Knowledge Base Category -

Medicare Transmittals & MLN Articles

September 5, 2024: MLN MM13784: Hospital Outpatient Prospective Payment System: October 2024 Update

This article contains updates for proprietary laboratory analyses (PLA) codes, device pass through, drugs, biologicals, and radiopharmaceuticals, skin substitutes, blood products, and other coding changes. https://www.cms.gov/files/document/mm13784-hospital-outpatient-prospective-payment-system-october-2024-update.pdf

September 5, 2024: MLN MM13880: Ambulatory Surgical Center Payment Update – October 2024

This MLN article provided payment system updates for October for new CPT and HCPCS codes, drugs and biologicals, and skin substitutes.

https://www.cms.gov/files/document/mm13800-ambulatory-surgical-center-payment-update-october-2024.pdf

September 18, 2024: MLN MM13734: Inpatient & Long-Term Care Hospital Prospective Payment Systems: FY 2025 Changes – Revised

This article, originally published on August 29, 2024, was updated on September 18, 2024. CMS corrected the number of deleted and total MS-DRGs for FY 2025 and updated the Change Request (CR) link. https://www.cms.gov/files/document/mm13734-inpatient-long-term-care-hospital-prospective-payment-system-fy-2025-changes.pdf

Coverage Updates

September 10, 2024: Final Rule to Amend the Mammography Quality Standards Act (MQSA)

On March 10, 2023, the FDA issued the final rule to amend the MQSA regulations. Facilities subject to the MQSA must comply with all applicable requirements, including the breast density notification, no later than September 10, 2024. https://www.fda.gov/radiation-emitting-products/mammography-quality-standards-act-and-program/important-information-final-rule-amend-mammography-quality-standards-act-mqsa

September 11, 2024: Noninvasive Positive Pressure Ventilation (NIPPV) in the Home for the Treatment of Chronic Respiratory Failure consequent to COPD

CMS received a request for reconsideration of National Coverage Determination (NCD) 280.1, to establish coverage policies for the use of noninvasive home mechanical ventilators and respiratory assist devices for Medicare beneficiaries with various respiratory conditions. CMS accepted the request for the indication of chronic obstructive pulmonary disease and will develop a new NCD section.

CMS is soliciting public comment relevant to the requester. They are particularly interested in comments that include scientific evidence, specifically any peer-reviewed literature, which describes the role of BPAP or HMVs in the home management of chronic respiratory failure in patients with COPD. They are also interested in aspects of health disparities and health equity that should be considered in the review. The comment period ends October 11, 2024. https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=315

September 30, 2024: Preexposure Prophylaxis (PrEP) Using Antiretroviral Therapy to Prevent Human Immunodeficiency Virus (HIV) Infection: Final Decision Memo

After considering public comments, CMS is expanding coverage from their proposed decision and will cover PrEP using antiretroviral drugs approved by the FDA to prevent HIV in individuals at increased risk of HIV Acquistion. This determination is made by the physician or health care practitioner who assesses the individual’s history. CMS also covers furnishing HIV PrEP using antiretroviral drugs, including the supplying, or dispensing of these drugs and the administration of injectable PrEP. https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=310&fromTracking=Y&

Compliance Education Updates

MLN Booklet MLN906765: Items and Services Not Covered Under Medicare – Revised

CMS updates this MLN booklet in July to add language about dental coverage exceptions. Substantive content changes are in dark red. https://www.cms.gov/outreach-and-education/medicare-learning-network-mln/mlnproducts/downloads/items-and-services-not-covered-under-medicare-booklet-icn906765.pdf

Other Updates

September 4, 2024: CMS Issues Request for Information on Potential Consolidation of Some Medicare Administrative Contractor Jurisdictions

In the September 6, 2024 edition of the CMS Round Up, CMS indicated they had issued a request for information on September 4^th to obtain feedback from the industry and the public about the potential consolidation of four Medicare Administrative Contractor (MAC) jurisdictions into two, as well as to obtain input on extending MAC contracts to 10 years. https://www.cms.gov/newsroom/cms-round-up/cms-roundup-september-6-2024

September 4, 2024: MLN Connects Hospital Price Transparency: Use a CMS Template Layout

CMS published the following information in the Thursday, September 4^th edition of MLN Connects

“As of July 1, 2024, hospitals must conform to a CMS template layout and data specifications for making public their standard charge information in a comprehensive machine-readable file (MRF). Starting January 1, 2025, you’re also required to encode additional elements.

We have resources to help you meet these new requirements:

• Visit the Data Dictionary GitHub Repository to access the CMS templates and data dictionary with technical instructions for encoding your required standard charge information
• Use the Online Validator Tool to check that your MRF complies with the CMS template layout and data encoding requirements

  Hospital Price Transparency regulations require each hospital operating in the U.S. to publish a comprehensive MRF with the standard charges for all items and services they provide.

   

  More information:

• Register for the October 21 webinar on meeting the upcoming January 2025 requirements.
• Email questions to PriceTransparancyHospitalCharges@cms.hhs.gov”

September 12, 2024: Rural Emergency Hospitals Provisions, Conversion Process, & Conditions of Participation: Revised

CMS announced in the Thursday, September 12th edition of MLN Connects that they have released guidance on the enrollment and conversion process for eligible facilities interested in participating in the Medicare and Medicaid programs as a rural emergency hospital. https://www.cms.gov/training-education/medicare-learning-network/newsletter/2024-09-12-mlnc

You can learn more about REHs on the CMS REH webpage at https://www.cms.gov/medicare/health-safety-standards/quality-safety-oversight-guidance-laws-regulations/hospitals/rural-emergency-hospitals

September 26, 2024: CMS Memorandum: Compliance with Residents’ Rights Requirements related to Nursing Home Residents’ Right to Vote

CMS issued this memorandum to affirm the regulatory expectations that ensures nursing home residents have the unimpeded ability to exercise their right to vote as a citizen of the United States. https://www.cms.gov/files/document/qso-24-21-nh.pdf

September 30, 2024: Order Your 4 Free At-home COVID-19 Tests

The federal government is once again providing free at-home COVID-19 tests. Each household is eligible to receive four at-home test kits. They began shipping for free September 30^th through the US Postal Service. To order your tests go to https://covidtests.gov/.

CMS published details about this five-year mandatory model as part of the FY 2025 IPPS and LTCH PPS Final Rule. CMS indicates that it will incentivize coordination between care providers during a surgery as well as the services provided during the 30 days after surgery with the aim of:

• Improving the quality of care of people with Medicare undergoing certain surgical procedures;
• reducing hospitalization and recovery time;
• lowering Medicare spending; and
• driving equitable outcomes.

The model is set to start in January 2026 and end in December 2030.

TEAM Participation

All acute care hospitals, with limited exceptions, located within the mandatory Core-Based Statistical Areas (CBSAs) that CMS selected will be required to participate in TEAM.

CMS will allow a one-time opportunity for hospitals that participate until the last performance period in the BPCI Advanced model or CJR model, that are not located in a mandatory CBSA to voluntarily opt into TEAM.

A final list of the selected mandatory CBSAs is available in the FY 2025 IPPS Final Rule Table X.Z.-05: Final List of CBSAs for Selection into TEAM

TEAM Episode

An Episode will include non-excluded Medicare Parts A and B items and services and would begin with an anchor hospitalization or anchor procedure and will end 30 days after hospital discharge.

The following table is available in the final rule and provides the specific TEAM episode categories and related billing codes.

Billing Medicare

TEAM participants will continue to bill Medicare FFS for services furnished to Medicare FFS beneficiaries. However, the TEAM participant may also receive a reconciliation payment amount from CMS depending on their Composite Quality Score (CQS) and if their performance year spending is less than their reconciliation target price.

Participants may also owe CMS a repayment amount, subject to their quality performance adjustment, if their spending is above the reconciliation target price.

Target Prices will be based on 3 years of baseline data, prospectively trended forward to the relevant performance year, and calculated at the level of MS-DRG/HCPCS episode type and region.

The Target Prices will include a discount factor, a normalization factor, a retrospective trend adjustment factor, and a beneficiary and provider level risk-adjustment.

Moving Forward

Determine if your hospital is in one of the selected mandatory CBSA. If your hospital will be part of this model, you can find additional information and resources available on the CMS Innovation Center’s TEAM webpage at:https://www.cms.gov/priorities/innovation/innovation-models/team-model

Resource

CMS FY 2025 IPPS Final Rule webpage: https://www.cms.gov/medicare/payment/prospective-payment-systems/acute-inpatient-pps/fy-2025-ipps-final-rule-home-page

Medicare MLN Articles

May 23, 2024: MLN MM13620: HCPCS Codes & Clinical Laboratory Improvement Amendments Edits: October 2024

This article reviews discontinued HCPCS codes, new HCPCS codes, and HCPCS codes subject to and excluded from CLIA edits as of October 1, 2024. https://www.cms.gov/files/document/mm13620-hcpcs-codes-clinical-laboratory-improvement-amendments-edits-october-2024.pdf

June 3, 2024: MLN MM13632: Hospital Outpatient Prospective Payment System: July 2024 Update

Make sure your billing staff knows about payment system updates for July including new CPT and HCPCS codes, covered devices for OPPS pass-through payments, drugs, biologicals and radiopharmaceutical, and skin substitutes.

https://www.cms.gov/files/document/mm13632-hospital-outpatient-prospective-payment-system-july-2024-update.pdf

June 13, 2024: MLN MM13658: DMEPOS Fee Schedule: July 2024 Quarterly Update

In this article you will find updates to CY 2024 fee schedule amounts for certain DMEPOS codes and information in changes in payment policy and new fee schedule information for HCPCS codes K1007 and E2298.

https://www.cms.gov/files/document/mm13658-dmepos-fee-schedule-july-2024-quarterly-update.pdf

June 13, 2024: MLN MM13656: Ambulatory Surgical Center Payment Update – July 2024

This article includes July updates for new CPT and HCPCS codes, coverage of Elios System for patients with primary open-angle glaucoma, and information about skin substitutes.

https://www.cms.gov/files/document/mm13656-ambulatory-surgical-center-payment-update-july-2024.pdf

June 13, 2024: MLN MM13651: Medicare Benefit Policy Manual Update: DMEPOS Benefit Category Determinations

This article highlights updates to Section 110.8, Medicare Benefit Policy Manual, Chapter 15, and information about added DMEPOS items and their national benefit category determination (BCDs).

https://www.cms.gov/files/document/mm13651-medicare-benefit-policy-manual-update-dmepos-benefit-category-determinations.pdf

Coverage Updates

May 24, 2024: MLN MM13598: National Coverage Determination 200.3: Monoclonal Antibodies for the Treatment of Alzheimer's Disease

Make sure your billing staff knows about FDA-approved monoclonal antibodies, criteria for coverage, coding information, and claims processing instructions. https://www.cms.gov/files/document/mm13598-national-coverage-determination-2003-monoclonal-antibodies-treatment-alzheimers-disease.pdf

June 20, 2024: National Coverage Analysis (NCA): Transcatheter Tricuspid Valve Replacement (TTVR)

CMS notes that TTVR is a new technology for use in treating tricuspid regurgitation (TR) and they have received a formal request to provide coverage for the EVOQUE tricuspid valve replacement system (EVOQUE system). This NCA will focus on clinical indications for use of TTVR among Medicare beneficiaries. The public comment period for this NCA is from June 20, 2024, to July 20, 2024. https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=314

June 25, 2024: NCA: Preexposure Prophylaxis (PrEP) Using Antiretroviral Therapy to Prevent Human Immunodeficiency Virus (HIV) Infection

CMS updated this NCA noting that they released a Technical Frequently Asked Questions for Pharmacies. In response feedback, this document provides technical detail following the previous posting of the fact sheet on April 15, 2024. CMS also noted the final NCD is expected to be similar to the proposed published July 12, 2023, and pharmacies should prepare not to ready for this transition. They are sharing as much information as possible before issuing the final NCD to avoid disruptions for beneficiaries. https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=310&ncacaldoctype=all&status=all&sortBy=status&bc=17

Compliance Education Updates

May 2024: MLN006559: Medicare Preventive Services

This MLN educational tool was revised in May to update the applicable codes for Hepatitis C screening. This tool includes helpful information related to HCPCS & CPT codes, ICD-10 codes, what Medicare covers, the frequency of screening, what the patient pays and additional miscellaneous notes. You will also find applicable coverage requirements when one has been published for the preventive service (i.e., for bone mass measurement you will find a link to national coverage determination 150.3: Bone (Mineral) Density Studies. https://www.cms.gov/Medicare/Prevention/PrevntionGenInfo/medicare-preventive-services/MPS-QuickReferenceChart-1.html#BONE_MASS  

May 28, 2024: CMS Updates to Include Marriage and Family Therapists and Mental Health Counselors for Hospice, Rural Health Clinics, and Federally Qualified Health Centers

In the memorandum summary sent to State Survey Agency Directors, CMS notes the CY 2024 PFS final rule updated the Hospice Conditions of Participation, the Rural Health Clinic (RHC) Conditions for Certification, and the Federally Qualified Health Center (FQHC) Conditions for Coverage to implement provisions of the Consolidated Appropriations Act, 2023.

For Hospices: The interdisciplinary team must now include at least one social worker, marriage and family therapist or mental health counselor as part of the team. The hospice personnel requirements were updated to add these disciplines.

For RHCs and FQHCs: Staffing and personnel requirements were updated to include marriage and family therapists and mental health counselors as part of the collaborative team approach to providing services. Also, definitions of several health care professionals who are already eligible to provide services at RHCs and FQHCs were updated, including the definition of “nurse practitioner,” to align with current standards of professional practice. https://www.cms.gov/files/document/qso-24-12-hospice-fqhc/rhc.pdf

Comprehensive Error Rate Testing Program: Reduced Sample Size Starting Reporting Year (RY) 2025

The CERT selects a stratified random sample of Part A/B claims submitted to the Medicare Administrative Contractors (MACs). The sample size allows CMS to calculate a national improper payment rate and contractor-and-service-specific improper payment rates. The sample size is considered to reflect all claims processed by the Medicare FFS program in the report period. CMS recently announced that beginning with the RY 2025, the sample size will be permanently reduced from 50,000 to 37,500 claims annually. CMS notes on their CERT webpage that “it is important to note that the improper payment rate is not a “fraud rate,” but is a measurement of payments that did not meet Medicare requirements.”

June 7, 2024: FDA Approves Expanded Age Indication for GSK’s Arexvy

GSK noted in their announcement that “over 13 million US adults aged 50-59 have a medical condition that increased their risk of RSV outcomes.” Further, the US FDA has approved Arexvy (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults 50 through 59 years who are at increased risk for example, adults with COPD, asthma, heart failure and/or diabetes.

• June 7, 2024 FDA Letter to GlaxoSmithKline (GSK) Biologicals: https://www.fda.gov/media/179248/download?attachment=&utm_medium=email&utm_source=govdelivery

June 10, 2024: OIG Semiannual Report to Congress

OIG released their semiannual report for the 6-month period ending March 31, 2024. Inspector General Christi A. Grim notes that OIG used experts and authorities, highly developed data analysis techniques, and strong partnerships with other law enforcement and oversight entities, OIG identified $2.76 billion in expected recoveries and issued 195 recommendations and completed 60 audits and 18 evaluations in this reporting period. Inspector General Grim went on to indicate that OIG’s health care work consistently yields a positive return on investment of around $10 returned to every $1 invested. https://oig.hhs.gov/documents/sar/9905/Spring_2024_SAR.pdf

June 11, 2024: Long COVID Defined

The National Academies of Sciences, Engineering, and Medicine (NASEM) released a new definition for “Long COVID” – “that it is an infection-associated chronic condition that occurs after COVID-19 infection and is present for at least three months as a continuous, relapsing and remitting, or progressive disease state that affects one or more organ systems.” https://www.nationalacademies.org/news/2024/06/federal-government-clinicians-employers-and-others-should-adopt-new-definition-for-long-covid-to-aid-in-consistent-diagnosis-documentation-and-treatment

June 20, 2024 MLN Connects: Watch out for Medicare Record Request Phishing Scam

Medicare Transmittals & MLN Articles

April 25, 2024: MLN MM13449: Stay of Enrollment – Revised

This article provides information about a new provider enrollment status called a stay of enrollment and related updates to the Medicare Program Integrity Manual, Chapter 10. On April 25^th, CMS reissued this article to revise the effective and implementation dates to May 30, 2024 and the web address of Change Request (CR) 13449. https://www.cms.gov/files/document/mm13449-stay-enrollment.pdf

May 3, 2024: MLN MM13487: Diabetes Screening & Definitions Update: CY 2024 Physician Fee Schedule Final Rule

CMS advises providers to make sure your billing staff knows about the revised regulatory definition of diabetes, the revised diabetes screening frequency limitations, and coverage of the Hemoglobin A1C (HbA1c) test for diabetes screening.

Prior to January 1, 2024 the HbA1C test (HCPCS code 83036) was covered for the purpose of diabetes management but not for diabetes screening. As of January 1, 2024, CMS now covers the HbA1c test for diabetes screening. https://www.cms.gov/files/document/mm13487-diabetes-screening-definitions-update-cy-2024-physician-fee-schedule-final-rule.pdf

May 3, 2024: MLN MM13486: Annual Wellness Visit: Social Determinants of Health Risk Assessment

Make sure your billing staff knows that the social determinants of health (SDOH) risk assessment is now an optional annual wellness visit (AWV) element and what the eligibility and billing requirements are for completing the SDOH risk assessment as part of the AWV. https://www.cms.gov/files/document/mm13486-annual-wellness-visit-social-determinants-health-risk-assessment.pdf

May 3, 2024: MLN MM13592: Updates for Split or Shared Evaluation & Management Visits

Information in this article for your billing staff include the definition of split or shared visit and substantive portion, and how to bill appropriately for split or shared evaluation and management (E/M) visits. https://www.cms.gov/files/document/mm13592-updates-split-or-shared-evaluation-management-visits.pdf

May 9, 2024: MLN MM13608: ESRD Prospective Payment System Quarterly Update

Make sure your billing staff knows about the Transitional Drug Add-On Payment Adjustment (TDAPA) for HCPCS code J0911 and the updated list of outlier services under the ESRD PPS. https://www.cms.gov/files/document/mm13608-esrd-prospective-payment-system-quarterly-update.pdf

May 16, 2024: MLN MM13617: Medicare Claims Processing Manual Update: Gap-Filling DMEPOS Fees

Make sure your billing staff knows about the revised Section 60.3 in the Medicare Claims Processing Manual, Chapter 23 and updated factors for gap-filling purposes.

https://www.cms.gov/files/document/mm13617-medicare-claims-processing-manual-update-gap-filling-dmepos-fees.pdf

May 23, 2024: MLN MM13598: NCD 200.3 – Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease (AD)

This article includes information about FDA-approved monoclonal antibodies, the criteria for coverage, coding information, and claims processing instructions. https://www.cms.gov/files/document/mm13598-national-coverage-determination-2003-monoclonal-antibodies-treatment-alzheimers-disease.pdf

May 24, 2024: MLN MM13613: Clinical Laboratory Fee Schedule & Laboratory Services Reasonable Charge Payment: Quarterly Update

This article was initially released on May 3^rd, 2024 with guidance from CMS to make sure your billing staff know that the next private payor data reporting period of January 1, 2025 – March 31, 2025 and new and deleted HCPCS codes. No substantive changes were made in the May 24^th revision other than to update the web address of the CR transmittal. https://www.cms.gov/files/document/mm13613-clinical-laboratory-fee-schedule-laboratory-services-reasonable-charge-payment-quarterly.pdf

Coverage Updates

April 30, 2024: New National Coverage Analysis (NCA)Tracking Sheet for Implanted Pulmonary Artery Pressure Sensor for Heart Failure Management (CAG-00466N)

CMS posted a National Coverage Analysis (NCA) Tracking Sheet regarding a request from Abbott to provide coverage for the CardioMEMS™ HF System. This device measures Pulmonary artery (PA) pressures by using a combination of an implantable PA pressure sensor and a remote hemodynamic monitoring system that is accessible by the physician. CMS is soliciting public comment until May 30, 2024 and has indicated a proposed Decision Memo due date of October 30, 2024. https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=313

May 2, 2024: CMS Statement on Proposed LCD for Skin Substitute Grafts/Cellular and Tissue-Based Products for Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers

CMS notes in the May 2, 2024 edition of MLN Connects that they are aware of the MACs having issued a collaborative proposed Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers Local Coverage Determination (LCD). CMS strongly encourages interested parties to provide comments during the public comment period that is open until June 8, 2024.  

May 10, 2024: MLN MM13596: ICD-10 & Other Coding Revisions to National Coverage Determinations: October 2024 Update

This article highlights new codes and recent coding changes related to the Next Generation Sequencing (NGS) (NCD 90.2), Bariatric Surgery for Treatment of Co-Morbid Conditions Related to Morbid Obesity (NCD 100.1), and the Aprepitant for Chemotherapy-Induced Emesis (NCD 110.18). https://www.cms.gov/files/document/mm13596-icd-10-other-coding-revisions-national-coverage-determinations-october-2024-update.pdf

May 13, 2024: MLN MM13604: National Coverage Determination 110.23: Allogeneic Hematopoietic Stem Cell Transplantation

Make sure your billing staff knows about coverage for HSCT using bone marrow, peripheral blood or umbilical cord blood stem cell products for Medicare patients and all other indications for stem cell transplantation not otherwise specified. https://www.cms.gov/files/document/mm13604-national-coverage-determination-11023-allogeneic-hematopoietic-stem-cell-transplantation.pdf

Compliance Education Updates

May 2024: MLN Fact Sheet: Swing Bed Services

CMS has updated this fact sheet to include information about covered Critical Access Hospital (CAH) swing bed services.  https://www.cms.gov/files/document/mln006951-swing-bed-services.pdf

Other Updates

May 9, 2024: CMS Publication – Part B Drug Payment Limits Overview

In the Thursday, May 9^th edition of MLN Connects, CMS noted they have published a Part B Drug Payment Limits Overview document to explain the Average Sales Price (ASP) payment limit calculation and other Medicare Part B drug payment methodologies including Wholesale Acquisition Cost (WAC), Average Wholesale Price (AWP), Average Manufacturer Price (AMP), Widely Available Market Price (WAMP), and Contractor Pricing.  

May 9, 2024: Mental Health: It’s Important at Every Stage of Life

Also in the Thursday, May 9^th edition of MLN Connects, CMS noted that mental and physical health are equally important components of overall health, and they provide links to information about appropriate preventive services and preventive services (i.e. Medicare & Mental Health Coverage) covered by Medicare.

May 21, 2024: CMS Launches New Option for Individuals to Report Potential Violations of the Emergency Medical Treatment and Labor Act (EMTALA)

CMS announced the launch of a new web resource to educate the public and promote patients’ access to emergency medical care to which they are entitled under federal law. https://www.cms.gov/newsroom/press-releases/biden-harris-administration-launches-new-option-report-potential-violations-federal-law-and-continue

“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 2025 IPPS Proposed Rule

New Technologies Eligible for Add-On Payment (NTAPs) Background

Effective for discharges beginning on or after October 1, 2002, Section 1886(d)(5)(K)(i) of the Act requires the Secretary to establish a mechanism to recognize the costs of new medical services and technologies under the payment system under the subsection which establishes the system for paying for the operating costs of inpatient hospital services.

The system of payment for capital costs is established in section 1886(g) of the Act. For this reason, capital costs are not included in the add-on payments for a new medical service or technology.

NTAPs are not budget neutral and the “newness” for payment is limited to the 2-to-3-year period after the point at which data begin to become available reflecting the inpatient hospital code assigned to the new service or technology.

There are three pathways for a new service or technology to be approved for the add-on payment (Traditional pathway, Certain Antimicrobial Products Alternative Pathway, and Certain Transformative New Devices Alternative Pathway).

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.”

Coding NTAPs

Section X New Technology was added to ICD-10-PCS effective October 1, 2015. CMS has indicated (https://www.cms.gov/Medicare/Coding/ICD10/Downloads/2016-Section-X-New-Technology-.pdf) 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.”  To receive payment for an eligible NTAP, the applicable section X New Technology ICD-10-PCS code must be on the claim submitted for adjudication.

NTAPs by the Numbers

For FY 2025, CMS has proposed to:

• Discontinue 7 technologies no longer considered to be “new,”
• Continue coverage for 24 technologies they consider to still be “new,” and
• Have assessed 26 applications.

For the 24 technologies that CMS considers to still be “new,” CMS estimates that collectively there will be 50,910 cases with an estimated total financial impact of just over $416 million.

Based on preliminary information from the FY 2025 applicants for new technology approval, CMS estimates the collective impact to be $345.3 million.

FY 2025 NTAP Program Proposals

Consistent with CMS’ Sickle Cell Disease Action Plan, CMS is proposing to increase the NTAP percentage from 65% to 75% for a gene therapy that is indicated specifically for the treatment of sickle cell disease (SCD) (subject to CMS’ determination in the FY 2025 IPPS final rule that any applicable gene therapy(ies) indicated and used specifically for treatment of SCD meets the criteria for approval for NTAP).

CMS has also proposed to use the October 1^st start of a new fiscal year, instead of April 1^st, to determine whether a technology is within its 2- to 3- year newness period. This change would be effective in FY 2026 for new applicants and extending the NTP an additional year for technologies initially approved in FY 2025.

CMS is accepting comments on the proposed rule through June 10, 2024.

Resource

FY 2025 IPPS Proposed Rule CMS webpage:

https://www.cms.gov/medicare/payment/prospective-payment-systems/acute-inpatient-pps/fy-2025-ipps-proposed-rule-home-page

The FY 2025 IPPS Proposed Rule (CMS-1808-P) was issued by CMS April 10, 2024. This article focuses on proposed changes to Medicare Severity Diagnosis-Related Group (MS-DRG) classifications.

MDC 05: Diseases and Disorders of the Circulatory System

Left Atrial Appendage Closure (LAAC) with Concomitant Ablation

Request: Create a new MS-DRG to better accommodate the cost of concomitant left atrial appendage closure and cardiac ablation for atrial fibrillation. “According to the requester, the manufacturer of the WATCHMAN™ Left Atrial Appendage Closure (LAAC) device, patients who are indicated for a LAAC device can also have symptomatic AF. For these patients performing a cardiac ablation and LAAC procedure at the same time is ideal.”

CMS Proposal: After claims analysis CMS indicated that “taking into consideration that it clinically requires greater resources to perform concomitant left atrial appendage closure and cardiac ablation procedures, we are proposing to create a new base MS-DRG for cases reporting a LAAC procedure and a cardiac ablation procedure in MDC 05. The proposed new MS-DRG is MS-DRG 317 (Concomitant Left Atrial Appendage Closure and Cardiac Ablation).”

CMS has proposed to include the nine ICD-10-PCS procedure codes that describe LAAC procedures and 27 ICD-10-PCS procedure codes describing cardiac ablation for the proposed new MS-DRG.

Neuromodulation Device Implant for Heart Failure (Barostim™ Baroreflex Activation Therapy)

The BAROSTIM™ system is the first neuromodulation device system designated to trigger the body’s main cardiovascular reflex to target symptoms of heart failure. The system is indicated for the improvement of symptoms of heart failure in a subset of patients with symptomatic New York Heart Association (NYHA) Class III or Class II heart failure, with a low left ventricular ejection fraction, who also do not benefit from guideline directed pharmacologic therapy or qualify for Cardiac Resynchronization Therapy (CRT).

This system was approved for new technology add-on payments for FY 2021 and FY 2022 and was discontinued in FY 2023.

Request: A request was submitted to reassign the ICD-10-PCS procedure codes describing the BAROSTIM™ system from MS-DRGs 252, 253, and 254 (Other Vascular Procedures with MCC, with CC, and without MCC respectively) to MS-DRGs 275 (Cardiac Defibrillator Implant with Cardiac Catheterization with MCC), MS-DRGs 276 and 277 (Cardiac Defibrillator Implant with MCC and without MCC respectively); or to other more clinically coherent MS-DRGs for implantable device procedures indicated for Class III heart failure patients. ICD-10-PCS codes uniquely identifying the implantation of the BAROSTIM™ system includes:

• 0JH60MZ (Insertion of stimulator generator into chest subcutaneous tissue and fascia, open approach)
• in combination with
• 03HK3MZ (Insertion of stimulator lead into right internal carotid artery, percutaneous approach) or
• 03HL3MZ (Insertion of stimulator lead into left internal carotid artery, percutaneous approach).

CMS Response: While there is no intravascular component when implanting a BAROSTIM™ system, they did agree that ICD, CRT-D, and CCM devices and the BAROSTIM™ system are clinically coherent in that they share an indication of heart failure, a major cause of morbidity and mortality in the United States, and that these cases demonstrate comparable resource utilization. As such, they are proposing to reassign the cases reporting procedure codes describing implantation of a BAROSTIM™ system to MS-DRG 276, even if there is no MCC reported, to better reflect the clinical severity and resource use involved.

They are also proposing to change the title of MS-DRG 276 from “Cardiac Defibrillator Implant with MCC” to “Cardiac Defibrillator Implant with MCC or Carotid Sinus Neurostimulator.”

Compliance Education Updates

March 2024: MLN8659122: MLN Fact Sheet Original Medicare vs. Medicare Advantage Updated

CMS updated the payment rules for patients enrolled in Medicare Advantage Organizations. https://www.cms.gov/files/document/mln8659122-original-medicare-vs-medicare-advantage.pdf

April 2024: MLN Educational Tool Medicare Preventive Services Revised

CMS has revised this tool to clarify social determinants of health information, add a link to the most current and comprehensive list of ICD-10 codes for bone mass measurement and colorectal cancer screening, add coding, coverage, and payment information for COVID-19 vaccine and administration, and replace Hepatis B information with a link to the Hepatitis B screening service. https://www.cms.gov/Medicare/Prevention/PrevntionGenInfo/medicare-preventive-services/MPS-QuickReferenceChart-1.html

Other Updates

March 26, 2024: GAO Improper Payments: Information on Agencies’ Fiscal Year 2023 Estimates

In this report the Government Accountability Office (GAO) indicates the importance of this information due to the fact that “improper payments – those that should not have been made or were made in the incorrect amount – have consistently been a government-wide issue. Since fiscal year 2003, cumulative improper payment estimated by executive branch agencies have totaled about $2.7 trillion. Reducing improper payments is critical to safeguarding federal funds.” With an estimated $51 billion in estimated improper payments HHC’s Medicare (Medicare Fee-for-Service (Parts A and B), Medicare Advantage (Part C), and Medicare Prescription Drug (Part D)) had the highest estimated improper payments across 14 government agencies.

https://www.gao.gov/assets/d24106927.pdf?emci=4185bdfa-36ed-ee11-aaf0-002248223794&emdi=645794fb-40ed-ee11-aaf0-002248223794&ceid=7931774

March 27, 2024: CMS Releases FY 2025 Inpatient Rehabilitation Facility Prospective Payment System Proposed Rule (CMS-1804-P)

CMS is proposing to update payment rates by 2.8 percent. This proposed rule includes annual updates to the prospective payment rates, the outlier threshold, the case-mix-group relative weights and average length of stay values, the wage index, associated impact analysis, and IRF Quality Reporting Program (QRP). Also included are two requests for information (RFIs) (1) Future Measure Concepts for the IRF QRP, and (2) Creating and IRF QRP Star Rating System.

CMS Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/fiscal-year-2025-inpatient-rehabilitation-facility-prospective-payment-system-proposed-rule-cms-1804

CMS Proposed Rule: https://www.cms.gov/medicare/payment/prospective-payment-systems/inpatient-rehabilitation/rules-related-files/cms-1804-p

IRF QRP webpage: https://www.cms.gov/medicare/quality/inpatient-rehabilitation-facility

March 28, 2024: CMS Issues 3 FY 2025 Proposed Rules: SNF, Inpatient Psych and Hospice

FY 2025 Skilled Nursing Facility Prospective Payment System Proposed Rule (CMS 1802-P) CMS Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/fy-25-skilled-nursing-facility-prospective-payment-system-proposed-rule-cms-1802-p

FY 2025 Medicare Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) and Quality Reporting (IPFQR) Updates Proposed Rule (CMS-1806-P) CMS Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/fiscal-year-2025-medicare-inpatient-psychiatric-facilities-prospective-payment-system-ipf-pps-and

• Of note, CMS has proposed to increase the per treatment amount for electroconvulsive therapy (ECT) from the current FY 2024 payment per treatment of $385.58 to $660.30. CMS believes this increase would help ensure that patients who need ECT are more able to access it. (ECT CPT 90870)

Medicare MLN Articles

March 20, 2024: MLN MM11003: Electronic Medical Documentation Requests via the Electronic Submission of Medical Documentation System – Revised

This MLN was first released February 1, 2019. In the March 20, 2024 revision to this article, CMS has added information about the implementation of a new feature to accept review outcome letters during October 2023 release. https://www.cms.gov/outreach-and-education/medicare-learning-network-mln/mlnmattersarticles/downloads/mm11003.pdf

April 4, 2024: MLN MM13577: Ambulatory Surgical Center Payment Update – April 2024

Make sure your billing staff knows about new CPT and HCPCS codes, Device code changes, iDose TR (travoprost intracameral implant) for the treatment of glaucoma, Drug and biological code changes, and Skin code updates. https://www.cms.gov/files/document/mm13577-ambulatory-surgical-center-payment-update-april-2024.pdf

April 15, 2024: MLN MM13574: DMEPOS Fee Schedule: April 2024 Quarterly Update – Revised

This MLN article was revised on April 15^th to show the addition of 4 HCPCS Level II codes to Common Working File category 58. CMS also revised the effective date and the web address of Change Request (CR) 13574). https://www.cms.gov/files/document/mm13574-dmepos-fee-schedule-april-2024-quarterly-update.pdf

April 15, 2024: MLN MM13587: Medicare Claims Processing Manual Update: Inpatient Rehabilitation Facility

CMS advised that you make sure your billing staff know that hospitals may open a new IRF unit at any time during the cost reporting year, and any IRF unit excluded during a cost reporting Year will stay excluded for the rest of the cost reporting year. https://www.cms.gov/files/document/mm13587-medicare-claims-processing-manual-update-inpatient-rehabilitation-facility.pdf

Coverage Updates

April 15, 2024: CMS Releases Fact Sheet for Potential NCD for Preexposure Prophylaxis (PrER) Using Antiretroviral Drugs to Prevent HIV

CMS is sharing this information to encourage pharmacies and other interested parties to prepare for a potential National Coverage Determination (NCD) for PrEP Using Antiretroviral Drugs to Prevent HIV.

• National Coverage Analysis (NCA) Tracking Sheet: https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?NCAId=310
• CMS Fact Sheet: https://www.cms.gov/files/document/fact-sheet-potential-medicare-part-b-coverage-preexposure-prophylaxis-prep-using-antiretroviral.pdf

April 16, 2024: MLN MM13512: National Coverage Determination 20.7: Percutaneous Transluminal Angioplasty

This article provides education about the changes in coverage for PTA of the carotid artery concurrent with stenting effective October 11, 2023:

• Patients don’t have to enroll in a clinical trial.
• Facilities don’t need CMS approval to perform this service.
• You must engage in a formal shared decision-making (SDM) process with the patient. This must include documentation of four key elements outlined in this MLN article.
• MACs can decide if this service is covered if it’s not addressed in this NCD.

Note, your MAC will adjust claims processed in error that you bring to their attention. https://www.cms.gov/files/document/mm13215-national-coverage-determination-207-percutaneous-transluminal-angioplasty.pdf