Knowledge Base Category -

Compliance Education Updates

MLN Educational Tool: Medicare Preventive Services

This MLN tool (link) was updated in September. Updates include pneumococcal shot resources, thirteen new bone mass measurement codes and three new hepatitis B screening codes.

MLN Educational Tool: Medicare Payment Systems

This MLN tool (link) was also updated in September to include updates for FY 2023 for:

• The Acute Care Hospital Inpatient Prospective Payment System (IPPS),
• The Hospice Payment System,
• The Inpatient Psychiatric Facility Prospective Payment System (IPF PPS),
• The Inpatient Rehabilitation Facility Prospective Payment System (IRF PPS),
• The Long-Term Care Hospital Prospective Payment System (LTCH PPS), and
• The Skilled Nursing Facility Prospective Payment System (SNF PPS).

MLN Booklet: Chronic Care Management Services

This Booklet (link) has been updated. Substantive content changes are in dark red font and includes:

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

COVID-19 Updates

October 13, 2022: Update to COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers

This CMS document (link) was updated on October 13th. The waiver related to the Director of Food and Nutrition Services was terminated on 10/1/2022 per the FY 2023 SNF Prospective Payment System Final Rule (1765-F).

Other Updates

September 23, 2022 Award of Medicare Administrative Contractor (MAC) Contract for Jurisdiction M

On September 23rd, Palmetto GBA, the incumbent MAC for Jurisdiction M (JM) was again awarded the contract for the administration of Medicare Part A and Part B Fee-for-Service claims in the states of North and South Carolina, Virginia, and West Virginia. The claims volume in JM equates to more than $26.4 billion in Medicare benefit payments annually. Palmetto GBA will provide Medicare services to more than three hundred hospitals, approximately 75,000 physicians, and 3.2 million beneficiaries.

CMS Implements Temporary Increase in Payment under Medicare for Qualifying Biosimilars

Section 11403 of the Inflation Reduction Act provides for a temporary increase in the add-on payment for qualifying biosimilars from the current ASP plus an add-on of 6% of the reference biological product’s ASP to ASP plus 8% for a 5-year period. CMS noted in the Thursday, October 6th edition of MLN Matters (link) that “the goal of the temporary add-on payment for providers is to increase access to biosimilars, as well as to encourage competition between biosimilars and reference biological products, which may, over time, lower drug costs and lead to savings to beneficiaries and Medicare.”

If you are interested in learning more about biosimilars, there are two FDA resources:

• FDA Biological Product Definition Fact Sheet (link), and
• A Curriculum Materials for Health Care Degree Programs / Biosimilars (link). The “FDA’s curriculum materials are intended to help educate students in health care professional degree programs, for medicine, nursing, physician assistants, and pharmacy, as well as practicing professionals, to improve understanding of biosimilar and interchangeable biosimilar products and the regulatory approval pathway in the United States.”

CMS Request for Information (RFI): Developing a National Directory of Health Care Providers and Services

On October 7, 2022, CMS published an RFI in the Federal Register (link) seeking comments on the establishment of a National Directory of Healthcare Providers & Services (NDH). CMS believes an NDH would serve multiple purposes for the end user, for example:

• Helping patients locate providers that meet their individual needs and preferences, and
• A modern NDH “should enable healthcare providers, payers, and others involved in patient care to identify one another’s digital contact information also referred to as digital endpoints, for interoperable electronic data exchange.”

On October 7, 2022, CMS published an RFI in the Federal Register (link) seeking comments on the establishment of a National Directory of Healthcare Providers & Services (NDH). CMS believes an NDH would serve multiple purposes for the end user, for example:

Did You Know?

A new code has been created to identify a non-ischemic myocardial injury (non-traumatic).

Why Should I Care?

Myocardial injury, in the absence of ischemia, is categorized as acute or chronic nonischemic myocardial injury. Previously, non-ischemic, non-traumatic, myocardial injury was assigned to code (I51.89) (Other ill-defined heart diseases). Effective October 1, 2021, non-ischemic, non-traumatic, myocardial injury is assigned to code I5A (CC).

Non-ischemic myocardial injury (non-traumatic) code (I5A) includes:

• Acute myocardial injury (non-ischemic)
• Chronic myocardial injury (non-ischemic)
• Unspecified myocardial injury (non-ischemic)

Instructions under I5A:

• Code first the underlying causes, if known and applicable, such as: acute kidney failure, acute myocarditis, cardiomyopathy, chronic kidney disease, etc.
• Excludes1: acute myocardial infarction and injury of heart
• Excludes2: other acute ischemic heart diseases

Clinicians can now determine whether patients have suffered a non-ischemic myocardial injury or one of the other myocardial injuries: Type 1 MI (myocardial ischemic injury) or Type 2 MI (supply/demand without acute atherothrombosis).

The new code will allow for the appropriate classification of these patients. Accurate coding of myocardial injury will allow for appropriate reimbursement and support resource costs as well.

What Should I Do?

If you see documentation of myocardial injury, remember that this condition is codable, even if the patient doesn’t have a myocardial infarction (ischemic).

References:

ICD-10-CM Official Coding Book

Coding Clinic for ICD-10-CM/PCS, Fourth Quarter, 2021: Page 14

Coding Clinic for ICD-10-CM/PCS, Second Quarter, 2019: Page 5

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.

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)

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. .

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