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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)

COVID-19 Updates

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

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

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

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

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

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

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

Other Updates

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

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

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

Monkeypox & Smallpox Vaccines: New Product Codes

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

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

Code 90611 for smallpox and monkeypox vaccine product:

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

Code 90622 for vaccinia (smallpox) virus vaccine product:

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

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

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

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

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

Code 90611 for smallpox and monkeypox vaccine product:

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

Code 90622 for vaccinia (smallpox) virus vaccine product:

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

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

Medicare MLN Articles & Transmittals

Inpatient Psychiatric facilities Prospective Payment System (IPF PPS) Updates for Fiscal Year (FY) 2023

• MLN Release Date: August 4, 2022
• What You Need to Know: This MLN article provides Key Changes for FY 2023 related to market basket update, wage index update, IPF quality reporting programs, PRICER updates, provider specific file update, ICD-10-CM/PCS updates, COLA adjustment, and rural adjustment.
• MLN MM12859: link)

Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) – October 2022 Update

• Transmittal 11544 Release Date: August 4, 2022
• What You Need to Know: This Change Request (CR) was issued to amend the 2022 MPFS Final Rule payment files. Changes includes new HCPCS and CPT codes, codes that are no longer valid and changes to a short descriptor.
• Transmittal 11544/Change Request 12869: link)

New Waived Tests

• MLN Release Date: August 4, 2022
• What You Need to Know: information about CLIA requirements, new CLIA waived tests approved by the FDA and the use of modifier QW for CLIA-waived tests can be found in this MLN article.
• MLN MM12841: link)

Inpatient Rehabilitation Facility (IRF) Annual Update: Prospective Payment System (PPS) Pricer Changes FY 2023

• MLN Release Date: August 5, 2022
• What You Need to Know: CMS advises you to make sure your billing staff knows about changes to the Fiscal Year (FY) 2023 payment rates and wage index cap.
• MLN MM12807: link)

International Classifications of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs) – January 2023 Update

• MLN Release Date: August 15, 2022
• What You Need to Know: Your staff needs to be aware of newly available codes added to NCDs, separate NCD coding revisions and coding feedback.
• MLN MM12822: link)

International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs)-January 2023 Update – 2 of 2

• MLN Release Date: August 15, 2022
• What You Need to Know: This is the second of two MLN matters articles detailing January 2023 updates to NCDs.
• MLN MM12842: link)

Significant Updates to Internet Only Manual (IOM) Publication (Pub.) 100-05 Medicare Secondary Payer (MSP) Manual, Chapter 5

• MLN Release Date: August 15, 2022
• What You Need to Know: This article highlights key updates of importance for providers, for example, “Medicare is the secondary payer throughout the entire 30-month ESRD coordination period when a patient is eligible for, or entitled to, Medicare on the basis of ESRD. (See section 30.3.1.).”
• MLN MM12765: link)

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

• MLN Release Date: August 15, 2022
• What You Need to Know: You will find information about updated to Advanced Diagnostic Laboratory Tests (ADLTs), the next CLFS data reporting period, and new codes added to the National HCPCS file in this MLN article.
• MLN MM12870: link)

Medicare MLN Articles & Transmittals

Change to the Laboratory National Coverage Determination (NCD) Edit Software for October 2022

• MLN Release Date: June 24, 2022
• What You Need to Know: CMS advises you to make sure your billing staff know about changes to the Laboratory NCD Edit Module for October 2022 and how to access the NCD spreadsheet that lists relevant changes.
• MLN MM12803: (link)

One-Time Notification: New Edit for PPS Outpatient and Inpatient Bill Types Receiving Outlier Payment When Device Credit is Reported

• Transmittal Release Date: July 7, 2022
• What You Need to Know: A new edit is being implemented to provide MACs with a way to review the charges and device reduction amount submitted on claims for fully or partially credited devices. Effective January 1, 2023, CMS will suspend outpatient and inpatient prospective payment claims getting an outlier payment when a device credit is reported. This will allow the MACs to review the charges and device reduction amounts for fully and partially credited devices.
• Transmittal 11488 (Change Request 12769): (link)

Coverage Updates

July 6, 2022: Cochlear Implantation Proposed Decision Memo (CAG-00107R)

CMS released a Proposed Decision Memo regarding the National Coverage Determination for Cochlear Implantation (50.3) (link). Among other things, CMS is proposing to expand coverage by broadening the patient criteria and removing the requirement that for individuals with hearing test scores of > 40 % and ≤ 60 %. The public comment period ends August 5, 2022.

July 8, 2022: Home Use of Oxygen Final Decision Memo

Per the Final Decision Memo (link), “Effective July 8, 2022, the MAC may determine reasonable and necessary coverage of oxygen therapy and oxygen equipment in the home for patients who are not described in section B or precluded by section C of this NCD. Initial coverage for patients with other conditions may be limited to the shorter of 90 days or the number of days included in the practitioner prescription at MAC discretion. Oxygen coverage may be renewed if deemed medically necessary by the MAC.”

Compliance Updates

Implanted Spinal Neurostimulators: Document Medical Records

In a recent report, the OIG found that Medicare improperly paid claims for implanted spinal neurostimulators when providers did not provide sufficient documentation supporting medical necessity. You will find a link to the OIG report and helpful resources in the Thursday July 21, 2022, edition of their MLN Connects e-newsletter ( https://www.cms.gov/outreach-and-educationoutreachffsprovpartprogprovider-partnership-email-archive/2022-07-21-mlnc">link).

COVID-19 Updates

Coding Long COVID

CMS offered the following advice regarding coding Long COVID in the Thursday July 7, 2022, edition of MLN Connects (link):

• For a post COVID-19 condition, unspecified, like Long COVID, use code DX U09.9. Add other codes for conditions related to the COVID-19 infection, like R50.9 for fever.
• For a current COVID-19 infection, use code DX U07.1. Do not use code DX U09.9.
• For a current COVID-19 infection and conditions from a previous COVID-19 infection, use code U09.9 with code DX U07.1. Add other codes for conditions related to the COVID-19 infection, like R06.02 for shortness of breath.
• For more information, see pages 30-31 of ICD-10-CM Official Guidelines for Coding and Reporting: Fiscal Year 2022 (PDF).

July 13, 2022: CDC Releases Resistant Infections Special Report

The CDC released a report (link) detailing the negative effect of the COVID-19 pandemic on recent years of progress in the United States combating antimicrobial resistance (AR). In a related announcement, the CDC noted the report “concludes that the threat of antimicrobial-resistant infections is not only still present but has gotten worse – with resistant hospital-onset infections and deaths both increasing at least 15% during the first year of the pandemic.”

July 15, 2022: COVID-19 Public Health Emergency Renewed

CMS waited until late Friday, July 15th to post an extension of the COVID-19 public health emergency (PHE) (link). This extends the PHE for ninety days.

Other Updates

July 7, 2022: Special Edition MLN Connects – Physician Fee Schedule Proposed Rule release

CCMS announced the release of the CY 2023 Physician Fee Schedule Proposed Rule in a special edition of their MLN Connects e-newsletter (link). You will find links to related fact sheets and the proposed rule in the newsletter. Comments are due to CMS by September 7, 2022.

July 7, 2022: Appropriate Use Criteria (AUC) Penalty Phase Delayed Again

CMS as posted the following notice on the AUC Program webpage (link), “The payment penalty phase will not begin January 1, 2023 even if the PHE for COVID-19 ends in 2022. Until further notice, the educational and operations testing period will continue. CMS is unable to forecast when the payment penalty phase will begin.”

July 16, 2022: New Nationwide 988 Crisis Hotline

HHS announced in a July 15th Press Release (link), the transition from the 10-digit National Suicide Prevention Lifeline to 988 “an easy-to-remember three-digit number for 24/7 crisis care…The 988 Suicide & Crisis Lifeline is a network of more than 200 state and local call centers supported by HHS through the Substance Abuse and Mental Health Services Administration (SAMHSA).”

June 2022 Medicare Transmittals and Proposed Rules

International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs)—July 2022

• Article Release Date: May 9, 2022 – Revised June 21, 2022
• What You Need to Know: This article details information about newly available codes, separate NCD coding revisions and coding feedback. It was updated on June 21, 2022, to reflect a revised Change Request (CR) 12705. The substance of the article did not change. NCDs updated includes:
• NCD 20.31 Intensive Cardiac Rehabilitation (ICR) Programs,
• NCD 20.31.1 Pritikin Program,
• NCD 20.31.2 Ornish Program for Reversing Heart Disease,
• NCD 20.31.3 ICR Benson-Henry Program,
• NCS 90.2 Next Generation Sequencing (NGS),
• NCD 160.18 Vagus Nerve Stimulation (VNS),
• NCD 180.1 Medical Nutrition Therapy (MNT), and
• NCD 270.3 Blood Derived Products for Chronic Non-healing Wounds
• MLN MM12705: (link)

International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs)—July 2021 Update

• Article Release Date: May 18, 2021 – 2nd Revision June 22, 2022
• What You Need to Know: This MLN was revised to reflect CR 12124 which changed the business requirements for NCD 90.2, Next Generation Sequencing. This change resulted in a new spreadsheet for this NCD by retaining all ICD-10 Not Otherwise Classified (NOC) diagnosis codes that had been proposed for deletion effective July 1, 2022. CMS advised that “Although we’re not moving forward with deleting the aforementioned ICD-10 NOC diagnosis codes from NCD 90.2, we continue to strongly encourage providers and laboratories to make sure they provide the best possible and most specific code on the claim in accordance with the implementation of ICD-10 in 2015. We’ll be monitoring these laboratory claims and may take future action to reinstate removal of these ICD-10 NOC codes.”
• MLN MM12124: (link)

July 2022 Update of the Ambulatory Surgical Center (ASC) Payment System

• Article Release Date: June 9, 2022 – Revised June 24, 2022
• What You Need to Know: This article was revised to remove two HCPCS codes from table 3 of the Change Request 12773 reducing the number of new codes from 16 to 14.
• MLN MM12773: ((link)

Medicare Proposed Rules

On Tuesday, June 21, 2022, CMS published a Special Edition MLN Connects ((link) spotlighting the release of two Calendar Year (CY) 2023 proposed rules:

• CY 2023 Home Health Prospective Payment System Rule Update and Home Infusion Therapy Services Requirements Proposed Rule (CMS-176-P), and
• ESRD Facilities: CY 2023 Proposed Rule.

The MLN connects includes links to Fact Sheets highlighting key provisions in each proposed rule. CMS is accepting comments through August 16, 2022, for the Home Health Proposed Rule and August 22, 2022, for the ESRD Facilities proposed rule.

Medicare MLN Articles & Transmittals

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

• MLN Release Date: May 31, 2022
• What You Need to Know: This article includes information about new COVID-19 CPT vaccine and administration codes. You will also find details about new CPT proprietary laboratory analyses (PLA) coding changes and new CPT Category III codes effective July 1, 2022.
• MLN MM127961: (link)

Update to 'J' Drug Code List for Billing Home Infusion Therapy (HIT) Services

• MLN Release Date: May 31, 2022
• What You Need to Know: This article provides information about a new HCPCS drug code for payment beginning July 1, 2022, and updates to the list of home infusion drugs.
• MLN MM12667: (link)

July 2022 Update of the Ambulatory Surgical Center (ASC) Payment System

• MLN Release Date: June 9, 2022
• What You Need to Know: Effective July 1, 2022, there is a new CPT Category III Code, newly established HCPCS codes for drugs, biologicals and radiopharmaceuticals and new skin substitute products and low-cost/high-cost group assignment.
• MLN MM12773: (link)

Revised Medicare MLN Articles & Transmittals

July 2022 Updates to the Hospital Outpatient Prospective Payment System (OPPS)

• Article Release Date: May 31, 2022 – Revised June 16, 2022
• What You Need to Know: This article was revised due to CMS rescinding Transmittal 11435 and replacing it with Transmittal 11457 to correct Table 1 in the attachment A, because it was missing some codes.
• MLN MM12761: (link)

Coverage Updates

Surgical Dressings: Medicare Requirements

Excerpt from May 26, 2022 edition of MLN Connects ((link)

“Medicare covers primary or secondary surgical dressings:

• When used to protect or treat a wound
• If needed after you debride a wound
You must:
• Include clinical information in patients’ medical records that demonstrates a reasonable and necessary need for the type and quantity of surgical dressings
• Evaluate the wound monthly and update the record, unless you document why you can't do a monthly evaluation and how you're monitoring the patient's ongoing use of dressings
For more information, see the Surgical Dressings – Policy Article.”

Beta Amyloid Positron Emission Tomography (PET) in Dementia and Neurodegenerative Disease Tracking Sheet

On June 16, CMS posted a Tracking Sheet (link) regarding National Coverage Determination (NCD) 220.6.20 Beta Amyloid Positron Tomography in Dementia and Neurodegenerative Disease. CMS generated this NCD analysis based on stakeholder feedback during the finalization of the NCD for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease. The purpose of the NCD reconsideration is to determine if the current policy of one PET scan per patient per lifetime should be revised.

Medicare MLN Articles & Transmittals

Section 127 of the Consolidated Appropriations Act: Graduate Medical Education (GME) Payment for Rural Track Programs (RTPs)

• Article Release Date: April 28, 2022
• What You Need to Know: Your billing staff needs to be aware of a new definition for RTPs, changes in Section 127 of the Consolidated Appropriations Act (CAA), 2021, and the documentation requirements for hospitals requesting indirect and direct GME rate increases.
• MLN MM12709: (link)

Update of Internet Only Manual (IOM), Pub. 100-04, Chapter 15 – Ambulance

• Article Release Date: April 28, 2022
• What You Need to Know: This article reports an update to the Medicare Claims Processing Manual. It also provides background guidance on how ambulance providers should bill for Medicare Part B ambulance services when a patient dies before the ambulance arrives and when a patient dies after being loaded on the ambulance.
• MLN MM12707: (link)

Changes to Beneficiary Coinsurance for Additional Procedures Furnished During the Same Clinical Encounter as Certain Colorectal Cancer Screening Tests

• Article Release date: April 29, 2022
• What You Need to Know: Beginning January 1, 2022, CMS began to gradually reduce the coinsurance for any procedure beyond a planned colorectal cancer screening test until the procedure is completely free for dates of service on or after January 1, 2030.
• MLN MM12656: (link)

Calendar Year 2023 Modifications/Improvements to Value-Based Insurance Design (VBID) Model – Implementation

• Article Release Date: April 29, 2022
• What You Need to Know: Information in this article is for hospices, hospitals, and suppliers billing MACs for services provided to Medicare hospice patients enrolled in Medicare Advantage (MA) plans participating in the voluntary Value-Based Insurance Design (VBID) Model’s Hospice Benefit component.
• MLN MM12688: (link)

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

• Article Release Date: May 5, 2022
• What You Need to Know: Links in this article will help you find updates pertaining to Advanced Diagnostic Laboratory Tests (ADLTs) and new codes effective July 1, 2022.
• MLN MM12737: (link)

International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs)---October 2022

• Article Release Date: May 9, 2022
• What You Need to Know: There are no policy changes in this ICD-10 quarterly update. Updates do include newly available codes.
• MLN MM12705: (link)

Revisions to Medicare Part B Coverage of Pneumococcal Vaccinations for the Medicare Benefit Policy Manual Chapter 15, Section 50.4.42

• Article Release Date: May 9, 2022
• What You Need to Know: CMS updated the Medicare coverage for pneumococcal vaccinations to align with the Advisory Committee on Immunization Practices (ACIP) recommendations that vary based on patient age and risk factors.
• MLN MM12723: (link)

Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) – July 2022 Update

• Transmittal 11408 (Change Request 12747) Release Date: May 12, 2022
• What You Need to Know: CR 12747 details information about new HCPCS and CPT codes, new G codes for the 180-day monitoring period for continuous glucose monitoring (CGM), and codes that are no longer valid.
• Transmittal 11408 (CR 12747): (link)

Elimination of Certificates of Medical Necessity & Durable Medical Equipment Information Forms

• MLN Release Date: May 12, 2022
• What You Need to Know: CMS published this Special Edition (SE) article to alert those that bill Durable Medical Equipment (DME) for services and supplies provided to Medicare patients that effective January 1, 2023, CMS will no longer require Certificates of Medical Necessity (CMNs) and DME Information Forms (DIFs)
• MLN SE22002: (link)

Revised Medicare MLN Articles & Transmittals

New Waived Tests

• Article Release Date: January 18, 2022 – Revised April 27, 2022
• What You Need to Know: CR 12581 changed the HCPCS code for the Cardinal Health H. Pylori Rapid Test – Whole Blood/Serum Cassette (Whole Blood) to 86318QW. This MLN article was updated to reflect the code change.
• MLN MM12581: (link)

Update to Chapter 7, “Home Health Services”, of the Medicare Benefit Policy Manual (Pub 100-02)

• Article Release Date: March 28, 2022 – Revised April 28, 2022
• What You Need to Know: CR 12615 changed the background and policy sections of the CR’s business requirements and manual attachment. This MLN article was updated to reflect the changes.
• MLN MM12615: (link)

Mental Health Visits via Telecommunications for Rural Health Clinics & Federally Qualified Health Centers

• Article Release Date: March 30, 2022 – Revised May 5, 2022
• What You Need to Know: This article was revised to show that RHCs must include modifier CG on claims for mental health visits via telecommunications.
• MLN SE22001: (link)

Coverage Updates

National Coverage Determination (NCD) 210.14 Reconsideration – Screening for Lung Cancer with Low Dose Computed Tomography (LDCT)

• Article Release Date: May 3, 2022
• What You Need to Know: This article details changes that have been made to NCD 210.14 including:
• Lowering the minimum age for screening,
• Removing the restriction on who can provide counseling and shared decision-making (SDM), and
• Removing the requirement that facilities participate in a registry.
• MLN MM12691: (link)

Proposed Decision Memo for Home Use of Oxygen (CAG-00296R3)

NCD 240.2 Home use of Oxygen was issued by CMS on September 27, 2021. On May 12, 2022 CMS issued a Proposed Decision Memo (link). CMS notes in the Decision Summary they are proposing to amend “the period of initial coverage for these patients from 120 days to 90 days, in order to align with the 90-day statutory time period.”

Medicare Educational Resources

MLN Booklet: Medicare Mental Health

This booklet (link)">link) explains Medicare-covered mental health and substance use services, eligible professionals, Medicare Advantage coverage, Medicare drug plan (Part D) coverage, medical record documentation and coding. March 2022 updates to this booklet includes updated information about telehealth services and new payment information specific to Clinical Nurse Specialists (CNS), Nurse Practitioners (NPs), Physician Assistants (PAs), and Certified Nurse-Midwifes (CNMs).

MLN Fact Sheet Medical Record Maintenance & Access Requirements (MLN4840534)

This Fact Sheet (link) provides information on updated documentation maintenance and access requirements for billing services to Medicare patients. It also tells you how long to keep the documentation and who is responsible for providing access. CMS updated this Fact Sheet in April to add information on medical records to support home health referrals.

Biosimilars Curriculum: Resources for Teaching Your Students

CMS provided information about the FDA’s Biosimilar Curriculum Toolkit in the May 12, 2022 MLN Connects newsletter (link). This toolkit can be used to instruct students in medicine, nursing, physician assistant and pharmacy programs.

New Comprehensive Error Rate Testing (CERT) Outreach and Education Task Force PowerPoint

On May 4, 2022, the CERT Medicare Administrative Contractor (MAC) Outreach and Education Task Force (link) posted a PowerPoint detailing the role of the MACs and the CERT Contractor in reducing the error rate.

COVID-19 Updates

April 29, 2022: Counterfeit At-Home OTC COVID-19 Diagnostic Tests

The FDA released a notice (link) indicating they are aware of counterfeit at-home over-the-counter (OTC) COVID-19 diagnostic tests being distributed or used in the United States and advises they should not be used or distributed. This notice provides information to help you determine if you have a counterfeit test. To date, the two products that they have identified as counterfeit are:

• Counterfeit Flowflex COVID-19 Test Kits, and
• Counterfeit iHealth COVID-19 Antigen Rapid Test Kits.

May 10, 2022: AHA and Others Urge Continuation of the COVID-19 Public Health Emergency (PHE)

In a letter to HHS Secretary Becerra (link), the American Hospital Association along with several other organizations (i.e., AARP, American Diabetes Association, American Medical and Nurses Associations) urge the PHE be maintained “until we experience an extended period of greater stability and, guided by science and data, can safely unwind the resulting flexibilities.” A little over a week later, there were less than 60 days before the end of the current PHE. As the government has indicated they will provided at least 60 days’ notice prior to ending the PHE, it appears it will continue at least to October 2022.

Medicare MLN Articles & Transmittals

Mental Health Visits via Telecommunications for Rural Health Clinics & Federally Qualified Health Centers

• Article Release Date: March 30, 2022
• What You Need to Know: This article provides information about regulatory changes for mental health visits in RHCs and FQHCs, and billing information for mental health visits done via telecommunications.
• MLN SE22001: (link)

Updates to MS-DRGs Subject to IPPS Replaced Devices Offered Without Cost or With a Credit Policy-Fiscal Years 2021-2022

• Transmittal Release Date: April 7, 2022
• What You Need to Know: CMS published this One Time Notification (Change Request 12662 / Transmittal 11346) to implement updates to the list of DRGs subject to the IPPS payment policy for reimbursement of replaced devices offered without cost or with a credit, effective for discharges on or after 10/1/2020.
• Transmittal 11346/CR 12662: (link)

Revised Medicare MLN Articles & Transmittals

Medicare Part B Clinical Laboratory Fee Schedule: Revised Information for Laboratories on Collecting & Reporting Data for the Private Payor Rate-Based Payment System

• Article Release Date: February 27, 2019 – Most recent revision March 24, 2022
• What You Need to Know: This article was revised to note that Clinical Diagnostic Laboratory Tests (CDLTs) that are not Advanced Diagnostic Laboratory Tests (ADLs), the data reporting period has been delayed by 1 year due to the December 10, 2021, Protecting Medicare & American Farmers from Sequester Cuts Act.
• MLN SE19006: (link)

Claims Processing Instructions for the New Pneumococcal 15-valen Conjugate Vaccine Code 90671 and Pneumococcal 20-valent Conjugate Vaccine Code 90677

• Article Release Date: November 1, 2021 – Most recent revision March 30, 2022
• What You Need to Know: This article was revised for a second time to show the MACs will adjust certain previously processed and rejected claims with HCPCS code 90671 after April 4, 2022.
• MLN MM12550: (link)

Coverage Updates

April 7, 2022: Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease Final Decision Memo (CAG-00460N)

CMS published a final decision memo for the coverage of aducanumab (brand name Aduhelm™) and any future monoclonal antibodies directed against amyloid approved by the FDA with an indication for use in treating Alzheimer’s disease. Of note, CMS incorporated over 10,000 stakeholder comments and more than 250 peer-reviewed documents into the determination.

CMS finalized coverage for therapies that receive traditional approval from the FDA under coverage with evidence development (CED). CMS, as a part of this decision, will provide enhanced access and coverage for people with Medicare participating in CMS-approved studies, such as a data collection through routine clinical practice or registries.

More information:

• Complete press release
• Fact sheet on Medicare coverage policy for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease
• Final NCD CED decision memorandum

Medicare Educational Resources

MLN Booklet: Advanced Practice Registered Nurses, Anesthesiologist Assistants, & Physician Assistants - Revised

This MLN Booklet (link) was updated in March 2022. A summary of changes is available on page three and substantive content updates highlighted in dark red font throughout the booklet. For example, effective January 1, 2022, Physician Assistants bill the Medicare Program directly for their services and get paid like NPs and CNSs.

April 21, 2022: Medicare Provider Compliance Newsletter

In the Thursday April 21st edition of MLN Connects (link), CMS provided a link to their most recent Medicare Provider Compliance Newsletter. Originally, published on a quarterly basis, this newsletter is now published twice a year. In the most recent edition, you can learn about guidance to address billing errors for three topics:

• Hospice certification and recertification of terminal illness,
• Refills of durable medical equipment, prosthetics, orthotics, and supplies: items provided on a recurrent basis, and
• Total hip arthroplasty: medical necessity and documentation requirements.

CMS has updated this FAQ document (link) which contains information on frequently asked questions from provider and facilities regarding No Surprises rules, independent dispute resolution, and exceptions to the new rules and requirements.

April 18, 2022: CMS Issues Fiscal Year (FY) 2023 Inpatient Prospective Payment System (IPPS) Proposed Rule

In an MLN Connects Special Edition (link), CMS announced the issuance of the FY 2023 IPPS Proposed Rule. They are proposing a 3.2% increase in operating payment rates for acute care IPPS hospitals that successfully participate in the Hospital Inpatient Quality Reporting Program and are meaningful electronic health record users. You will find links to a complete press release, proposed payment fact sheet, maternal health and health equity measures fact sheet, White House statement on reducing maternal mortality and morbidity, and the proposed rule in the announcement. Comments on the proposed rule must be in by June 17, 2022.

COVID-19 Updates

March 30, 2022: New COVID.gov website Launched

The Biden Administration announced the launch of COVID.gov. (link), “a new one-stop shop website to help all people in the United States gain even better access to lifesaving tools like vaccines, tests, treatments, and masks, as well as get the latest updates on COVID-19 in their area.”

April 14, 2022: FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples

The FDA announced the issuance of an emergency use authorization (EUA) for the first COVID-19 diagnostic test that detects chemical compounds in breath samples association with COVID-19 (link). The test is named the InspectIR COVID-19 Breathalyzer.

About the InspectIR COVID-19 Breathalyzer test:

• Is authorized to be performed in environments where the patient specimen is both collected and analyzed, such as doctor’s offices, hospitals, and mobile testing sites, using an instrument about the size of a piece of carry-on luggage.
• Is authorized to be performed by a qualified, trained operator under the supervision of a healthcare provider licensed or authorized by state law to prescribe tests and can provide results in less than three minutes.
• Is for people ages eighteen and older without symptoms or other epidemiological reasons to suspect COVID-19.

April 14, 2022: Update to Publication 100.04, Chapter 18 and Publication 100-02, Chapter 15, Section to Add Data Regarding Novel Coronavirus (COVID-19) and its Administration to Current Claims Processing Requirements and Other General Updates

• Article Release Date: April 14, 2022
• What You Need to Know: Updates have been made to the Medicare Claims Processing Manual (Publication 100-04) and the Benefits Policy Manual (Publication 100-02) to add information for COVID-19 claims for example, CMS has added COVID-19 to the list of preventive vaccines that Medicare Part B covers without coinsurance or deductible. In addition to COVID-19 claims updates, the centralized billing enrollment process has been revised to streamline provider enrollment.
• MLN MM12634: https://www.cms.gov/files/document/mm12634-update-publication-100-04-chapter-18-and-publication-100-02-chapter-15-section-add-data.pdf

CDC Call: Evaluating and Supporting Patients Presenting with Cognitive Symptoms Following COVID

The CDC will be holding a Clinician Outreach and Communication Activity (COCA) call on May 5th. During this call, presenters will discuss post-COVID conditions (PCC), that are present four or more weeks after infection. Cognitive symptoms, often described as “brain fog,” are frequently reported following a patient’s COVID-19 illness. If you are interested but unable to attend the live call, you can go to the CDC webpage specific for this call (link), after May 5th to find the call materials.

Other Updates

March 30, 2022: FY 2023 Hospice Payment Rate Update – Proposed Rule

CMS announced, in a special edition MLN connects (link), the issuance of a proposed rule (CMS-1773-P) that would update hospice base payments and the aggregate cap amount for FY 2023. The comment period ends on May 31, 2022.

March 31, 2022: FY 2023 Inpatient Psychiatric Facilities and Inpatient Rehabilitation Facilities Proposed Rules

CMS announced, in a special edition MLN connects (link), the issuance of the Inpatient Psychiatric Facilities and Inpatient Rehabilitation Facilities Proposed Rules. You will find links to a summary of key provisions for each proposed rule as well as the proposed rules in this edition of MLN connects. The comment period for both proposed rules end on May 31, 2022.

April 6, 2022: CMS Updates FAQ Document for Providers about the No Surprises Rules

CMS has updated this FAQ document (link) which contains information on frequently asked questions from provider and facilities regarding No Surprises rules, independent dispute resolution, and exceptions to the new rules and requirements.

April 18, 2022: CMS Issues Fiscal Year (FY) 2023 Inpatient Prospective Payment System (IPPS) Proposed Rule

In an MLN Connects Special Edition (link), CMS announced the issuance of the FY 2023 IPPS Proposed Rule. They are proposing a 3.2% increase in operating payment rates for acute care IPPS hospitals that successfully participate in the Hospital Inpatient Quality Reporting Program and are meaningful electronic health record users. You will find links to a complete press release, proposed payment fact sheet, maternal health and health equity measures fact sheet, White House statement on reducing maternal mortality and morbidity, and the proposed rule in the announcement. Comments on the proposed rule must be in by June 17, 2022.