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This week we highlight key updates spanning from March 31st through April 5th of 2021.

Resource Spotlight: Medicare COVID-19 Data Snapshot Updated March 24,2021

The Medicare COVID-19 Data Snapshot provides summary data and visuals from Medicare Fee-for-Service (FFS) claims data, Medicare Advantage (MA) plans encounter data, and Medicare enrollment information.

COVID-19 cases and hospitalization are identified by ICD-10-CM codes:

·        B97.29 from January 1st through March31st 2020, and

·        U071 effective April 1, 2021 forward.

The most recent update to the Data Snapshot represents claims data from January 1, 2020 through December 26,2020. As of late 2020 around 63.1 million Americans are enrolled in Medicare with 60% in Medicare FFS, and 40% in MA plans. CMS cautions that data is preliminary as there is always a “claims lag” between services provided and when the claim is in the database.  With that in mind the specific dates of service includes claims received by January22, 2021.

Since the last Data Snapshot release:

·        For the first time since CMS began publishing the Data Snapshot, rural cases of COVID-19 (4,271 per 100,000) is higher than in urban areas (4,151 per 100,00),

·        Medicare FFS spending associated with COVID-19hospitals grew to $10.3 billion, and

·        Hypertension remains the most prevalent chronic condition among Medicare FFS COVID-19 hospitalized beneficiaries at 78%.

You can read more about the recent Data Snapshot update in a related CMS Press Release.

April 1, 2021:  Advancements in Over-the-Counter (OTC) Tests for COVID-19

The FDA announced they had taken “swift action this week to get more tests for screening asymptomatic individuals on the market” by authorizing three tests with serial screening claims. They go on to note these tests had already been authorized for use by the agency to test individuals with COVID-19 symptoms, but this week’s authorization is for testing asymptomatic individuals when used for serial testing.

April 1, 2021: Repayment of COVID-19 Accelerated and Advance Payments began March 30, 2021

CMS published MLN article SE21004 on April 1stto inform all Medicare providers and suppliers who requested and receivedCOVID-19 Accelerated and Advance Payments (CAAPs) that they began recovering those payments as early as March 30, 2021. Also included in the article is information on how to identify recovered payments.

Additional information including a Press Release, Fact Sheet and Frequently Asked Questions is available on the CMS COVID-19 Accelerated and Advance Payments webpage.

April 1, 2021: No Out-of-Pocket Costs to Patients for COVID-19 Vaccine Administration

Currently, the United States Government has purchased all COVID-19 vaccine in the U.S. for administration exclusively by enrolled providers through the CDC COVID-19 Vaccination Program.The Thursday April 1, 2021 edition of the CMS MLN Connects newsletter includes the following reminders for participants in this program:

“If you participate in the CDC COVID-19 Vaccination Program, you must:

·        Administer the vaccine with no out-of-pocket cost to your patients for the vaccine or administration of the vaccine

·        Vaccinate everyone, including the uninsured,regardless of coverage or network status

You also can’t:

·        Balance bill for COVID-19 vaccinations

·        Charge your patients for an office visit or other fee if COVID-19 vaccination is the only medical service given

·        Require additional medical or other services during the visit as a condition for getting a COVID-19 vaccination

Report any potential violations of these requirements to the HHS Office of the Inspector General:

·        Call 1-800-HHS-TIPS

·        Submit an online complaint

Submit claims for administering COVID-19 vaccines to:

·        Medicare, if your patient has Medicare Part B coverage or, for 2020 and 2021, Medicare Advantage (Part C)

·        Private insurance company (PDF), including if your patient only has Medicare Part A coverage with supplemental coverage from a private insurer  

·        Your state’s Medicaid program for patients with Medicaid and Children’s Health Insurance Program (CHIP) coverage

·        Health Resources & Services Administration (HRSA) COVID-19 Uninsured Program ,including if your Medicare patient only has Part A coverage with no supplemental coverage”

April 2, 2021: International Travel During COVID-19 – CDC Guidance Updated

The CDC has updated their guidance regarding international travel during COVID-19 to note that “fully vaccinated travelers are less likely to get and spread COVID-19. However, international travel poses additional risks and even fully vaccinated travelers are at increased risk for getting and possibly spreading new COVID-19 variants. CDC recommends delaying international travel until you are fully vaccinated.” The update also includes tips for getting tested after travel and self-quarantining.

April 5, 2021: Acute Hospital Care at Home Program List of Approved Hospitals Updated

This program is an expansion of the CMS Hospitals Without Walls Initiative launched over a year ago now in March 2020. CMS once again updated the list of approved hospitals. The updated list also includes a note that this list will be moving to the CMS Hospital at Home webpage beginning April 9, 2021.

Reading CMS’s recently released Change Request (CR) 12104  titled Claims Processing Instructions for National Coverage Determination (NCD) 20.4 Implantable Cardiac Defibrillators (ICDs) made me feel like I had entered the land of Fantasia from The Never Ending Story or as if I was waking up to Sonny and Cher singing I Got You Babe for the umpteenth time in the Bill Murray classic Ground Hog’s Day. Either way, it has been a long road from the release of a Proposed Decision Memo to the transmittal providing claims processing instructions.

The Never Ending Story, Gets It’s Ending

·        May 30, 2017: CMS announced the opening of a National Coverage Analysis (NCA)for Implantable Cardioverter Defibrillators.

·        November 20, 2017: CMS issued a Proposed Decision Memo.

·        February 15, 2018: CMS issued a Final Decision Memo.

·        November 21, 2018: Transmittal 209 (CR 10865) was issued reflecting the reconsideration of an updated version of NCD 20.4. CMS noted that a subsequent CR would be released at a later date containing a Claims Processing Manual update with accompanying instructions. Until that time, CMS instructed that Medicare Administrative Contractors (MACs) shall be responsible for implementing NCD 20.4.

·        February 15, 2019: Transmittal 211 was rescinded and replaced with Transmittal 213 to change the implementation date from February 26, 2019 to March 26, 2019.

·        March 26, 2019: CMS’ final implementation date for NCD20.4.

·        March 26, 2019: Eleven of the twelve MACs published a Local Coverage Article titled Billing and Coding: Implantable Automatic Defibrillators including:

        o   First Coast Service Options, Inc. (Jurisdiction N) – Article A56341,

       o   National Government Services, Inc. (Jurisdictions 6 and K) – Article A56326,

        o   Noridian Healthcare Solutions, LLC (Jurisdiction E) – Article A56340,

        o   Noridian Healthcare Solutions, LLC (Jurisdiction F) - Article A56342,

        o   Novitas Solutions, Inc. (Jurisdictions H and L) – Article A56355,

        o   Palmetto GBA (Jurisdictions J and M) – Article A56343, and

        o   Wisconsin Physician Service Insurance Corporation (Jurisdictions 5 and 8) – ArticleA56391.

·        March 2, 2020: CMS published MLN SE20006 updating providers on Medicare coverage rules and policies for NCD 20.4. Specifically, this article addresses concerns related to requiring the use of heart failure diagnosis codes. They end this article by stating that “it is incumbent upon the provider to select the proper code(s). We believe the listed covered codes encompass the various clinical scenarios that occur for patients who meet the NCD coverage requirements and are provided, not to write additional parameters into the NCD, but to ensure there is an appropriate code for the covered indications.”

·        March 23, 2021: CMS released CR 12104 and a related MLN MM12104 on March 24, 2021 detailing the claims processing instructions for NCD 20.4.

In Ground Hog’s Day, Bill Murry keeps reliving the same day over and over until he finally turns it around into the perfect day. Almost four years from the opening of the coverage analysis, CMS has provided the final piece to implantable cardiac defibrillators.  

Moving Forward to Your Happy Ending

·        First, now is a good time to review NCD 20.4 to understand the indications for when an ICD implantation is considered medically necessary by CMS.

·        Transmittal 12104 details the codes you “shall” use on your claims when billing for services provided. To assist in understanding the codes, I recommend that you read your MAC’s related coding and billing article as it outlines codes specific to each CMS indication for coverage in the NCD.

·        For patients clinically meeting the indications for a pacemaker and an ICD, all twelve MACs have published billing and coding: single chamber and dual chamber permanent cardiac pacemaker articles related to the single and dual chamber pacemaker NCD 20.8.3.

·        This is also a good time to review a sample of claims at your hospital for documentation supporting medical necessity as well as appropriate coding.

·        Be aware that all Recovery Auditors have been approved to perform audits for medical necessity and documentation requirements for implantable automatic defibrillators in the outpatient (Issue RAC Issue 0093) and inpatient (RAC Issue 0195) setting.  

·        Last, know that the implementation date for Transmittal 12104 is July 6, 2021. However, take note that CMS indicates that MACs will not search their files for claims for ICD services between February 15, 2018, and the implementation date of this transmittal. “However, MACs should adjust those claims that are brought to their attention.”

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SEQUESTRATION SUSPENSION EXTENSION, COVID-19 ACCELERATED/ADVANCED PAYMENTS RECOUPMENT IS ALMOST HERE, CMS TO RESUME HOSPITAL SURVEY ACTIVITIES, CDC REPORTS ON EFFICACY OF PFIZER & MODERNA VACCINES

This week we highlight key updates spanning from March 23rd through the 30th of 2021.

March 24, 2021:  OIG Report – Hospitals Operating in Survival Mode

The OIG released the Report in Brief titled, Hospitals Reported That the COVID-19 Pandemic Has Significantly Strained Health Care Delivery. This report is a compilation of perspectives shared by front-line in hospital administrators at 320 hospitals nationwide during brief interviews conducted from February 22nd through the 26th of 2021. The OIG calls this process a “Pulse Survey.” The first Pulse Survey highlighting challenges hospitals are facing was conducted in March 2020. The OIG notes that “this pulse survey offers hospital administrators’ perspectives on the most significant strains that the response to COVID-19 has exerted on hospitals, as well as their perspectives on the longer-term implications of these strains.” The following list are examples of Hospital-Reported Challenges in this report:

• Difficulty balancing the complex and resource-intensive care needs for COVID-19 patients with efforts resuming routine hospital care,
• Staffing shortages have affected patient care,
• Exhaustion and trauma have taken a toll on staff’s mental health, and
• Challenges associated with vaccine distribution efforts and concerns about hesitancy to receive a vaccine.

March 24, 2021: FDA Consumer Update: Learn More About COVID-19 Vaccines from the FDA

In this Consumer Update, common questions about COVID-19 vaccines are answered by the FDA. The update also provides a link to a YouTube video providing four facts about COVID-19 vaccines.

March 25, 2021: COVID-19 Legislation Related to Sequestration Suspension

• The Budget Control Act of 2011 included a 2.00% across-the-board sequestration reduction to Medicare Fee-for-Service claims payments.
• The Coronavirus Aid, Relief, and Economic Security (CARES) Act suspended this payment adjustment from May 1, 2020 through December 31, 2020.
• Subsequently, the Consolidated Appropriations Act, 2021, signed into law on December 27, 2020, extended this suspension to March 31, 2021.
• On March 19, 2021, the U.S. House passed House Resolution (HR) 1868, which would extend the sequestration suspension through December 31, 2021.
• On March 25, 2021, the U.S. Senate passed Senate Amendment SA 1410 titled, Extension of Temporary Suspension of Medicare Sequestration. Similar to HR 1868, this Amendment extends the Sequestration suspension through December 31, 2021.

In the March 25, 2021 Senate Congressional Record discussion, Senator Shaheen (D-NH) noted in her remarks that “this week, I heard from Wentworth-Douglass Hospital in Dover, NH. They highlighted that this legislation would result in $2.1 million in desperately needed additional revenue for the hospitals…by passing a continued moratorium through 2021, Wentworth-Douglass will be in a better place to care for those in need and respond to any future crisis affecting the health of our community.”

The American Hospital Association (AHA) released a Special Bulletin in response to passage of the Senate bill. The AHA notes in the bulletin that “the House is expected to take up the Senate-passed bill the week of April 13 when it returns to Washington D.C. It is expected that the Centers for Medicare & Medicaid Services will hold the Medicare claims until the bill is signed into law as it has done in the past.”

March 26, 2021: COVID-19 Accelerated/Advance Payments (CAAPs) Recoupment Fast Approaching

Palmetto GBA, the Medicare Administrative Contractor for Jurisdictions J and M sent the following notice regarding CAAPs to those subscribed to receive emails:

“Providers and suppliers requesting and receiving COVID-19 Accelerated/Advance Payments (CAAPs) in 2020 will receive an email in the coming days reminding them that the recoup period is fast approaching. The emails are being issued to a provider or supplier designated CAAP point of contact.

Included in the email is a copy of the October 2020 reminder email that includes details regarding any CAAPs issued to that entity. Please note the amount due as listed on the October 2020 email attachment does not reflect any amount already refunded towards that balance. There is no need to call the provider contact center. Your current amount owed can be located in eServices’ Financial Tools tab, under Overpayment Data. No offset will begin occurring unless there is still an outstanding CAAP balance for the provider, supplier or an affiliated provider with the same tax identification number.  

Resource: Accelerated and Advance Payment Repayment & Recovery Frequently Asked Questions (October 8, 2020) (PDF, 45 KB)”

March 26, 2021: CMS to Resume Hospital Survey Activities

On January 20, 2021, CMS issued a memo limiting hospital surveys for 30 days “to ensure quality of care oversight while providing hospitals the ability to focus on serving their patients and communities.” The limitations were extended on February 18, 2021 for an additional 30 days through March 22, 2021. On March 26, 2021, CMS issued the Memorandum titled Resuming Hospital Survey Activities Following 30-Day Restrictions to inform State Survey Agency Directors with their plan to resume survey activities.

March 26, 2021: Department of Justice and COVID-19 Fraud

The Department of Justice published a notice detailing actions they have taken to combat COVID-19 related fraud. They note that as of March 26th:

• 474 defendants have been publicly charged with criminal offenses for fraud related schemes connected to the COVID-19 pandemic,
• Cumulatively, this represents attempts to obtain over $569 million from the U.S. government and unsuspecting individuals.

Acting Assistant Attorney General Nicholas L. McQuaid of the Justice Department’s Criminal Division following message is included in this announcement: “To anyone thinking of using the global pandemic as an opportunity to scam and steal from hardworking Americans, my advice is simple – don’t…no matter where you are or who you are, we will find you and prosecute you to the fullest extent of the law.”

March 29, 2021: CDC Resource for Healthcare Providers: Caring for Patients at Higher Risks for Developing Severe Outcomes of COVID-19

The CDC has published this webpage specifically as an evidence-based resource for Healthcare Providers and notes that this page is distinct from the People with Certain Medical Conditions webpage which is intended for the general public. Following are examples of information shared on this webpage:

• Age is the strongest risk factor for severe COVID-19 outcomes as people 65 years or older accounts for more than 80% of the U.S. COVID-19 related deaths.
• Adults of any age with certain underlying medical conditions are at increased risk for severe illness from COVID-19. This risk increases as the number of underlying medical conditions for a person increases.
• The most common comorbidities, based on key findings from a retrospective study of 64,781 patients with COVID-19, includes:
• 46.7% of the patients had hypertension (HTN),
• 28.9% of the patient patients had a diagnosis of hyperlipidemia,
• 27.9% of the patients were a diabetic, and
• 16.1% of the patients had a chronic pulmonary condition.

March 29, 2021: CDC Study Confirms Protective Benefits of mRNA COVID-19 Vaccines

The CDC announced in a Press Release the findings of a new study which “provides strong evidence that mRNA COVID-19 vaccines are highly effective in preventing SARS-CoV-2 infections in real-world conditions among health care personnel, first responders, and other essential workers.”  Results among study participants revealed the following:

• Following a single dose of the Pfizer-BioNTech or Moderna mRNA vaccines the risk of infection with SARS-CoV-2 was reduced by 80% two or more weeks after vaccination, and
• Following the second dose of vaccine, risk of infection was reduced by 90% two or more weeks after vaccination.

March 30, 2021: Special Edition MLN Connects: Temporary Claims Hold

CMS released the following notice in a Special Edition MLN Connects regarding the pending congressional action to extend the Sequestration Suspension:

“In anticipation of possible Congressional action to extend the 2% sequester reduction suspension, we instructed the Medicare Administrative Contractors (MACs) to hold all claims with dates of service on or after April 1, 2021, for a short period without affecting providers’ cash flow. This will minimize the volume of claims the MACs must reprocess if Congress extends the suspension; the MACs will automatically reprocess any claims paid with the reduction applied if necessary.”

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MEDICARE MLN ARTICLES & TRANSMITTALS – RECURRING UPDATES

April 2021 Integrated Outpatient Code Editor (I/OCE) Specifications Version 22.1

• Article Release Date: March 8, 2021
• What You Need to Know: Included in this MLN article are changes to the April 2021 version of the I/OCE instructions and specifications for the I/OCE that Medicare uses under the OPPS and non-OPPS for hospital outpatient departments, community mental health centers, all non-OPPS providers, limited services when provided in a home health agency not under the HH PPS, and for a hospice patient for treating a non-terminal illness.
• MLN MM12187: https://www.cms.gov/files/document/mm12187.pdf

Clinical Laboratory Fee Schedule – Medicare Travel Allowance Fees for Collection of Specimens

• Article Release Date: March 9, 2021
• What You Need to Know: Changes to CY 2021 travel allowances bill per mileage basis (HCPCS P9603) and on a flat rate basis (HCPCS P9604) are included in this article. Note, “Medicare Part B allows payment for a specimen collection fee and travel allowance, when medically necessary, for a laboratory technician to draw a specimen from either a nursing home patient or homebound patient under Section 1833(h)(3) of the Act. Payment for these services is made based on the Clinical Laboratory Fee Schedule (CLFS).”
• MLN MM12140: https://www.cms.gov/files/document/mm12140.pdf

April 2021 Update to the Fiscal Year (FY) 2021 Inpatient Prospective Payment System

• Article Release Date: March 9, 2021
• What You Need to Know: This MLN Article provides notice of changes that CMS is making for the April 2021 update of the FY 2021 Inpatient Prospective Payment System (IPPS). CMS notes that MACs will be reprocessing certain claims as explained in this article.
• MLN MM12062: https://www.cms.gov/files/document/mm12062.pdf

April 2021 Update of the Hospital Outpatient Prospective Payment System (OPPS)

• Article Release Date: March 8, 2021
• What You Need to Know: Related CR 12175 describes changes to and billing instructions for various payment policies implemented in the April 2021 Outpatient Prospective Payment System (OPPS) update. The April 2021 Integrated Outpatient Code Editor (I/OCE) will reflect the HCPCS, Ambulatory Payment Classification (APC), HCPCS Modifier, and Revenue Code additions, changes, and deletions identified in CR 12175.
• MLN MM 12175: https://www.cms.gov/files/document/mm12175.pdf

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

• Article Release Date: March 10, 2021
• What You Need to Know: Quarterly updates to the Clinical Laboratory Fee Schedule (CLFS) are detailed in this MLN article, including a table of new codes effective April 1, 2021.
• MLN Article MM12178: https://www.cms.gov/files/document/mm12178.pdf

Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) – April 2021 Update

• Article Release Date: March 10, 2021
• What You Need to Know: This MLN article provides highlights from Change Request (CR) 12155 which includes April 2021 updates to the 2021 MPFS. CMS notes in the article that “MACs won’t search their files to either retract payment for claims already paid or to retroactively pay claims. However, MACs will adjust claims that you bring to their attention.”
• MLN MM12155: https://www.cms.gov/files/document/mm12155.pdf

One-Time Transmittal 10599 (Change Request 12089): HIPAA Electronic Data Interchange (EDI) Front End Updates for July 2021

• Transmittal Release Date: March 11, 2021
• What You Need to Know: The purpose of this Change Request (CR) is to provide the July 2021 Combined Common Edits/Enhancements Module (CCEM) edits for the Part A and Part B Medicare Administrative Contractors (A/B MACs) and the Common Electronic Data Interchange (CEDI) contractor. Additionally, this CR directs Shared Systems to appropriately update the CCEM.
• Change Request 12089: https://www.cms.gov/files/document/r10599otn.pdf

April Quarterly Update for 2021 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule

• Article Release Date: March 12, 2021
• What You Need to Know: This article details changes in the DMEPOS fee schedules that Medicare updates on a quarterly basis.
• MLN MM12193: https://www.cms.gov/files/document/mm12193.pdf

Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code (CARC), Medicare Remit Easy Print (MREP) & PC Print Update

• Article Release Date: March 12, 2021
• What You Need to Know: This article details updates to the RARC and CARC lists and instructs Medicare’s Shared System Maintainers (SSMs) to update MREP and PC Print.
• MLN MM12102: https://www.cms.gov/files/document/mm12102.pdf

Implementation of Changes in the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Payment for Dialysis Furnished for Acute Kidney Injury (AKI) in ESRD Facilities for Calendar Year (CY) 2021

• Article Release Date: March 17, 2021
• What You Need to Know: Included in this article are the Calendar Year 2021 rate updates and policies for the ESRD PPS. Of note, the January 2021 ESRD PRICER did not apply the network reduction to Intermittent Peritoneal Dialysis (IPD) revenue code 0831 and ultrafiltration revenue code 0881 in error. The revised PRICER is correcting this error.
• MLN MM12188: https://www.cms.gov/files/document/mm12188.pdf

April 2021 Quarterly Update to HCPCS Codes Used for Skilled Nursing Facility (SNF) Consolidated Billing (CB) Enforcement

• Article Release Date: March 25, 2021
• What You Need to Know: Updates to lists of HCPCS codes subject to the consolidated billing provision of the SNF Prospective Payment System (PPS) are provided in this MLN article.
• MLN MM12212: https://www.cms.gov/files/document/mm12212.pdf

Changes to the Laboratory National Coverage Determination (NCD) Edit Software for July 2021

• Article Release Date: March 23, 2021
• What You Need to Know: This article and related Change Request (CR) 12171 announced changes in the July 2021 quarterly release of the edit module for clinical diagnostic laboratory services.
• MLN MM12171: https://www.cms.gov/files/document/mm12171.pdf

OTHER MEDICARE MLN ARTICLES & TRANSMITTALS

Updated Billing Requirements for Home Infusion Therapy (HIT) Services on or after January 1, 2021

• Article Release Date: March 15, 2021
• What You Need to Know: Following is an excerpt from this article regarding new changes to Medicare claims processing for HIT services on or after January 1, 2021:
• “As described in the 21st Century Cures Act, Medicare will make a separate payment for HIT services under the permanent HIT benefit to qualified home infusion suppliers, effective January 1, 2021. Home infusion drugs are assigned to three payment categories, as determined by the HCPCS J-code:
• Payment Category 1: Includes certain intravenous antifungals and antivirals, uninterrupted long-term infusions, pain management, inotropic, and chelation drugs
• Payment Category 2: Includes subcutaneous immunotherapy and other certain subcutaneous infusion drugs
• Payment Category 3: Includes certain chemotherapy drugs. MLN Matters article MM11880 lists the home infusion therapy service G-codes and corresponding home infusion therapy drug J-codes.
• MLN MM12108: https://www.cms.gov/files/document/mm12108.pdf

Common Working File (CWF) Edits for Medicare Telehealth Services and Manual Update

• Article Release Date: March 18, 2021
• What You Need to Know: This article is for physicians, non-physician practitioners, nursing facilities, and other providers submitting telehealth claims to MACs for nursing facility services.
• MLN MM12068: https://www.cms.gov/files/document/mm12068.pdf

Update to Rural Health Clinic (RHC) Payment Limits

• Article Release Date: March 16, 2021
• What You Need to Know: This article provides information about the payment limits for RHCs effective April 1, 2021.
• MLN MM12185: https://www.cms.gov/files/document/mm12185.pdf

Update to the Manual for Telephone Services, Physician Assistant (PA) Supervision, and Medical Record Documentation for Part B Services

• Article Release Date: March 24, 2021
• What You Need to Know: This article serves as notice regarding updates made to Chapter 15 of the Medicare Benefit Policy Manual for Physician Supervision for Physician Assistant (PA) Services and Medical Record Documentation for Part B services.
• MLN MM11862: https://www.cms.gov/files/document/mm11862.pdf

New Provider Enrollment Administrative Action Authorities

• Article Release Date: March 24, 2021
• What You Need to Know: This Special Edition MLN article provides information about the CMS Final Rule titled Program Integrity Enhancement to the Provider Enrollment Process. This Final Rule was issued on September 10, 2019. Included in this MLN article is the following note, “In light of the pandemic and various other factors, we will not begin updating the Form CMS-855 applications with affiliation disclosure for at least another 12 months.”
• MLN SE21003: https://www.cms.gov/files/document/se21003.pdf

REVISED MEDICARE MLN ARTICLES & TRANSMITTALS

Fiscal Year (FY) 2021 Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) PPS Changes

• Article Release Date: September 22, 2020 – Revised March 9, 2021
• What You Need to Know: In CR 11879, CMS changes the 25th percentile wage index value from 0.8465 to 0.8649. This MLN article reflects this change.
• MLN MM11879: https://www.cms.gov/files/document/mm11879.pdf

Healthcare Common Procedure Coding System (HCPCS) Codes Subject to and Excluded from Clinical Laboratory Improvement Amendments (CLIA) Edits

• Article Release Date: February 23, 2021 – Revised March 9, 2021
• What You Need to Know: This MLN article was revised to reflect the revised CR 12131, which changed the date CMS added HCPCS code 87428 to the correct date of November 10, 2020.
• MLN MM12131: https://www.cms.gov/files/document/mm12131.pdf

MEDICARE COVERAGE UPDATES

OIG Reports and Guidance regarding Polysomnography Services

MACs paid providers approximately $885 million for selected polysomnography services provided to Medicare beneficiaries from January 1, 2017 through December 31, 2018. The OIG identified in prior audits payments being made with inappropriate diagnosis codes, without documentation supportive of the services provided and to providers exhibiting questionable billing patterns. These findings in combination with increased spending as noted above prompted the OIG to conduct additional audits. This month, the OIG has released reports for two polysomnography audits.

• OIG Report: Peninsula Regional Medical Center: Audit of Medicare Payments for Polysomnography
• 10 of 100 randomly selected beneficiary claims included 12 lines of service that did not comply with Medicare requirements. Based on the net overpayments of $17,499, the OIG estimated that Peninsula received at least $66,647 in overpayments for polysomnography services during the audit period.
• OIG Report: North Mississippi Medical Center: Audit of Medicare Payments for Polysomnography
• 12 of 100 randomly selected beneficiary claims included 13 lines of services that did not comply with Medicare requirements. Based on the next overpayments of $7,624, the OIG estimated that North Mississippi received at least $67,038 in overpayments for polysomnography services during the audit period.

CMS included the following additional resources for Providers related to correct billing for Polysomnography services in the March 18, 2021 edition of their weekly eNewsletter, MLN Connects:

• Provider Compliance Tips for Polysomnography (Sleep Studies) (PDF)fact sheet to help you bill correctly.
• Medicare Claims Processing Manual, Chapter 15 (PDF), Section 70
• Questionable Billing for Polysomnography ServicesOIG Report.

Claims Processing Instructions for National Coverage Determination (NCD) 20.4 Implantable Cardiac Defibrillators (ICDs)

• Article Release Date: March 23, 2021
• What You Need to Know: This article provides follow-up instructions for the MACs related to Medicare claims processing system changes for ICDs with dates of service on or after February 15, 2018. Note, the implementation date for the related Change Request (CR) 12104 is July 6, 2021.
• MLN MM12104: https://www.cms.gov/files/document/mm12104.pdf
• CR 12104: https://www.cms.gov/files/document/r10635CP.pdf

MEDICARE EDUCATIONAL RESOURCES

MLN Booklet: Behavioral Health Integration Services

• Updated March 2021
• What You Need to Know: CMS made the following updates to this MLN Booklet:
• Added CY 2021 MPFS Final Rule CMS-1734-F Updates
• Added new HCPCS code G2214 - Initial or subsequent psychiatric collaborative care management, first 30 minutes in a month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional
• MLN909432 March 2021: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/BehavioralHealthIntegration.pdf

MLN Booklet: Evaluation and Management Service Guide

• Updated February 2021
• What You Need to Know: This MLN education guide has been updated with 2021 Medicare Physician Fee Schedule final rule dates and links.
• MLN906764 February 2021: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/eval-mgmt-serv-guide-ICN006764.pdf

January 2021 Medicare Quarterly Compliance Newsletter

CMS Posted a link to this newsletter in the March 18, 2021 MLN Connects eNewsletter. In this quarter’s newsletter you can learn about:

• Prefabricated and custom-fabricated knee orthoses: medical necessity and documentation requirements, and
• Ankle-foot orthoses and knee-ankle foot orthoses within the reasonable useful lifetime: excessive units.

March 15, 2021” Medicare Learning Network® (MLN) Provider Compliance Products

CMS published a list of Provider Compliance Education Products. These products provide education on how to avoid common coverage and coding/billing errors (i.e. Complying with Medical Record Documentation Requirements (MLN909160), Complying with Medicare Signature Requirements (MLN905364), and Provider Compliance Tips for Polysomnography (Sleep Studies) (MLN4013531)).

• MLN909307 March 2021: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/ProvCmpl_Products.pdf

OTHER MEDICARE UPDATES

Happy National Nutrition Month®

CMS included the following information in the March 4th edition of MLN Connects:

“Did you know that Medicare covers the following preventive services for nutrition-related health conditions like diabetes, chronic kidney disease, and obesity?

• Medical nutrition therapy
• Diabetes screening
• Diabetes self-management training
• Intensive behavioral therapy for obesity
• Intensive behavioral therapy for cardiovascular disease
• Annual wellness visit

During National Nutrition Month®, encourage your patients to develop healthy eating patterns and make food choices to meet their individual nutrient needs, goals, backgrounds, and tastes. More Information:

• Medicare Preventive Services Educational Tool
• Preventive Serviceswebpage
• National Nutrition Monthwebsite —“Personalize Your Plate”
• National Institute of Diabetes and Digestive and Kidney Diseaseswebsite
• Million Hearts®website
• Find a Registered Dietitian/Nutritional Professional”

Information for your patients on nutritional therapy services, diabetes screenings, diabetes self-management training, obesity behavioral therapy, cardiovascular behavioral therapy, and yearly “wellness” visits

MLN Fact Sheet: Health Professional Shortage Area Physician Bonus Program

This fact sheet explains how the Medicare Health Professional Shortage Area (HPSA) Physician Bonus Program works. It has information about how to get bonus payments when you deliver Medicare-covered services to patients in a geographic HPSA. Key Takeaways noted in this Fact Sheet includes:

• HPSAs are geographic areas of populations that lack enough health care providers to meet the health care needs of that population.
• CMS pays a 10 percent bonus payment when health care providers deliver Medicare-covered services to patients in a geographic HPSA.
• CMS pays HPSA bonuses quarterly based on the amount paid for professional services.

Link to MLN Fact Sheet (ICN MLN903196) February 2021: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/HPSAfctsht.pdf

March 17, 2021: American Hospital Association (AHA) Response to the American Rescue Plan Act of 2021 (ARP)

President Biden signed this $1.9 trillion coronavirus relief plan into law on March 11, 2021. In a related American Hospital Association Legislative Advisory, AHA notes their concern “that the law does not include an extension of relief from Medicare sequester cuts, which will go back into effect at the beginning of next month, and also fails to provide loan forgiveness for Medicare accelerated payments for hospitals.”

You can read more about the ARP Act of 2021 in related HHS and CMS Fact Sheets:

• Link to HHS Fact Sheet: https://www.hhs.gov/about/news/2021/03/12/fact-sheet-american-rescue-plan-reduces-health-care-costs-expands-access-insurance-coverage.html
• Link to CMS Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/american-rescue-plan-and-marketplace

March 12, 2021: CMS Published Lists of Participants for Emergency Triage, Treat and Transport (ET3) Model

Link to Model CMS webpage:
link to Press Release: https://www.cms.gov/newsroom/press-releases/cms-announces-final-participants-emergency-triage-treat-and-transport-et3-model-furthers-commitment

March 18, 2021: MLN Connects Clinical Laboratory Data Reporting Delayed Until 2022 Reminder

CMS included the following information regarding the Protecting Access to Medicare Act of 2014 (PAMA) data collection and reporting periods:

For Clinical Diagnostic Laboratory Tests that are not Advanced Diagnostic Laboratory Tests, the requirement for you to report private payor data between January 1 and March 31, 2020, was delayed 2 years.  You must report data from the original collection period. Reporting will resume on a 3-year cycle beginning in 2025. (Section 3718 of the Coronavirus Aid, Relief, and Economic Security Act). Current timeline:

• Collect Data for January 1 through June 30, 2019
• Report data between January 1 and March 31, 2022

For more information, see the PAMA Regulations webpage.

March 17, 2021: Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” Final Rule Delayed

CMS published an interim final rule in the Federal Register in keeping with the January 20, 2021 “Regulatory Freeze Pending Review” Memorandum. The Final Rule is being delayed until May 15, 2021. CMS is seeking public comments through April 16, 2021. In addition to operational practicalities cited by CMS as making them incapable of implementing the MCIT program on March 15, 2021, CMS notes the following additional reasons:

• “The higher than anticipated volume of devices receiving FDA breakthrough device designation exponentially complicates the operational concerns that we have identified. Further, public comments highlighted the importance of the agency having the ability to not only cover an FDA-designated breakthrough device expeditiously, but also to be able to have coding and payment levels established at the same time.”

My youngest nephew is currently the number one pitcher for his high school baseball team. His team recently participated in a spring break tournament in Memphis, Tennessee. Unfortunately, they only won one game. However, as my brother said, it was a valuable experience for the coaches to identify what the challenges are for the team for the rest of the season.

Similarly, hospitals are challenged with identifying who all of the players are that perform Medicare Fee-for-Service record reviews and what risk areas are they targeting. So, instead of Abbott and Costello trying to clarify “Who’s on First, What’s on second, and I Don’t Know’s on third,” this article identifies the Who’s (OIG, MAC, RAC, SMRC, CERT, and PEPPER), so you won’t feel like the third baseman “I Don’t Know.”

Office of Inspector General (OIG):

In June of 2017 the OIG began updating their once Annual Work Plan on a monthly basis. In an announcement they indicated that the Work Planning Process is “dynamic and adjustments are made throughout the year to meet priorities and to anticipate and respond to emerging issues with the resources available. You can learn more about the work plan, recently added items, all active work plan items and a work plan archive on the OIG website. You can access the Work Plan on the OIG website.

Medicare Administrative Contractors (MACs):

In October 2017, CMS implemented a Target Probe and Educate (TPE) Review Process for the MACs. With this type of approach, MACs focus on providers/suppliers who have the highest claim error rates or billing practices that vary significantly from their peers. In general, MACs will post a current Active Medical Log to their website. Depending on the MAC, this can sometimes be a challenge to find.

At this time, due to the ongoing COVID-19 Pandemic, TPE Reviews are on hold. However, MACs are conducting Post-Payment Reviews. Similar to TPE Reviews, MACs have been posting their post-payment review targets and audit findings to their websites.

If you are unsure of who your MAC is, you can find out on the CMS MAC Website List webpage.

Recovery Audit Program (RACs)

The RACs review claims on a post-payment basis. CMS maintains a RAC webpage where you will find links to each of the RACs across the country, Proposed Topics and Approved RAC Topics for review. A few of their current Approved Topics includes Total Knee Arthroplasty, Polysomnography, and Implantable Automatic Defibrillators (ICDs) medical necessity and documentation requirements reviews.

Supplemental Medical Review Contractor (SMRC)

The SMRC performs reviews at the direction of CMS with the aim of lowering improper payment rates.

On February 13, 2018 CMS announced that Noridian Healthcare Solutions, LLC, was awarded the new $227 million contract. Similar to the RACs, one of the current projects for Noridian is polysomnography. They are also conducting a medical review of COVID-19 claims in response to the 20% add on payment as a result of the Coronavirus Aid, Relief, and Economic Security (CARES) Act enacted on March 27, 2020.

The Comprehensive Error Rate Testing (CERT) Program

CMS implemented the CERT program to measure improper payments in the Medicare Fee-for-Service program. Annually, the CERT selects a stratified random sample of approximately 50,000 claims submitted to Part A/B MACs and Durable Medical Equipment MACs (DMACs) for review. It is important to keep in mind that the CERT reports a measurement of payments not meeting Medicare requirements and is not a “fraud rate.”

Every year an Annual Report and Report Appendices is published on the CERT CMS webpage. Reviewing these reports can help you identify high error prone case types. For example, in the 2020 Medicare Fee-for-Service Supplemental Improper Payment Data, the top four service types with highest improper payments in the hospital inpatient setting included:

• Major Hip and Knee Joint Replacement or Reattachment of Lower Extremity (MS-DRGs 469 and 470),
• Endovascular Cardiac Valve Replacements (MS-DRGs 266, and 267),
• Spinal Fusion Except Cervical (MS-DRGs 459 and 460), and
• Percutaneous Intracardiac Procedures (MS-DRGs 273 and 274).

Beneficiary and Family Centered Care Quality Improvement Organizations (BFCC-QIOs)

In 2015, CMS made the decision to move Short Stay reviews from the MACs to the BFCC-QIOs. These reviews are for hospital inpatient admissions with a length of stay less than two midnights and focus on ensuring doctors and hospitals are following the Part A payment policy for inpatient admission. Effective May 8, 2019, CMS temporarily suspended Short Stay reviews to find one contractor to perform Short Stay and Higher Weighted DRG (HWDRG) reviews. To date, CMS has not announced who this will be. In the meantime, you can find out who your BFCC-QIO is at this website: https://qioprogram.org/contact.

Program for Evaluating Payment Patterns Electronic Report (PEPPER)

The PEPPER is an electronic data report containing a single hospital’s claims data statistics for MS-DRGs and discharges at risk for improper payment due to billing, coding and/or admission necessity issues. Each report compares a hospital to their state, MAC Jurisdiction and the nation. “The Office of Inspector General encourages hospitals to develop and implement a compliance program to protect their operations from fraud and abuse. As part of a compliance program, a hospital should conduct regular audits to ensure charges for Medicare services are correctly documented and billed. The Program for Evaluating Payment Patterns Electronic Report (PEPPER) can help guide the hospital’s auditing and monitoring activities.” In general, a hospital’s Quality Department can provide the report to key departments (i.e. Case Management and HIM).

MMP’s Protection Assessment Report (PAR)

In January of 2017, the OIG, in collaboration with a group of compliance professionals, released a Resource Guide to measure the effectiveness of compliance programs.  Items 5.27-5.36 emphasize that a Risk Assessment is key to developing an effective Compliance audit/work plan.  As you can see from the list of Contractors above, the number of Medicare risk areas to consider can be overwhelming and the financial risk is great.

Medical Management Plus, Inc. (MMP) can help.  Our proprietary Protection Assessment Report incorporates current OIG, MAC, RAC, SMRC, CERT, and PEPPER risk areas into one report. Working closely with RealTime Medicare Data (RTMD), hospital specific Medicare fee-for-service paid claims data (volume, charges and payments) for risk areas is included in this report. If you are interested in learning more about this Report, please contact us using the form below or 205-941-1105.

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This week we highlight key updates spanning from March 16th through 22nd of 2021.

March 15, 2021: FDA Launches COVID-19 Adverse Events Reporting System (FAERS) Public Dashboard

The FDA has launched this dashboard with the intent to make adverse event data publically available. In the Public Dashboard announcement, the FDA does note that there are limitations to the data. “For example, while FAERS contains reports on a particular drug or biologic, this does not mean that the drug or biologic caused the adverse event.”

March 16, 2021: CDC Updates Regarding SARS-CoV-2 Variants

The CDC updated their SARS-CoV-2 Variants webpage. Multiple variants have now been detected and a US government interagency group has developed a Variant Classification scheme to define the three classes of variants:

• Variant of Interest,
• Variant of concern, and
• Variant of High Consequence.

To date, California has seen two variants of concern (B.1.427 and B.1.429). Both of the variants may be about 20 percent more transmissible.

https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/variant-surveillance/variant-info.html

Two variants in California are now considered “variants of concern”

March 17, 2021:  American Rescue Plan (ARP) Act of 2021 Funding for COVID-19

President Biden signed the ARP Act into law on March 11, 2021. The following list highlights how some of the $1.9 trillion will be allocated to continue the fight against COVID-19:

• $10 billion will be used to ramp up screening testing to help schools reopen,
• $2.25 billion to scale up testing in underserved populations, and provide new guidance on asymptomatic screening testing in schools, workplaces, and congregate settings, and
• $255 million for the production and delivery of 50 million Abbot BinaxNOW rapid point-of-care antigen tests for COVID-19 to support continued screening testing in long-term care facilities.

You can read more about where funding is being allocated in a March 17, 2021 HHS Press Release. 

March 17, 2021: First SARS-CoV-2 Diagnostic Test Permitted to be Marketed beyond the Public Health Emergency

The FDA announced that the BioFire Respiratory Panel 2.1 (RP2.1) has been granted marketing authorization using the De Novo premarket review pathway. The BioFire Respiratory Panel is “a diagnostic test for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of COVID-19 and other respiratory tract infections.” This test is for use in patients suspected of respiratory tract infections, including COVID-19.

March 18, 2021: CPT Codes Inadvertently Added to Telehealth Services

The 2021 Physician Fee Schedule final rule was issued on December 1, 2020. A related CMS Fact Sheet indicates that CMS finalized a third temporary category of criteria for adding services to the list of Medicare telehealth services. “Category 3 describes services added to the Medicare telehealth list during the public health emergency (PHE)…for the COVID-19 pandemic that will remain on the list through the calendar year in which the PHE ends.”  CMS published final and interim final rule corrections in the March 18, 2021 Federal Register. Specific to the Category 3 list, CMS notes that the following four CPT codes were “inadvertently” added to the services for temporary addition to telehealth services list:

• CPT code 96121: Neurobehavioral Status Examination,
• CPT code 99221: New or established patient initial hospital inpatient care services,
• CPT code 99222: New or established patient initial hospital inpatient care services, and
• CPT code 99223: New or established patient initial hospital inpatient care services.

March 18, 2021: FDA Revises Fact Sheets to Address SARS-CoV-2 Variants for Monoclonal Antibody Products under EUA

The FDA announced revisions to health care provider fact sheets “to include additional information on the susceptibility of SARS-CoV-2 variants to each of the monoclonal antibody (mAb) therapies that are available through an Emergency Use Authorization (EUA) treatment of COVID-19.” Specifically, fact sheets for Bamlanivimab, Bamlanivimab and Etesevimab and REGEN_COV (Casirivimab and Imdevimab) has been revised.

March 19, 2021: U.S. House Passes Bill to Extend Halt on Sequestration

The Budget Control Act of 2011 included a 2.00% across-the-board sequestration reduction to Medicare Fee-for-Service claims payments. The Coronavirus Aid, Relief, and Economic Security (CARES) Act suspended this payment adjustment from May 1, 2020 through December 31, 2020. Subsequently, the Consolidated Appropriations Act, 2021 that was signed into law on December 27, 2020 extended this suspension to March 31, 2021. Now, as we are closing in on the end of March, the U.S. house has passed House Resolution (HR) 1868 that would extend this extension to December 31, 2021.

MLN Matter Article MM12175 was released March 9th and highlights changes in related CR12175 that have an effective date of April 1, 2021 and an implementation date of April 5, 2021. Following is a list of changes effective April 1st along with what you need to know:

Revised APC Assignments for Pfizer-BioNTech and Moderna COVID-19 CPT Administration Codes - What you need to know:

The APC assignments for the administration codes are being reassigned.

• CPT codes 0001A (Pfizer Administration/Immunization code – first dose) and 0011A (Moderna Administration/Immunization code – first dose) from APC 1492 to APC 9397, and
• CPT codes 0002A (Pfizer Administration/Immunization code – second dose) and 0012A (Moderna Administration/Immunization code – second dose) from APC 1493 to APC 9398.

You will find a link to Table 1 of CR 12175 that lists the APC titles for the two new COVID-19 vaccine administration codes in this article.

Janssen/Johnson & Johnson COVID-19 Vaccine and Vaccine Administration Code – What you need to know:

The American Medical Association (AMA) released 2 new CPT codes associated with this vaccine:

• CPT code 91303 – vaccine product code, and
• CPT cod 0031A – Administration/Immunization code.

The FDA issued an emergency use authorization (EUA) for this vaccine on February 27, 2021.

New Monoclonal Antibody Therapy Product Administration Codes – What you need to know:

Following is a list of new HCPCS codes for therapies that have been granted a EUA by the FDA and the effective date for the codes:

• M0239 and Q0239 established effective November 9, 2020 for bamlanivimab,
• M0243 and Q0243 established effective November 21, 2020 for casirivimab and imdevimab,
• M0245 and Q0245 established effective February 9, 2021 for bamlanivimab and etesevimab administered together.

The MLN article provides detail regarding payment for a monoclonal antibody product.

CPT Proprietary Laboratory Analyses (PLA) Coding Change Effective April 1, 2021 – What you need to know:

Six new PLA codes have been established by the AMA CPT Editorial Panel with an effective date of April 1, 2021. This article provides a link to the table of new codes, which includes the code, long descriptor of the code and the OPPS Status Indicator (SI) for each code.

New HCPCS Codes – What you need to know:

The following two new HCPCS codes were established and are effective April 1, 2021:

• HCPCS code C9776: describes the application of intraoperative near-infrared fluorescence imaging using indocyanine green on the extrahepatic ducts. The administration of this is associated with laparscopy cholecystectomy, and
• HCPCS code C9777: describes the technology associated with esophageal mucosal integrity testing by Electrical Impedance.

Drugs, Biologicals, and Radiopharmaceuticals – What you need to know:

• Three new HCPCS codes have been created and are effective April 1, 2021 for reporting drugs and biologicals in the hospital outpatient setting where there was no specific code available.
• C9074 – Injection, lumasiran, 0.5 mg (Status Indicator G and APC 9407),
• J7212 – Factor viia (antihemophilic factor, recombinant)-jncw (sevenfact), 1 microgram (Status Indicator G and APC 9395), and
• Q5122 – Injection, pegfilgrastim-apgf, biosimilar, (nyvepria), 0.5 mg (Status Indicator G and APC 9406).
• 10 HCPCS codes will have their pass-through status end on March 31, 2021. Table 11 of CR 12175 lists these codes and can be linked to from the MLN article. Effective April 1, 2021, the status indicator for all 10 HCPCS codes will change from G to K.
• Seven new drug, biological, and radiopharmaceutical HCPCS codes have been established with an effective date of April 1, 2021. These codes are listed in Table 12 of CR 12175.
• Two drug, biological, and radiopharmaceutical HCPCS codes will be deleted April 1, 2021:
• J7333 – Hyaluronan or derivative, visco-3, for intra-articular injection, per dose, and
• J7401 – Mometasone furoate sinus implant, 10 micrograms.
• HCPCS code Q5122 (injection, pegfilgrasim-apgf, biosimilar, (Nyveprio), 0.5 mg) status indicator for January 1, 2021 through March 31, 2021 will be changed retroactively from E2 to K in the April I/OCE.

Drugs and Biologicals with Payments Based on Average Sale Price (ASP)

“Effective April 1, 2021, payment rates for many drugs and biologicals will change from the values published in the CY 2021 OPPS/ASC final rule with comment period as a result of the new ASP calculations based on sales price submissions from the third quarter of CY 2020. In cases where adjustments to payment rates are necessary, they will be incorporated into the April 2021 Fiscal Intermediary Shared System (FISS) release. We are not publishing updated payment rates in this CR implementing the April 2021 OPPS update. However, the updated payment rates effective April 1, 2021, are in the April 2021 update of the OPPS Addendums A and B.”

Note, this MLN article also includes additional changes to specific HCPCS codes (i.e. changes to the long descriptor of a code and status indicator changes/corrections). I encourage key stakeholders in your facility to read MLN MM12175 and Change Request 12175.