Knowledge Base Category -

Compliance Updates

MLN Booklet: Chronic Care Management (CCM) Services

This MLN booklet (link) was updated this month. Changes made to this booklet are highlighted in dark red font and include:

• Beginning 2022, Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) can bill Chronic CCM and Transitional Care Management (TCM) services for the same patient during the same time period,
• In 2021, CMS added five codes to report staff-provided Principal Care Management (PCM) services under physician supervision, and
• Beginning 2022 G2058 was replaced with 99439.

COVID-19 Updates

September 12, 2022: COVID-19 Vaccines Providing Protection from Omicron Variant Available at No Cost

CMS published a special edition MLN Connects (link) announcing that “people with Medicare, Medicaid, Children’s Health Insurance Program coverage, private insurance coverage, or no health coverage can get COVID-19 vaccines, including the updated Moderna and Pfizer-BioNTech COVID-19 vaccines, at no cost, for as long as the federal government continues purchasing and distributing these COVID-19 vaccines.”

You will also find information in the newsletter about the four new CPT codes effective August 31, 2022, that CMS has issued for the Pfizer-BioNTech and Moderna Bivalent vaccines.

September 13, 2022: CDC Clinical Outreach and Communication Activity (COCA) Call: Recommendations for Bivalent COVID-19 Booster

The CDC held a COCA call (link) to discuss their new guidance on bivalent COVID-19 booster doses for people ages 12 years and older, included those who are moderately or severely immunocompromised. In the overview of the call the CDC noted that “Updated COVID-19 vaccines add an Omicron BA.4/5 spike protein component to the previous monovalent composition. These bivalent booster doses help restore protection that has waned since previous vaccination by targeting more transmissible and immune-evading variants. These boosters also broaden the spectrum of variants that the immune system is ready to respond to.” A recording of the call, slides and transcript are now available on this CDC webpage.

September 20, 2022: CDC COCA Call: Evaluating and Supporting Patients Presenting with Cardiovascular Symptoms Following COVID

In the “Overview” section on the CDC webpage (link), the CDC notes that of all of the post-COVID conditions (PCC) that people experience “cardiovascular symptoms and complications are among the most common and debilitating.” Presenters during this call outlined “the recommended clinical approach to identifying and managing cardiovascular complications in these patients.” A recording of the call and slides are now available.

Other Updates

National Correct Coding Initiative: October Quarterly Update

In the Thursday, September 15, 2022 edition of MLN Connects (link), CMS encourages you to get the National Correct Coding Initiative (NCCI) fourth quarter edit files, effective October 1, 2022 and provides links to the Procedure-to-Procedure Edits, Medically Unlikely Edits, and Add-on Code Edits webpages.

CMS Resources by Language

Did you know that there is a collection of CMS resources categorized by language? This CMS webpage (link) was last modified on September 13th and includes resources in 18 languages “to help people make informed healthcare decisions and be active partners in their healthcare and the healthcare of their families.” These resources can be downloaded or ordered at no cost. A link to additional Medicare resources in 23 languages can also be found on this webpage. .

Medicare MLN Articles & Transmittals

Exceptions to Average Sales Price (ASP) Payment Methodology – Claims Processing Manual Changes

• MLN Release Date: August 30, 2022
• What You Need to Know: Your billing staff need to be made aware of updates to Chapter 17 Section 20.1.3 (Exceptions to Average Sales Price (ASP) Payment Methodology) and Section 20.3 (Calculation of the Payment Allowance Limit for DME MAC Drugs) of the Medicare Claims Processing Manual
• MLN MM12854: link)

Changes to the Laboratory National Coverage Determination (NCD) Edit Software for January 2023

• MLN Release Date: September 6, 2022
• What You Need to Know: This article lists the lab specific NCDs with coding updates effective January 1, 2023.
• MLN MM12888: link)

Billing for Hospital Part B Inpatient Services

• Change Request (CR) 12816 Release Date: September 8, 2022
• What You Need to Know: The purpose of this CR is to provide billing instructions for hospital Part B inpatient services. Specifically, there are additions to the “Not Allowed Revenue Codes.” No policy change is being made in this CR. You can find more information in the following CMS manuals:
• Section 10 Medicare Benefit Policy Manual, Chapter 6 (link): when to bill Part B for inpatient services
• Section 70 Medicare Claims Processing Manual, Chapter 1 (link): time limitations for filing Part B claims
• Section 240 Medical Claims Processing Manual, Chapter 4 (link): services allowed on inpatient Part B claims
• CR 12816: link)

October 2022 Update of the Hospital Outpatient Prospective Payment System (OPPS)

• MLN Release Date: September 13, 2022
• What You Need to Know: CMS advises that your billing staff should know about the new COVID-19 CPT vaccine and administration codes, redosing update for EVUSHELD™, and a new procedure to assess coronary disease severity using computed tomography angiography that is detailed in this article.
• MLN MM12885: link)

Ambulatory Surgical Center Payment System: October 2022 Update

• MLN Release Date: September 26, 2022
• What You Need to Know: Your billing staff needs to know about updates to the ASC payment system, a new OPPS device pass-through code, new HCPCS codes for drugs and biologicals, and new skin substitute products low-cost or high-cost group assignment.
• MLN MM12915: link)

Revised Transmittals & MLN Articles

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

• MLN Release Date: August 15, 2022 – Revised September 8, 2022 – Revised September 19, 2022
• What You Need to Know: The article was revised on September 8th to reflect the change in CR 12870. Specifically, a note was added about code 0340U in dark red font on page 3 of the article. It was once again revised on September 19th to correct an acronym on page three.
• MLN MM12870: link)

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)

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?

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.

“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?

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.

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).

COVID-19 Updates

August 18, 2022: Roadmap for the End of the COVID-19 Public Health Emergency

CMS published a blog (link), announcing their efforts to create a roadmap for the end of the COVID-19 PHE. CMS reminds you that “HHS Secretary Becerra has committed to giving states and the health care community writ large 60 days’ notice before ending the PHE. In the meantime, CMS encourages health care providers to prepare for the end of these flexibilities as soon as possible and to begin moving forward to reestablishing previous health and safety standards and billing practices.”

Included in this CMS Blog is a list of fact sheets summarizing the status of Medicare Blanket waivers and flexibilities by provider type. The fact sheets include information about waivers and flexibilities that:

• Have already been terminated,
• Will be made permanent, or
• Will end at the end of the PHE.

CMS expects “that the health care system can begin taking prudent action to prepare to return to normal operations and to wind down those flexibilities that are no longer critical in nature.”

The COVID-19 PHE declaration was last extended on July 15, 2022 (link). PHE declarations last for the duration of the emergency or 90 days and may be extended by the Secretary meaning the current COVID-19 PHE declaration will last until October 13, 2022.

With the CMS release of a Road Map to wind down the COVID-19 PHE, it seems hospitals are being put on notice that the end of the PHE is near.

Other Updates

Friday, July 27, 2022: CMS Releases Three FY 2023 Final Rules

In late July, CMS published Fiscal Year (FY) 2023 Final Rules. You can read about each of the Final Rules in related CMS Fact Sheets.

• FY 2023 Inpatient Rehabilitation Facility (IRF) Prospective Payment System Final Rule (CMS-1767-F) CMS Fact Sheet: link
• FY 2023 Medicare Inpatient Psychiatric Facility Prospective Payment System Final Rule (CMS-1769-F) CMS Fact Sheet: link
• FY 2023 Hospice Payment Rate Update Final Rule (CMS-1773-F) CMS Fact Sheet: link

Monkeypox & Smallpox Vaccines: New Product Codes

CMS included the following guidance related to monkeypox and smallpox vaccines in the August 11, 2022 edition of MLN Connects (link).

On July 23, the World Health Organization declared monkeypox a public health emergency, and HHS issued a statement regarding the Biden-Harris Administration’s actions to make vaccines, testing, and treatments available. CMS issued two new CPT codes effective July 26, 2022:

Code 90611 for smallpox and monkeypox vaccine product:

• Long descriptor: Smallpox and monkeypox vaccine, attenuated vaccinia virus, live, non-replicating, preservative free, 0.5 mL dosage, suspension, for subcutaneous use
• Short descriptor: SMALLPOX&MONKEYPOX VAC 0.5ML

Code 90622 for vaccinia (smallpox) virus vaccine product:

• Long descriptor: Vaccinia (smallpox) virus vaccine, live, lyophilized, 0.3 mL dosage, for percutaneous use
• Short descriptor: VACCINIA VRS VAC 0.3 ML PERQ

CORRECTION: Monkeypox & Smallpox Vaccines: Include Product Code on Claims

Initially, Medicare instructed to only bill for vaccine administration when you got the vaccine at no cost from the government. In the September 1, 2022 MLN Connects newsletter, these instructions were changed. These new instructions are to include these 3 elements on your claim, even if you get the vaccine from the government for free:

1. product code (90611 or 90622)
2. applicable ICD-10-CM diagnosis code
3. administration code

We’ll address the no cost government vaccine product payment adjustments during claims processing. You’ll see it on your remittance advice.

Code 90611 for smallpox and monkeypox vaccine product:

• Long descriptor: Smallpox and monkeypox vaccine, attenuated vaccinia virus, live, non-replicating, preservative free, 0.5 mL dosage, suspension, for subcutaneous use
• Short descriptor: SMALLPOX&MONKEYPOX VAC 0.5ML

Code 90622 for vaccinia (smallpox) virus vaccine product:

• Long descriptor: Vaccinia (smallpox) virus vaccine, live, lyophilized, 0.3 mL dosage, for percutaneous use
• Short descriptor: VACCINIA VRS VAC 0.3 ML PERQ

Patient cost sharing applies. Your Medicare Administrative Contractor will give you more information soon about coverage and billing.

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)