Knowledge Base Category -

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.”

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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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.

This week we highlight key updates spanning from March 10th through 15th of 2021.

Resource Spotlight: Long COVID Alliance

The Long COVID Alliance began in 2020 with a group of 21 science, post-viral disease and patient advocacy organizations calling for the government to invest in Long COVID research. To date 50+ partners have joined this alliance. Why is this collective so important? Long COVID also known as Post-acute COVID-19 syndrome, Long Haulers, Long-term COVID-19, or LTC-19 as a group, have lingering symptoms and has to date impacted 3.2 million Americans. In fact, “these symptoms persist in an estimated 25-35% of COVID-19 patients, regardless of infection severity, even after the patient no longer tests positive for the virus or antibodies…Long COVID generally refers to cases where symptoms continue to persist for 90 days or more.” I encourage you to check out the Alliance’s website to learn about their goals, and the impact to date that their efforts have made.

March 10, 2021: Trust for America’s Health Ready or Not 2021 Report

The Trust for America’s Health (TFAH) “develops reports and other resources and initiatives, and recommends policies, to advance an evidence-based public health system that is ready to meet the challenges of the 21st century.” On March 10th, TFAH released the report, Ready or Not 2021: Protecting the Public's Health Against Diseases, Disaster and Bioterrorism, measuring states’ performance on specific indicators. John Auerbach, President and CEO of TFAH is quoted in the announcement about this report that “The importance of this report is that it gives states actionable data to adopt policies that save lives. The COVID-19 crisis shows that we have much more work to do to protect Americans from health threats, particularly in the ways in which structural racism create and exacerbate health risks within communities of color. States need to take aggressive steps to shore up their preparedness for all types of public health emergencies.”

March 10, 2021: CMS Revises Nursing Home Visitation Recommendations

CMS has updated the September 17, 2020 memorandum titled Nursing Home Visitation – COVID-19. Revisions include new guidance for visitation in nursing homes during the COVID-19 Public Health Emergency (PHE), including the impact of COVID-19 vaccination. First and foremost, the Core Principles of COVID-19 Infection Prevention remains in place. The first principle has been updated to now include denial of entry to a facility for “those who have had close contact with someone with COVID-19 infection in the prior 14 days (regardless of the visitor’s vaccination status).” You can also read more about the revisions in a related CMS Fact Sheet.

March 11, 2021: HHS News: Vaccine Program Expanded to 950 Community Health Centers

HHS announced in this Press Release that an additional 700 Health Resource and Services Administration (HRSA) supported health centers are to be invited to join the Health Center COVID-19 Vaccine Program. These 700 centers “serve high proportions of low-income and minority patients, provides services to rural or frontier populations, operate Tribal/Urban Indian Health Programs, and/or utilize mobile vans to deliver services.” 

March 11, 2021: Adults 18 and over Eligible for Vaccination no later than May 1st

President Biden announced in his first Prime Time speech to the nation that “All adult Americans will be eligible to get a vaccine no later than May 1. That's much earlier than expected. Let me be clear. That doesn't mean everyone's going to have that shot immediately, but it means you'll be able to get in line beginning May 1. Every adult will be eligible to get their shot, and to do this, we're going to go from a million shots a day that I promised in December before I was sworn in to beating our current pace of two million shots a day, outpacing the rest of the world.”

March 12, 2021: Emergency Use Authorization (EUA) for Propofol-Lipuro

The FDA’s March 12th COVID-19 Update Bulletin included the announcement of an EUA for Propofol-Lipuro 1% injection emulsion for use in patients older than 16 requiring sedation via continuous infusion who are in an intensive care unit on mechanical ventilation. The FDA notes that “Propofol-Lipuro 1% injectable emulsion for infusion is not FDA-approved and has important differences in its formulation compared to FDA-approved propofol drugs; providers should consult the Health Care Provider Fact Sheet for more information before administering it.”

March 12, 2021: Palmetto GBA Article – COVID-19 Laboratory Test Place of Service Limitation

Included in Palmetto GBA’s March 12, 2021 Daily Newsletter was an article indicating that “CMS has directed Medicare Administrative Contractors (MACs) to make any necessary Part B claim editing changes to ensure the following COVID-19 laboratory tests when billed with place of service 19 (off-campus outpatient hospital), 21 (inpatient hospital), 22 (on-campus outpatient hospital), or 23 (emergency room-hospital) are denied.”

March 15, 2021: OIG COVID-19 Portal Redesign

The OIG announced that their COVID-19 Portal has been redesigned and features additional resources, including a searchable list of their COVID-19 reports and downloadable graphics.

March 15, 2021: CMS Increases Medicare Payment for Administering COVID-19 Vaccine

CMS announced in a Press Release that the payment amount for administering the COVID-19 is increasing and noted that “this new and higher payment rate will support important actions taken by providers that are designed to increase the number of vaccines they can furnish each day.” Effective for COVID-19 vaccines administered on or after March 15, 2021, the national average payment rate for physicians, hospitals, pharmacies and other immunizers is increasing from approximately $28 to administer each dose of the vaccine to $40.

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.

This week we highlight key updates spanning from March 2nd through 9th of 2021.

Resource Spotlight: CDC Guidance when You’ve Been Fully Vaccinated

The CDC has updated their guidance for when you have been fully vaccinated. Following is what has changed: If you’ve been fully vaccinated:

• “You can gather indoors with fully vaccinated people without wearing a mask.

• You can gather indoors with unvaccinated people from one other household (for example, visiting with relatives who all live together) without masks, unless any of those people or anyone they live with has an increased risk for severe illness from COVID-19.
• If you’ve been around someone who has COVID-19, you do not need to stay away from others or get tested unless you have symptoms.
• However, if you live in a group setting (like a correctional or detention facility or group home) and are around someone who has COVID-19, you should still stay away from others for 14 days and get tested, even if you don’t have symptoms.”

March 2, 2021: Merck and Johnson & Johnson COVID-19 Production Collaboration

An HHS Press Release details that that HHS will be coordinating with Merck to “repurpose some of its existing Merck facilities for rapid large-scale manufacturing of vaccines and therapeutics for use in public health emergencies included the current pandemic.” Janssen Pharmaceuticals will be the first federal partner to use these facilities to manufacture COVID-19 vaccines.

March 4, 2021: Alabama Safer at Home Order Extended until April 9, 2021 at 5 p.m.

On March 4th, Alabama Governor Kay Ivey once again extended the Safer at Home order. While the mask requirements did not change there are a few new changes to the order, for example:

• Hospitals and Nursing Homes: Subject to reasonable restrictions, patients and residents will be allowed visits from as many as two caregivers (up from one) or as many as two visitors (up from one) at a time and
• Senior Citizen Centers: Programs other than congregate meals may resume, but only outdoors and subject to guidelines by the Alabama Department of Senior Services. Meals still available by curbside pick-up or delivery.

March 4, 2021: COVID-19 Health Equity Task Force Meeting

HHS has filed a notice in the Federal Register to provide notice that the COVID-19 Health Equity Task Force is conducting a virtual meeting on Friday March 26, 2021 from approximately 12 p.m. to 3 p.m. ET. They do note the time is tentative and subject to change. The purpose of this meeting is to discuss equitable vaccine access and acceptance. The meeting is open to the public and will be live streamed at www.hhs.gov/live. Information about the meeting will be posted on the HHS Office of Minority Health website at www.minorityhealth.hhs.gov/healthequitytaskforce/.

March 4, 2021: MLN Connects – COVID Vaccine Resources for Hard to Reach Patients

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

“The COVID-19 pandemic is disproportionately affecting Medicare-Medicaid dually eligible individuals, racial and ethnic minority groups, and individuals with disabilities. You can help make sure hard to reach Medicare patients get COVID-19 vaccination information during this public health emergency.

More Information:

• CMS Office of Minority Health COVID-19 Resources on Vulnerable Populationswith fact sheets in multiple languages to assist organizations who work with those most vulnerable, such as older adults, those with underlying medical conditions, racial and ethnic minorities, rural communities, and people with disabilities
• CDC Communication Toolkitfor migrants, refugees, and other limited-English-proficient populations”

March 5, 2021: COVID-19 Scams

The OIG updated their Fraud Alert: COVID-19 Scams webpage to alert the public about fraudulent offers of COVID-19 tests, HHS grants, and Medicare prescription cards in exchange for personal details including Medicare information. “These scammers use the coronavirus pandemic to benefit themselves, and beneficiaries face potential harm. The personal information collected can be used to fraudulently bill federal health care programs and commit medical identity theft.”

March 5, 2021: First Molecular Non-Prescription, At-Home COVID-19 Test Granted Emergency Use Authorization

The FDA issued a EUA for Cue COVID-19 Test for Home and Over the Counter (OTC) Use. “Cue COVID-19 Test for Home and Over The Counter (OTC) Use test is authorized for non-prescription home use for the qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal (nasal) swab specimens collected with the Cue Sample Wand. This test is intended for use in adults (self-swabbing) or children two years of age or older (swabbed by an adult) with or without symptoms or other epidemiological reasons to suspect COVID-19.”

March 5, 2021: EUA for Adaptive Biotechnologies T-Detect COVID Test

The FDA announced in a bulletin the issuance of a EUA for the T-Detect COVID test developed by Adaptive Biotechnologies. The test can aid in identifying people with recent or prior infection with SARS-CoV-2 and “is indicated for use by qualified healthcare professionals on samples from individuals who are 15 days or more post-symptom onset.”

CDC COVID Data Tracker – United States COVID-19 Cases

I was first introduced to the concept of Clinical Documentation Improvement (CDI) in 1998. Fast forward to 2021 to CDI now being an acronym for Clinical Documentation Integrity (CDI). Put simply, CDI is a collaboration between Physicians, CDI Specialists, and Coding Professionals with an end goal of accurately telling the patient’s story. On the Physicians end, the story is told through what he or she documents in the medical record. The CDI Specialist works as a bridge between the Physician and the Coding Professional who interprets documentation and tells the story through codes (ICD-10-CM, ICD-10-PCS, CPT, etc.).

On February 24, 2021, the OIG released a Data Brief titled Trend Toward More Expensive Inpatient Hospital Stays in Medicare Emerged Before COVID-19 and Warrants Further Scrutiny. Hospitals and more specifically Physicians, CDI Specialists and Coding professionals should be aware that the OIG is calling into question the story that is being told about patient hospitalizations across the country. This is evident by the Data Brief’s three takeaways:  

• Hospitals increasingly billed for inpatient stays at the highest severity level – the most expensive level – from FY 2014 through FY 2019.
• There are indications that these stays are vulnerable to inappropriate billing practices, such as upcoding.
• We recommend that CMS conduct targeted reviews of MS-DRGs and stays that are vulnerable to upcoding, as well as the hospitals that frequently bill for them.

Key OIG Findings by the Numbers

The OIG reviewed inpatient hospital claims with dates of service from CMS Fiscal Year (FY) 2014 through FY 2019. Listed below are key findings that led the OIG to conclude that hospitals may be upcoding.

OIG Findings from FY 2014 to FY 2019

• There was an almost 20% increase in claims billed to Medicare Severity Diagnostic Related Groups (MS-DRGs) with a major co-morbidity or complication (MCC).
• The Average Length of Stay (ALOS) for this group of claims decreased while the overall ALOS remained fairly flat.

In general, MCC’s are diagnoses that when present, you would anticipate the need to use more resources to care for the patient and the patient would have a longer length of stay. For example, you would expect the patient admitted with simple pneumonia that develops acute respiratory failure (which is an MCC) would require more resources and remain in the hospital longer than the patient admitted and discharges with only simple pneumonia.

FY 2019 Specific OIG Findings:

• $3.5 million (40%) of claims were billed to MS-DRGs with an MCC,
• Medicare spent $109.8 billion for inpatient stays and nearly half of this amount ($54.6 billion) was for claims billed to MS-DRGs with an MCC,
• The MS-DRG severity split in FY 2019 was found to be
• 7% were MS-DRGs with MCC,
• 1% were MS-DRGs with CC,
• 5% were MS-DRGS with a CC or MCC, and
• 7% of the claims were for claims where an MCC or CC does not impact the MS-DRG assignment (i.e. MS-DRG 313 [Chest Pain] or MS-DRG 312 [Syncope]),
• The average payment for stays with an MCC was $15,500, and
• Septicemia or severe sepsis with an MCC (MS-DRG 871) was the most frequently billed MS-DRG in FY 2019 (581,000 claims). Medicare paid $7.4 billion to hospitals for this one MS-DRG.

Short Length of Stay Claims

For this data review, the OIG defined short stays as MS-DRGs with LOS 20% shorter than the geometric mean length of stay (GMLOS) for the MS-DRG. Certain discharge dispositions were also excluded where a short stay would be expected (patient expired, patient left against medical advice (AMA), patient transferred to another acute care facility or patient elected hospice care).

The OIG provides specific examples of MS-DRGs with MCC that were more likely to have a short LOS. Specifically, they found that a third of the claims billed to the following MS-DRGs were short stays:

• MS-DRG 193: Simple Pneumonia and Pleurisy with MCC,
• MS-DRG 291: Heart Failure and Shock with MCC, and
• MS-DRG 682: Renal Failure with MCC.

MS-DRGs with One MCC

Over half (54%) of the claims billed with an MCC in FY 2019 were assigned to an MS-DRG based one just one diagnosis designated as an MCC. The OIG notes in their data brief that “stays that reach the highest severity level because of one diagnosis are particularly vulnerable to upcoding. Previous OIG work has found that inappropriate billing of a single major complication can lead to significant Medicare overpayments. In addition, CMS states that a high amount of stays with a single major complication could indicate “over-coding” (i.e., upcoding) of the complications.”

Similar to short length of stay claims, the OIG provides specific examples of MS-DRGs with MCC that were more likely to have only one diagnosis designated as an MCC.

• Over 80% of claims billed to MS-DRG 689 (Kidney and Urinary Traction Infections with MCC) only had one MCC on the claim.
• Nearly 70% of the following three MS-DRGs had only one MCC on the claim:
• MS-DRG 190: Chronic Obstructive Pulmonary Disease with MCC,
• MS-DRG 193: Simple Pneumonia and Pleurisy with MCC, and
• MS-DRG 682: Renal Failure with MCC.

OIG Acknowledges Limitations of Study

The OIG does note their study was based on claims data and not medical record reviews. In saying that, they acknowledge that record reviews would be necessary to validate whether or not individual claims were inappropriately billed. Examples of specific factors considered by the OIG that may have impacted the data includes:

• The transition to ICD-10,
• The 2-midnight policy,
• Shifts of surgical procedures to the outpatient setting,
• Increases in efficiencies of care, and
• Advancements in technology.

However, they note that “None fully account for the trends described in the report. For example, the fact that the average length of all hospital stays largely remained the same undermines the idea that efficiencies of care or advancements in technology are driving factors. In addition, the billing trends described in this report began before the transition to ICD-10 in FY 2016 and continued well after, refuting that as a significant factor as well.”

There are a couple of things that I believe the OIG did not consider. First, is the Association for Clinical Documentation Integrity Specialists (ACDIS). This Association began on October 1, 2007 which coincided with the go-live date for the transition to the new MS-DRG system which brought about the advent of MCCs. Per the ACDIS Code of Ethics, Clinical documentation improvement specialists shall “Facilitate accurate, complete, and consistent clinical documentation within the health record to support coding and reporting of high-quality healthcare data.”

Speaking only for myself, I believe this group of dedicated professionals collaborating with and educating physicians has resulted in more accurate and complete medical record documentation. The end result being an increase in CMI and reimbursement that is not due to up-coding.

Another issue I believe the OIG did not consider is hospital coding productivity requirements. When discussing review findings with our clients, it is not uncommon that we are told that once they find an MCC or CC to impact the MS-DRG assignment, they do not continue to look for additional MCCs or CCs.

OIG Recommendations

As mentioned earlier in this article, the OIG is recommending that in general, CMS conduct targeted reviews of MS-DRGs and hospital stays that are vulnerable to upcoding, which they define as claims billed with an MCC and the hospitals that frequently bill them. More specifically, review targets should be directed at hospitals that bill MS-DRGs with the following characteristics:   

• MS-DRGs with an MCC with a short stay,
• MS-DRGs with only one MCC driving the MS-DRG assignment, and
• Specific MS-DRGs with MCC with a high proportion of stays that are a short stay and or only have one MCC driving the MS-DRG (i.e. MS-DRG 193: Simple Pneumonia and Pleurisy with MCC).

The OIG notes that in addition to using targeted review results to recoup overpayments, “CMS should use them to educate hospitals about appropriate billing, modify coding policies, and consider whether further steps should be taken to disincentivize inappropriate billing.”

CMS Response to Recommendations

CMS does not agree with the targeted reviews recommendations stating “that there is more work to be done to determine conclusively which changes in billing are attributable to upcoding. CMS also said that it would share our findings with its Recover Audit Contractors for their consideration in updating their strategies for reviewing MS-DRGs.”

MMP Recommendations Moving Forward

Hospitals should carefully read the story that this OIG Data Brief provides and find answers to the following questions:

• Has there been an increase in your short stays where the claim codes to an MS-DRG with an MCC? Is this true for your claims coding to MS-DRG 193 (Simple Pneumonia and Pleurisy with MCC), MS-DRG 291 (Heart Failure and Shock with MCC), and MS-DRG 682 (Renal Failure with MCC)?
• Do your claims coded to MS-DRGs with MCC only have one MCC? Is this true for your claims coding to MS-DRG 689 (Kidney and Urinary Tract Infections with MCC), MS-DRG 190 (Chronic Obstructive Pulmonary Disease with MCC), MS-DRG 193 (Simple Pneumonia and Pleurisy with MCC) and MS-DRG 682 (Renal Failure with MCC)?

While you can data mine internally to answer these questions. Do you know how you compare to other hospitals? If not, do you know where you can find answers?

PEPPER

One resource is the Short-Term Acute Care Program for Evaluating Payment Patterns Electronic Report or PEPPER. This report provides a hospital with a compare to their state, their Medicare Administrative Contractor (MAC) Jurisdiction and the nation for specific review targets “at risk for improper payment due to billing, coding, and/or admission necessity items.” Related to the OIG Data Brief, the PEPPER provides a compare of your discharges for MS-DRGs assigned on the bases of only one CC or MCC being coded on the claim.

RealTime Medicare Data

Another potential resource is our sister company, RealTime Medicare Data (RTMD). RTMD collects over 1.2 billion Medicare claims annually from 48 states and the District of Columbia, and allows for searching of over 10 billion historical claims and counting.

One report available in their suite of Inpatient Hospital reports is a One Day Stay Report. Similar to the OIGs definition of short stays, this report excludes claims with a discharge status for Expired (20), left against medical advice (07), hospice (50 & 51) and /or were transferred to another Acute care facility (02). This report enables a hospital to view one day stay paid claims data by DRG and Physician to direct where audits should be focused.

Another report available is a DRG Severity Report that can help you trend your mix of claims coded to MS-DRGs with MCC, with CC, and without CC/MCC respectively. This report provides a compare to your state, your defined market and specific hospitals within your defined market.

For further information on all that RTMD has to offer you can visit their website at https://rtmd.org.

This week we highlight key updates spanning from February 23rd through March 2nd, 2020.

Resource Spotlight: VaccineFinder

According to the CDC, “VaccineFinder is a free, online service where users can search for pharmacies and providers that offer vaccination. Information about where COVID-19 vaccines are available is provided directly by pharmacies and providers, in collaboration with states, and is updated daily. VaccineFinder is operated by Boston Children’s Hospital, in partnership with CDC.”

At this time VaccineFinder is launching in four states and will expand information for additional states in the coming weeks. If information is not yet available where you live, the CDC has advised that you visit your state health department’s website. Links to State and Territorial Health Department websites are available on the CDC website.  

February 24, 2021: FDA’s New Webpage: COVID-19 Vaccination & the Food and Agriculture Sector

The FDA launched this new webpage to provide information for the food and agriculture sector about the following:

• Safety and effectiveness of COVID-19 vaccines authorized for emergency use by the FDA,
• Benefits of COVID-19 vaccination, and
• Information about the availability of vaccines in your community.

February 25, 2021: FDA Flexibilities for Storing Pfizer-BioNTech COVID-19 Vaccine

In an FDA Bulletin, the FDA announced their decision to allow “undiluted frozen vials of the Pfizer-BioNTech COVID-19 Vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks.” This announcement includes an updated Fact Sheet for Health Providers Administering Vaccine.

February 26, 2021: FDA Vaccine Advisory Committee working towards Emergency Use Authorization for Janssen Biotech Inc. COVID-19 Vaccine

Acting Commissioner Janet Woodcock, M.D. and Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research announced in an FDA bulletin that “Following today’s positive advisory committee meeting outcome regarding the Janssen Biotech Inc. COVID-19 Vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified our federal partners involved in vaccine allocation and distribution so they can execute their plans for timely vaccine distribution.”

February 27, 2020: Janssen COVID-19 Vaccine Granted Emergency Use Authorization

A little over twenty four hours after the FDA’s Vaccine Advisory Committee met they published a bulletin announcing emergency use authorization for the Janssen COVID-19 vaccine for individuals 18 years of age and older. “The Janssen COVID-19 Vaccine is manufactured using a specific type of virus called adenovirus type 26 (Ad26). The vaccine uses Ad26 to deliver a piece of the DNA, or genetic material that is used to make the distinctive “spike” protein of the SARS-CoV-2 virus. While adenoviruses are a group of viruses that are relatively common, Ad26, which can cause cold symptoms and pink eye, has been modified for the vaccine so that it cannot replicate in the human body to cause illness. After a person receives this vaccine, the body can temporarily make the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.”

February 27, 2020: Johnson & Johnson COVID-19 Vaccine Press Release

Johnson & Johnson announced the EUA for their vaccine indicating that the “vaccine was 85 percent effective in preventing severe disease across all regions studies, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.” Unique to this COVID-19 vaccine, it is a single shot vaccine. Side effects that have been reported with the vaccine include:

• Injection site reactions: pain, redness of the skin, and swelling
• General side effects: headache, feeling very tired, muscle aches, nausea, and fever.

Johnson & Johnson indicates that the company has already started shipping the vaccine and “expects to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million people in the U.S.”

March 1, 2021: CMS COVID-19 Vaccines and Monoclonal Antibodies Webpage

CMS continues to add to this webpage as additional COVID-19 vaccines and certain monoclonal antibodies receive Emergency Use Authorization. On this page you will find tables for COVID-19 vaccines and monoclonal antibodies detailing the code, CPT descriptor, the vaccine/procedure name, payment allowance and effective dates. There is also a wealth of information available in the Additional Resources section. Most recently added is a Medicare Monoclonal Antibody COVID-19 Infusion Program Instruction download.  This webpage was last modified on March 1, 2021 to include information about the new Janssen COVID-19 vaccine by Johnson & Johnson. I encourage you to check this webpage often for updates.

March 1, 2021: Quidel QuickVue At-Home COVID-19 Test

The FDA issued a EUA for the Quidel QuickVue At-Home COVID-19 Test. Specifically, The QuickVue At-Home COVID-19 Test is authorized for prescription home use with self-collected anterior nasal (nares) swabs from individuals ages 14 and older or individuals ages 8 and older with swabs collected by an adult. The test is authorized for individuals suspected of COVID-19 by their healthcare provider within the first six days of symptom onset.”

March 2, 2021: CDC Call – What Clinicians Need to Know about Johnson & Johnson’s Janssen COVID-19 Vaccine

The CDC hosted a Clinical Outreach and Communication Activity (COCA) call on March 2nd to provide clinicians an overview of the J&J Janssen COVID-19 vaccine including vaccine characteristics and administration, vaccinating special populations, and contraindications. You can access call materials from this presentation on the CDC website. 

MEDICARE MLN ARTICLES & TRANSMITTALS – RECURRING UPDATES

April 2021 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files

• Article Release Date: February 23, 2021
• What You Need to Know: This article informs providers about the Average Sales Price (ASP) methodology, which is based on quarterly data manufacturers submit to CMS.
• MLN Article MM12133: https://www.cms.gov/files/document/mm12133.pdf

Quarterly Updated for the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP) – April 2021

• Article Release Date: February 23, 2021
• What You Need to Know: The DMEPOS CBP files are updated on a quarterly basis to implement necessary changes to HCPCS codes, ZIP codes, single payment amounts, and supplier files.
• MLN Article MM12128: https://www.cms.gov/files/document/mm12128.pdf

OTHER MEDICARE MLN ARTICLES & TRANSMITTALS

Review of Hospital Compliance with Medicare’s Transfer Policy with Resumption of Home Health Services & Other Information on Patient Discharge Status Codes

• Article Release Date: February 22, 2021
• What You Need to Know: CMS reminds providers that an accurate discharge status code is essential to assure proper payment under the Medicare Severity-Diagnosis Related Group (MS-DRG) payment system. Detailed information regarding the CMS Transfer Policy is included in this article.
• MLN Article SE21001: https://www.cms.gov/files/document/se21001.pdf

Billing for Services when Medicare is a Secondary Payer

• Article Release Date: February 23, 2021
• What You Need to Know: CMS details what to do if you think a claim was inappropriately paid and provides key reminders related to billing for services when Medicare is a secondary payer.
• MLN Article SE21002: https://www.cms.gov/files/document/se21002.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
• What You Need to Know: New HCPCS codes for 2021 that are subject to and excluded from CLIA edits are discussed in this article.
• MLN Article MM12131: https://www.cms.gov/files/document/mm12131.pdf

MEDICARE EDUCATIONAL RESOURCES

MLN Fact Sheet: Intravenous Immune Globulin (IVIG) Demonstration (Demonstration Ends on December 31, 2023)

The IVIG demonstration began in October 2014, has been extended twice, and is now set to end on December 31, 2023. This MLN Fact Sheet, dated February 2021, provides education on the IVIG demonstration and includes information on:

• Supplier eligibility and participation,
• Beneficiary eligibility and participation, and
• Billing and coding requirements.

OTHER MEDICARE UPDATES

Medicare Mid-Build Off-Campus Outpatient Department Exception Audit Results

On February 2nd CMS posted a webpage dedicated to their 21st Century Cures Act Mid-Build Audits. In overview, the Cures Act provided the criteria which off-campus departments of a provider must meet to comply with Mid-build exception requirements. CMS completed 334 provider audits that requested the mid-build exception. They found that 202 of the facilities failed to qualify for the exception. They note in the audit findings that “Providers that failed the mid-build exception audit and have been billing for the services provided by their off-campus provider-based departments under the OPPS, likely have received overpayments. Also, providers that have passed the mid-build exception audit and have not been billing for the services provided by their off-campus provider-based departments under the OPPS, likely have been underpaid.

CMS will issue audit determination letters to all affected providers on January 19, 2021. The letter will provide the final determination on meeting the exception, the appropriate point of contact information, and further instructions. The 21st Century Cures Act states that the mid-build exception audit determinations are final and may not be appealed.” The Audit Results and FAQ documents are available on this CMS webpage.

Improving Accuracy of Medicare Payments

CMS shared the following information in the Thursday February 4, 2021 Edition of MLN Connects:  

The U.S. Bureau of Labor Statistics (BLS) conducts numerous surveys of hospitals and health care providers that are used by the government to make economic decisions that affect the entire medical care system. Key users include CMS, the Federal Reserve Bank, and the U.S. Congress.  CMS uses these surveys to adjust Medicare Fee-for-Service payments each year, affecting approximately $300 billion in payments.

If you’re contacted by BLS, please participate in the survey to help ensure the data are as accurate as possible. Recently, many health care providers didn’t complete the survey, which can reduce the representativeness of the data and increase volatility in estimates. Your participation in these surveys helps address these issues and increase the validity of the data. Participation is voluntary, confidential, and the data are only used for statistical purposes.

More Information:

• BLS Survey Respondentswebpage
• BLS Confidentiality Pledge and Lawswebpage
• CMS Market Basket Datawebpage
• BLS Geographic Informationwebpage: Contact a BLS expert or get information on surveys, data, and reports”

February 22, 2021: OIG Report – $4 Million in improper payments for Spinal Facet-Joint Injections

The OIG found that 49 of 100 sampled claims were inappropriately paid by Noridian Healthcare Solutions, LLC to physicians in Jurisdiction E for spinal facet-joint injections. They note that improper payments occurred due to insufficient education to physicians and their billing staff. Based on their findings, the OIG estimated that $4.2 million was improperly paid to physicians. Recommendations for Noridian included recovering the $12,546 in improper payments found in the sampled claims, notify appropriate physicians so they can identify, report, and return any overpayments in accordance with the 60-day rule and provide annual training to physicians and their billing staff. You can read the entire report at https://oig.hhs.gov/oas/reports/region9/92003010.pdf.