Knowledge Base Category -

Compliance Education

March 9, 2023: Medicare Part B Inflation Rebate Guidance: Use of the 340B Modifier – Revised

In the March 9^th edition of MLN Connects CMS encouraged readers to learn about the requirement to include a modifier on claims for separately payable Part B drugs and biologicals acquired under the 340B Program. Along with the announcement, CMS provided links to an updated MLN Fact Sheet and Updated FAQs. https://www.cms.gov/outreach-and-education/outreach/ffsprovpartprog/provider-partnership-email-archive/2023-03-09-mlnc

March 27, 2023: The Livanta Claims Review Advisor: Short Stay Review (SSR) – Review Findings from Year One

In Livanta’s March 2023 edition of their Claims Review Advisor newsletter, they report findings from the first year of reviews, noting that Medicare short stay reviews were paused in May 2019 and resumed in October 2021. Of the 18,672 claims reviewed, 2,663 (14%) were admission denials. The first common reason cited by Livanta for denials was insufficient documentation to support a two-midnight expectation at the time of the admission order. You can find past issues of the Livanta Claims Review Advisor as well as the full Review Findings from Year One report on Livanta’s website at https://www.livantaqio.com/en/ClaimReview/Provider/provider_education.html.

COVID-19 Updates

February 27, 2023: CMS PHE Fact Sheet: What Do I Need to Know? Waivers, Flexibilities, and the Transition Forward

CMS published a fact sheet covering COVID-19 vaccines, testing, and treatments; telehealth services; continuing flexibilities for health care professionals; and inpatient hospital care at home when the PHE expires at the end of the day on May 11, 2023. https://www.cms.gov/files/document/what-do-i-need-know-cms-waivers-flexibilities-and-transition-forward-covid-19-public-health.pdf

March 10, 2023: OIG’s COVID-19 PHE Flexibilities End May 11, 2023

The OIG published a notice to describe the flexibilities they had implemented in response to the COVID-19 PHE (i.e., their March 17, 2020 Telehealth Policy Statement), and to remind the health care community said flexibilities will end on May 11, 2023.  https://oig.hhs.gov/coronavirus/covid-flex-expiration.asp

 March 13, 2023: FDA’s Guidance Documents related to COVID-19

The FDA published this notice in the Federal Register “to provide clarity to stakeholders with respect to the guidance documents that will no longer be effective with the expiration of the PHE declaration and the guidance’s that FDA is revising to continue in effect after the expiration of the PHE declaration.” Specifically, there are 72 COVID-19 related guidance documents currently in effect addressed in this notice. Twenty-two will expire at the end of the COVID-19 PHE, another twenty-two will continued for 180 days after the PHE ends, twenty-four will remain in effect with plans to revise (i.e., guidance related to emergency use authorization for vaccines to prevent COVID-19), and the remaining four will also remain in effect. https://www.federalregister.gov/documents/2023/03/13/2023-05094/guidance-documents-related-to-coronavirus-disease-2019-covid-19

March 16, 2023: MLN Connects: Do not Report CR Modifier & DR Condition Code After Public Health Emergency

CMS included the following in the March 13^th edition of MLN Connects: “The end of the COVID-19 public health emergency (PHE) is expected to occur on May 11, 2023. Since the CR modifier and DR condition code should only be reported during a PHE when a formal waiver is in place, plan to discontinue using them for claims with dates of service on or after May 12, 2023.” https://www.cms.gov/outreach-and-education/outreach/ffsprovpartprog/provider-partnership-email-archive/2023-03-16-mlnc#_Toc129789600

Other Updates

February 28, 2023: New Region 2 Recovery Auditor

On February 28^th, Performant posted a general program update alerting providers that on February 7, 2023, CMS approved Performant to begin performing on their new Region 2 contract. Coming soon to their website will be Provider Outreach and education plans. https://performantrac.com/cms-rac/cms-rac-resources/cms-rac-provider-resources/default.aspx

March 9, 2023: MLN Connects: New Inflation Reduction Act Resources

This addition of MLN Connects includes information about the Inflation Reduction Act (IRA), including a recently issues social media toolkit that stakeholders can use to educate people with Medicare about the new insulin benefit and additional vaccines available at no cost and additional resources to provide to your patients that need it. https://www.cms.gov/outreach-and-education/outreach/ffsprovpartprog/provider-partnership-email-archive/2023-03-09-mlnc

Medicare Transmittals & MLN Articles

February 27, 2023: MLN MM12103: Extension of Changes to the Low-Volume Hospital Payment Adjustment & the Medicare Dependent Hospital Program

Affected Providers includes Low-volume hospitals and Medicare-dependent hospitals (MDHs). This article includes information and criteria and payment adjustments for FY 2023 and the extension of the MDH program through September 30, 2023. https://www.cms.gov/files/document/mm13103-extension-changes-low-volume-hospital-payment-adjustment-medicare-dependent-hospital-program.pdf

March 16, 2023: Pub 100-20 One Time Notification: Instructions Relating to the Evaluation of Section 1115 Waiver Days in the Calculation of Disproportionate Share Hospital Reimbursement

The purpose of this Change Request (CR) 12669 is to provide updated direction related to the evaluation of Section 1115 Waiver days in the calculation of Disproportionate Share Hospital (DSH) reimbursement for open cost reports and cost reports currently under administrative appeal. https://www.cms.gov/files/document/r11912otn.pdf

March 16, 2023: MLN MM13143: Ambulatory Surgical Center Payment System: April 2023 Update

Make sure your billing staff know about the new HCPCS codes for drugs and biologicals, corrected 2023 ASC code pair file, and skin substitute product coding updates. This article was revised on March 24, 2023 to remove a code paid from Table 1 and corrected language associated with this code pair. https://www.cms.gov/files/document/mm13143-ambulatory-surgical-center-payment-system-april-2023-update.pdf

March 17, 2023: MLN MM13136: Hospital Outpatient Prospective Payment System: April 2023 Update

This article highlights payment system updates and new codes for COVID-19, drugs, biologicals, radiopharmaceuticals, devices, and other items and services. Of note, once the COVID-19 PHE ends, CMS instructs that they will package payment for COVID-19 treatments into the payment for a comprehensive APC (C-APC) when services are billed on the same outpatient claim, subject to standard exclusions under the C-APC policy. https://www.cms.gov/files/document/mm13136-hospital-outpatient-prospective-payment-system-april-2023-update.pdf

March 17, 2023: MLN MM13153: DMEPOS Fee Schedule: April 2023 Update

The DMEPOS fee schedule is updated on a quarterly basis, when necessary to implement fee schedule amounts for new and existing codes as applicable and apply changes to payment policies. In this update, pay close attention to guidance regarding payment policies as the COVID-19 PHE ends. https://www.cms.gov/files/document/mm13153-dmepos-fee-schedule-april-2023-update.pdf

March 17, 2023: MLN MM13118: Medicare Part B Coverage of Pneumococcal Vaccinations

Effective October 19, 2022, CMS updated the part B requirements to align with the CDC’s Advisory Committee on Immunization Practices (ACIP) recommendations. This MLN article details the updated recommendations. https://www.cms.gov/files/document/mm13118-medicare-part-b-coverage-pneumococcal-vaccinations.pdf

March 20, 2023: MLN MM13094: Supervision Requirements for Diagnostic Tests: Manual Update

This article provides information about the expanded list of provider types authorized to supervise diagnostic tests and updates to the Medicare Benefit Policy Manual. https://www.cms.gov/files/document/mm13094-supervision-requirements-diagnostic-tests-manual-update.pdf

Coverage Updates

March 1, 2023: MLN Matters MM13073: National Coverage Determination: Cochlear Implantation

This article provides information about the expanded coverage for cochlear implantation services that was effective September 26, 2022 and an implementation date of March 24, 2023. https://www.cms.gov/files/document/mm13073-national-coverage-determination-cochlear-implantation.pdf

March 22, 2023: OIG Report: Medicare Improperly Paid Physicians an Estimated $30 Million for Spinal Facet-Joint Interventions

The OIG performed this audit due to prior audits revealing that facet-joint interventions are at risk for overutilization and improper payments for these services. Of the 120 sampled sessions, 66 sessions did not comply with 1 or more of the requirements. Based on audit results, the OIG estimated that Medicare improperly paid physicians $29.6 million.

In calendar year 2023, all 12 MACs updated their Local Coverage Determination (LCD) and Local Coverage Article (LCA) for facet-joint interventions. Updated policies include new guidance not in the prior versions (i.e., updated LCAs state a physician should append modifier KX to a claim line if a diagnostic face-joint injection was administered – to distinguish the injection from a therapeutic facet-joint injection). https://oig.hhs.gov/oas/reports/region9/92203006.pdf

In an August 18, 2022 special edition of MLN connects, CMS sounded the call for providers to begin to prepare hospitals for operations after the COVID-19 Public Health Emergency (PHE) comes to an end.

Some five months later, On January 30, 2023, the Biden administration communicated their intent to end the COVID-19 national emergency and public health emergency (PHE) on May 11, 2023, noting that “This wind-down would align with the Administration’s previous commitments to give at least 60 days’ notice prior to termination of the PHE.”

CMS was quick to follow-up on this announcement and on February 1, 2023, they posted an update to the coronavirus waivers & flexibilities CMS webpage:   

• “Update: On Thursday, December 29, 2022, President Biden signed into law H.R. 2716, the Consolidated Appropriations Act (CAA) for Fiscal Year 2023. This legislation provides more than $1.7 trillion to fund various aspects of the federal government, including an extension of the major telehealth waivers and the Acute Hospital Care at Home (AHCaH) individual waiver that were initiated during the federal public health emergency (PHE).

• Additionally, on January 30, 2023, the Biden Administration announced its intent to end the national emergency and public health emergency declarations on May 11, 2023, related to the COVID-19 pandemic.
• CMS is committed to updating supporting resources and providing updates as soon as possible. Please continue to use the provider-specific fact sheets for information about COVID-19 Public Health Emergency (PHE) waivers and flexibilities.” Note, all provider-specific fact sheets were recently updated on February 1, 2023 and include information about the status of waivers when the PHE ends, for example:  

 

Fact Sheet: Physicians and Other Clinicians: CMS Flexibilities to Fight COVID-19

• Medicare Telehealth: The Consolidated Appropriations Act of 2023 provides for an extension for some of the flexibilities through December 31, 2024. However, when the PHE ends Clinicians must once again have an established relationship with the patient prior to providing remote patient monitoring (RPM).
• Reducing Administrative Burden: “Stark Law” waivers: When the PHE ends, all Stark Law waivers will terminate, and physicians and entities must immediately comply with all provisions of the Stark Law.
• National Coverage Determinations (NCDs) for Percutaneous Left Atrial Appendage Closure, Transcatheter Aortic Valve Replacement, Transcatheter Mitral Valve Replacement and Ventricular Assist Devices: CMS has not enforced the procedural volume requirements contained in these four NCDs for facilities and providers that, prior to the public health emergency for COVID-19, met the volume requirements. This enforcement discretion ensures that beneficiaries continue to have access to the services that are covered under these NCDs. This waiver will end at the conclusion of the PHE. 

 

Fact Sheet: Hospitals and CAHs (including Swing Beds, DPUs), ASCs and CMHCs: CMS Flexibilities to Fight COVID-19

• Enhanced Medicare Payments for New COVID-19 Treatments: Hospital Inpatient Stays: Immediately following the end of the PHE, effective for discharges occurring on or after November 2, 2020, and through the end of the FY in which the COVID-19 PHE ends, the Medicare program has provided an enhanced payment for eligible inpatient cases that involve use of certain new products authorized or approved to treat COVID-19 (86 FR 45162). The enhanced payment is equal to the lesser of 1) 65% of the operating outlier threshold for the claim; or 2) 65% of the costs of the case beyond the operating Medicare payment (including the 20% add-on payment under section 3710 of the CARES Act) for eligible cases.
• Separate Medicare Payment for New COVID-19 Treatments: Hospital Outpatient Departments: CMS has excluded FDA-authorized or approved drugs and biologicals (including blood products) authorized or approved to treat COVID-19 (and for which the FDA authorization or approval does not limit use to the inpatient setting) from being packaged into the Comprehensive Ambulatory Payment Classification (C-APC) payment when these treatments are billed on the same claim as a primary C-APC service. Instead, Medicare has been paying for these drugs and biologicals separately for the duration of the PHE. After the PHE, payment for these treatments will be packaged into the payment for a C-APC when these services are billed on the same outpatient claim.
• Utilization Review: CMS has been waiving the entire Utilization Review Conditions of Participation (CoP) at §482.30 as “removing these administrative requirements allows hospitals to focus more resources on providing direct patient care.” This waiver will end at the conclusion of the PHE.

 

I have provided only a select few examples of what will happen when the PHE ends and encourage you to check for updates to the provider-specific fact sheets often as you develop a plan for your hospital beyond the end of the COVID-19 PHE.

 

Resources

• August 18, 2022 MLN Connects: https://www.cms.gov/outreach-and-educationoutreachffsprovpartprogprovider-partnership-email-archive/2022-08-18-mlnc-se
• January 30, 2023 Office of Management and Budget Statement of Administration Policy: https://www.whitehouse.gov/wp-content/uploads/2023/01/SAP-H.R.-382-H.J.-Res.-7.pdf
•  CMS Coronavirus waivers & flexibilities webpage: https://www.cms.gov/coronavirus-waivers 

Medicare Transmittals & MLN Articles

Travel Allowance Fees for Specimen Collections: 2023 Updates

• MLN Release Date: January 9, 2023
• What You Need to Know: Make sure your billing staff knows about the specimen collection fees and travel allowances for 2023.
• MLN MM13071: (link)

Revised Transmittals & MLN Articles

National Coverage Determination 110.24: Chimeric Antigen Receptor T-cell Therapy

• MLN Release Date: December 1, 2022 – Revised January 5, 2023
• What You Need to Know: This article was revised to clarify that providers should not bill more than 1 unit per HCPCS code.
• MLN MM12928: (link)

Home Health Prospective Payment System: CY 2023 Update

• MLN Release Date: November 10, 2022 – Revised January 5, 2023
• What You Need to Know: This article was revised to show that the rural add-on is extended through CY 2023 as part of the Consolidated Appropriations Act of 2023.
• MLN MM12957: (link)

Coverage Updates

Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting

In June 2022, the Multispecialty Carotid Alliance (MSCA) submitted a formal request for reconsideration of the National Coverage Determination (NCD) 20.7: PTA that provides coverage for carotid artery stenting (CAS). In their letter they indicated evidence supports the following changes to the NCD:

1. Expand patient selection criteria to reflect the established data from research:
1. Revise the patient selection criteria for PTA and CAS with embolic protection to cover the following:
1. Patients who have asymptomatic carotid artery stenosis ≥ 70%, and
2. Patients who have symptomatic carotid artery stenosis ≥ 50%.
2. Eliminate the requirement that patients be at high risk for CEA:
2. Eliminate the minimum standards for facility requirements; and
3. Leave coverage for any CAS procedures not described by the NCD to the discretion of the local Medicare Administrative Contractors (MACs).

On January 12, 2023, CMS accepted the formal request, initiated a National Coverage Analysis (link) and are accepting public comments from January 12, 2023 through February 11, 2023. The expected due date for a proposed decision memo is July 12, 2023.

Compliance Education Updates

MLN Fact Sheet: Rural Emergency Hospitals

In October 2022, CMS published a Rural Emergency Hospitals (REHs) MLN Fact Sheet (link). Starting January 1, 2023, Medicare will pay for Medicare-enrolled REHs to deliver emergency hospital, observation, and other services to Medicare patients on an outpatient basis.

COVID-19 Updates

January 11, 2023: Public Health Emergency Declaration Renewed

As expected, on January 11, 2023, the Public Health Emergency (PHE) renewed for the twelfth time. PHE declarations last for the duration of the emergency of 90 days and may be extended by the Secretary. Ninety days from January 11th will be April 11, 2023. Specific to the COVID-19 PHE, HHS has indicated that they will provide a 60-day notice prior to termination of the COVID-19 PHE (March 12, 2023). It is unclear if the PHE will last beyond April 2023.

Other Updates

New ICD-10 Diagnosis and Procedure Codes Effective April 1, 2023

As a reminder, there are 34 new procedure codes and 42 new diagnosis codes that will be effective April 1, 2023. In their announcement listing the new diagnosis codes they note that “In an effort to better enable the collection of health-related social needs (HRSNs), defined as individual-level, adverse social conditions that negatively impact a person’s health or healthcare, are significant risk factors associated with worse health outcomes as well as increased healthcare utilization, the Centers for Disease Control and Prevention’s (CDC) National Center for Health Statistics (NCHS) is implementing 42 new diagnosis codes into the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM), for reporting effective April 1, 2023.”

Compliance Education Updates

Biosimilars & Interchangeable Products: Free Continuing Education Courses from FDA

CMS reminded providers in the December 8, 2022 edition of MLN Connects (link) that the FDA has free accredited continuing education courses for health care providers on biosimilars and interchangeable products.

Other Updates

December 2, 2022: Letter to U.S. Governors from HHS Secretary Xavier Becerra on COVID-19, Flu, and RSV Resources

HHS Secretary Xavier Becerra noted in a letter to U.S. Governors (link) that “I write today to reinforce that the Biden-Harris Administration stands ready to continue assisting you with resources, supplies, and personnel, as it has throughout our fight against COVID-19.”

December 6, 2022: CMS Proposed Rule to Expand Access to Health Information and Improve the Prior Authorization Process

CMS provided the following information in the December 8, 2022 MLN Connects Newsletter (link):

As part of the Biden-Harris Administration’s ongoing commitment to increasing health data exchange and investing in interoperability, CMS issued a proposed rule that would improve patient and provider access to health information and streamline processes related to prior authorization for medical items and services. CMS proposes to modernize the health care system by requiring certain payers to implement an electronic prior authorization process, shorten the time frames for certain payers to respond to prior authorization requests, and establish policies to make the prior authorization process more efficient and transparent. The rule also proposes to require certain payers to implement standards that would enable data exchange from one payer to another payer when a patient changes payers or has concurrent coverage, which is expected to help ensure that complete patient records would be available throughout patient transitions between payers.

Medicare National Correct Coding Initiative: Annual Policy Manual Update for 2023

On December 1st, CMS posted the updated Medicare National Correct Coding Initiative Policy Manual effective January 1, 2023. Additions and revisions to the manual are noted in red font.

National Correct Coding Initiative: January Update

You can find the National Correct Coding Initiative (NCCI) fourth quarter edit files, effective January 1, 2023, on these Medicare NCCI webpages:

• Procedure-to-Procedure Edits
• Medically Unlikely Edits
• Add-on Code Edits

December 14, 2022: Guidelines for Achieving a Compliant Query Practice (2022 Update)

In December, the final version of the 2022 update to the Guidelines for Achieving a Compliant Query Practice was released. This document is a joint effort of the Association of Clinical Documentation Integrity Specialists (ACDIS) and the American Health Information Management Association (AHIMA). This document supersedes all previous versions of this document. As noted in this practice brief, it “should be used to guide organizational policy and process development for a compliant query practice.” You can read more about this document in a related AHIMA press release (link).

December 15, 2022: OIG’s Top Unimplemented Recommendations 2022 Report

The OIG announced the publication of their 2022 Top Unimplemented Recommendations: Solutions to Reduce Fraud, Waste, and Abuse in the HHS Programs report (link). Specific to Medicare Parts A and B and in keeping with the 2020 and 2021 reports, unimplemented recommendation for inpatient rehabilitation facilities (IRFs) and a call for CMS to seek legislative authority to comprehensively reform the hospital wage index system remains on the list. The third unimplemented recommendation was also in the 2021 report and calls for CMS to recover overpayment of $1 billion resulting from incorrectly assigning severe malnutrition diagnosis codes to inpatient hospital claims.

December 21, 2022 Joint Commission Announces Major Standard Reductions and Freezes Hospital Accreditation Fees

On Wednesday, December 21st, the Joint Commission announced (link) the elimination of 168 standards (14%), the revision of 14 other standards and that they would not be “raising its accreditation fees for domestic hospitals in 2023 in recognition of the many financially challenges hospitals and health systems continue to face.”

December 23, 2022: First Generic Drug Approvals

The FDA has published a list of First-Time Generic Drug Approvals in 2022 (link). They note that first generics “are just what they sound like – the first approval by FDA which permits a manufacturer to market a generic drug product in the United States.”

PAMA Regulations Update

On December 30, 2022, CMS updated their PAMA (Protecting Access to Medicare Act of 2014) CMS webpage (link) with the following information:

DELAY!!! IMPORTANT UPDATE: The next data reporting period is January 1, 2024 through March 31, 2024, will be based on the original data collection period of January 1, 2019 through June 30, 2019.

On December 29, 2022, Section 4114 of Consolidated Appropriations Act, 2023 revised the next data reporting period for CDLTs that are not ADLTs and the phase-in of payment reductions under the Medicare private payor rate-based CLFS. The next data reporting period of January 1, 2024 through March 31, 2024 will be based on the original data collection period of January 1, 2019 through June 30, 2019. After the next data reporting period, there is a three-year data reporting cycle for CDLTs that are not ADLTs (that is 2027, 2030, etc.).

Medicare Transmittals & MLN Articles

Inpatient & Long-Term Care Hospital Prospective Payment System: FY 2023 Changes

• MLN Release Date: December 1, 2022
• What You Need to Know: This article highlights FY 2023 updates. For example, providers are reminded that CMS is not adjusting payments for any hospital in the Hospital Value Based Purchasing program or the Hospital Acquired Condition Reduction Program for FY 2023.
• MLN MM12814: (link)

DMEPOS Fee Schedule: CY 2023 Update

• MLN Release Date: December 2, 2022
• What You Need to Know: This article provides information for your billing staff about the annual update to fee schedule amounts for new and existing codes and payment policy changes.
• MLN MM13006: (link)

Clinical Laboratory Fee Schedule: CY 2023 Annual Update

• MLN Release Date: December 9, 2022
• What You Need to Know: This article provides information for your billing staff about instructions for the CY 2023 Clinical Laboratory Fee Schedule (CLFS), mapping for new codes, and updates for laboratory costs subject to the reasonable charge payment.
• MLN MM13023: (link)

HCPCS Codes & Clinical Laboratory Improvement Amendments (CLIA) Edits: April 2023

• MLN Release Date: December 9, 2022
• What You Need to Know: This article provides information for your billing staff about new HCPCS and discontinued HCPCS codes and required CLIA certificates.
• MLN MM13024: (link)

Laboratory Edit Software Changes: April 2023

• MLN Release Date: December 12, 2022
• What You Need to Know: NCDs with April 2023 updates includes 190.18 – Serum Iron Studies, 190.22 – Thyroid Testing, 190.23A – Lipids Testing, and 190.23B – Lipids Testing.
• MLN MM13026: (link)

Hospital Outpatient Prospective Payment System: January 2023 Update

• MLN Release Date: December 14, 2022
• What You Need to Know: CMS advises providers to make sure their billing staff knows about payment system updates and new codes for COVID-19, drugs, biologicals, radiopharmaceuticals, devices and other items and services.
• MLN MM13031: (link)

New Medicare Part B Immunosuppressant Drug Benefit

• MLN Release Date: December 16, 2022
• What You Need to Know: Your billing staff needs to know about the extension of Medicare coverage for immunosuppressant drugs beyond 36 months for certain patients with kidney transplants and coverage of premiums and cost sharing for these patients. This is a new benefit that was included in the Consolidated Appropriations Act (CAA) and is effective January 1, 2023.
• MLN MM12804: (link)

Ambulatory Surgical Center Payment System: January 2023 Update

• MLN Release Date: December 22, 2022
• What You Need to Know: CMS advises providers to make sure your billing staff knows about new HCPCS C-codes on the ASC Covered Procedure List (CPL), new HCPCS codes for drugs and biologics, and the skin substitute product assignments to high and low-cost groups.
• MLN MM13041: (link)

Revised Transmittals & MLN Articles

Extension of Changes to the Low-Volume Hospital Payment Adjustment and the Medicare Dependent Hospital Program

• MLN Release Date: October 21, 2022 – Revised December 9, 2022
• What You Need to Know: This article was revised due to a revised Change Request (CR) 12970. CMS will give your MAC 60 days to reprocess claims affected by the CR.
• MLN MM12970: (link)

Coverage Updates

National Coverage Determination 110.24: Chimeric Antigen Receptor T-cell Therapy

• MLN Release Date: December 1, 2022
• What You Need to Know: CMS advises providers to make sure your billing staff know about the following changes to CAR-T billing:
• Include additional place of services (POS) codes for office and independent clinics,
• Bill in 0.1-unit fractions, and
• Use 3 modifiers, including the new modifier -LU.
• MLN MM12928: (link)

National Coverage Determination 200.3: Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease

• MLN Release Date: December 8, 2022
• What You Need to Know: This article provides information about FDA-approved monoclonal antibodies and CMS-approved studies that your billing staff needs to know.
• MLN MM12950: (link)

COVID-19 Updates

COVID-19 PHE Extended

The Secretary of Health and Human Services, Xavier Becerra, renewed the COVID-19 public health emergency on October 13th (link). As a reminder, PHE declarations last for the duration of the emergency or 90 days and may be extended by the Secretary. Ninety days from October 13th will be January 11th, 2023. Specific to the COVID-19 PHE, HHS has indicated that they will provide a 60-day notice prior to the termination of the COVID-19 PHE. The sixty days prior to January 11, 2023 came and went without notice from the Secretary so it appears the COVID-19 PHE will last at least to April 2023.

HHS Releases Long COVID Report

In a November 21, 2022 press release (link), the U.S. Department of Health and Human Services (HHS) announced the release of a new report highlighting patients’ experience of Long COVID. “Long COVID is a set of conditions. Researchers have cataloged more than 50 conditions linked to Long COVID that impact nearly every organ system. Estimates vary, but research suggests that between 5 percent and 30 percent of those who had COVID-19 may have Long COVID symptoms, and roughly one million people are out of the workforce at any given time due to Long COVID. This figure equates to approximately $50 billion annually in lost salaries.”

Other Updates

October 27, 2022: OIG Report – CMS Can Use OIG Audit Reports to Improve Its Oversight of Hospital Compliance

In this Report (link), the OIG notes that they performed this audit to determine CMS’s actions taken regarding 12 Hospital Compliance Audits during calendar years (CYs) 2016 through 2018. Collectively, the OIG reviewed 1,290 claims from the 12 hospitals. The most common error types identified by the OIG were incorrectly billed Inpatient Rehabilitation Facility (IRF) services and incorrectly billed HCPCS codes.

The OIG determined that, after considering results of first and second level appeals, the 12 hospitals received overpayments totaling $82 million. While the OIG found that CMS had taken some recommended actions based on these audits, they noted that CMS provided insufficient information to be able to identify if actions had been taken to ensure the hospitals had repaid funds or followed the 60-day rule.

The categories of claims at high risk for noncompliance with Medicare requirements, for this report, included the following “risk areas” that were the focus of the 12 hospital compliance audits:

• Inpatient rehabilitation facility claims,
• Inpatient claims billed with high CERT DRG codes,
• Inpatient claims billed with high-severity level DRG codes,
• Inpatient claims paid in excess of billed charges,
• Inpatient claims billed with adverse events, inpatient claims billed with elective procedures,
• Inpatient claims billed with mechanical ventilation,
• Inpatient claims covering same day discharge and readmission,
• Inpatient psychiatric facility claims,
• Inpatient claims paid in excess of $150,000,
• Inpatient claims paid in excess of $25,000,
• Outpatient claims paid in excess of charges,
• Outpatient claims billed with right heart catheterizations HCPCS codes,
• Outpatient surgery claims billed with units greater than one,
• Outpatient claims billed with bypass modifiers,
• Outpatient skilled nursing facility (SNF) consolidated billing claims, and
• Outpatient claims paid in excess of $25,000.

The OIG notes that “if CMS used our provider-specific audit reports, it could improve Medicare program oversight by focusing on services at high risk for improper payment. In addition, CMS’s actions could lead to improvements in hospital specific internal controls.”

October 28, 2022: Implementing Certain Provisions of the Consolidated Appropriations Act (CAA), 2021 and other Revisions to Medicare Enrollment and Eligibility Rules (CMS-4199-F)

Currently, for those approaching sixty-five, the date when your coverage becomes effective depends on when you enroll. As noted in a CMS Fact Sheet related to this final rule (link):

• “If an individual enrolls during any of the first three months of their Initial Enrollment Period (IEP), their coverage will start the first month of eligibility (e.g., age 65).
• If an individual enrolls during their IEP in the month they become eligible, their coverage will start the month after they enroll.
• If an individual enrolls during any of the last three months of their IEP, their coverage will start 2-3 months after they enroll.
• If an individual enrolls during the General Enrollment Period (GEP), which runs from January 1st through March 31st every year, their coverage will start

As mandated in the CAA and finalized in this rule, beginning January 1, 2023, Medicare coverage will become effective the month after enrollment for individuals enrolling in the last three months of their IEP or in the GEP, reducing any potential gaps in coverage.

October 31, 2022: CY 2023 Home Health Prospective Payment System rate Update and Home Infusion Therapy Services Requirements – Final Rule (CMS-1766-F)

In a Fact Sheet (link), CMS estimates that Medicare payments to Home Health Agencies (HHAs) in CY 2023 will increase $125 million compared to CY 2022.

October 31, 2022: CY 2023 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) Final Rule (CMS-1768-F)

CMS projects that payment updates for CY 2023 will increase the total payments to all ESRD facilities by 3.1% compared to CY 2022. You can read about this Final Rule in the CMS Fact Sheet announcing the release of the final rule (link).

Medicare Transmittals & MLN Articles

Telehealth Home Health Services: New G-Codes

• MLN Release Date: November 2, 2022
• What You Need to Know: Starting on or after January 1, 2023, Home Health (HH) providers may voluntarily report the use of telecommunications technology in providing HH services on HH payment claims. Starting July 1, 2023, providers will be required to report this information. This MLN article details the three G-codes that will need to be used when submitting the use of telecommunication technology on the HH claim.
• MLN MM12805: link)

Billing for Hospital Part B Inpatient Services

• Transmittal Issue Date: November 9, 2022.
• What You Need to Know: The purpose of this Change Request (CR) 12965 is to provide billing instructions for hospital Part B inpatient services. For example, effective 7/1/2022 three new “Not Allowed Revenue Codes” were added to the list of codes a Medicare Administrative Contractor will set a revenue code edit to prevent payment on Type of Bill 012X. The implementation date for the updates is December 12, 2022.
• CR 12965: link)

ESRD & Acute Kidney Injury Dialysis: CY 2023 Updates

• MLN Release Date: November 10, 2022
• What You Need to Know: This article details information about rates and policies for the ESRD Prospective Payment System and payment for renal dialysis services provided to patients with acute kidney injury in ESRD facilities.
• MLN MM12978: link)

Home Health Prospective Payment System: CY 2023 Updates

• MLN Release Date: November 10, 2022
• What You Need to Know: This article highlights changes related to 30-day period payment rates, national per-visit amounts, and cost-per-unit payment amounts used for calculating outlier payments under the Home Health Prospective Payment System. These changes will be effective January 1, 2023.
• MLN MM12957: link)

Medicare Physician Fee Schedule Final Rule Summary: CY 2023

• MLN Release Date: November 17, 2022
• What You Need to Know: This article details updates effective January 1, 2023 to the telehealth originating site facility fee payment amount, expansion of coverage for colorectal cancer screening, coverage of audiology services, and other covered services.
• MLN MM12982: link)

New Waived Tests

• MLN Release Date: November 23, 2022
• What You Need to Know: This article highlights seven newly added waived complexity tests that must have the modifier QW to be recognized as a waived test.
• MLN MM12996: link)

Revised Medicare MLN Articles & Transmittals

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

• MLN Release Date: September 6, 2022 – Revised November 10, 2022
• What You Need to Know: This article was revised due to a revised Change Request (CR) 12888. No substantive changes were made to the article.
• MLN MM12888: link)

Coverage Updates

ICD-10 & Other Coding Revisions to National Coverage Determinations: April 2023 Update

• MLN Release Date: November 9, 2022
• What You Need to Know: This MLN is related to CR 12960 which is a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. Relevant NCD coding changes in CR 12960 include:
• NCD 20.4 (Implantable Automatic Defibrillators ICDs): ICD-10 diagnosis code I47.2 end effective date was September 30, 2022. New codes effective on or after October 1, 2022 includes I47.20, I47.21, and I47.29.
• NCD 210.10 (Screening for STIs): CPT 0353U is a new code for this NCD with an effective date October 1, 2022.

CMS notes that MACs will adjust any claims processed in error associated with CR 12960 that you bring to their attention.

• MLN MM12960: link)

Compliance Education Updates

Medicare Provider Compliance Tips – Revised

CMS noted in the Thursday, November 3, 2022 edition of MLN Connects (link) that the educational tool Medicare Provider Compliance Tips has been updated with the latest improper payment rates, denial reasons, and codes. Additional information and new tips have been added to several of the topics included in this tool (i.e., new tips for cataract removal, lipid panels and psychiatry).

Federally Qualified Health Center — Revised
Excerpt from 11/23 MLN Matters newsletter:

This MLN booklet (link)">link) was reviewed in October 2022 and includes the following changes:

• Payment for hospice attending physician services by specific providers
• Mental health services using telecommunications
• Concurrent billing for chronic care management and transitional care management services
• Changes to care management services codes
• CMS also added information on COVID-19 shot and monoclonal antibody therapy administration.

Did You Know?

On September 28, 2022, the United States District Court for the District of Columbia vacated (link) the previously applied differential payment rates for 340B-acquired drugs in the Calendar Year (CY) 2022 Outpatient Prospective Payment System (OPPS) final rule.

Why it Matters?

As a result of this of this ruling, CMS will revert to paying the default rate (generally ASP plus 6%) under the Medicare status for 340B-acquired drugs.

CMS noted in the Thursday, October 13, 2022 edition of MLN Connects (link) that “CMS is uploading revised OPP drug files that will apply the default rate (generally ASP plus 6%) to 340B-acquired drugs for the rest of the year. CMS also will reprocess claims our contractors paid on or after September 28, 2022, using the default rate.”

What Can You Do?

To receive payments for claims prior to September 28, 2022, providers will need to submit adjustment claims to recalculate their payments. Medicare Administrative Contractors (MACs) nationwide have posted information about this issue on their websites. For example, Noridian JF, the MAC for Alaska, Arizona, Idaho, Montana, North Dakota, Oregon, South Dakota, Utah, Washington and Wyoming has posted the following information in their October 27, 2022 daily email (link):

Provider/Supplier Action Required:

“Although MACs shall not reprocess 2022 date of service claims prior to 09/28/22 as contractor-initiated adjustments, MACs shall process provider-submitted adjustments to 2022 date of service claims that were paid prior to September 28, 2022. The adjustments can be submitted using type of bill (TOB) XX7 with condition code D9 and remarks indicating “340B adjustment”.