t er .com / JoeDesider io/ st at u s/ 1529867282016616448, that it is not just ?Or staff ?, or ?Or AI?, but it is #AndNotOr. Like the article and interview states, the solution to the great resignation is not ?just more staff ? or ?just add AI and tech solutions?, but it?s the adaptation of the two and educating teams about the importance of both working well together. Thus, #AndNotOr.

Tak e a look at t h e ar t icle an d give t h e in t er view a list en : h t t ps:/ / w w w.you t u be.com / w at ch ?v=xdIqh ULAVjY

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PARA Weekly eJournal: June 29, 2022

BILLING FOR IRRADIATED BLOOD PRODUCTS

Hospitals should take care to report the appropriate blood product HCPCS code on outpatient claims, particularly when providing irradiated blood. Most irradiated blood products are reported with HCPCS codes that indicate the irradiated status within the blood product code.

Here is a list of the irradiated blood HCPCS codes currently in effect, as displayed in the PARA Dat a Edit or Calculator Tab.

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PARA Weekly eJournal: June 29, 2022

BILLING FOR IRRADIATED BLOOD PRODUCTS

Since the irradiation procedure may be performed at the facility or by the blood bank supplier, some hospitals have inaccurately reported the HCPCS code for the irradiation procedure, 86945 (Irradiation of blood product, each unit) separately, rather than reporting the single HCPCS which describes the unit of irradiated blood.

For example, P9040 represents a unit of irradiated leukocyte-reduced red blood cells; the same blood product would be reported with P9016 (Red blood cells, leukocyte reduced, each unit) if not irradiated. OPPS hospitals risk losing Medicare reimbursement unless the appropriate irradiated product HCPCS is reported.

Under OPPS payment packaging rules, CPT® 86945 will not be separately reimbursed when billed with another payable code on the same claim ? the hospital will be paid for the un-irradiated blood code.

Here?s an example of a 2022 OPPS claim which reported 86945 separately from the blood product code ? the irradiation procedure, 86945, is packaged to the other payable codes on the same claim:

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PARA Weekly eJournal: June 29, 2022

BILLING FOR IRRADIATED BLOOD PRODUCTS

When billing for irradiated units of blood, CMS instructs hospitals to report the specific HCPCS P-code for irradiated blood, if one is available. If there are no appropriate HCPCS describing the irradiated blood product, providers may report CPT® code 86945 in conjunction with a non-irradiated HCPCS code.

As always, the use of irradiated blood products must be reasonable and necessary for the treatment of the particular patient?s medical condition. Irradiated blood is typically used to prevent a blood transfusion complication called Transfusion-Associated Graft-Versus-Host Disease (TA-GvHD).

Patients more susceptible to TA-GvHD include, but are not limited to patients: - With Hodgkin?s disease, Leukemia, or Lymphoma - With hereditary immune disorders - With developed immune system disorders due to certain drug treatments or bone marrow/stem cell transplants - Unborn babies or newborns

The Medicare Claims Processing Manual offers the following instruction:

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c04.pdf

231.5 - Billin g f or Ir r adiat ion of Blood Pr odu ct s (Rev. 496, Issued: 03-04-05, Effective: 07-01-05, Implementation: 07-05-05) In situations where a beneficiary receives a medically reasonable and necessary transfusion of an irradiated blood product, an OPPS provider may bill the specific HCPCS code which describes the irradiated product, if a specific code exists, in addition to the CPT® code for the transfusion. If a specific HCPCS code for the irradiated blood product does not exist, then the OPPS provider should bill the appropriate HCPCS code for the blood product, along with CPT® code 86945 (irradiation of blood product, each unit).

EXAM PLE: If an OPPS provider transfuses the product described by P9040 (red blood cells, leukocytes reduced, irradiated, each unit), it would not be appropriate to bill an additional CPT® code for irradiation of the blood product since charges for irradiation should be included in the charge for P9040.

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PARA Weekly eJournal: June 29, 2022

BILLING FOR IRRADIATED BLOOD PRODUCTS

The American Association of Blood Banks (AABB) offers its Billing Guide for Blood Products and Related Services (July 2020) at the following link: https://www.aabb.org/docs/default-source/default-document-library/resources/ aabb-billingguide-for-blood-products-and-related-services.pdf

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PARA Weekly eJournal: June 29, 2022

NAVIGATING COMPLIANCE: NO SECRETS IN PRICE TRANSPARENCY

The American Hospital Association said patients should be wary of reports regarding federal hospital price transparency compliance reports from organizations other than CMS. The group said in a June 16, 2022 post on its website that organizations have reached "wildly different conclusions about the status of implementation across the hospital field." It points to two reports as examples. A report from Patient Rights Advocate said 14 percent of hospitals are compliant. Another from Milliman found a 68 percent compliance rate.

The American Hospital Association said these groups are ignoring CMS's guidance on aspects of the rule, such as how to fill in an individual negotiated rate when such a rate does not exist due to patient services being bundled and billed together. In this instance a blank cell is appropriate, but outside reports count any file with blank cells as non-compliant.

"CMS, the only true arbiter, has indicated about 160 hospitals remain out of compliance, a much smaller number than either the Patient Rights Advocate or Milliman reports suggest," the American Hospital Association said in the post.

CMS h an ded dow n the first price transparency violation fines June 7. Atlanta-based Northside Hospital was fined more than $1 million for noncompliance at two of its hospitals.

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PARA Weekly eJournal: June 29, 2022

JULY 2022 OPPS CODING UPDATE

This paper summar izes t heJuly 2022 OPPS updat eas conv ey ed in t he CMS t r ansmit t al dat ed May 26, 2022. For a det ail ed l ist ing of t he OPPS codes, st at us indicat or s, and coding updat es, v isit t he OPPS t r ansmit t al at : https://www.cms.gov/files/document/r11435cp.pdf

Readers are advised that the July 2022 update to the OPPS Addendum A and Addendum B files was not available as of the date of this publication. The status indicator and payment information reported herein was derived entirely from the transmittal cited above.

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PARA Weekly eJournal: June 29, 2022

JULY 2022 OPPS CODING UPDATE

Su m m ar y of Ch an ges The update includes HCPCS additions, HCPCS changes, and payment policy indicators are generally described below; where the list of included HCPCS codes was lengthy, the list is provided on separate pages at the end of this paper.

- Pr opr iet ar y Lab An alysis Codes ? added 9 new codes for lab tests that are proprietary ? in other words, the test method applicable to that CPT® is owned by the patent holder for the test - Advan ced Diagn ost ic Lab Test - 1 new code was retroactively approved as an Advanced Diagnostic Lab Test (ADLT) to 3/24/2022. The ?TissueCypher Barrett?s Esophagus Assay?, CPT® 0108U, is OPPS Status Indicator A (paid under a fee schedule) - 24 n ew CPT Cat egor y III - codes have been added effective 7/1/2022. The AMA releases new codes in July and January of each year; Category III codes are temporary codes for emerging technology, services, procedures, and service paradigms - Pr ocedu r es assign ed t o New Tech n ology APC?s were updated: - Added CPT® 0721T -- The Optellum Lung Cancer Prediction (LCP) Procedure, which applies an algorithm to a patient?s CT scan to produce a raw risk score for a patient?s pulmonary nodule.Status indicator S, APC 1508 ($600-$700); effective 7/1/2022 - Added CPT® 0723T ? Quantitative Magnetic Resonance Cholangiopancreatography Procedure, which produces a three-dimensional reconstruction of the biliary tree, pancreatic duct, along with volume and duct metrics.Status indicator S, APC 1511 (Level 11, $900-$1,000), effective July 1, 2022 - Excluded the Argus®II Retinal Prosthesis implant codes, as the device is no longer available in the marketplace. The implantation procedure and programming procedures (0100T, 0472T, 0473T, C1841) will be assigned status E2, excluded from coverage, effective July 1, 2022 - Updated the description for HCPCS C9782 (CardiAMP cell therapy IDE study), which was established 4/1/2022.CMS revised the HCPCS description to specify inclusion of the device within the procedure code; assigned Status Indicator T, New Technology Level 39 ($15,001-$20,000.)

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PARA Weekly eJournal: June 29, 2022

JULY 2022 OPPS CODING UPDATE

- Sk in Su bst it u t es - Four Skin Substitute codes are newly assigned to the High Cost skin substitute group effective July 1, 2022.Among the four,A2001 (Innovamatrix ac, per square centimeter), will be retroactively payable as High-Cost effective April 1, 2022

- Dr u gs, Biologicals, an d Radioph ar m aceu t icals -Sixteen new drug codes were established effective July 1, 2022 ? of those, nine new codes were assigned pass-thru status, and four existing drugs with prior HCPCS assigned to pass-through status will have HCPCS updates to a new code:

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PARA Weekly eJournal: June 29, 2022

JULY 2022 OPPS CODING UPDATE

- J0879 (Injection, Difelikeafalin, 0.1 microgram (for End Stage Renal Disease on dialysis)) will become retroactively payable as status K under OPPS effective April 1, 2022.

- Covid-19 Labor at or y t est s an d ser vices (an d on e ot h er lab code)

- CMS provided a comprehensive list of COVID-19 lab tests and related services and OPPS status indicators. CPT® 87913 is relatively new, having been added in February 2022 - One lab code listed along with the COVID test codes, 0014M, is listed in this section, although it is not a COVID-19 lab test.It had been inadvertently omitted in the April OPPS update - HCPCS K1034 (Over-the-Counter Covid-19 Tests Demonstration) for providers who wish to supply home COVID-19 test kits to Medicare beneficiaries.HCPCS K1034 has been available to report dispensed test kits since April 4, 2022 - New Covid-19 Vaccin e an d Adm in ist r at ion codes - Effective 3/29/2022, CMS will recognize and reimburse the Moderna COVID-19 vaccine booster dose (91309) and its administration (0094A), which coincides with the date this vaccine received an Emergency Use Authorization (EUA) from the FDA - Several other new CPT ® codes were established by the AMA but cannot be billed to Medicare until they receive an Emergency Use Authorization (EUA), including the Sanofi Pasteur booster vaccine for adults 18 years and older, and the Pfizer booster code for pediatric patients 5-11 years old

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JULY 2022 OPPS CODING UPDATE

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PARA Weekly eJournal: June 29, 2022

CMS ANNOUNCES NEW HCPCS EFFECTIVE JULY 1, 2022

CMSissuedadocument reporting HCPCScodingdecisionsinresponseto manufacturer appl ications for newcodeassignment eachquarter. The first quarter 2022report incl udes anumber of HCPCSfor drugsand biol ogics, whichwil l becomeeffectiveJuly 1, 2022. https://www.cms.gov/files/document/2022-hcpcs-application-summary-quarter-1-2022drugs-and-biologicals.pdf

A summary of the decisions is provided below in three sections ? Medicine, Wound Care, and Radiopharmaceuticals.

M edicin e - FYARRO® -- which is currently reported with temporary HCPCS C9091, will be assigned HCPCS J9331 ? ?Injection, sirolimus protein-bound particles, 1 mg.? This drug is used to treat advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa) - LEQVIO® -- will be assigned HCPCS J1306 ? Injection, inclisiran, 1 mg. LEQVIO® is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH)] or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of low-density lipoprotein cholesterol (LDL-C)

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PARA Weekly eJournal: June 29, 2022

CMS ANNOUNCES NEW HCPCS EFFECTIVE JULY 1, 2022

- SUSVIM O? , an intraocular injection used to treat patients with age-related macular degeneration, will be assigned two HCPCS, one for the injection, and another for the implant. The recommended dose of SUSVIMO? is 2 mg (0.02 mL of 100mg/mL solution) continuously delivered via the SUSVIMO? ocular implant with refills administered every 24 weeks (approximately 6 months). The new HCPCS are: J2779 ?Injection, ranibizumab, via intravitreal implant (susvimo), 0.1 mg?, and C9093 ?Injection, ranibizumab, via intravitreal implant (susvimo), 0.1 mg?

- RYPLAZIM ® , which is indicated for the treatment of patients with plasminogen deficiency type 1 (hypoplaminogenemia), will be assigned HCPCS J2998 ?Injection, plasminogen, human-tvmh, 1 mg?. Apparently this medication is considered a self-administered drug unless delivered by IV infusion; modifier JA ?administered intravenously? must be appended when delivered by IV infusion to qualify for Medicare coverage - XIPERE? (Triamcinolone acetonide) is a synthetic glucocorticoid (glucocorticoids are often referred to as corticosteroids) with immunosuppressive and anti-inflammatory activity.

The newly assigned HCPCS will be J3299 ?Injection, triamcinolone acetonide (xipere), 1 mg?

- VYVGART? , is indicated for the treatment of adult patients with generalized myasthenia gravis who are anti-acetylcholine receptor antibody positive. This drug may have been reported with miscellaneous/unclassified codes previously. The newly assigned HCPCS is J9332 ?Injection, efgartigomod alfa-fcab, 2 mg?

- cu t aqu ig®, which prevents infections of a wide variety of bacterial and viral agents in immunodeficient adults by temporarily restoring IgG levels in circulating plasma, will be assigned HCPCS J1551, ?Injection, immune globulin (cutaquig), 100 mg?

- TEZSPIRE? is an add-on maintenance treatment of adult and pediatric patients aged 12 years and older with uncontrolled asthma while receiving treatment with medium- or high-dose inhaled corticosteroids (ICS) plus at least one additional controller medication with or without oral corticosteroids (OCS). The newly assigned HCPCS will be J2356, ?Injection, tezepelumab-ekko, 1 mg?

- APRETUDE, which reduces the risk of sexually acquired HIV-1 infection, is an intramuscular injection kit that must be administered by a healthcare provider. The new HCPCS assigned by CMS will be J0739, ?Injection, cabotegravir, 1 mg?.

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PARA Weekly eJournal: June 29, 2022

CMS ANNOUNCES NEW HCPCS EFFECTIVE JULY 1, 2022

Sk in Su bst it u t es an d Wou n d Car e Pr odu ct s - Celer a? Du al M em br an e an d Celer a? Du al Layer skin substitutes will be assigned new HCPCS Q4259 ?Celera dual layer or celera dual membrane, per square centimeter.?

Previously, this product may have been reported with Q4100 ?Skin Substitute, Not Otherwise Specified.?

- Sign at u r e APat ch , a wound protection barrier/cover will be assigned HCPCS Q4260 ?Signature APatch, per square centimeter ?

- TAG, a wound protection barrier/cover, will be assigned HCPCS Q4261, ?Tag, per square centimeter ?.

Radioph ar m aceu t icals - Illu cix ® , a radioactive prostate cancer PET imaging product, will be assigned HCPCS A9596 ?Gallium ga-68 gozetotide, diagnostic, (illuccix), 1 millicurie?. Providers using this agent in PET scans are hopeful that the new HCPCS will offer better reimbursement for this expensive radiopharmaceutical. (The payment status will be announced with the next update to the OPPS Addendum B, expected in June, 2022.)

- TAUVID? , a radioactive diagnostic agent used in PET imaging of the brain to evaluate patients for Alzheimer ?s disease will be assigned HCPCS A9601 ?Flortaucipir f 18 injection, diagnostic, 1 millicurie?

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PARA Weekly eJournal: June 29, 2022

CMS ANNOUNCES NEW HCPCS EFFECTIVE JULY 1, 2022

The CMS document also listed the applications for which it declined to assign a HCPCS for various reasons: - RETHYM IC® - used only in inpatient settings - Lidocidex? - a compounded drug (CMS does not issue HCPCS for compounded drugs) - Cocoon Du al-Layer an d Sin gle-Layer M em br an es ? due to differences in the HCPCS application and information submitted to the FDA - Palin Gen ® Du al Layer M em br an es are dehydrated, human allografts derived from the placenta ? due to differences in the HCPCS application and information submitted to the FDA - Esan o AAA, a triple layer decellularized, dehydrated human amniotic membrane allograft for wound care, due to differences in the HCPCS application and information submitted to the FDA - San opellis are dehydrated, human allografts derived from the placenta for wound care, due to differences in the HCPCS application and information submitted to the FDA - 3L Biovan ce® Tr i-Layer an d 3L Biovan ce ® , a human amniotic membrane allograft for wound care, due to differences in the HCPCS application and information submitted to the FDA - Pem et r exed, a single agent in the treatment of locally advanced and metastatic non-squamous non-small cell lung cancer, due to an incomplete HCPCS application.

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PARA Weekly eJournal: June 29, 2022

Click an yw h er e on t h is page t o be t ak en t o t h e f u ll on lin e docu m en t .

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PARA Weekly eJournal: June 29, 2022

MLN CONNECTS

PARA in vit es you t o ch eck ou t t h e m ln con n ect s page available f r om t h e Cen t er s For M edicar e an d M edicaid (CM S). It 's ch ock f u ll of n ew s an d in f or m at ion , t r ain in g oppor t u n it ies, even t s an d m or e!

Each w eek PARA w ill br in g you t h e lat est n ew s an d lin k s t o available r esou r ces. Click each lin k f or t h e PDF!

Th u r sday, Ju n e 23, 2022

New s -

Ambulance Prior Authorization Model Expands August 1 Orthoses Referring Providers: Comparative Billing Report in June Medical Records Correspondence Address Inpatient Rehabilitation Facility Provider Preview Reports: Review by July 15 Long-Term Care Hospital Provider Preview Report: Review by July 15 Cognitive Assessment: What?s in the Written Care Plan?

Claim s, Pr icer s, & Codes -

Quarterly Update to the National Correct Coding Initiative [NCCI] Procedure-to-Procedure [PTP] Edits, Version 28.2, Effective July 1, 2022

M LN M at t er s® Ar t icles -

July Quarterly Update for 2022 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Fee Schedule

Pu blicat ion s -

Medicare Diabetes Self-Management Training ? Revised

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r a n s mi t t a l s

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Ther e w er e NINE new or r evised Tr ansmittal s r el eased this w eek .

To go to the ful l Tr ansmittal document simpl y cl ick on the scr een shot or the l ink .

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PARA Weekly eJournal: June 29, 2022

TRANSMITTAL R211475CP

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TRANSMITTAL R11474CP

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TRANSMITTAL R11471CP

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TRANSMITTAL R11468CP

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TRANSMITTAL R11463CP

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TRANSMITTAL R11465CP

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TRANSMITTAL R11472CP

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TRANSMITTAL R11467CP

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TRANSMITTAL R11466CP

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ed l ea r n s

Ther e w er e THREE new or r evised MedLear n r el eased this w eek .

To go to the ful l Tr ansmittal document simpl y cl ick on the scr een shot or the l ink .

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MEDLEARN MM12803

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MEDLEARN MM12773

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MEDLEARN MM12774

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FOR YOUR INFORMATION

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Nothing herein constitutes, is intended to constitute, or should be relied on as, legal advice. ParaRev expressly disclaims any responsibility for any direct or consequential damages related in any way to anything contained in the materials, which are provided on an ?as-is?basis and should be independently verified before being applied.

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