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September is Prostate Cancer Awareness Month. Prostate cancer is the second leading cause of male cancer-related death in the U.S.[1] According to the American Cancer Society, it is estimated that in 2023 there will be 288,300 new cases of prostate cancer and 34,700 prostate-cancer related deaths in the U.S.[2]

Historically, there have been limited options in managing patients with advanced prostate cancer. However, in the last several years, we have seen remarkable progress in the development of new diagnostic and therapeutic tools. One of these, PSMA PET imaging for prostate cancer, is a particularly exciting development and is the focus of this article. Medical oncologist Michael Morris from Memorial Sloan Kettering Cancer Center calls this new imaging technology “the biggest advance in prostate cancer detection since the PSA test was developed in the 1980s.”[3]

PSMA PET Imaging: A New Diagnostic Tool

Prostate-Specific Membrane Antigen, or PSMA, is a protein that is present at a higher level in prostate cancer cells, and in addition, is often found on the surface of prostate cells.[4] These characteristics of PSMA make it a good target for imaging prostate cancer that might have escaped from the prostate and traveled to other parts of the body. PSMA should not be confused with Prostate-Specific Antigen, or PSA, which is a protein produced by the prostate.[5] The PSA test measures the level of PSA in the blood. An elevated PSA in the blood can be an indication of prostate cancer, although it can be due to other factors.

Imaging for advanced prostate cancer has been problematic for many years, with men often having to undergo a conventional CT scan and a bone scan to see if there is evidence of metastatic disease. However, according to the National Cancer Institute, both of these conventional imaging technologies have limitations since “neither is particularly good at finding individual prostate cancer cells, and thus can miss very small tumors.”[6] PSMA PET imaging promises to improve the sensitivity of detecting prostate cancer metastases compared to conventional imaging approaches, and thereby better inform the treatment and management of patients with advanced disease.[7]

Clinical trials have shown some promising results for this new imaging technology. For example:

• In the CONDOR trial, a total of 208 men were enrolled in the study. The men had a rising PSA after surgery or radiotherapy. The study evaluated the radiotracer ¹⁸F-DCFPyL and its ability to detect prostate cancer in these men when performing a PET/CT. The trial demonstrated that the radiotracer correctly localized disease in approximately 85% of men with prostate cancer biochemical recurrence, all of whom had uninformative conventional imaging.[8]
• In another trial, 276 prostate cancer patients were enrolled to evaluate the clinical impact of ⁶⁸Ga-prostate-specific membrane antigen positron emission tomography/computed tomography on the planned management of prostate cancer patients with biochemical recurrence after surgery.[9] It was found that the use of this imaging technology allowed clinicians to radically change the intended treatment approach before imaging evaluation, in roughly two out three individuals.

FDA Approvals

During the last several years, the FDA has approved several radioactive tracers for use in PSMA PET imaging. For example:

• On December 1, 2020, the FDA approved the radioactive tracer Gallium (Ga) 68 PSMA-11 for use in PET imaging of patients with suspected prostate cancer metastasis who are potentially curable by surgery or radiation therapy.[10] The tracer can also be used for patients with suspected prostate cancer recurrence based on elevated serum PSA levels.
• On May 26, 2021, the FDA approved a second PSMA-targeted PET imaging drug, Pylarify (piflufolastat F 18), for the same prostate cancer imaging indications as Ga 68 PSMA-11.[11] The FDA noted that with this approval, certain men with prostate cancer will have greater access to PSMA-targeted PET imaging that can aid health care providers in assessing prostate cancer.

Additional FDA approvals have followed for Illuccix (gallium Ga 68 gozetotide) (12/17/2021)[12], Locametz (gallium Ga 68 gozetotide) (3/23/2022)[13], and Posluma (flotufolastat F 18) (5/25/2023)[14].

Once a PSMA-targeted radioactive tracer is injected into the patient, the tracer travels throughout the body and attaches to PSMA; the cells thus flagged will then “light up” when a PET scan is performed.[15]

PSMA Tracers by the Numbers

To measure the growth in utilization of this new imaging technology, RealTime Medicare Data constructed a Tableau visualization using its nationwide Medicare Fee-for-Service (FFS) paid claims database. Here is some key trending information from that visualization:

Data Source: RealTime Medicare Data, LLC. Time period: 12/1/2020-3/31/2023. Geography: all 50 states and D.C. CMS 1500 Office POS and Outpatient Hospital Medicare Fee-for-Service. The following HCPCS Codes were included in the data queries: A9593-GALLIUM GA-68 PSMA-11 DIAGNOSTIC UCSF 1 MCI, A9594-GALLIUM GA-68 PSMA-11 DIAGNOSTIC UCLA 1 MCI, A9595-PIFLUFOLASTAT F-18 DIAGNOSTIC 1 MCI, A9596-GALLIUM GA-68 GOZETOTIDE DIAG ILLUCCIX 1 MCI, A9597-POSITRON EMISSION TOMOGRAPHY RP DX TUMOR ID NOC, and A9800-GALLIUM GA-68 GOZETOTIDE DIAGNOSTIC 1 MCI. PDx's not related to prostate cancer, and CPT Modifier 26 (relating to professional fees), were filtered from the data.

As the above chart indicates, PSMA tracer utilization among the Medicare FFS population has increased substantially over the study period, especially during CY 2022. In addition, there has been a shift in the place of service where these procedures are being performed; indeed, by 2022 procedure volume in the Office setting was fast approaching that in the Outpatient Hospital setting.

From Imaging to Targeted Therapy

In addition to being a target for prostate cancer imaging, can PSMA be a target for prostate cancer therapy? In 2022, the FDA weighed into this question with these exciting developments:

• On March 23, 2022, the FDA approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for the treatment of adult patients with PSMA-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy.[16]
• On the same day, the FDA approved the radioactive tracer Locametz (gallium Ga 68 gozetotide) for positron emission tomography (PET) of PSMA-positive lesions, including the selection of patients with metastatic prostate cancer for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated.[17] The FDA noted that Locametz is the first radioactive tracer approved for patient selection in the use of a radioligand therapeutic agent.

Pluvicto acts by binding to PSMA; a radioactive particle then kills the cancer cells.[18] In a clinical trial leading to the FDA approval, the trial demonstrated a statistically significant improvement in the primary endpoints of overall survival and radiographic progression-free survival.[19]

Questions remain as to who might be able to receive the new therapy drug beyond those who have already been treated with chemotherapy, whether it will benefit patients during earlier stages of prostate cancer, and whether its effectiveness will be improved if combined with other therapies.[20]

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Disclaimer: This article does not provide medical advice. It is intended for general informational purposes only. It is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read in this article.

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

• Source: Appendix A: Economic Analysis of FY 2024 IPPS Final Rule

 

There are eighteen days until the October 1^st start to the 2024 CMS Fiscal Year. As you continue to prepare, this article focuses on New Technologies Add-On Payments (NTAPs). Section E. Add-On Payments for New Services and Technologies for FY 2024 begins on page 58,793 of the FY 2024 IPPS Final Rule.

 

New Technologies Eligible for Add-On Payment (NTAPs) Background

Section 1886(d)(5)(K)(i) of the Act requires the Secretary to establish a mechanism to recognize the costs of new medical services and technologies under the payment system under the subsection which establishes the system for paying for the operating costs of inpatient hospital services.

 

The system of payment for capital costs is established in section 1886(g) of the Act. For this reason, capital costs are not included in the add-on payments for a new medical service or technology.  

 

NTAPs are not budget neutral and the “newness” for payment is limited to the 2-to-3-year period after the date a technology becomes available.

 

In response to the COVID-19 public health emergency (PHE) and as new therapies received approval to treat COVID-19, CMS established the New COVID-19 Treatments Add-on Payment (NCTAP). With the PHE ending in May of this year, the add-on payments for NCTAPs will end September 30, 2023.

 

There are three pathways for a new service or technology to be approved for the add-on payment (Traditional pathway, Certain Antimicrobial Products Alternative Pathway, and Certain Transformative New Devices Alternative Pathway).

 

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

 

Coding NTAPs

Section X New Technology was added to ICD-10-PCS effective October 1, 2015. CMS has indicated (https://www.cms.gov/Medicare/Coding/ICD10/Downloads/2016-Section-X-New-Technology-.pdf) that “Section X was created in response to public comments received regarding New Technology proposals presented at ICD-10 Coordination and Maintenance Committee Meetings, and general issues facing classification of new technology procedures.”  To receive payment for an eligible NTAP, the applicable section X New Technology ICD-10-PCS code must be on the claim submitted for adjudication.

 

NTAPs by the Numbers

Before looking ahead to FY 2024, I wanted to see what new technologies have been coded in FY 2023 claims with dates of service from October 1, 2022 through March 31, 2023. The following claims volume was provided by our sister company RealTime Medicare Data (RTMD), represents claims volume for the entire nation, and is specific to the Medicare Fee-for-Service population.   

FY 2023

25: The number of technologies eligible for add-on payment.

 

94,210: The number of claims with dates of service from October 1, 2022 through March 2023 that included an ICD-10-PCS code eligible for add-on payment.

 

7,551: The number of claims with an ICD-10-PCS new technology code when the technologies eligible for the COVID-19 Treatments Add-On Payment (NCTAP) (convalescent plasma, Olumiant, and Veklury® (remdesivir)) were excluded from the claims volume. 

 

FY 2024

33: The number of technologies eligible for add-on payment.

 

58,524.5: The number of Medicare beneficiaries that CMS expects will receive one of the new technologies. Note, the .5 is not an error. CMS’ estimated cases for the NTAP Livtencity™ is 129.5 cases.

 

$495,497,861.97: CMS’ estimated Medicare spending on NTAPs in FY 2024.

 

Moving Forward

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

• Is your hospital providing any of these services or technologies?
• Who needs to be aware of what the new technologies are? (i.e., Physicians, Pharmacy, Coding Professionals, Clinical Documentation Integrity Specialists, Case Managers)
• What process do you have in place to alert your Coding Staff of the need to code the new technology ICD-10-PCS codes?

 

Resource

FY 2024 IPPS CMS webpage: https://www.cms.gov/medicare/payment/prospective-payment-systems/acute-inpatient-pps/fy-2024-ipps-final-rule-home-page

We have a couple of questions regarding the coding of hyperlipidemia with hypercholesterolemia.

 

Question#1

If a provider has documented mixed hyperlipidemia and hypercholesterolemia in the record, do you code both conditions?

Answer#1

Only assign code E78.2 for mixed hyperlipidemia.  Pure hypercholesterolemia, unspecified (E78.00) is included with code E78.2 so it is not coded separately. 

Effective date:  June 9, 2023

 

Question#2

How do you code unspecified hyperlipidemia and hypercholesterolemia?

Answer#2

In this case, only the code for pure hypercholesterolemia, unspecified (E78.00) is assigned.  Hyperlipidemia, unspecified (E78.5) is not coded separately since hypercholesterolemia identifies the specific blood lipid elevated.

Effective date:  June 3, 2022

 

Hypercholesterolemia is defined as a high blood cholesterol level.

Hyperlipidemia is defined as high lipid or fat levels in the blood. 

 

References:

ICD-10-CM Official Coding Book

Coding Clinic for ICD-10-CM/PCS, Second Quarter 2023, Page 9

Coding Clinic for ICD-10-CM/PCS, Second Quarter 2022, Pages 5 and 6

August 10, 2023: New Place of Service Code 27 – Outreach Site/Street

CMS published Change Request (CR) 13314 to inform providers about the new Place of Service (POS) code 27 for “Outreach Site/Street” – a non-permanent location on the street or found environment, not described by any other POS code, where health professionals provide preventive, screening, diagnostic, and/or treatment services to unsheltered homeless individuals. This code becomes effective on October 1, 2023.

 

In the August 25^th MLN connects e-newsletter, CMS noted “at this time, Medicare won’t use this code in claims processing. If you submit a claim with this code, we’ll return it to you.”

https://www.cms.gov/outreach-and-education/outreach/ffsprovpartprog/provider-partnership-email-archive/795634753/2023-08-24-mlnc#_Toc143610547

 

August 10, 2023: Review Choice Demonstration for Inpatient Rehabilitation Facility Services FAQs

On May 15, 2023, CMS announced the new initiative, The Review Choice Demonstration (RCD) for Inpatient Rehabilitation Facility (IRF) Services. This demonstration started in Alabama with the first cycle of review dates being August 21, 2023 through February 29, 2024.

 

Palmetto GBA Jurisdiction J is the Medicare Administrative Contractor for Alabama, and they have a dedicated webpage specific to this demonstration (https://palmettogba.com/palmetto/jja.nsf/DID/FHT2JV6UCF). On August 28^th, they posted a link to FAQs. Topics covered in this document include general questions, choice selection questions, submission questions, pre-claim review (PCR) questions, and medical necessity questions.

 

For IRF Providers outside of Alabama, I encourage you to pay close attention to the general question 4 asking what states does this demonstration impact.

 

CMS notes the demonstration initially for providers physically located in the state of Alabama and bill to MAC Jurisdiction J. The demonstration will then expand to Pennsylvania, Texas, and California, “as well as any state that bill to the MAC jurisdictions JJ, JL, JH, and JE, regardless of where they are physically located.”

 

Here is one example included in the answer to question 4:

I am an IRF located in a demonstration state but bill to a different MAC than the one for that state.

“You are included in the demonstration if the MAC that you bill to is JJ, JE, JL, or JH. If you bill to another MAC, then you are not included in the demonstration.”

You can find additional information about this demonstration on the CMS website at https://www.cms.gov/research-statistics-data-systems/medicare-fee-service-compliance-programs/prior-authorization-and-pre-claim-review-initiatives/review-choice-demonstration-inpatient-rehabilitation-facility-services#timeline.

 

August 21, 2023: CMS Issues Draft Guidance on New Program to Allow People with Traditional Medicare Fee-for-Service to Pay Out-of-Pocket Prescription Drug Costs in Monthly Payments

The Inflation Reduction Act of 2022 was signed into law on August 16, 2022. This law caps annual out-of-pocket prescription drug costs at $2,000 for 2025.

 

In addition to capping the out-of-pocket amount, the law gives people with Medicare prescription drug coverage (Medicare Part D) the option to make monthly payments spread over the year, also starting in 2025. On August 21^st, CMS published draft guidance for comment outlining the requirements and procedures for spreading out the cost sharing over the year.

 

Due to the size of the new program, CMS indicated they would release the guidance in two parts. Part one was released August 21^st and focuses on “helping Medicare Part D plan sponsors and pharmacies prepare for the new programs and build necessary infrastructure for successful implementation.” CMS is soliciting comments on topics and strategies included in the guidance to ensure eligible Part D enrollees benefit from the programs.

 

You can submit comments to CMS on the first draft guidance through September 30, 2023.

 

The planned release date for part two of the guidance will be in early 2024. This second release will focus on Medicare Part D enrollee outreach and education, Medicare Part D plan bid information, monitoring and compliance. “CMS also intends to develop tools, such as calculators, to help people with Medicare Part D and their caregivers learn what monthly payments may look like under the new program.”

 

Links to a Fact Sheet about the Medicare Prescription Payment Plan, an implementation timeline, and the August 21^st draft guidance are included in an August 21^st CMS Press Release. https://www.cms.gov/newsroom/press-releases/cms-issues-draft-guidance-new-program-allow-people-medicare-pay-out-pocket-prescription-drug-costs

Did You Know?

Noridian Healthcare Solutions, LLC (Noridian) is the current Supplemental Medical Review Contractor (SMRC). “With CMS directed topic selections and timeframes, Noridian conducts nationwide medical reviews (Part A, Part B, and DME), in accordance with all applicable statutes, laws, regulations, national and local coverage determination policies, and coding guidance, to determine whether Medicare claims have been billed in compliance with coverage, coding, payment, and billing practices.”

 

Reviews are assigned to the SMRC based on analysis of national claims data issues identified by other Federal agencies (i.e., OIG, Government Accountability Office (GAO), the Comprehensive Error Rate Testing Program (CERT), and Program for Evaluating Payment Patterns Electronic Report (PEPPER)).

 

Why It Matters?

As of August 15, 2023, the SMRC has thirteen current projects. Examples of current projects includes hyperbaric oxygen of lower extremities diabetic wounds, hospice general inpatient (GIP) level of care, cryosurgery of the prostate, and Mohs surgery.

 

Also, as of August 15, 2023, Noridian has completed sixty projects since being awarded the $227 million SMRC contract by CMS in 2018. Error rates for their completed projects range from 1% to 98%.

 

The 1% error rate was for a sample of claims reviewed related to the 20% add-on payment for COVID-19 that was in place during the COVID-19 Public Health Emergency. The 98% error rate was for a review of claims for Medicare Part B emergency ambulance services.

 

In July of this year, in addition to reporting an error rate for the reviewed claims, Noridian began reporting an error rate for the number of claims denied due to no response to an Additional Documentation Request (ADR). To date, SMRC medical review findings that include the no response error rate, includes:

 

Project 01-080: Vitamin B12 with Modifier 25 Findings of Medical Review

Error Rate for Reviewed Claims: 43%

No Response to ADR Denials: 39%

Results Published July 18, 2023

https://noridiansmrc.com/completed-projects/01-080/

 

Project 01-081: Outpatient Dental Services CPT 41899 Findings of Medical Review

Error Rate for Reviewed Claims: 95%

No Response to ADR: 20%

Results Published July 18, 2023

https://noridiansmrc.com/completed-projects/01-081/

 

Project 01-093: Overlapping Claims – Hospital Transfers During the PHE Findings of Medical Review

Error Rate for Reviewed Claims: 12%

No Response to ADR: 8%

Results Published July 18, 2023

https://noridiansmrc.com/completed-projects/01-093/

 

Project 01-050: Podiatry Findings of Medical Review

Error Rate for Reviewed Claims: 45%

No Response to ADR Denials: 29%

Published August 8, 2023

https://noridiansmrc.com/completed-projects/01-050/

 

Project 01-072: Neurostimulator Implantation Findings of Medical Review

Error Rate for Reviewed Claims: 39%

No Response to ADR Denials: 23%

Results Published August 15, 2023

https://noridiansmrc.com/completed-projects/01-072/

 

Noridian notes they must notify CMS of identified improper payments and noncompliance with documentation requests. They will initiate claims adjustments and/or overpayment recoupment by the standard overpayment recovery process.

 

What Can I Do?

First and foremost, make sure you have a process to receive and respond to ADR requests from the SMRC and other review contractors (i.e., CERT).

 

If a claim is denied for no receipt of documentation, you can complete the following steps posted to the Noridian Jurisdiction E (JE) MAC website:

 

SMRC Reviews Denied for No Documentation

“When a claim is denied for no receipt of documentation requested by the SMRC, the next step is to submit the documentation to the MAC that issued the demand letter for the overpayment. This must occur within 120 calendar days of the demand letter.

 

This situation is considered a reopening and the MAC will send the submitted documentation to the SMRC for a re-review decision. The SMRC has up to 60 calendar days to make this decision. The SMRC will then mail a letter to the supplier with their findings, either to pay the claim or they will outline the reasons for denial.

 

The SMRC will next notify the MAC of the payment or denial decision. The MAC will adjust the claim and a remittance advice with the adjustment results will be generated. The provider has the right to appeal the SMRC decision, if the claim remains denied.

 

Based on the timeframes and steps listed above, please call the MAC about the status of the SMRC re-review only after at least 140 days have passed from when documentation was sent.”

 

Last, become familiar with information available on the SMRC website (https://noridiansmrc.com/). 

July 21, 2023: MLN MM13240: Patient Driven Payment Model Claim Edits

CMS advises that Skilled Nursing Facilities (SNFs) and Hospitals need to make sure your billing staff knows about edits for SNFs billing on Type of Bill (TOB) 21X and Swing Bed TOB 18X, and hospitals billing during an interrupted stay. https://www.cms.gov/files/document/mm13240-patient-driven-payment-model-claim-edits.pdf

 

July 21, 2023: MLN MM13248: Processing Services During Disenrollment from the Program of All-Inclusive Care for the Elderly (PACE)

Hospitals, SNFs and other providers billing Medicare Administrative Contractors (MACs) for inpatient services they provide to PACE-eligible Medicare patients need to make sure your billing staff knows how CMS handles payment for Medicare patients disenrolling from PACE and condition codes and value code (VC) CMS requires to prevent claims denials. https://www.cms.gov/files/document/mm13248-processing-services-during-disenrollment-program-all-inclusive-care-elderly.pdf

 

July 27, 2023: MLN MM13275: ESRD Prospective Payment System: October 2023 Update

Make sure your billing staff knows about billing J0889 for daprodustat and new ICD-10-CM codes for comorbidity payment adjustment and acute kidney injury. https://www.cms.gov/files/document/mm13275-esrd-prospective-payment-system-october-2023-update.pdf

 

Augst 3, 2032: MLN MM13299: HCPCS Codes Used for Skilled Nursing Facility (SNF) Consolidated Billing (CB) Enforcement: October 2023 Update

Make sure billing staff knows about updates to the lists of HCPCS codes that are subject to the CB provision of the SNF prospective payment system (PPS), and additions and deletions of certain chemotherapy, blood clotting factors, and therapies inclusion codes from the Medicare Part A SNF files. https://www.cms.gov/files/document/mm13299-hcpcs-codes-used-skilled-nursing-facility-consolidated-billing-enforcement-october-2023.pdf

 

August 10, 2023: MLN MM13289: Hospice Payments: FY 2024 Update

This article provides information about payment rates, inpatient and aggregate caps and wage index update effective October 1, 2023 for hospices and providers billing for hospice services. https://www.cms.gov/files/document/mm13289-hospice-payments-fy-2024-update.pdf

 

August 16, 2023: SE19007 Revised: Activation of Validation Edits for Providers with Multiple Service Locations

This special edition MLN article was originally published on March 26, 2019 and recently updated for the fifth time on August 16^th. CMS has added information about the practice location address screen for round 3 testing Substantive changes are in dark red on pages 3 and 4.

 

Effective August 1, 2023, CMS started deploying the systematic validation edits requirements in Section 170 of the Medicare Claims Processing Manual, Chapter 1. MACs have been told to develop implementation plans to permanently turn on the Reason Codes and set them up to RTP claims that don’t exactly match.

 

CMS notes in the MLN article that they “expect that the almost 7-year time frame that the edits haven’t been active gave you ample time to validate your claims submission system and the PECOS information for your off-campus provider departments are exact matches.” https://www.cms.gov/outreach-and-education/medicare-learning-network-mln/mlnmattersarticles/downloads/se19007.pdf

 

August 17, 2023: MLN MM13321: Clinical Laboratory Fee Schedule & Laboratory Services Reasonable Charge Payment: Quarterly Update

Make sure your billing staff know about private payor data reporting (you must report data between January – March 2024), general specimen collection fee increase, and new and deleted HCPCS codes. https://www.cms.gov/files/document/mm13321-clinical-laboratory-fee-schedule-laboratory-services-reasonable-charge-payment-quarterly.pdf

 

August 24, 2023: Transmittal 12222: Inpatient Psychiatric Facilities Prospective Payment System Updates for Fiscal Year 2024

This Change Request (CR) 13335 identifies changes that are required as part of the annual IPF PPS update and applicable to discharges occurring from October 1, 2023 through September 30, 2024. https://www.cms.gov/files/document/r12222cp.pdf

Coverage Updates

 

August 9, 2023: MLN MM13278: ICD-10 & Other Coding Revisions to National Coverage Determinations: January 2024 Update

Relevant National Coverage Determinations (NCDs) include NCD 50.3 (Cochlear Implants), NCD 90.2. (Next Generation Sequencing (NGS), and NCD 210.1 (Prostate Screening Tests). Make sure your billing staff are aware of newly available codes, recent coding changes, and how to find NCD coding information. https://www.cms.gov/files/document/mm13278-icd-10-other-coding-revisions-national-coverage-determinations-january-2024-update.pdf

 

August 9, 2023: MLN MM13288: National Coverage Determination 30.3.3 – Acupuncture for Chronic Low Back Pain

Make sure your billing staff knows about updated frequency edits for acupuncture for chronic low back pain (cLBP) and relevant codes for acupuncture and dry needling services starting January 1, 2024. Reminder, CMS won’t cover more than 20 acupuncture treatments annually. https://www.cms.gov/files/document/mm13288-national-coverage-determination-3033-acupuncture-chronic-low-back-pain.pdf

 

Compliance Education Updates

 

August 2023: MLN Booklet Federally Qualified Health Center Revised

There have been several updates made to this MLN booklet. For example, CMS clarified the definition of telehealth and added consent for information for care management and virtual communications services. https://www.cms.gov/files/document/mln006397-federally-qualified-health-center.pdf

 

Other Updates

July 27, 2023: MLN Connects Notification: CMS Updated the Discarded Drugs and Biologicals – JW Modifier and JZ Modifier Policy FAQs

In the July 27, 2023 edition of MLN Connects, CMS notes that they have updated the Discarded Drugs and Biologicals – JW Modifier and JZ Modifier Policy FAQs to clarify the applicability of the reporting requirements to various outpatient settings and certain not otherwise classified billing codes. They also clarify how to use the JW and JZ modifiers when you prepare the dose with more than 1 single-dose container.

 

Finally, they remind providers that they use the JW and JZ Modifiers to collect information on discarded drug amounts from drugs that are packaged in single-dose containers that are separately payable under Part B.

 

Starting July 1, 2023, report the JZ modifier when there are no discarded amounts and report the JQ modifier when there are discarded amounts. https://www.cms.gov/outreach-and-education/outreach/ffsprovpartprog/provider-partnership-email-archive/1368246344/2023-07-27-mlnc

 

 

August 16, 2023: CMS Fact Sheet: Anniversary of the Inflation Reduction Act: Update on CMS Implementation

In this Fact Sheet, CMS details Milestones that they have met for implementing the provisions in this Act. You will also find links to public education resources that CMS has produced to help people with Medicare and those who assist them understand the changes under the new drug law (i.e., Frequently Asked Questions: Medicare Part B & D Insulin Benefit). https://www.cms.gov/newsroom/fact-sheets/anniversary-inflation-reduction-act-update-cms-implementation

Did You Know?

It has been almost two years since the October 2021 release of the CMS Change Request (CR) 12471 (https://www.cms.gov/files/document/R11059CP.pdf). There were two stated purposes for this CR noted in the Summary of Changes: 

• Implement system changes needed to update the Shared System Maintainer (SSM) interface with the Java MCE to accept new MCE Edit 20-Unspecific Code Edit, and
• Provide a mechanism to systematically bypass the new edit when a specific billing note is present in the claim remarks field to indicate the primary reason why laterality could not be determined.

 

Why this Matters?

In ICD-10-CM there are unspecified codes for when documentation in the record does not provide detail needed to report a more specific code. “However, in the inpatient setting, there should generally be very limited and rare circumstances for which the laterality (right, left, bilateral) of a condition is unable to be documented and reported.”

 

Effective for claims with dates of service on or after April 1, 2022, new Code Edit 20- will be triggered when an unspecified diagnosis code currently designated as either a Complication or Comorbidity (CC) or Major Complication or Comorbidity (MCC), that includes other codes in that code subcategory that further specify the anatomic site, is entered.

 

You will find the initial complete list of 3,432 ICD-10-CM unspecified codes subject to this edit in table 6P.3a associated with the FY 2022 IPPS/LTCH Final Rule (https://www.cms.gov/medicare/acute-inpatient-pps/fy-2022-ipps-final-rule-home-page).

 

This edit is meant to signal providers that there is a more specific laterality code available to report. It will be the provider’s responsibility to determine if documentation in the medical record supports a more specific code. “If, upon review, additional information to identify the laterality from the available medical record documentation by any other clinical provider is unable to be obtained or there is documentation in the record that the physician is clinically unable to determine the laterality because of the nature of the disease/condition, then the provider must enter that information in the remarks section.”

 

Mechanism to Bypass new MCE Edit 20-

The provider may enter a remark:

• Either “UNABLE TO DET LAT 1” to indicate that they are unable to obtain additional information to specify laterality, or
• “UNABLE TO DET LAT 2” to indicate the physician is clinically unable to determine laterality. 

Entering this language will enable your MAC to systematically bypass the edit and process your claim.

However, “if there is no language entered into the remarks section as to the availability of additional information to specific laterality and the provider submits the claim for processing, the claim would be returned to the provider.”

 

New Unspecified Codes Subject to MCE Edit 20-

In the FY 2024 IPPS Final Rule, CMS finalized the addition of six new diagnosis codes that are designated as a CC to the Unspecified code edit code list and four diagnosis codes that were inadvertently omitted from the Unspecified code edit list effective with discharges on or after April 1, 2022.

 

New FY 2024 Unspecified ICD-10-CM Diagnosis Codes

1. M80.0B9A: Age-related osteoporosis with current pathological fracture, unspecified pelvis, initial encounter for fracture
2. M80.0B9K: Age-related osteoporosis with current pathological fracture, unspecified pelvis, subsequent encounter for fracture with nonunion
3. M80.0B9P: Age-related osteoporosis with current pathological fracture, unspecified pelvis, subsequent encounter for fracture with malunion
4. M80.8B9A: Other osteoporosis with current pathological fracture, unspecified pelvis, initial encounter for fracture
5. M80.8B9K: Other osteoporosis with current pathological fracture, unspecified pelvis, subsequent encounter for fracture with nonunion
6. M80.8B9P: Other osteoporosis with current pathological fracture, unspecified pelvis, subsequent encounter for fracture with malunion
7. L89.103: Pressure ulcer of unspecified part of back, stage 3
8. L89.104: Pressure ulcer of unspecified part of back, stage 4
9. L89.93: Pressure ulcer of unspecified site, stage 3
10. L89.94: Pressure ulcer of unspecified site, stage 4

What Can You Do?

Share this information with key stakeholders at your facility (i.e., Billing, Coding, Clinical Documentation Integrity Specialists) including background information found in CR 12471 and related MLN Matters article MM12471 (https://www.cms.gov/files/document/mm12471-april-2022-update-java-medicare-code-editor-mce.pdf).

CMS finalized several changes to the Major Diagnostic Category (MDC) 05: Diseases and Disorders of the Circulatory System for FY 2024. This article focuses on the finalized changes in MDC 5. You can read about finalized changes in other MDCs in a related article in this week’s newsletter.

Surgical Ablation

A request was made for CMS to review the MS-DRG assignment of cases involving open concomitant surgical ablation procedures, recommending that open concomitant surgical ablation procedures for atrial fibrillation (AF) be reassigned from MS-DRGs 219, 220, and 221 (Cardiac Valve and Other Major Cardiothoracic Procedures without Cardiac Catheterization with MCC, with CC, and without CC/MCC, respectively) to MS-DRGs 216, 217, and 218 or create new MS-DRGs for all open mitral or aortic valve repair or replacement procedures with concomitant surgical ablation of AF.

Analysis showed that these cases require greater resources, have higher average costs and generally longer lengths of stay compared to all other cases in their assigned MS-DRG. Based on this analysis, CMS finalized their proposal to create a new base MS-DRG 212 (Concomitant Aortic and Mitral Valve Procedures) for cases reporting an aortic valve repair or replacement procedure, a mitral valve repair or replacement procedure, and another concomitant procedure in MDC 05.

In response to comments that the logic intent for assignment to new MS-DRG 212 was not clear. CMS clarified that cases reporting: (1) aortic valve repair or replacement procedure; (2) a mitral valve repair or replacement procedure; and (3) at least one other concomitant procedure, as defined in the GROUPER logic, would be assigned to new MS-DRG 212.

External Heart Assist Device

Currently, the three ICD-10-PCS procedure codes describing the insertion of a short-term heart assist device are recognized as extensive O.R. procedures assigned to MS-DRG 215 (Other Heart Assist System Implant) in MDC-05. Procedure code 02HA0RZ (Insertion of short-term external heart assist system into heart, open approach) describes an open approach. The other two procedure codes describe a percutaneous approach.

CMS has finalized their proposal to reassign the open approach procedure code when reported as a standalone procedure from MS-DRG 215 in MDC-05 to Pre-MDC MS-DRGs 001 and 002. Effective October 1, 2023, procedure code 02HA0RZ code will no longer need to be reported as a part of a procedure code combination or procedure code “cluster” to satisfy the logic assignment for MS-DRGs 001 and 002.

Ultrasound Accelerated Thrombolysis (UAST) for Deep Vein Thrombosis

A request was made to reassign cases reporting USAT of peripheral vascular structures procedures with the administration of thrombolytic(s) for deep venous thrombosis from MS-DRGs 252, 253, and 254 (Other Vascular Procedures with MCC, with CC, and without CC/MCC, respectively) to MS-DRGs 270, 271, and 272 (Other Major Cardiovascular Procedures with MCC, with CC, and without CC/MCC, respectively).

CMS found this subset of cases did not clinically align with patients undergoing surgery for acute myocardial infarction. However, the identified difference in resource consumption did warrant creating a new MS-DRG to reflect more appropriate payment for USAT and standard catheter-directed thrombolysis (CDT) procedures of peripheral vascular structures. CMS finalized their proposal to create new MS-DRGs 278 and 279 (Ultrasound Accelerated and Other Thrombolysis of Peripheral Vascular Structures with MCC and without MCC, respectively).

Coronary Intravascular Lithotripsy

A request was made to review MS-DRG assignment of cases describing percutaneous intravascular lithotripsy (IVL) involving the insertion of drug eluting and non-drug eluting stents. According to the requestor, cases involving IVL are more complex as this is a therapy deployed exclusively in several calcified coronary lesions that are associated with longer procedure times and increased resources.

CMS analysis showed that cases reporting percutaneous coronary IVL, with or without a stent had higher average costs and lengths of stay. CMS finalized their proposal to create MS-DRGs 323 and 324 (Coronary Intravascular Lithotripsy with Intraluminal Device with MCC and without MCC, respectively), and MS-DRG 325 (Coronary Intravascular Lithotripsy without Intraluminal Device).

Eliminating Distinction Between Bare-Metal and Drug-Eluting Stent (DES)

CMS noted in the proposed rule that it appears to no longer be necessary to subdivide the MS-DRGs for percutaneous cardiovascular procedures based on the type of coronary intraluminal device inserted. After consideration of public comments, CMS finalized their proposals to

• Delete MS-DRGs 246, 247, 248, and 249,
• Create new MS-DRG 321 (Percutaneous Cardiovascular Procedures with Intraluminal Device with MCC or 4+ Arteries/Intraluminal Devices) and MS-DRG 322 (Percutaneous Cardiovascular Procedures with Intraluminal Device without MCC),
• Reassign procedure codes from current MS-DRGs 246, 247, 248, and 249 to the new MS-DRGs 321 and 322, and
• Revise the titles for MS-DRGs 250 and 251 from “Percutaneous Cardiovascular without Coronary Artery Stent with MCC, and without MCC, respectively” to “Percutaneous Cardiovascular Procedures without Intraluminal Device with MCC, and without MCC, respectively” to better reflect the ICD-10-PCS terminology of “intraluminal devices” versus “stents” as used in the procedure code titles within the classification.

Cardiac Defibrillators and Shock

During a review of cardiogenic shock, CMS noted data analysis shows the average costs and length of stay are generally similar for cardiac defibrillator cases without regard to the presence of AMI, Heart Failure (HF), or shock. CMS finalized their proposals to:

• Delete MS-DRGs 222, 223, 224, 225, 226, and 227,
• Create three new MS-DRGs: MS-DRG 275 (Cardiac Defibrillator Implant with Cardiac Catheterization and MCC, and MS-DRGs 276 and 277 (Cardiac Defibrillator Implant with MCC, and without MCC, respectively), and
• Specific to MS-DRG 275, designate procedure codes describing cardiac catheterization as non-O.R. procedures affecting the MS-DRG.

The finalized changes go into effect October 1, 2023.

Resource: FY 2024 IPPS Final Rule (CMS-1785-F) webpage at https://www.cms.gov/medicare/acute-inpatient-pps/fy-2024-ipps-final-rule-home-page

The FY 2024 IPPS Final Rule (CMS-1785-F) was issued August 1, 2023. This article focuses on final changes to Medicare Severity Diagnosis-Related Group (MS-DRG) classifications in Major Diagnostic Categories (MDCs) 02, 04, and 06 (Diseases and Disorders of the Eye, Respiratory System, and Digestive System, respectively).

 

MDC 02: Diseases and Disorders of the Eye: Retinal Artery Occlusion

A request was made to review the MS-DRG assignment of cases involving central retinal artery occlusion (CRAO). The assertion was that CRAO is a form of acute ischemic stroke which occurs when a vessel supplying blood to the brain is obstructed and there is growing recognition of this diagnosis as a vascular neurological problem. New evidence outlines treatment of patients with CRAO with acute stroke protocols, specifically with intravenous thrombolysis or hyperbaric oxygen therapy, to improve outcomes. Based on this request, data analysis and examining clinical considerations, CMS finalized their proposals to:  

 

• Reassign ICD-10-CM diagnosis codes H34.10, H34.11, H34.12, H34.13, H34.231, H34.232, H34.233, and H34.239 from MDC 02 MS-DRG 123 to MS-DRGs 124 and 125,
• Add procedure codes describing the administration of a thrombolytic agent listed in this section to MS-DRG 124,
• As part of the logic for MS-DRG 124, designate the administration of thrombolytic agent codes as non-O.R. procedures affecting the MS-DRG, and
• Change the titles of MS-DRGs 124 and 125 from “Other Disorders of the Eye, with and without MCC, respectively,” to “Other Disorders of the Eye with MCC or Thrombolytic Agent, with without MCC, respectively” to better reflect the assigned procedures.

   

  MDC 04: Diseases and Disorders of the Respiratory System: Ultrasound Accelerated Thrombolysis for Pulmonary Embolism

  A request was made to reassign cases reporting ultrasound accelerated thrombolysis (USAT) with administration of thrombolytic(s) for the treatment of pulmonary embolism (PE) from MS-DRGs 166, 167, and 168 (Other Respiratory O.R. Procedures with MCC, with CC, and without CC/MCC, respectively) to MS-DRGs 163, 164, and 165 (Major Chest Procedures with MCC, with CC, and without CC/MCC, respectively).

   

  Clinical and data analyses support creating a new base MS-DRG for cases reporting a principal diagnosis of PE and USAT or standard catheter directed thrombolysis (CDT) procedures with or without thrombolytics. CMS finalized their proposal to create a new MS-DRG 173 (Ultrasound Accelerated and Other Thrombolysis with Principal Diagnosis Pulmonary Embolism).

   

  MDC 04: Respiratory Infections and Inflammations Logic

  There are two logic lists for case assignment to MS-DRGs 177, 178, and 179 (Respiratory Infections and Inflammations with MCC, with CC, without CC/MCC, respectively). All diagnosis codes in the first logic list are designated as MCCs.

   

  Currently, if the principal diagnosis is from the second logic list and any of the diagnoses from the first logic list are also on the claim, the case would be assigned to MS-DRG 177. This is inconsistent with how other similar logic lists function in the ICD-10 grouper software. Therefore, CMS proposed to correct the logic for cases assigned to MS-DRG 177 by excluding the 15 diagnosis codes in the first logic list from acting as an MCC when reported as a secondary diagnosis when the principal diagnosis is from the second logic list.

   

  CMS finalized their proposal with the modification of excluding 11 diagnosis codes in the first logic list from acting as an MCC when any one of the listed codes is reported as a secondary diagnosis with a diagnosis code in the second logic list.

   

  The 11 diagnosis codes includes A48.1 (Legionnaire’s disease), J15.0 (Pneumonia due to Klebsiella pneumoniae), J15.1 (Pneumonia due to Pseudomonas), J15.20 (Pneumonia due staphylococcus, unspecified), J15.211 (Pneumonia due to Methicillin susceptible Staphylococcus aureus), J15.212 (Pneumonia due Methicillin resistant Staphylococcus aureus), J15.29 (Pneumonia due to other staphylococcus), J15.5 (Pneumonia due to Escherichia coli), J15.61 (Pneumonia due to Acinetobacter baumannii), J15.69 (Pneumonia due to other Gram-negative bacteria), and J15.8 (Pneumonia due to other specified bacteria).

   

  The five influenza codes in the first logic list (J10.00, J10.01, J10.08, J11.00, or J11. 08) will continue to be allowed to act as an MCC with a principal diagnosis from the second logic list in specific clinical scenarios.

   

  MDC 06: Diseases and Disorders of the Digestive System: Appendicitis

  ICD-10-CM diagnosis codes K35.20 (Acute appendicitis with generalized peritonitis, without abscess) and K35.21 (Acute appendicitis with generalized peritonitis, with abscess) will no longer be effective October 1, 2023. At that time, six new diagnosis codes describing acute appendicitis with generalized peritonitis, with and without perforation or abscess will become effective. The new codes are assigned to MS-DRGs 371, 372, and 373 (Major Gastrointestinal Disorders and Peritoneal Infections with MCC, with CC, and without MCC/CC, respectively).

   

  CMS notes that clinically both localized and generalized peritonitis in association with an appendectomy require the same level of patient care and believe the distinction between “complicated” versus “uncomplicated” is no longer meaningful regarding resource consumption. After consideration of comments received, CMS finalized their proposals to:

   

• Delete MS-DRGs 338, 339, 340, 341, 342, and 343,
• To create new MS-DRGs 397, 398, and 399 (Appendix Procedures with MCC, with CC, and without CC/MCC, respectively), and
• To no longer require a diagnosis in the definition of the logic for case assignment for the new MS-DRGs.

 

The finalized changes go into effect October 1, 2023.