Knowledge Base Category -

MMP’s Protection Assessment Report (P.A.R.) combines current Medicare Fee-for-Service review targets (i.e., MAC, RAC, OIG) with hospital specific paid claims data made possible through a collaboration with RealTime Medicare Data (RTMD). Monthly, our newsletter spotlights current review activities. This month we focus on the Shared Decision-Making (SDM) requirement for Left Atrial Appendage Closure (LAAC) and Implantable Cardioverter Defibrillator procedures.

Did You Know?

The Agency for Healthcare Research and Quality (AHRQ) (link) defines Shared Decision-Making (SDM) as “a model of patient-centered care that enables and encourages people to play a role in the medical decisions that affect their health,” and goes on to note that “the innovation of shared decision making is the use of evidence-based tools, known as patient decision aids, to inform patients and help them set their own goals and clarify their values.”

Why It Matters?

There are two National Coverage Determinations (NCDs) for a cardiac procedure in which an SDM encounter is listed as one of the nationally covered indications for coverage of the procedure.

• NCD 20.34: Left Atrial Appendage Closure (LAAC)
• NCD 20.4 Implantable Automatic Defibrillators

This matters because the Comprehensive Error Rate Testing (CERT) Contractor lists both procedures in Table D4 of the 2021 Comprehensive Error Rate Testing (CERT) supplemental improper payment data report. This table details the top 20 service types with the highest improper payments in the Part A hospital inpatient prospective payment system (IPPS) setting.

DRG pair 273 and 274 (Percutaneous Intracardiac Procedures) had the third highest projected improper payment at $160,504,177 and a 29.3% improper payment rate. LAAC procedures group to this DRG pair. Insufficient documentation accounted for 83% of the improper payment rate and 17% of the improper payment rate was attributed to medical necessity issues.

DRG pair 226 and 227 (Cardiac Defibrillator Implant without Cardiac Catheterization) had the fifth highest projected improper payment rate at $">link),790,870 and a 22.7% improper payment rate. Insufficient documentation accounted for 85.3% of the improper payment rate and 14.7% of the improper payment rate was attributed to medical necessity issues.

CMS recently provided the following guidance in the Thursday, December 1, 2022 edition of MLN Connects (link):

“Shared decision-making (SDM) is an important part of person-centered health care. You work with your patient to make decisions that meet their needs based on:

• Evidence-based information about available options
• Your knowledge and experience
• Patient's values and preferences

When you provide SDM for percutaneous left atrial appendage closure (LAAC) and implantable cardioverter defibrillators (ICDs):

• Document the SDM encounters correctly in medical records before you implant.
• Get preoperative documents from all providers before submitting medical records. While not mandatory, it speeds processing of your claims.

The Comprehensive Error Rate Testing (CERT) contractor reviews your claim documentation to determine if it meets SDM requirements. If it doesn’t, CMS will:

• Issue an error for overpaid claims for these procedure codes
• Recoup the overpayment”

What Can I Do?

If your hospital provides either of these services:

• Ensure documentation in your medical record meets the requirements detailed in the NCD. Palmetto GBA, the Medicare Administrative Contractor (MAC) for Jurisdiction J (Alabama, Georgia, and Tennessee) has published two resources to assist you:
• A Cardiac Procedure Checklist (link) for when a claim is selected for review by the CERT contractor, and
• A Left Atrial Appendage Closure education module (link). Palmetto notes, “This module provides an overview of what Palmetto GBA, and the Comprehensive Error Rate Contractor (CERT) requires in your documentation to support billing of these claims. Shared decision-making (SDM) encounters with the patient is a very intricate part of your documentation.”
• Share this information with your Physicians,
• Respond to Additional Documentation Requests (ADRs) in a timely manner, and
• Have a process in place to ensure that all documents needed to support the medical necessity of the services provided are included when responding to Additional Documentation Requests (ADRs) from Medicare Contractors (i.e., CERT, Recovery Auditor).

Did You Know?

December 5th – 9th, 2022 is National Influenza Vaccination Week (NIVW). This annual observance is a time to remind everyone that for individuals 6 months and older there is still time to get vaccinated against the flu. This is especially important for individuals at higher risk (i.e., people 65 years and older, diabetics, people with heart disease, and young children) for developing serious complications from the flu.

Why It Matters?

The CDC estimated, that during the 2021 – 2022 influenza season (link), influenza was associated with:

• 9 million illnesses,
• 4 million medical visits,
• 10,000 hospitalizations, and
• 5,000 deaths.

The CDC estimates that, from October 1, 2022 through November 26, 2022, there have been:

• 8.7 – 19 million flu illnesses,
• 4.2 – 9.5 million flu medical visits,
• 78,000 – 170,000 flu hospitalizations, and
• 4,500 – 13,000 flu deaths.

Note, the above 2022 estimates were last reviewed December 2, 2022, are preliminary and change week-by-week as new hospitalizations are reported to the CDC.

What Can I Do?

If you are a healthcare provider, CMS has updated their Flu Shot Toolkit (link) with information about payment for the 2022-2023 flu season, frequency and coverage, billing, coding, and additional resources.

Receiving an annual flu vaccine reduces your risk of flu. Seasonal influenza viruses are detected year-round, however most flu activity peaks between December and February. As a healthcare consumer, if you have not already received your flu shot, it is not too late to get one.

MMP’s Protection Assessment Report (P.A.R.) combines current Medicare Fee-for-Service review targets (i.e., MAC, RAC, OIG) with hospital specific paid claims data made possible through a collaboration with RealTime Medicare Data (RTMD). Monthly, our newsletter spotlights current review activities. This month we focus on the new service to be added to the Prior Authorization for Certain Hospital Outpatient (OPD) Services effective July 1, 2023.

Did You Know?

CMS implemented the Prior Authorization for Certain Hospital Outpatient Department (OPD) Services through the Calendar Year (CY) 2020 Outpatient Prospective Payment System/Ambulatory Surgical Center (OPPS/ASC) Final Rule (CMS-1717-FC).

Initially, effective July 1, 2020 blepharoplasty, botulinum toxin injections, panniculectomy, rhinoplasty and vein ablation required a prior authorization when performed in the hospital OPD. For claims on or after July 1, 2021, implanted spinal neurostimulators and cervical fusion with disc removal were added to the list.

New for 2023, CMS finalized the addition of facet joint interventions requiring prior authorization for claims on or after July 1, 2023. This service category includes facet joint injections, medial branch blocks, and facet joint nerve destruction. A list of the specific CPT codes that will require prior authorization are listed in Table 103 of the CY 2023 OPPS/ASC Final Rule (CMS-1772-FC).

Why it Matters?

Reviewing facet joint records has been a target by several different entities.

Medicare Administrative Contractors

Noridian Jurisdiction E (JE) Part B MAC has conducted a Targeted and Probe and Educate (TPE) review of CPT 64635 (Destruction by Neurolytic Agent, Paravertebral Facet Joint Nerve). Dates of service reviewed were January 2020 through March 2020. The claims error rate was 75% with the top denial reasons being:

• Failure to return records,
• Documentation does not support the medical necessity as listed in the Coverage Requirement, and
• Duplicate billing.

Noridian indicated in their review results that “Local Coverage Determination L34993 provides an overview of the coverage requirements for these services. Documentation must support the history of pain which has not been responsive to conservative measures. Documentation must also support the conservative measures that have been tried and failed. The LCD also further clarifies that documentation must support a clinical assessment which supports that the pain is a result of the facet joint and that there is no other pathology that may be causing the pain.

Documentation must reflect the patient pre and post procedure pain rating, procedure report, and the injectate used is within the LCD requirements.”

Other Part B MACs that have reviewed or are currently reviewing facet joint injections include Novitas JH and JL and WPS J8.

Office of Inspector General (OIG)

CMS notes in the OPPS/ASC final rule that the OIG has published multiple reports indicating questionable billing practices, improper Medicare payments, and questionable utilization of facet joint interventions. Based on their findings, the OIG recommended that CMS and its contractors provide additional oversight on claims for facet joint injections to prevent additional improper payments.

Supplemental Medical Review Contractor

Just last month on October 10th, the Supplemental Medical Review Contractor (SMRC) posted their review findings of Project 01-304: facet joint injections. The October 2020 OIG report was referenced in the review results. Claims reviewed included hospital outpatient and critical access hospitals with dates of service in CY 2019. The claims error rate was 92% and common denial reasons included:

• Documentation submitted was insufficient or incomplete,
• Documentation submitted did not support medical necessity as listed in National and Local Coverage Determinations, and
• No response to the documentation request by the provider.

What Can I Do?

You can begin to prepare for the July 1, 2023 addition of Facet joint procedures to the Prior Authorization for Certain Hospital OPD Services now by:

• Identifying applicable Medicare Coverage Documents (Local Coverage Determinations (LCDs) and Local Billing and Coding Articles (LCAs)), and
• Ensuring key stakeholders are aware of the need for prior authorization effective July 1, 2023 (i.e., Outpatient Department Nurse Manager, Scheduling, Physicians performing these procedures) and educate them on applicable documentation requirements found in the LCDs and LCAs.

The CMS released the Calendar Year (CY) 2023 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule on November 1, 2022. Following are highlights from the final rule:

CY 2023 OPPS and ASC Payment Rates

CMS is updating the CY 2023 OPPS and ASC payment rate by 3.8%.

• The estimated total payments to OPPS providers in CY 2023 would be approximately $86.5 billion, an increase of approximately $6.5 billion compared to CY 2022 OPPS payments.
• The estimated total payments to ASCs for CY 2023 will be approximately $5.3 billion, an increase of approximately $230 million compared to CY 2022 ASC payments.

Comprehensive Ambulatory Payment Categories (C-APCs) for CY 2023

C-APCs were first implemented on January 1, 2015. A C-APC is defined as “a classification for the provision of a primary service and all adjunctive services provided to support the delivery of the primary service.”

CMS expanded the C-APC methodology in 2016 to include a “Comprehensive Observation Services” C-APC (C-APC 8011). The payment rate for C-APC 8011 in CY 2023 is $2,439.02.

For CY 2023, CMS finalized one new C-APC, C-APC 5372 (Level 2 Urology and Related Services).

For the duration of the COVID-19 PHE, any new FDA approved drug or biological approved for emergency use authorization (EUA) to treat COVID-19 that is authorized for use in the outpatient setting, or not limited to use in the inpatient setting, will be separately paid and will not package into the C-APC when provided on the same claim as the primary C-APC service.

Rural Emergency Hospital (REH)

REH is a new Medicare Provider type that includes facilities who elect to convert either from a critical access hospital (CAH) or a rural hospital with less than fifty beds to an REH. Policies for this new provider type will take effect January 1, 2023.

By statute REH services include emergency department services and observation care. Specific to observation care, CMS notes “there may be instanced in which REH patients receive observation services at an REH for a period exceeding 24 hours, but REHs are not required to provide required notification under the NOTICE Act, known as the Medicare Outpatient Observation Notice (MOON), because REHs are excluded from the definition of “hospital.”

An REH can also elect to provide other outpatient medical and health services furnished on an outpatient basis. CMS finalized the proposal that REHs may provide outpatient services not otherwise paid under the OPPS (i.e., services paid under the Clinical Lab Fee Schedule, post-hospital extended care services in a distinct part unit licensed as a skilled nursing facility).

REHs will receive a monthly facility payment of $272,866. This payment will increase in subsequent years by the hospital market basket percentage increase.

340B-Acquired Drugs

“CMS notes in the final rule that “for CY 2023, in light of the Supreme Court decision in American Hospital Association v. Becerra, 142 S. Ct. 1896 (2022), we are applying the default rate, generally average sales price (ASP) plus 6 percent, to 340B acquired drugs and biologicals in this final rule with comment period for CY 2023 and removing the increase to the conversion factor that was made in CY 2018 to implement the 340B policy in a budget neutral manner.

We are still evaluating how to apply the Supreme Court’s decision to prior calendar years. In the CY 2023 OPPS/ASC proposed rule, we solicited public comments on the best way to craft any potential remedies affecting cost years 2018-2022, and we will take these comments into consideration for separate rulemaking that will be published in advance of the CY 2024 OPPS/ASC proposed rule.”

Reminder, for 2022 claims prior to September 28th, providers will need to submit adjustment claims to recalculate their payments (link).

Medicare Inpatient Only (IPO) List

For CY 2023, CMS is removing 11 services and adding 8 newly created CPT codes to the IPO List. Table 65 of the final rule includes all services to be removed or added to the IPO list.

ASC Covered Procedure Lists

Procedures on the ASC Covered Procedure List (CPL) are surgical procedures that are appropriately performed on an inpatient basis in a hospital but that can also be safely performed in an ASC, a CAH, or an HOPD. Four procedures are being added to this list and can be found in table 80 of the final rule.

Hospital Outpatient Department Prior Authorization Process: New Service Category

Effective for dates of service on or after July 1, 2023, Facet joint interventions will be added to the list of service categories that hospital outpatient departments will be required to get prior authorization to receive payment. Specific Facet Joint CPT codes that will require prior authorization are listed in Table 103 of the final rule.

Outpatient Non-PHP Mental Health Services Furnished Remotely by Hospital Staff to Beneficiaries in Their Homes

CMS finalized its proposal to consider mental health services furnished remotely by hospital staff using communication technology to a beneficiary in his or her home a covered outpatient department service.

An in-person service will be required within 6 months prior to the initiation of remote service and then every 12 months thereafter, exceptions may be made to this requirement based on a beneficiary’s clinical needs and the reason being documented in the medical record. The in-person requirement will not apply to beneficiaries who began receiving mental health telehealth services during the PHE or during the 151-day period after the end of the PHE.

Audio-only interactive telecommunications systems may be used when a beneficiary is not capable of, or does not consent to, the use of two-way, audio/video technology.

Resources

CY 2023 OPPS Final Rule CMS Press Release: https://www.cms.gov/newsroom/press-releases/hhs-continues-biden-harris-administration-progress-promoting-health-equity-rural-care-access-through

CY 2023 OPPS Final Rule Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/cy-2023-medicare-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center-2

Did You Know?

Chances are you; a family member, close friend or acquaintance has been impacted by breast cancer. October is Breast Cancer Awareness Month. According to a CDC (link), each year:

• About 264,000 women in the United States get breast cancer and 42,000 women die from the disease,
• Men can also get breast cancer, but it is not common. About one out of every one hundred breast cancers diagnoses in the United States is found in a man, and
• While most breast cancers are found in women who are 50 years old or older, breast cancer also affects younger women.

Why Should You Care?

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

A related RealTime Medicare (RTMD) infographic, in this week’s newsletter, highlights the impact of the COVID-19 pandemic on the volume of Medicare Fee-for-Service beneficiaries undergoing screening mammography in RTMD’s footprint.

NCD 220.4 Mammograms

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

Diagnostic Mammography

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

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

Screening Mammography

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

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

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

What Can I Do?

Know Ways to Lower Your Risk for Breast Cancer

The CDC details thing you can do to help lower your risk of breast cancer including:

• Keep a health weight and exercise regularly,
• Choose not to drink alcohol, or dink alcohol in moderation,
• If you are taking hormone replacement therapy or birth control pills, ask your doctor about the risks, and
• Breastfeed your children, if possible.

Know the Warning Signs of Breast Cancer

While there are different symptoms of breast cancer, and some people have no symptoms at all, symptoms can include:

• Any change in the size or shape of the breast,
• Pain in any area of the breast,
• Nipple discharge other than breast milk (including blood),
• A new lump in the breast or underarm, thickening or swelling or part of the breast,
• Irritation or dimpling of the breast,
• Redness or flaky skin in the nipple area of the breast.

Be Your Own Patient Advocate

If you have any signs or symptoms that worry you, follow-up with a health care provider as soon as possible.

Talk to your health care provider about when and how often to get a screening mammogram. If you are worried about the cost, the CDC’s National Breast Cancer Early Detection Program (NBCCEDP) (link) provides breast and cervical cancer screenings and diagnostic services to women who have low incomes and are uninsured or underinsured.

This past weekend my brother and I had the daunting task of downsizing my mom’s living space from an Assisted Living Facility apartment to a long-term care room. While a tough move for my mom, we did find a few hidden treasures and memories. One such memory was finding pictures from a 1976 vacation taken by my grandmother aboard a cruise ship that was part of the 1970s TSS Mardi Gras, The Golden Fleet Carnival Cruise Line. In addition to finding the pictures, there was a packet of daily activities and a map of the different levels of the ship.

In keeping with the cruise ship treasures that we found, this week we celebrate the 12th annual Clinical Documentation Integrity (CDI) Week with the theme Under the Sea-DI. A CDI Week Fact Sheet (link) published by the Association of Clinical Documentation Integrity Specialists (ACDIS), indicates that “CDI specialist review patient medical records and assess whether all conditions and treatments are documented. This documentation helps paint an accurate picture of the severity of the patient’s illness and the extent of the care required. When the documentation is unclear or deficient, CDI specialists prompt (also known as “query”) physicians to provide clarification. CDI specialists serve as the bridge between health information management (HIM) and clinical staff. They must comply with Medicare and/or private payer rules and regulations.”

Just as it takes the entire crew to make a cruise ship run smoothly, it takes the CDI team coordinating with doctors, other departments participating in the care of a patient (i.e., physical therapy, dietician, pharmacy), and coding professionals to find all the hidden treasure in a patient’s medical record.

MMP would like to wish all the hard-working CDI Professionals that we have the privilege to work with a happy CDI week. To help you prepare for the new CMS fiscal year, while celebrating this week, following are links to key treasure for a successful start to the CMS FY 2023.

FY 2023 IPPS Final Rule Home Page (link)

On this webpage you will find a links to:

• The FY 2023 IPPS Final Rule,
• FY 2023 Final Rule Tables
• Table 5: MS-DRGs, Relative Weighting Factors, Geometric and Arithmetic Mean Lengths of Stay, and Post-Acute Transfer designated MS-DRGs
• Table 6: New Diagnosis Codes,
• Table 6B: New Procedure Codes
• Table 6I: Complete MCC List,
• Table 6I.1: Additions to the MCC List,
• Table 6I.2: Deletions to the MCC List,
• Table 6J: Complete CC list,
• Table 6J.1: Additions to the CC list,
• Table 6J.2: Deletions to the CC list
• FY 2023 MAC Implementation Files
• MAC Implementation File 7: FY 2023 MS-DRGs Subject to the Replaced Devices Policy,
• MAC Implementation File 8: FY 2023 New Technology Add-on Payment

2023 ICD-10-CM Files (link)

Downloads available on this webpage includes:

• 2023 POA Exempt Codes,
• 2023 Conversion Table,
• 2023 Code Description in Tabular Order,
• 2023 Addendum,
• 2023 Code Tables, Tabular and Index, and
• FY 2023 ICD-10-CM Coding Guidelines.

The ICD-10-Files are also available on the CDC’s Comprehensive Listing ICD-10-CM Files webpage (link).

2023 ICD-10-PCS Files (link)

Downloads available on this webpage includes:

• 2023 ICD-10-PCS Order File,
• 2023 Official ICD-10-PCS Coding Guidelines,
• 2023 Version Update Summary,
• 2023 ICD-10-PCS Codes File,
• 2023 ICD-10-PCS Conversion table, 2023 ICD-10-PCS Code Tables and Index, and
• 2023 ICD-10-PCS Addendum.

MS-DRG Definitions Manual and Software

The ICD-10 MS-DRG Version 40 (V40) Grouper Software, ICD-10 MS-DRG Definitions Manual, and the Definitions of Medicare Code Edits V 40 files are publicly available on the CMS MS-DRG Classifications and Software webpage (link).

Again, happy CDI week from our team to yours.

Did You Know?

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).

Why is Matters?

The NCTAP for eligible COVID-19 products will extend through the end of the fiscal year in which the PHE ends.

On Thursday, August 18, 2022, CMS released a Roadmap for the End of the COVID-19 Public Health Emergency (link).

Based on this information there are key notes and dates to keep in mind related to the ending of the PHE:

• HHS will provide a 60-day notice prior to the renewal date of the COVID-19 PHE if they are not going to extend it.
• The most recent PHE extension was on July 15th and lasts for 90 days (October 13, 2022).
• The 60-day notice has already passed (August 14th) for CMS to provide notice about the end of the PHE.
• The COVID-19 PHE will likely be extended in October for at least one more 90-day period.
• If the PHE is not extended past January 11, 2023, NCTAPs would end September 30, 2023.

What Can You Do?

Visit CMS’ COVID-19 NCTAP specific webpage (link) to identify the therapies that are eligible for the NCTAP.

“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 2023 IPPS Final Rule

CMS published the Fiscal Year (FY) 2023 Inpatient Prospective Payment System (IPPS) Final Rule (CMS-1771-F) in the Federal Register on Wednesday, August 10, 2022. Section F. Add-On Payments for New Services and Technologies for FY 2023 begins on page 48903. This article reviews the pathways to receiving new technology status, payment, coding, FY 2023 new technologies by the numbers and what to do moving forward.

New Technology Add-On Payment Pathways

There are several pathways for a new service or technology to be approved for New Technology Add-On Payments (NTAPs) including:

• Traditional Pathway: To meet this pathway, the medical service or technology must be new, must be costly such that the DRG rate otherwise applicable to discharges involving the NTAP is inadequate, and must demonstrate a substantial clinical improvement over existing services or technologies.
• Certain Antimicrobial Products Alternative Pathway: In FY 2021 the alternative pathway for Qualified Infectious Disease Products (QIDPs) was expanded to include products approved under the Limited Population for Antibacterial and Antifungal Drugs (LPAD) pathway. In the Final Rule, CMS finalized referring more broadly to “certain antimicrobial products” rather than specifying FDA programs for antimicrobials (i.e., QIDPs and LPADs). Products approved through this pathway will be considered new and not substantially similar to an existing technology and will not need to demonstrate that it meets the substantial clinical improvement criterion. However, the technology will need to meet the cost criterion.
• Certain Transformative New Devices Alternative Pathway: Beginning in FY 2021, “if a medical device is part of FDA’s Breakthrough Devices Program and received FDA marketing authorization, it will be considered new and not substantially similar to an existing technology for purposes of the new technology add-on payment under the IPPS.” However, the new device must meet the cost criterion and must receive marketing authorization for the indication covered by the Breakthrough Device Program designation.

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.”

Payment for NTAPs

Payment is based on the cost to hospitals for the new medical service or technology. As set forth in § 412.88(b)(2), unless the discharge qualifies for an outlier payment, the additional Medicare payment will be limited to the following:

• For “Traditional Pathway” and “Certain Transformative New Devices”, Medicare will make an add-on payment equal to the lesser of: (1) 65 percent of the costs of the new medical service or technology; or (2) 65 percent of the amount by which the costs of the case exceed the standard DRG payment.
• For Certain Antimicrobial NTAPs (QIDPs and LPADs), Medicare will make an add-on payment equal to the lesser of: (1) 75 percent of the costs of the new medical service or technology; or (2) 75 percent of the amount by which the costs of the case exceed the standard DRG payment.

Coding NTAPs

Section X New Technology was added to ICD-10-PCS effective October 1, 2015. CMS has indicated

//www.cms.gov/Medicare/Coding/ICD10/Downloads/2016-Section-X-New-Technology-.pdf">link) 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.”

FY 2023 NTAPs by the Numbers

NTAPs are not budget neutral and are limited to the 2-to-3-year period after the date a technology becomes available. In FY 2022, due to the COVID-19 Public Health Emergency (PHE), CMS finalized a one-year extension of NTAPs for technologies that would have otherwise been discontinued beginning October 1, 2021. This was a one-time extension and will not extend the NTAP for technologies no longer considered to be new in FY 2023.

By the Numbers

• Twenty-five services or technologies have been approved for NTAPs,
• The estimated total amount to be paid to hospitals is $783,559,450.89, and
• The estimated number of cases is 205,148.5.

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?

Resources:

FY 2023 IPPS CMS webpage: https://www.cms.gov/medicare/acute-inpatient-pps/fy-2023-ipps-final-rule-home-page

CMS Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/fy-2023-hospital-inpatient-prospective-payment-system-ipps-and-long-term-care-hospital-prospective

Did You Know?

New Technology Add-on Payments (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.

Why it Matters?

The trigger for the add-on payment is including the applicable ICD-10-PCS code on your claim. Twenty-five services or technology will be eligible for the add-on payment effective October 1, 2022. This article highlights the ten services new for Fiscal Year 2023.

Cerament® G

Applicant: BONESUPPORT AB

CERAMENT® G is an injectable bone-void filler made of calcium sulfate, hydroxyapatite, and gentamicin sulfate indicated for the surgical treatment of osteomyelitis. The new technology indication is for use as a bone void filler in skeletally mature patients as an adjunct to systemic antibiotic therapy and surgical debridement (standard treatment approach to a bone infection) as part of the surgical treatment of osteomyelitis in defects in the extremities.

• ICD-10-PCS Code: XW0V0P7 (Introduction of antibiotic-eluting bone void filler into bones, open approach, new technology group 7)

GORE® TAG® Thoracic Branch Endoprosthesis

Applicant: W.L. Gore and Associates, Inc.

This is a modular device consisting of three components, an Aortic Component, a Side Branch Component, and an optional Aortic Extender Component, each of which is pre-mounted on a catheter delivery system for treatment of thoracic aortic aneurysms, traumatic aortic transection, and aortic dissection. The new technology indication is for endovascular repair of lesions of the descending thoracic aorta, while maintaining flow into the left subclavian artery, in patients who are at high risk for debranching subclavian procedures and who have appropriate anatomy.

ICD-10-PCS Codes:

• 02VW3DZ (Restriction of thoracic aorta, descending with intraluminal device, percutaneous approach) in combination with,
• 02VX3EZ (Restriction of thoracic aorta, ascending/arch with branched or fenestrated intraluminal device, one or two arteries, percutaneous approach)

iFuse Bedrock Granite Implant System

Applicant: SI-BONE

The iFuse Bedrock Granite Implant System is a sterile, single-use permanent implant intended to provide sacropelvic fusion of the sacroiliac joint and fixation to the pelvis when used in conjunction with commercially available pedicle screw fixation systems as a foundational element for segmental spinal fusion.

ICD-10-PCS Codes:

• XNH6058 (Insertion of internal fixation device with tulip connector into right pelvic bone, open approach, new technology group 8), or
• XNH6358 (Insertion of internal fixation device with tulip connector into right pelvic bone, percutaneous approach, new technology group 8), or
• XNH7058 (Insertion of internal fixation device with tulip connector into left pelvic bone, open approach, new technology group 8), or
• XNH7358 (Insertion of internal fixation device with tulip connector into left pelvic bone, percutaneous approach, new technology group 8), or
• XRGE058 (Fusion of right sacroiliac joint using internal fixation device with tulip connector, open approach, new technology group 8), or
• XRGE358 (Fusion of right sacroiliac joint using internal fixation device with tulip connector, percutaneous approach, new technology group 8), or
• XRGF058 (Fusion of left sacroiliac joint using internal fixation device with tulip connector, open approach, new technology group 8), or
• XRGF358 (Fusion of left sacroiliac joint using internal fixation device with tulip connector, percutaneous approach, new technology group 8.

Thoraflex™ Hybrid Device

Applicant: Terumo Aortic

This Device is a sterile single-use, gelatin sealed Frozen Elephant Trunk (FET) surgical medical device. It is deployed through an opened aortic arch and then positioned into the descending thoracic aorta. Once it is completely deployed, the collar is sutured to the aorta, and graft anastomoses are then performed in a manner depending upon the chosen product design (which the applicant specified as either the Plexus or the Ante-Flo). The device has a unique gelatin sealant that acts as a seal, preventing blood loss through the polyester fabric product wall. The new technology indication is for the open surgical repair or replacement of damaged or diseased vessels of the aortic arch and descending aorta, with or without involvement of the ascending aortic, in cases of aneurysm and/or dissection.

ICD-10-PCS Codes:

• X2RX0N7 (Replacement of thoracic aorta arch with branched synthetic substitute with intraluminal device, new technology group 7), in combination with
• X2VW0N7 (Restriction of thoracic descending aorta with branched synthetic substitute with intraluminal device, new technology group 7)

ViviStim® Paired VNS System

Applicant: MicroTransponder, Inc.

This system is a paired vagus nerve stimulation therapy intended to stimulate the vagus nerve during rehabilitation therapy to reduce upper extremity motor deficits and improve motor function in chronic ischemic stroke patients with moderate to severe arm impairment. The system is comprised of an Implantable Pulse Generator (IPG), an implantable stimulation Lead, and an external paired stimulation controller which is composed of the external Wireless Transmitter (WT) and the external Stroke Application and Programming Software (SAPS).

• ICD-10-PCS Code: X0HQ3R8 (Insertion of neurostimulator lead with paired stimulation system into vagus nerve, percutaneous approach, new technology group 8)

DefenCath™

Applicant: CoMedix Inc.

DefenCath™ is a proprietary formulation of taurolidine, a thiadiazinane antimicrobial, and heparin, an anti-coagulant, that is under development for use as catheter lock solution, with the aim of reducing the risk of catheter-related bloodstream infections (CRBI) from in-dwelling catheters in patients undergoing hemodialysis (HD) through a central venous catheter (CVC).

ICD-10-PCS Code: XY0YX28 (Extracorporeal introduction of taurolidine anti-infective and heparin anticoagulant, new technology group 8)

Carvykti™

Applicant: Janssen Biotech

CARVYKTI™ is an autologous chimeric-antigen receptor (CAR) T-cell therapy directed against B cell maturation antigen (BCMA) for the treatment of patients with multiple myeloma.

ICD-10-PCS Codes

• XW033A7 (Introduction of ciltacabtagene autoleucel into peripheral vein, percutaneous approach, new technology group 7), or
• XW043A7 (Introduction of ciltacabtagene autoleucel into central vein, percutaneous approach, new technology group 7)

DARZALEX FASPRO®

Applicant: Janssen Biotech

DARZALEX FASPRO® is a combination of daratumumab (a monoclonal CD38-directed cytolytic antibody), and hyaluronidase (an endoglycosidase) indicated for the treatment of light chain (AL) amyloidosis in combination with bortezomib, cyclophosphamide and dexamethasone (CyBorD) in newly diagnosed patients and is administrered through a subcutaneous injection.

ICD-10-PCS Codes

• XW01318 (Introduction of daratumumab and hyaluronidase-fihj into subcutaneous tissue, percutaneous approach, new technology group 8), in combination with
• ICD-10-CM diagnosis code E85.81 (Light chain (AL) amyloidosis.

Hemolung Respiratory Assist System (RAS)

Applicant: Alung Technologies, Inc.

Hemolung RAS is the first and only FDA authorized technology for the treatment of acute, hypercapnic respiratory failure by providing low-flow, veno-venous extracorporeal carbon dioxide removal (ECCO2R) using a 15.5 French dual lumen catheter inserted percutaneously in the femoral or jugular vein, providing partial ventilatory lung support independent of the lungs as an alternative or supplement to invasive mechanical ventilation.

ICD-10-PCS Code: 5A0920Z (Assistance with respiratory filtration, continuous)

Livtencity™

Applicant: Takeda Pharmaceuticals U.S.A.

LIVTENCITY™ (maribavir) is a cytomegalovirus (CMV) pUL97 kinase inhibitor indicated for the treatment of adults and pediatrics (12 years of age and older and weighing at least 35 kg) with post-transplant CMV infection/disease that is refractory to treatment (with or without genotypic resistance) to ganciclovir, valganciclovir, cidofovir, or foscarnet. Per the applicant, it is the only antiviral therapy indicated to treat post-transplant patients with CMV in solid organ transplant (SOT) and hematopoietic stem cell transplant (HCT).

What Can I Do?

Familiarize yourself will all twenty-five services or technologies by reviewing pages 48903 – 48900 of the Final Rule and share this information with key stakeholders in your facility (i.e., Physicians, Pharmacy, Coding Professionals, Clinical Documentation Integrity Specialists, Case Managers).

Did You Know?

Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) is a new COVID-19 vaccination that the FDA has approved for Emergency Use Authorization (PHE) for individuals 18 years or older (link).

Why is Matters?

This is the first protein-based COVID-19 vaccine to receive Emergency Use Authorization and CDC endorsement (link) in the United States. This vaccine is to be administered as a series of two doses given three weeks apart. It is not authorized for use as a booster dose.

According to an HHS Press Release (link), “The Novavax COVID-19 vaccine is designed and manufactured differently than the mRNA COVID-19 vaccines. The Novavax COVID-19 vaccine contains SARS-CoV-2 recombinant spike protein, which is also known as an “antigen” of the SARS-CoV-2 virus, in combination with an adjuvant, which enhances the immune system response to the spike protein.

FDA-approved protein-based vaccines have been used widely for decades; examples of more recently approved vaccines that contain a purified protein combined with an adjuvant include vaccines to prevent hepatitis B and shingles. The Novavax COVID-19 vaccine offers an option to individuals who may be allergic to a component in the mRNA vaccines, or who have a personal preference for receiving a vaccine other than an mRNA-based vaccine.”

What Can You Do?

As a health care professional review the CDC’s overview and safety information about this vaccine (link), and become familiar with how to code and bill for this newly vaccine.

Coding and Billing

CMS issued new codes for this vaccine, effective July 13.

• Vaccine code: 91304,
• Administration codes: 0041A and 0042A,