Knowledge Base Category -

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.

“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).

When first employed at MMP, there were two big challenges for me, identifying what I did not know but needed to know and knowing where to find the information. To that end, following are key resources you will need to prepare for the start of the new CMS Fiscal Year 2023 on October 1, 2022.

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).

In addition to finding the codes, here are additional resources highlighting key facts from the FY 2023 Final Rule.

MLN Connects

• Monday, August 1, 2022 Special Edition: New CMS Rule Increases Payments for Acute Care Hospitals & Advances Health Equity, Maternal Health: https://www.cms.gov/outreach-and-educationoutreachffsprovpartprogprovider-partnership-email-archive/2022-08-01-mlnc-se

CMS Newsroom

• Monday, August 1, 2022 Fact Sheet: FY 2023 Hospital Inpatient Perspective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) Final Rule – CMS-1771-F: https://www.cms.gov/newsroom/fact-sheets/fy-2023-hospital-inpatient-prospective-payment-system-ipps-and-long-term-care-hospital-prospective
• Monday, August 1, 2022 Fact Sheet: FY 2023 Hospital Inpatient Prospective Payment System (IPPS) and Long Term Care Hospital (LTCH PPS) Final Rule – CMS-1771-F Maternal Health: https://www.cms.gov/newsroom/fact-sheets/fy-2023-hospital-inpatient-prospective-payment-system-ipps-and-long-term-care-hospitals-ltch-pps-1

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,

CMS recently released the Calendar Year (CY) Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System proposed rule. In last week’s newsletter (link) we reviewed proposed changes to the Inpatient Only (IPO) List. This week’s focus is on the Ambulatory Surgery Center Covered Procedure List (CPL) and the Hospital Outpatient Prior Authorization Program proposals.

Ambulatory Surgery Center (ASC) Covered Procedure List (CPL)

The CMS evaluates the ASC CPL yearly to determine whether to add or remove specific procedures from the list. Covered surgical procedures performed on or after January 1, 2022, are:

• Procedures specified by the Secretary and published in the Federal Register,
• Separately paid under the OPPS,
• Would not be expected to post a significant safety risk to a Medicare beneficiary when performed in an ASC, and
• Standard medical practice dictates the expectation that the beneficiary would not typically require active medical monitoring and care at midnight following the procedure.

For CY 2023, CMS proposed to add one procedure to the ASC CPL:

• CPT 38531 (Biopsy or excision of lymph node(s); open, inguinofemoral node(s)).

RTMD Data Analysis

I turned to our sister company, RealTime Medicare Data (RTMD) to help estimate the potential impact to hospital outpatients if this procedure can also occur in an ASC setting. The claims data represents Medicare Fee-for-Service paid claims in calendar year 2021 for CPT 38531 for all states in the RTMD footprint. Currently, this includes all states except Kentucky and Ohio.

• Overall Claims Volume: 4,606
• CPT Payment: $13,088,298.18
• Top 5 States
• California had 411 claims with a payment of $1,468,801.23,
• Florida had 338 claims with a payment of $939,648.34,
• Texas had 253 claims with a payment of $705,682.74,
• Pennsylvania had 245 claims with a payment of $721,419.95, and
• New York has 229 claims with a payment of $651,816.93.

CMS ends this section of the proposed rule by noting they “believe that any additions to the CPL should be added in a carefully calibrated fashion to ensure that the procedure is safe to be performed in the ASC setting for a typical Medicare beneficiary. We expect to continue to gradually expand the ASC CPL, as medical practice and technology continue to evolve and advance in future years. We encourage stakeholders to submit procedure recommendations to be added to the ASC CPL, particularly if there is evidence that these procedures meet our criteria and can be safely performed on the typical Medicare beneficiary in the ASC setting.”

Hospital Outpatient Prior Authorization Program

The Prior Authorization for Certain Hospital Outpatient Department (OPD) Services initiative became effective on July 1,2020 and made a prior authorization request (PAR) a condition of payment for specific service categories. Service categories effective July 1, 2020, included:

• Blepharoplasty,
• Botulinum toxin injections,
• Panniculectomy,
• Rhinoplasty, and
• Vein ablation.

Effective July 1, 2021, CMS added cervical fusion with disc removal and implanted neurostimulators as new service categories.

You can learn more about this initiative on the CMS Hospital OPD Services initiative webpage (link).

CMS has proposed to add Facet Joint Interventions as a new service category and would include facet joint injections, medial branch blocks and facet joint nerve destruction CPT codes. This list of applicable CPT codes is in Table 79 of the proposed rule. If finalized, this would be effective for dates of services on or after March 1, 2023.

CMS Data Analysis

CMS performed data analysis of CPT codes 64490-64495 (Facet Injections and Medical Branch Blocks) and CPT Codes 64633-64636 (Nerve destruction services). Analysis revealed facet joint intervention claims volume increased by 47 percent between 2012 and 2021. This reflected a 4 percent average annual increase which is higher than the 0.6 percent annual increase for all outpatient department services.

Contractor Scrutiny

As part of the discussion for adding facet joint interventions to this initiative, CMS includes discussion of prior audits performed by the OIG and Department of Justice.

• OIG Report Medicare Improperly Paid Physicians for More Than Five Spinal Facet-Joint Injections Sessions During a Rolling 12-Month Period (A-09-20-03003) published October 2020 (link): The OIG found that MACs in the 11 jurisdictions with a coverage limitations made improper payments of $748,555.
• OIG Report Medicare Improperly Paid Physicians for Spinal Facet-Joint Denervation Sessions (A-09-21-03002) published December 2021 (link): The OIG found that Medicare improperly paid physicians $9.5 million.

In addition to past reports, there are two active OIG Work Plan items related to facet joint procedures.

• In the Department of Justice case reference in the proposed rule, the DOJ reported on a $250 million health care fraud scheme where “to obtain prescriptions, the evidence showed that the patients had to submit to expensive, unnecessary and sometimes painful back injections, known as facet joint injections.”

CMS notes, “both our data analysis and research show that the increases in volume for these procedures are unnecessary, and further program integrity action is warranted.”

RTMD Data Analysis

I once again turned to RTMD to help estimate the potential impact of adding Facet Joint Interventions to the prior authorization initiative. Keep in mind that data volume includes all procedures and there may be claims that could include multiple facet procedures in the same encounter.

Facet Injections and Medical Branch Blocks (CPT 64490-64495)

• Overall Claims Volume: 391,410
• CPT Payment: $141,144,372.81
• Top 5 States
• Texas had 40,472 claims with a payment of $13,102,475.35
• California had 24,109 claims with a payment of $11,433,125.41,
• Massachusetts had 23,738 claims with a payment of $9,892,874.58,
• New York had 18,901 claims with a payment of $6,922,608.02, and
• Pennsylvania had 18,624 claims with a payment of $6,764,696.64.

Facet Joint Nerve Destruction (CPT codes 64633-64636)

• Overall Claims Volume: 185,564
• Sum CPT Paid: $124,386,756.18
• Top 5 States
• Texas had 19,051 claims with a payment of $12,335,211.47,
• California had 11,620 claims with a payment of $10,144,086.72,
• Florida had 8,641 claims with a payment of $4,970,708.01,
• Illinois had 8,023 claims with a payment of $4,782,664.98, and
• Pennsylvania had 7,711 claims with a payment of $5,205,371.13.

CMS is accepting comments on the proposed rule through September 13, 2022.

Resource

CMS CY 2023 Proposed Rule webpage: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Annual-Policy-Files

True to form, the CMS announced the release of the Calendar Year (CY) 2023 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System proposed rule late last Friday July 16th. This week we review the proposed changes to the Inpatient Only (IPO) list.

CMS once again reminds providers in this proposed rule that “Designation of a service as inpatient only does not preclude the service from being furnished in a hospital outpatient setting but means that Medicare will not make payment for the service if it is furnished to a Medicare beneficiary in the hospital outpatient setting (65 FR 18443). Conversely, the absence of a procedure from the list should not be interpreted as identifying that procedure as appropriately performed only in the hospital outpatient setting (70 FR 68696).”

Before reviewing proposals, here is a quick look back at the “flip flopping” of CMS over the past two calendar years. In CY 2021, CMS removed 298 musculoskeletal-related services from the IPO List and finalized the elimination of the list over three years. In CY 2022, CMS did an about face and finalized the following changes:

• The IPO list will not be eliminated over three years,
• Most procedures removed from the IPO list in CY 2021 were added back to the list for CY 2022, and
• The five longstanding criteria for determining whether a service or procedure should be removed from the IPO list was codified in regulation text.

Calendar Year 2023 Proposed Procedures for Removal from the IPO List

CMS is proposing to remove ten procedures from the IPO list.

CPT code 16036 (Escharotomy; each additional incision (list separately in addition to code for primary procedure)). This code is an add-on code typically billed with primary procedure CPT 10635 (escharotomy; initial incision) which was removed from the IPO list in CY 2007.

CPT code 22632 (Arthrodesis, posterior interbody technique, including laminectomy and/or discectomy to prepare interspace (other than for decompression), single interspace; each additional interspace (list separately in addition to code for primary procedure)). This code is an add-on code typically billed with primary procedure CPT 22630 (Arthrodesis, posterior interbody technique, including laminectomy and/or discectomy to prepare interspace (other than for decompression), single interspace; lumbar), which was removed from the IPO list in CY 2021. Note, this code was removed from the IPO list in CY 2021 and replaced back on the list for CY 2022.

The remaining eight procedures proposed for removal from the IPO list are all maxillofacial procedures removed from the IPO list in CY 2021 and replaced back on the list for CY 2022:

• CPT code 21141 (Reconstruction midface, lefort I; single piece, segment movement in any direction (e.g., for long face syndrome), without bone graft).
• CPT code 21142 (Reconstruction midface, lefort I; 2 pieces, segment movement in any direction, without bone graft).
• CPT code 21143 (Reconstruction midface, lefort I; 3 or more pieces, segment movement in any direction, without bone graft).
• CPT code 21194 (Reconstruction of mandibular rami, horizontal, vertical, C, or L osteotomy; with bone graft (includes obtaining graft)).
• CPT code 21196 (Reconstruction of mandibular rami and/or body, sagittal split; with internal rigid fixation).
• CPT code 21347 (Open treatment of nasomaxillary complex fracture (lefort II type); requiring multiple open approaches).
• CPT code 21366 (Open treatment of complicated (e.g., comminuted or involving cranial nerve foramina) fracture(s) of malar area, including zygomatic arch and malar tripod; with bone grafting (includes obtaining graft)); and
• CPT code 21422 (Open treatment of palatal or maxillary fracture (lefort I type);).

Calendar Year 2023 Proposed Additions to the IPO List

CMS has proposed the addition of eight newly created codes by the AMA CPT Editorial Panel to the IPO list for CY 2023:

• 157X1 (Implantation of absorbable mesh or other prosthesis for delayed closure of defect(s) (i.e., external genitalia, perineum, abdominal wall) due to soft tissue infection or trauma,
• 228XX (Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other than for decompression); second interspace, lumbar (List separately in addition to code for primary procedure),
• 49X06 (Repair of anterior abdominal hernia(s) (i.e., epigastric, incisional, ventral, umbilical, spigelian), any approach (i.e., open, laparoscopic, robotic), initial, including placement of mesh or other prosthesis when performed, total length of defect(s); greater than 10 cm, incarcerated or strangulated),
• 49X10 (Repair of anterior abdominal hernia(s) (i.e., epigastric, incisional, ventral, umbilical, spigelian), any approach (i.e., open, laparoscopic, robotic), recurrent, including placement of mesh or other prosthesis when performed, total length of defect(s); 3 cm to 10 cm, incarcerated or strangulated),
• 49X11 (Repair of anterior abdominal hernia(s) (i.e., epigastric, incisional, ventral, umbilical, spigelian), any approach (i.e., open, laparoscopic, robotic), recurrent, including placement of mesh or other prosthesis when performed, total length of defect(s); greater than 10 cm, reducible,
• 49X12 (Repair of anterior abdominal hernia(s) (i.e., epigastric, incisional, ventral, umbilical, spigelian), any approach (i.e., open, laparoscopic, robotic), recurrent, including placement of mesh or other prosthesis when performed, total length of defect(s); greater than 10 cm, Incarcerated or strangulated,
• 49X13, (Repair of parastomal hernia, any approach (i.e., open, laparoscopic, robotic), initial or recurrent, including placement of mesh or other prosthesis, when performed; reducible), and
• 49X14 (Repair of parastomal hernia, any approach (i.e., open, laparoscopic, robotic), initial or recurrent, including placement of mesh or other prosthesis, when performed; incarcerated or strangulated).

All proposed changes to the IPO list, including the CPT code, longer descriptor, proposed action (deletion or addition), proposed status indicator and for proposed deletions the proposed APC assignment are listed in Table 46 of the proposed rule.

CMS is accepting comments on the proposed rule through September 13, 2022.

Resources

CY 2023 OPPS Proposed Rule

• CMS Press Release: https://www.cms.gov/newsroom/press-releases/cms-proposes-rule-advance-health-equity-improve-access-care-and-promote-competition-and-transparency
• CMS Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/cy-2023-medicare-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center
• Proposed Rule: https://www.federalregister.gov/public-inspection/2022-15372/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment

Did You Know?

According to a National Cancer Institute, bladder cancer:

• Is the fourth most commonly diagnosed malignancy in men in the United States,
• Occurs about four times higher in men than in women,
• Is diagnosed almost twice as often in White individuals as in Black individuals of either sex; and
• The incidence of bladder cancer increases with age.

Blood in the urine is the most common presenting sign of bladder cancer, occurring in about 90% of cases. Other presenting symptoms include dysuria, urinary frequency or urgency, and less commonly, flank pain secondary to obstruction, and pain from pelvic invasion or bone metastasis.

Although hematuria is the most common presenting symptom, most people experiencing hematuria do not have bladder cancer.

Why it Matters?

There are risk factors related to being diagnosed with bladder cancer, most common being tobacco use, especially smoking cigarettes. Examples of additional risk factors includes:

• Having a family history of bladder, cancer,
• Having certain changes in the genes that are linked to bladder cancer,
• Being exposed to paints, dyes, metals, or petroleum products in the workplace,
• Past treatment with radiation therapy to the pelvis or with certain anticancer drugs, such as cyclophosphamide or ifosfamide,
• Taking Aristolochia fangchi, a Chinese herb,
• Drinking water from a well that has high levels of arsenic,
• Drinking water that has been treated with chlorine,
• Having a history of bladder infections, and
• Using urinary catheters for a long time.

What Can You Do?

First and foremost, if you smoke, quit! If you think you may be at risk for bladder cancer and/or are experiencing symptoms common for bladder cancer, discuss this with you physician. Time matters. The earlier bladder cancer is identified, the better chance a person has of surviving five years after diagnosis. The current five years relative survival rate is 77.1%.

What Can You Do?

• National Cancer Institute Cancer Stat Facts: Bladder Cancer: (https://seer.cancer.gov/statfacts/html/urinb.html)
• National Cancer Institute Bladder and Other Urothelial Cancers Screening (PDQ®) Patient Version: (https://www.cancer.gov/types/bladder/patient/bladder-screening-pdq)
• National Cancer Institute Bladder and Other Urothelial Cancers Screening (PDF®) Health Profession Version: (https://www.cancer.gov/types/bladder/hp/bladder-screening-pdq )