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Did You Know?

• An estimated 12.1 million people will have A-Fib in 2030,
• In 2019, A-fib was mentioned on 183,321 death certificates and was the underlying cause of death in 26,535 of those deaths,
• People of European descent are more likely to have A-fib than African Americans, and
• Because the number of A-fib cases increases with age and women generally live longer than men, more women than men experience A-fib.

Why it Matters?

• More than 454,000 hospitalizations with A-fib as the primary diagnosis happen each year in the United States,
• A-fib increases a person’s risk of stroke. In fact, A-fib causes 1 in 7 strokes and strokes caused by A-fib tend to be more severe than strokes with other underlying causes, and
• The death rate from A-fib as the primary or a contributing cause of death has been rising for more than two decades.

What Can I Do?

Know the risk factors for A-fib

• Advancing age,
• Family member with a history of A-fib increases your chances of having A-fib,
• High blood pressure,
• Obesity,
• European ancestry,
• Diabetes,
• Heart failure,
• Ischemic heart disease,
• Hyperthyroidism,
• Chronic Kidney Disease,
• Moderate to heavy alcohol use,
• Smoking,
• Enlargement of the chambers on the left side of the heart,
• A-fib is the most common complication after heart surgery,

Know the symptoms of A-fib

• Irregular heartbeat,
• Heart palpitations (rapid, fluttering, or pounding),
• Lightheadedness,
• Extreme fatigue,
• Shortness of breath, and
• Chest pain.

Note, it is possible to have no symptoms, or in my mom’s experience, she thought was having panic attacks when on further study by her physician, she was experiencing episodes of A-fib.

Know Common “Triggers” That May Cause an Episode of A-fib

• Caffeine and energy drinks. The American Heart Association notes that “although normal amounts of coffee shouldn’t trigger Afib, further study may be warranted for energy drinks and excessive caffeine intake.”
• Excessive alcohol,
• Stress or anxiety, and
• Poor sleep and/or sleep apnea.

Know the Treatment Options

• Medicines to control your heart’s rhythm and rate,
• Non-surgical procedures (i.e., electrical cardioversion and radiofrequency ablation), and
• Surgical procedures (i.e., pacemaker, left atrial appendage closure implant (Watchman™) for non-valvular A-fib).

While other conditions can cause similar symptoms, if you experience any symptoms of A-fib, contact your doctor. If you are diagnosed with A-fib there is good news. According to the American Heart Association, “people can live long healthy and active lives with AFib. Controlling your risk factors for heart disease and stroke and knowing what can possibly trigger your AFib will help improve your long-term management of AFib.”

Resources

• CDC Atrial Fibrillation (A-fib): https://www.cdc.gov/heartdisease/atrial_fibrillation.htm
• American Heart Association: https://www.heart.org/en/health-topics/atrial-fibrillation/who-is-at-risk-for-atrial-fibrillation-af-or-afib

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 provide medical review updates and educate resources from the Medicare Administrative Contractors (MACs)

CGS Administrators, LLC J15 MAC

Review of Implantable Automatic Defibrillator CERT Errors Education Session

CGS is offering this education session on Monday September 26, 2022, from 10:00 AM – 11:00 AM CDT (link). During this session they will discuss an increase in CERT errors related to the “formal shared decision-making encounter using an evidence-based decision tool prior to implantation” as outlined in National Coverage Determination (NCD) 20.4.

First Coast Service Options, Inc. JN MAC

TPE Rehabilitation Services (Outpatient) Review Results

First Coast recently published review results for outpatient rehabilitation services (CPT® 97110, 97112 and 97140) (link). In addition to CPT specific review results, First Coast provides a link to a documentation checklist to help providers when responding to medical documentation requests for therapy and rehabilitation services.

National Government Services (NGS), Inc. J6/JK MAC

Prior Authorization Exemption Status Inquiry Tool Alert

This month NGS announced (link) that they have developed this tool as a way to unnecessary prior authorization requests by exempt providers.

Noridian Healthcare Solutions, LLC JE/JF MAC

Noridian JE Medical Record Review Results

On August 31st, TPE medical record review results were posted on the Noridian JE (link) and Noridian JF (link) websites.

Noridian JE Medical Record Review Results

• Cataract Removal (CPT® 66984): Error rate 48.78%,
• Lumbar Epidural Injection (CPT® 64483): Error rate 34.43%, and
• Dual-energy X-ray absorptiometry (DXA) (CPT®77080): Error rate 26.43%.

Noridian JF Medical Record Review Results

• Cataract Removal (CPT® 66984): Error rate 55.64%, and
• Total Knee Arthroplasty (CPT® 27447): Error rate 44.83%.

Review Results for both jurisdictions were for dates of service April 1, 2022, through June 30, 2022. Articles for review topics includes top denial reasons, links to educational resources, and education specific to documentation requirements and medical necessity.

Novitas Solutions, Inc. JH/JL MAC

Forms Catalog for Medicare Part A

Novitas Solutions has recently modified their Forms Catalog for Medicare Part A webpage (link). Examples of forms you will find on this webpage includes:

• Link to the Advanced Beneficiary Notice (ABN) Form (CMS-R-131),
• Hospital-Issued Notices of Noncoverage (HINNs), and
• Prior authorization request for certain hospital outpatient department services.

Palmetto GBA JJ/JM MAC

MACtoberfest®

Annually, Palmetto GBA, the Medicare Administrative Contractor (MAC) for Jurisdictions J and M, hosts their provider education event MACtoberfest. This virtual three-day conference includes a Medicare Part A and Part B track. Registration is now open and you can learn more about this event on their website (link).

New Local Coverage Determination (LCD)

Palmetto published LCD L39270 Allogeneic Hematopoietic Cell Transplantation for Primary Refractory or Relapsed Hodgkin’s and Non-Hodgkin's Lymphoma with B-cell or T-cell Origin (link). This policy is effective for services performed on or after September 4, 2022. There is a National Coverage Determination (NCD) 110.23 Stem Cell Transplantation. Palmetto notes in their LCD, “This policy describes additional locally covered indications for allo-HSCT for primary refractory or relapsed Hodgkin's and non-Hodgkin's lymphomas with B-cell or T-cell origin that are medically necessary in patients for whom there are no other curative intent options.”

WPS J5/J8 MAC

WPS recently published Quarter 2 Targeted Probe and Educate (TPE) review results for WPS J5 (link) and WPS J8 (link).

WPS J5 TPE Review Results

• Infusion Services (CPT® 96413 or 96415): Trending error rate 99%. The top reason for denial cited by WPS was the documentation did not support frequent monitoring.
• Routine Foot Care: Trending error rate 24%. The top reason for denial being documentation did not support the presence of severe systemic conditions.
• Outpatient Therapy (CPT® 97110): Trending error rate 52%. The top denial reason was documentation did not support the skills of a licensed professional therapist.
• Group Psychotherapy (CPT® 90853): Trending error rate 49%. The top denial reason was claim billing did not meet the National Correct Coding Initiative (NCCI) guidelines.

WPS J8 TPE Review Results

• Wound Care (CPT® 11042): Trending error rate 43%. The top denial reason was that documentation did not contain initial wound measurements.
• Infusion Services (CPT® 96361): Trending error rate 53%. Denials occurred due to documentation supporting intravenous fluids for the purpose of keeping a vein open. “According to CPT coding guidelines providers should not bill codes 96360 and 96361, when the purpose of the fluids is to keep open a vein.”
• Basic Life Support (BLS) Ambulance transports (HCPCS A0429): Trending error rate 29%. Denials occurred cue to the Assignment of Benefits (AOB) being incomplete or missing.

Question

The patient presented with seizures and was intubated in the ED. The physician documented "acute respiratory failure" on the H & P, noting "Respiratory failure-intubated in ED for airway protection. Maintain on ventilator overnight. Attempt to wean and extubate when no longer having seizures". On a progress note, "Acute Respiratory Failure” and “Respiratory failure-intubated in ED for airway protection. Maintain on ventilator overnight" was documented. On the Discharge Summary, "Acute Respiratory Failure. Respiratory failure-intubated in ED for airway protection. Now extubated. Doing well" was documented. Based on the documentation, should we code the Acute Respiratory Failure as a secondary diagnosis, query for clarification, or leave it off since it was "for airway protection"?

Answer

If a patient is intubated for airway protection, and Acute Respiratory Failure is documented, a code for the Acute Respiratory Failure can be assigned. However, if a patient is intubated for airway protection and there is no documentation of Respiratory Failure, coders cannot assume or assign a code for Respiratory Failure, just because the patient was intubated and placed on a mechanical vent.

Remember to also code the procedure codes for the Mechanical Ventilation and ETT, if appropriate.

References

Coding Clinic for ICD-10-CM/PCS, Third Quarter 2012: Page 21

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?

CAR T-cell Therapy entails the use of CAR T-cells that have been genetically altered to improve the ability of the T-cells to fight cancer. The genetic modification creating a CAR can enhance the ability of the T-cell to recognize and attach to a specific protein, called an antigen, on the surface of a cancer cell.

In 2017, the FDA gave approval to two CAR T-cell therapies (Kymriah® and Yescarta®). Effective October 1, 2018, both therapies were approved for new-technology add-on payments with a maximum add-on payment of $186,500.

Effective for claims with dates of service on or after August 7, 2019, Medicare began covering autologous treatment for cancer with T-cells expressing at least 1 Chimeric Antigen Receptor (CAR) when the treatment is:

• Administered at healthcare facilities enrolled in the FDA Risk Evaluation and Mitigation Strategies (REMS), and
• Is used for a medically accepted indication as defined at section 1861(t)(2)-i.e., or
• Is used for either an FDA-approved indication (according to the FDA-approved label for that product, or for other uses when the product has been FDA-approved and the use is supported in one or more CMS-approved compendia.

Not surprisingly, CAR T-cell therapy is expensive. So much so that CMS clinical advisors noted in the Fiscal Year (FY) 2021 IPPS proposed rule that they had found a vast discrepancy in resource consumption and clinical differences warranting the creation of new MS-DRG. Effective October 1, 2020, CAR T-cell therapy had its own MS-DRG 018 (Chimeric Antigen Receptor (CAR) T-cell immunotherapy).

In the current CMS FY 2022, MS-DRG 018 has a relative weight of 37.4501. On the October 1, 2022, start date of the CMS 2023 FY, MS-DRG 018 will once again have the highest relative weight at 36.1452.

Since 2017, the FDA has approved additional CAR T-cell therapies. Three of these are eligible for a New Technology Add-On Payment (NTAP) in Fiscal Year 2023:

• ABECMA® and CARVYKTI ™ to treat patients with relapsed or refractory multiple myeloma with a maximum add-on payment of $289,532.75, and
• TECARTUS® to treat relapsed or refractory mantle cell lymphoma with a maximum add-on payment of $259,350.00.

Why it Matters?

In addition to CMS guidance, several of the Medicare Administrative Contractors (MACs) have published guidance regarding CAR T-cell therapy. If your hospital provides this service, I encourage you to become familiar with both CMS and the MACs guidance.

CMS Guidance

• National Coverage Determination Chimeric Antigen Receptor (CAR) T-cell Therapy (NCD 110.24): (link)
• MLN Matters Article National Coverage Determination (NCD 110.24): Chimeric Antigen Receptor (CAR) T-cell therapy – This CR Rescinds and Fully Replaces CR 11783 (MM12177): (link)
• MLN Matters Article Chimeric Antigen Receptor (CAR) T-Cell Therapy Revenue Code and HCPCS Setup Revisions (SE19009): (link)
• MLN Matters Article International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs) – January 2023 Update: link)
• Note: Revisions to NCD 110.24 include updated codes and coding guidance for all currently available CAR T-cell therapies.

MAC Specific Guidance

• CGS J15 (KY and OH) Article (link)
• NGS JK (CT, NY, ME, MA, NH, RI, VT) FAQs (link)
• Novitas JH (AR, CO, LA, MS, MN, OK, TX) Article (link)

Did You Know?

Even if it was true that fifty is the new forty, for men, fifty is fifty when it comes to thinking about when to begin prostate cancer screening.

Why it Matters?

While all men are at risk for prostate cancer, according to the CDC, age is the most common risk factor. For men aged 50 and older with Medicare Part B, coverage of prostate cancer screening by Medicare begins the day after your 50th birthday (link).

What Should I Do?

The U.S. Preventive Services Task Force recommendation is that men aged 55 to 69 years should participate in a shared decision-making process with their physician by discussing the potential benefits and harms of screening with a PSA test and incorporating their values and preferences in the decision (link).

This recommendation applies to men who:

• Are at average risk for prostate cancer,
• Are at increased risk for prostate cancer,
• Do not have symptoms of prostate cancer, and
• Have never been diagnosed with prostate cancer.

According to the CDC (link), men can have varying symptoms or no symptoms at all for prostate cancer. If you are experiencing any of the following symptoms, first keep in mind the symptoms can be caused by other conditions, but err on the side of caution and see your doctor sooner rather than later:

• Difficulty starting urination.
• Weak or interrupted flow or urine.
• Urinating often, especially at night.
• Trouble emptying the bladder completely.
• Pain or burning during urinations.
• Blood in urine or semen.
• Pain in the back, hips, or pelvis that does not go away.
• Painful ejaculation.

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).

Medicare MLN Articles & Transmittals

Inpatient Psychiatric facilities Prospective Payment System (IPF PPS) Updates for Fiscal Year (FY) 2023

• MLN Release Date: August 4, 2022
• What You Need to Know: This MLN article provides Key Changes for FY 2023 related to market basket update, wage index update, IPF quality reporting programs, PRICER updates, provider specific file update, ICD-10-CM/PCS updates, COLA adjustment, and rural adjustment.
• MLN MM12859: link)

Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) – October 2022 Update

• Transmittal 11544 Release Date: August 4, 2022
• What You Need to Know: This Change Request (CR) was issued to amend the 2022 MPFS Final Rule payment files. Changes includes new HCPCS and CPT codes, codes that are no longer valid and changes to a short descriptor.
• Transmittal 11544/Change Request 12869: link)

New Waived Tests

• MLN Release Date: August 4, 2022
• What You Need to Know: information about CLIA requirements, new CLIA waived tests approved by the FDA and the use of modifier QW for CLIA-waived tests can be found in this MLN article.
• MLN MM12841: link)

Inpatient Rehabilitation Facility (IRF) Annual Update: Prospective Payment System (PPS) Pricer Changes FY 2023

• MLN Release Date: August 5, 2022
• What You Need to Know: CMS advises you to make sure your billing staff knows about changes to the Fiscal Year (FY) 2023 payment rates and wage index cap.
• MLN MM12807: link)

International Classifications of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs) – January 2023 Update

• MLN Release Date: August 15, 2022
• What You Need to Know: Your staff needs to be aware of newly available codes added to NCDs, separate NCD coding revisions and coding feedback.
• MLN MM12822: link)

International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs)-January 2023 Update – 2 of 2

• MLN Release Date: August 15, 2022
• What You Need to Know: This is the second of two MLN matters articles detailing January 2023 updates to NCDs.
• MLN MM12842: link)

Significant Updates to Internet Only Manual (IOM) Publication (Pub.) 100-05 Medicare Secondary Payer (MSP) Manual, Chapter 5

• MLN Release Date: August 15, 2022
• What You Need to Know: This article highlights key updates of importance for providers, for example, “Medicare is the secondary payer throughout the entire 30-month ESRD coordination period when a patient is eligible for, or entitled to, Medicare on the basis of ESRD. (See section 30.3.1.).”
• MLN MM12765: link)

Quarterly Update for Clinical Laboratory Fee Schedule (CLFS) and Laboratory Services Subject to Reasonable Charge Payment

• MLN Release Date: August 15, 2022
• What You Need to Know: You will find information about updated to Advanced Diagnostic Laboratory Tests (ADLTs), the next CLFS data reporting period, and new codes added to the National HCPCS file in this MLN article.
• MLN MM12870: link)