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Medicare Educational Resources

MLN Education Tool: Medicare Payment Systems

CMS alerted readers in the Thursday, March 3, 2022 edition of MLN Connects (link) that the MLN education tool Medicare Payment Systems has been updated to include 2022 regulation changes to payment, quality, and policy across several settings (i.e., acute care hospital, skilled nursing facility, and home health).

MLN Booklet: SBIRT Services Updated

Screening, Brief Intervention, and Referral to Treatment (SBIRT) is an evidence-based, early intervention approach for people with non-dependent substance use before they need more extensive or specialized treatment. CMS SBIRT Booklet MLN904084 (link) was recently updated to inform providers that beginning January 1, 2022, CMS covers Naloxone HCPCS Code G1028.

COVID-19 Updates

February 28, 2022: CMS COVID-19 FAQs on Medicare Fee-for-Service Billing Documented Updated

This CMS document (link) includes FAQs for providers and suppliers that bill Medicare (i.e., labs, hospitals, ambulance services, physician services) and was last updated on February 28, 2022. Specifically, on February 16th, CMS updated the answer to the following question:

• Question: The FDA has expanded the approved indication for the antiviral drug Veklury (remdesivir), and it is now authorized for the treatment of COVID-19 in certain adults and pediatric patients who are not hospitalized in addition to those that are hospitalized. How will CMS pay for remdesivir if it is administered in the outpatient setting?

March 3, 2022: Preliminary Medicare COVID-19 Data Snapshot

Medicare most recently updated their Preliminary Medicare COVID-19 Data Snapshot webpage (link) on March 3rd. The data snapshot reports COVID-19 cases and hospitalization data for Medicare beneficiaries diagnosed with COVID-19. Following are highlights from this data release:

• There have been 1,636,501 total Medicare COVID-19 hospitalizations,
• Of those hospitalized, most beneficiaries (38%) were discharged home. The other top three discharge dispositions include home health (17%), skilled nursing facility (17%), and expired (17%),
• The top five chronic conditions among hospitalized beneficiaries includes hypertension (81%), hyperlipidemia (65%), chronic kidney disease (58%), ischemic heart disease (49%) and diabetes (48%),
• Total Medicare Fee-for-Service payment to date for COVID-19 hospitalizations is $23.4B, and
• The average payment per beneficiary hospitalization with COVID-19 is $24,304.

March 10, 2022: MLN Matters Notice Revised Emergency Use Authorization (EUA) for EVUSHELD

CMS published the following information about a revised EUA for the COVID-19 monoclonal antibody cilgavimab (EVUSHELD) in the March 10, 2022, edition of MLN Matters (link):

“On February 24, the FDA revised the emergency use authorization for tixagevimab co-packaged with cilgavimab (EVUSHELD™) to change the initial dose for the authorized use as pre-exposure prophylaxis of COVID-19 in certain adults and pediatric patients. For more information about dosage and administration, including information about dosing for patients who got the original lower dose, review the fact sheet (ZIP) (link).

• Long Descriptor: Injection, tixagevimab and cilgavimab, for the pre-exposure prophylaxis only, for certain adults and pediatric individuals (12 years of age and older weighing at least 40kg) with no known sars-cov-2 exposure, who either have moderate to severely compromised immune systems or for whom vaccination with any available covid-19 vaccine is not recommended due to a history of severe adverse reaction to a covid-19 vaccine(s) and/or covid-19 vaccine component(s), 600 mg
• Short Descriptor: Tixagev and cilgav, 600mg

Visit the COVID-19 Monoclonal Antibodies webpage for more information (link). Note: you may need to refresh your browser if you recently visited this webpage.”

March 22, 2022: 2019-Novel Coronavirus (COVID-19) Medicare Provider Enrollment Relief Frequently Asked Questions (FAQs)

On March 23rd, CMS updated their COVID-19 Current Emergencies webpage (link) by adding a COVID-19 Medicare Provider Enrollment Relief FAQs document (link). The first question in this document answers the question of how CMS is using its 1135 blanket waiver authority to offer flexibilities with Medicare provider enrollment to support the COVID-19 national emergency.

Other Updates

March 16, 2022: Annual Civil Monetary Penalties Inflation Adjustment Published

The Office of the Assistant Secretary for Financial Resources, Department of Health and Human Services (HHS) published the Annual Civil Monetary Penalties Inflation Adjustment Final Rule (link) on March 17, 2022. Examples of actions that can come under a civil monetary penalty includes:

• Penalty for knowing of an overpayment and failing to report and return.
• Penalty for failure to grant timely access to HHS OIG for audits, investigations, evaluations, and other statutory functions of HHS OIG.
• Penalty for a Medicare Advantage organization that substantially fails to provide medically necessary, required items and services.
• Penalty for improper billing by Hospitals, Critical Access Hospitals, or Skilled Nursing Facilities.

Medicare MLN Articles & Transmittals

The Supplemental Security Income (SSI)/Medicare Beneficiary Data for Fiscal Year (FY) 2020 for Inpatient Prospective Payment System (IPPS) Hospitals, Inpatient Rehabilitation Facilities (IRFs), and Long-Term Care Hospitals (LTCHs)

• Article Release Date: February 24, 2022
• What You Need to Know: This MLN article was revised to reflect a revised Change Request (CR) 12403. HCPCS G0465 was added and additional information for HCPCS G0460 was also added. Also, the implementation date has been revised to February 14, 2022.
• MLN MM12628: (link)

April 2022 Update to the Fiscal Year (FY) 2022 Inpatient Prospective Payment System (IPPS)

• Article Release Date: March 7, 2022
• What You Need to Know: This article provides information about coding needs and coding criteria for reprocessing inpatient claims involving Pfizer’s PAXLOVID™ or Merk’s Molnupiravir. Both drugs were granted FDA emergency use authorization in December 2021.
• MLN MM12631: (link)

One-Time Notification: Correction to Processing When Osteoporosis Drugs are Billed for Other Indications

• Transmittal Release Date: March 9, 2022
• What You Need to Know: This Change Request (CR) 12551 permanently removes an edit requiring osteoporosis drugs be billed only by home health agencies.
• Transmittal 11290 (CR 12551): (link)

April Quarterly Update for 2022 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule

• Article Release Date: March 11, 2022
• What You Need to Know: This article provides information about the April 2022 quarterly update for the DMEPOS fee schedule and fee schedule amounts for new and existing codes.
• MLN MM12654: (link)

Quarterly Update to the End-Stage Renal Disease Prospective Payment System (ESRD PPS)

• Article Release Date: March 18, 2022
• What You Need to Know: Make sure your billing staff knows about how to code for difelikefalin injection and modifier use for code J0879.
• MLN MM12583: (link)

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

• Transmittal 11305/Change Request 12666 Release Date: March 24, 2022
• What You Need to Know: The effective date for the updates is April 1, 2022. Examples of items included in this update are:
• o New COVID-19 CPT vaccines and administration codes,
• o Changes for COVID-19 monoclonal antibody therapy product and administration codes,
• o A new HCPCS code describing the InSpace Subacromial Tissue Spacer System procedure to treat irreparably torn rotator cuff tendons, and
• o New separately payable procedure codes for medical procedures.
• Link to CR 12666: (link)

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

• Article Release Date: March 24, 2022
• What You Need to Know: Changes to make your billing staff aware of (updates to payment rates for separately payable procedures, services, drugs, and biologicals and descriptors for newly created CPT and Level II HCPCS codes) are detailed in this MLN article.
• MLN MM12679: (link)

Revised Medicare MLN Articles & Transmittals

Internet-Only Manual Updated for Critical Care Evaluation and Management Services

• Article Release Date: Initial article January 22, 2022 – Revised March 2, 2022
• What You Need to Know: This article was revised to reflect a revised Change Request (CR). All other information is the same. As a reminder, CMS has added language to the definition of a Global Surgical Package to direct you to critical care updates in section 30.6.12.7 of the Medicare Claims Processing Manual, Chapter 12.
• MLN MM12550: (link)

Coverage Updates

Revisions to National Coverage Determination (NCD) 240.2 (Home Use of Oxygen) and 240.2.2 (Home Oxygen Use for Cluster Headache)

• Article Release Date: February 16, 2022
• What You Need to Know: You will learn about revisions to NCD 240.2 and 240.2.2. For example, CMS notes that “Medical documentation requirements aren’t contained within the revised NCDs. The absence of medical documentation in these revised NCDs doesn’t otherwise remove or modify Medicare requirements of the Certificate of Medical Necessity (CMN) Form 484 itself or other medical documentation requirements under other existing authorities.”
• MLN MM12607: (link)

March 1, 2022: CMS Posts New Tracking Sheet for the Cochlear Implantation NCD (50.3)

According to a new Tracking Sheet link), “this NCD analysis will align with the scope of the request and focus on individuals with hearing test scores of > 40% and ≤ 60%, for whom coverage is available only when the provider is participating in, and patients are enrolled in a clinical study.” The initial public comment period is from March 1, 2022, to March 31, 2022.

Medicare MLN Articles & Transmittals – Recurring Updates

Expedited Review Process for Hospital Inpatients in Original Medicare

• Article Release Date: January 21, 2022
• What You Need to Know: CMS has reformatted the current instructions for delivery of the Important Message from Medicare (IMM) and the beneficiary’s rights to an expedited review. While this MLN article notes in bold to “make sure your staff knows this is a reformatting of the current instructions and there are no policy or instructional changes,” following are three noteworthy clarifications:
• The effective date for the related Change Request is April 21, 2022.
• A new exception of who you would not provide an IMM to is the beneficiary that ends care on their own initiative by electing the hospice benefit.
• A new note indicates “the IM should only be given when an inpatient admission is pending or has occurred. It should not be given ‘just in case,’ such as a hospital delivering to all Medicare patients being treated in a hospital emergency room.”
• CMS has included a statement that “an IM must be delivered even if the beneficiary agrees with the discharge.”
• MLN MM12546: (link)

Internet-Only Manual Updates for Critical Care Evaluation and Management Services

• Article Release Date: January 22, 2022
• What You Need to Know: You will learn about critical care updates for a patient in a global surgical period and the use of modifier FT.
• MLN MM12550: (link)

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

• Article Release Date: January 27, 2022
• What You Need to Know: This article provides instructions for the April 2022 update to the CLFS and new codes effective April 1, 2022.
• MLN MM12612: (link)

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

• Article Release Date: February 10, 2022
• What You Need to Know: This article provides information about newly available codes, separate NCD coding revisions, and coding feedback.
• MLN MM12606: (link)

Gap Billing Between Hospice Transfers

• Article Release Date: February 10, 2022
• What You Need to Know: A new CWF edit will no longer allow gaps of care to occur during a transfer.
• MLN 12619: (link)

Omnibus Change Request to Remove Two NCDs, Updates Medical Nutritional Therapy Policy and Updates to Pulmonary Rehabilitation, (PR), Cardiac Rehabilitation (CR), and Intensive Cardiac Rehabilitation (ICR) Conditions of Coverage

• Change Request 12613/Transmittal 11272 Release Date: February 18, 2022
• What You Need to Know: Updates became effective January 1, 2022, by statute with an implementation date of July 5, 2022. Specific to PR, the CY 2022 MPFS final rule removed the requirements for direct physician-patient contact and expanded coverage of PR for beneficiaries with confirmed or suspected COVID-19 and experience persistent symptoms that include respiratory dysfunction for at least 4 weeks. The two NCDs being removed are:
• NCD 180.2 Enteral/Parenteral Nutritional Therapy, and
• NCD 220.6 Positron Emission Tomography (PET) Scans.
• Transmittal 11272: (link)

Revised Medicare MLN Articles & Transmittals

April 2022 Update to the MS-DRG Group and Medicare Code Editor Version 39.1 for ICD-10 Diagnosis Codes for 2019 COVID-19 Vaccination Status and ICD-10-PCS codes for Introduction or Infusion of Therapeutics and Vaccines for COVID-19 Treatment

• Article Release Date: Initial article January 19, 2022 – Revised February 8, 2022
• What You Need to Know: This article was revised to add two new procedure codes describing the introduction or infusion of therapeutics including vaccines for COVID-19 treatment, effective April 1, 2022.
• MLN MM12578: (link)

Coverage Updates

National Coverage Determination (NCD) 270.3 Blood-Derived Products for Chronic, Non-Healing Wounds

• Article Release Date: September 15, 2021 – Latest Revision January 24, 2022
• What You Need to Know: This MLN article was revised to reflect a revised Change Request (CR) 12403. HCPCS G0465 was added and additional information for HCPCS G0460 was also added. Also, the implementation date has been revised to February 14, 2022.
• MLN MM12403: (link)

CWF Editing – NCD 270.3 Blood-Derived Products for Chronic, Non-Healing Wounds

• Article Release Date: February 16, 2022
• What You Need to Know: This article provides information about new edits for autologous Platelet-Rich Plasma (PRP) claims for diabetes and chronic ulcers.
• MLN MM12611: (link)

Final Decision Memo: Screening for Lung Cancer with Low Dose Computed Tomography (LDCT)

CMS posted a Final Decision Memo ((link) for Lung Cancer Screening with LDCT on February 10, 2022. The eligibility age for screening has decreased from 55 years to 50 years. The tobacco smoking history has decreased from thirty packs per year to at least twenty packs per year. Counseling and shared decision-making are required prior to a beneficiary’s first screening test. Shared Decision Making (SDM) shall “include the use of one or more decision aids, to include benefits and harms of screening, follow-up diagnostic testing, over-diagnosis, false positive rate, and total radiation exposure.”

COVID-19 Updates

January 31, 2022: FDA Approves Second COVID-19 Vaccine

The FDA announced the approval of a second COVID-19 vaccine ((link). The vaccine under emergency use authorization has been known as the Moderna COVID-19 vaccine. The approved vaccine will be marketed as Spikevax. Spikevax has the same formulation as the EUA Moderna COVID-19 Vaccine and is administered as a primary series of two doses, one month apart.

February 18, 2022: FDA Authorized Monoclonal Antibody Bebtelovimab

CMS announced in a special edition of MLN Connects ((link) that the FDA has approved the monoclonal antibody Bebtelovimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients when specific criteria apply. CMS has created three new codes for administering this drug. You can find information about this and other monoclonal antibody drugs on the CMS COVID-19 Monoclonal Antibodies webpage (link).

Other Updates

February 1, 2022: DOJ News: False Claims Act Settlements and Judgements Exceed $5.6 Billion in Fiscal Year 2021

In this DOJ announcement ((link) the DOJ reports that over $5 billion of the more than $5.6 billion in settlements in the past fiscal year related to matters involving the health care industry, “including drug and medical device manufacturers, managed care providers, hospitals, pharmacies, hospice organizations, laboratories and physicians.”

Medicare MLN Articles & Transmittals – Recurring Updates

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

• • Article Release Date: January 18, 2022
• • What You Need to Know: This article provides information about CY 2022 changes to travel allowances when you bill on a per mileage basis and on a flat rate basis.
• • MLN MM12593: https://www.cms.gov/files/document/mm12593-clinical-laboratory-fee-schedule-medicare-travel-allowance-fees-collection-specimens.pdf

Internet-Only Manual Updates (IOM) for Critical Care, Split/Shared Evaluation and Management Visits, Teaching Physicians, and Physician Assistants

• • Article Release Date: January 18, 2022
• • What You Need to Know: You will learn about Medicare manual revisions for critical care services, split/shared E&M visits, teaching physician services and physician assistant billing and payment.
• • MLN MM12543: https://www.cms.gov/files/document/mm12543-internet-only-manual-updates-iom-critical-care-split-shared-evaluation-and-management-visits.pdf

New Waived Tests

• • Article Release Date: January 18, 20221
• • What You Need to Know: You will learn about the latest tests approved by the FDA as waived tests under CLIA, laboratory claim edits, and facility certification requirements.
• • MLN MM12581: https://www.cms.gov/files/document/mm12581-new-waived-tests.pdf

CY 2022 Telehealth Update Medicare Physician Fee Schedule

• • Article Release Date: January 19, 2022
• • What You Need to Know: There are two additional modifiers for CY 2022 for telehealth services and this article includes a link to the updated telehealth services list.
• • MLN MM12549: https://www.cms.gov/files/document/mm12549-cy2022-telehealth-update-medicare-physician-fee-schedule.pdf

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

• • Article Release Date: January 20, 2022
• • What You Need to Know: You will learn about discontinued and new HCPCS codes and which codes are subject to and excluded from CLIA edits.
• • MLN MM12573: https://www.cms.gov/files/document/mm12573-healthcare-common-procedure-coding-system-hcpcs-codes-subject-and-excluded-clinical.pdf

Expedited Review Process for Hospital Inpatients in Original Medicare

• • Article Release Date: January 21, 2022
• • What You Need to Know: CMS has reformatted the manual section of chapter 30 of the Medicare Claims Processing Manual to improve “readability and understanding.” CMS makes a point to note in bold font that no policy or instructional changes have been made.
• • MLN MM12546: https://www.cms.gov/files/document/mm12546-expedited-review-process-hospital-inpatients-original-medicare.pdf

Revised Medicare MLN Articles & Transmittals

International Classification of Diseases, 10th revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs) – April 2022 (CR 1 of 2)

• • Article Release Date: Initial article November 1, 2021 – Revised January 13, 2022
• • What You Need to Know: The CR release date, transmittal number, and the web address of the CR has been updated. The revisions did not affect the substance of the article.
• • MLN MM12480: https://www.cms.gov/files/document/mm12480-international-classification-diseases-10th-revision-icd-10-and-other-coding-revisions.pdf

Calendar year (CY) 2022 Annual Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment

• • Article Release Date: Initial article December 13, 2021 – Revised January 13, 2022
• • What You Need to Know: This article was revised to show the delay in the CLFS data reporting period for clinical diagnostic lab tests and note the delay in the application of the 15% phase-in reduction.
• • MLN MM12558: https://www.cms.gov/files/document/mm12558-calendar-year-cy-2022-annual-update-clinical-laboratory-fee-schedule-and-laboratory-services.pdf

Medicare Coverage Updates

January 11, 2022: Proposed Decision Memo for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease

CMS published a Proposed Decision Memorandum (https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&ncaid=305&fromTracking=Y&)88 in which they are proposing to cover FDA approved monoclonal antibodies that target amyloid for the treatment of Alzheimer’s disease through Coverage with Evidence Development (CED). The public comment period is from January 11, 2022 through February 20, 2022. You can read more about this proposed policy in a related CMS Press Release (https://www.cms.gov/newsroom/press-releases/cms-proposes-medicare-coverage-policy-monoclonal-antibodies-directed-against-amyloid-treatment)88.

Medicare Educational Updates

CMS MLN Fact Sheet: Original Medicare vs. Medicare Advantage

This MLN Fact Sheet (https://www.cms.gov/files/document/mln8659122-original-medicare-vs-medicare-advantage.pdf)88 describes what providers need to know about how different coverage affects seeing patients, processing claims and filing appeals.

January 5, 2022: CDC Expands Booster Shot Eligibility for 12-17 Year Old’s

The CDC announced in a newsroom release (link), they are endorsing the Advisory Committee on Immunization Practices’ (ACIP) recommendation to expand eligibility of booster doses to those 12 to 15 years old. They are also recommending that those 12 to 17 years old should receive a booster shot 5 months after their initial Pfizer-BioNTech vaccination series.

January 7, 2022: New HCPCS Code for Remdesivir Antiviral Medication

CMS issued a Special Edition MLN Connects (link) to let providers know they had created a HCPCS code J0248 for VEKLURY™ (remdesivir) antiviral medication when administered in the outpatient setting. This code is available for use by all payers and is effective for dates of service on or after December 23, 2021. They note that the MACs will determine Medicare coverage for HCPCS code J0248 administered in the outpatient setting and the MACs will be sharing coverage and claims processing information for this code.

December 31, 2021: CDC Health Advisory – Using Therapeutics to Prevent and Treat COVID-19

• Article Release Date: April 17, 2020 – most recent revision: January 13, 2022
• What You Need to Know: This article was revised to add 2022 payment rate information for distant site telehealth services and information on RHC payment limits.
• MLN SE20016: https://www.cms.gov/files/document/se20016-new-expanded-flexibilities-rhcs-fqhcs-during-covid-19-phe.pdf

January 12, 2022: 2 New Procedure Codes Effective April 1, 2022

CMS published an ERRATA (link) to the ICD-10 MS-DRGs Version 39.1 effective April 1, 2022 to inform providers of “2 new procedure codes, in addition to the 7 new procedure codes previously announced, bringing the total to 9 new procedure codes, to describe the introduction of infusion or therapeutics, including vaccines for COVOID-19 treatment, into the” ICD-10-PCS. The 2 new codes are:

• XW023X7: Introduction of tixagevimab and cilgavimab monoclonal antibody into muscle, percutaneous approach, new technology group 7, and
• XW023Y7: Introduction of other new technology monoclonal antibody into muscle, percutaneous approach, new technology group 7.

January 13, 2022: COVID-19 Updates in CMS MLN Connects

The Thursday January 13th edition of MLN Connects (link) included information and resources about the following topics:

• Updated Materials for Visiting Nursing Homes During Omicron Surge,
• Vaccine Access in Long-Term Care Settings,
• New HCPCS Code for Remdesivir Antiviral Medication – Updated NIH Treatment Guidelines Panel Link, and
• Pfizer Booster Doses for Ages 12+ & Immunocompromised Ages 5-11.

January 14, 2022: Public Health Emergency Declaration due to COVID-19 Renewed

As expected, the COVID-19 Public Health Emergency was extended again on Friday, January 14th (link). This means waivers will remain in effect for 90 days (April 14, 2022).

April 2022 Update to the Medicare Severity-Diagnosis Related Group (MS-DRG) Grouper and Medicare Code Editor (MCE) Version 39.1 for ICD-10 Diagnosis Codes for 2019 COVID-19 Vaccination Status and ICD-10-PCS Codes for Introduction or Infusion of Therapeutics and Vaccines for COVID-19 Treatment

• Article Release Date: January 19, 2022
• What You Need to Know: You will learn about new ICD-10-CM diagnosis codes for reporting COVID-19 vaccination status, seven new ICD-10-PCS codes describing the introduction of infusion of therapeutics, including vaccines for COVID-19 treatments, and update for a new MCE list.
• MLN MM12578: https://www.cms.gov/files/document/mm12578-april-2022-update-medicare-severity-diagnosis-related-group-ms-drg-grouper-and-medicare-code.pdf

January 24, 2022: Free At-Home COVID-19 Tests

The CDC’s January 24th COVID-19 updates included a notice (link) that “every home in the United States is eligible to order 4 free at-home COVID-19 rapid antigen tests. Orders will usually ship in 7-12 days. These tests give results within 30 minutes (no lab drop-off required).” You can also go to https://www.covidtests.gov/ to order your tests.

In December 2021, the FDA announced (link) an Emergency Use Authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kg [about ">link) pounds]).

According to the announcement, Evusheld is for people not currently infected with or who have not had recent exposure to an individual who has COVID-19. Additionally, the EUA requires that the individual either have:

• “moderate to severely compromised immune systems due to a medical condition or due to taking immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination (examples of such medical conditions or treatments can be found in the fact sheet for health care providers) or;
• a history of severe adverse reactions to a COVID-19 vaccine and/or component(s) of those vaccines, therefore vaccination with an available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended.”

The FDA reinforces the fact that this medication is not a substitute for a COVID-19 vaccine and “urges the public to get vaccinated if eligible.” They also advise patients to talk with their health care provider to determine if this is an appropriate prevention option.

CMS has updated their COVID-19 Vaccines and Monoclonal Antibodies webpage (link) to include the code and the national payment allowance for Evusheld.

Also, CMS reminded providers in the December 16 edition of MLN Connects (link) that “if you vaccinate or administer monoclonal antibody treatment to patients enrolled in Medicare Advantage (MA) plans on or after January 1, 2022, submit claims to the MA Plan. Original Medicare won’t pay these claims.”

COVID-19 Updates

December 16, 2021: MLN Connects Reminder: Changes for MA Plan Claims Starting January 1, 2022

CMS reminded providers in the December 16 edition of MLN Connects (link) that “if you vaccinate or administer monoclonal antibody treatment to patients enrolled in Medicare Advantage (MA) plans on or after January 1, 2022, submit claims to the MA Plan. Original Medicare won’t pay these claims.”

December 22nd & 23rd, 2021: FDA Authorizes First Oral Antiviral for Treatment of COVID-19 by Pfizer

• December 22nd: The FDA announced (link) the issuance of an Emergency Use Authorization (EUA) for Pfizer’s Paxlovid for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients twelve years and older weighing at least 40 kilograms.
• December 23rd: The FDA announced (link) the issuance of an EUA for Merck’s molnupiravir to treat mild-to-moderate COVID-19 in adults with a positive test for the disease and “who are at high risk for progression to severe COVID-19, including hospitalization or death.”

December 24, 2021: CDC Health Advisory – Rapid Increase of Omicron Variant Infections in the United States

The CDC released an official CDC Health Advisory (link) containing updated recommendations “to enhance protection for healthcare personnel, patients, and visitors, and ensure adequate staffing in healthcare facilities” in response to the increased transmissibility of the Omicron variant.

December 31, 2021: CDC Health Advisory – Using Therapeutics to Prevent and Treat COVID-19

In this Health Advisory (link), the CDC acknowledges that the SARS-CoV-2 Omicron variant has become the dominant variant of concern in the United States and that there are therapeutics available for preventing and treating COVID-19 in specific at risk populations. The CDC notes that this advisory “serves to familiarize healthcare providers with available therapeutics, understand how and when to prescribe and prioritize them, and recognize contraindications.

January 3, 2022: FDA Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine

The FDA announced (link) amendments to the EUA for the Pfizer-BioNTech COVID-19 vaccine to:

• “Expand the use of a single booster dose to include use in individuals 12 through 15 years of age,
• Shorten the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 Vaccine and a booster dose to at least five months, and
• Allow for a third primary series dose for certain immunocompromised children 5 through 11 years of age.”

Other Updates

Revised MLN Fact Sheet: Intravenous Immune Globulin (IVIG) Demonstration

CMS noted in the December 23rd Edition of MLN Connects that the IVIG Demonstration Fact Sheet (link) has been revised to add the 2022 payment rate for Q2052 and added Asceniv (J1554) to the list of drugs covered in this demonstration.

December 16, 2021: Medicare Clinical Laboratory Fee Schedule Private Payor Data Reports – Delayed until 2023

CMS included the following information in the December 16th Edition of MLN Connects (link):

“On December 10, the Protecting Medicare and American Farmers from Sequester Cuts Act delayed the Clinical Laboratory Fee Schedule private payor reporting requirement:

• Next data reporting period is January 1 – March 31, 2023
• Reporting is based on the original data collection period, January 1 – June 30, 2019

The Act also extended the statutory phase-in of payment reductions resulting from private payor rate implementation:

• No payment reductions for Calendar Years (CYs) 2021 and 2022
• Payment won’t be reduced by more than 15% for CYs 2023 through 2025

Visit the PAMA Regulations webpage for more information on what data you need to collect and how to report it.”

December 21, 2021: Medicare Overpayment for Chronic Care Services

Palmetto GBA, the Medicare Administrative Contractor (MAC) for Jurisdictions J and M published a notice (link) regarding overpayments for Chronic Care Management (CCM) Services noting that the MACs have been directed by CMS to recoup CCM Services claims identified as overpayments by the OIG.

December 27, 2021: CMS Posts FAQ Document regarding Good Faith Estimates (GFEs) for uninsured (and self-pay) Individuals

The CMS has posted an FAQ document (link) regarding implementation of Section 112 of Title I (the No Surprises Act (NSA)). The very first FAQ is a reminder that “providers and facilities are required to provide GFEs to uninsured (or self-pay) individuals in connection with items or services scheduled, or upon the request of the uninsured (self-pay) individual, on or after January 1, 2022.”

December 28, 2021: CMS Removed CPT Code from Prior Authorization and Pre-Claim Review Initiatives

CMS posted the following update (link) to their Prior Authorization for Certain Hospital Outpatient Department (OPD) Services webpage:

“Beginning for dates of service on or after January 7, 2022, CMS is removing CPT 67911 (correction of lid retraction) from the list of codes that require prior authorization as a condition of payment. This service is not likely to be cosmetic in nature and commonly occurs secondary to another condition. The full list of HCPCS codes has been updated to reflect this change.”

Medicare MLN Articles & Transmittals – Recurring Updates

Addition of the QW Modifier to Healthcare Common Procedure Coding System (HCPCS) Code 86328

• Article Release Date: December 10, 2021
• What You Need to Know: You will find information about the addition of the QW modifier to HCPCS 86328, the Emergency Use Authorization (EUA) that the FDA can issue during Public Health Emergencies (PHEs), and the first EUA issued to detect COVID-19 antibodies for use in patient care.
• MLN MM12557: (link)

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

• Article Release Date: December 13, 2021
• What You Need to Know: This article provides information about new COVID-19 CPT vaccine and administration codes, OPPS updates for January 2022 and new drugs, biologicals, and radiopharmaceuticals.
• MLN MM12552: (link)

Calendar Year (CY) 2022 Annual Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment

• Article Release Date: December 13, 2021
• What You Need to Know: You will find instructions for the CY 2022 Clinical Laboratory Fee Schedule (CLFS), mapping for new codes for clinical laboratory tests, and updates for laboratory costs subject to the reasonable charge payment.
• MLN MM12558: (link)

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

• Article Release Date: December 16, 2021
• What You Need to Know: You will find information about updates to the ASC payment system in January 2022, payment offsets for HCPCS codes C1832 and C1833, and changes to the ASC Covered Procedure List Policy for CY 2022.
• MLN MM12553: (link)

Changes to the Laboratory National Coverage Determination (NCD) Edit Software for April 2022

• Article Release Date: December 22, 2021
• What You Need to Know: This article alerts providers that April 2022 changes to the NCD Edit Software is available.
• MLN MM12575: (link)

Revised Medicare MLN Articles & Transmittals

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

• Article Release Date: Initial article November 1, 2021– Revised December 15, 2021
• What You Need to Know: This article has been revised to include guidance about the Pneumococcal 15-valent Conjugate vaccine code 90671 that became effective for dates of service on or after July 16, 2021. You can read more about the different types of available pneumococcal vaccines in a related MMP article (link).
• MLN MM12439: (link)

Medicare Coverage Updates

Transvenous (Catheter) Pulmonary Embolectomy National Coverage Determination (NCD) Section 240.6

• Article Release Date: December 20, 2021
• What You Need to Know: CMS has removed the NCD for Transvenous Pulmonary Embolectomy (TPE) and in the absence of an NCD, your MAC will make coverage determinations for this procedure.
• MLN MM12537: (link)

Medicare MLN Articles & Transmittals – Recurring Updates

Reduced Payment for Physical Therapy and Occupational Therapy Services Furnished in Whole or In Part by a Physical Therapy Assistant or an Occupational Therapy Assistant

• Article Release Date: November 30, 2021
• What You Need to Know: This article provides information regarding payments reductions for services provides by PTAs and OTAs effective January 1, 2022.
• MLN MM12397:(link)

Update to Medicare Deductible, Coinsurance and Premium Rates for Calendar Year (CY) 2022

• Article Release Date: December 1, 2021
• What You Need to Know: You will find information about Calendar Year (CY) 2022 Medicare rates, Part A and B deductibles and coinsurance rates, and Part A and B premium rates in this article.
• MLN MM12507:(link)

Calendar Year 2022 Update for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Fee Schedule

• Article Release Date: December 2, 2021
• What You Need to Know: This article includes information about the CY 2022 update to the DMEPOS fee schedule.
• MLN MM12521:(link)

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

• Article Release Date: December 13, 2021
• What You Need to Know: You will learn about new COVID-19 CPT vaccine and administration codes, OPPS 2022 updates and new drugs, biologicals and radiopharmaceuticals.
• MLN MM12552: (link)

Calendar Year 2022 Annual Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment

• Article Release Date: December 13, 2021
• What You Need to Know: You will learn about instructions for the 2022 CLFS, mapping for new codes and updates for lab costs subject to the reasonable charge payment.
• MLN MM12558:(link)

Revised Medicare MLN Articles & Transmittals

Summary of Policies in the CY 2022 Medicare Physician Fee Schedule (MPFS) Final Rule, Telehealth Originating Site Facility Fee Payments Amount and Telehealth Services List, CT Modifier Reduction List, and Preventive Services List

• Article Release Date: Initial article November 17, 2021– Revised December 3, 2021
• What You Need to Know: Language added to this article shows that the originating site facility fee does not apply to Medicare telehealth services when the originating site is the patient’s home. Also, for mental telehealth services, CMS shows that there must be a non-telehealth service every 12 months (instead of 6 months) after initiating telehealth.
• MLN MM12519:(link)

Medicare Educational Resources

CMS MLN Fact Sheet: Ordering External Breast Prostheses & Supplies

CMS had not updated this Fact Sheet (link)) since 2018. Substantive changes are in dark red font which includes almost all the information in the document and as such, CMS encourages providers to read the entire infographic.

CMS MLN Fact Sheet: Checking Medicare Eligibility

This Fact Sheet (link)) was updated in October. Changes in the document includes:

• Getting Preventive Services eligibility dates (page 4), and
• Hiring billing agency, clearinghouse, or software vendor (page 4).

CMS MLN Booklet Revised: Independent Diagnostic Testing Facility (IDTF)

CMS has revised this MLN booklet and noted in the December 9, 2021 edition of MLN Connects (link)) that this was done to delete incorrect information that didn’t apply to supervising diagnostic tests performed in IDTFs. They also noted that “the COVID-19 public health emergency supervision flexibility (PDF) only applies to certain nonphysician practitioners; it didn’t change the diagnostic tests supervision requirements under the IDTF regulations.”

Other Updates

December 3, 2021: New HHS Telehealth Utilization Study and Medicare Telemedicine Snapshot

An HHS Press Release (link) highlights findings from a New HHS study that showed a 63-fold increase in Medicare telehealth utilization during the pandemic.

The Press Release also highlights a new CMS snapshot (link) that currently highlights findings from Medicare beneficiary (Medicare Fee-for-Service and Medicare Advantage (MA)) telemedicine claims between March 1, 2020 and February 28, 2021 that were received by September 9, 2021. CMS notes that in response to COVID-19, telemedicine services were expanded to increase access to care including:

• Lifting of geographic area restrictions with services allowed to be delivered in the patients’ home, allowing for both new and established patients,
• Expanding eligible services and the types of providers, and
• Allowing for a select set of audio-only telehealth services.

Telemedicine users during the March to February time in 2019 totaled 910,490 vs a pandemic total of 28,255,180. This volume represents 53% of Medicare users.

December 8, 2021: CMS Special Open-Door Forum: Provider Requirements Under the No Surprises Act

CMS held a Special Open-Door Forum (SODF) to explain provider requirements under the No Surprises Act. CMS noted in the announcement that “Starting January 1, 2022, consumers will have new billing protections when getting emergency care, non-emergency care from out-of-network providers at in-network facilities, and air ambulance services from out-of-network providers. These requirements generally apply to items and services provided to people enrolled in group health plans, group or individual health insurance coverage, Federal Employees Health Benefits plans, and the uninsured.

These requirements don’t apply to people with coverage through programs like Medicare, Medicaid, Indian Health Services, Veterans Affairs Health Care, or TRICARE that have other protections against high medical bills.”

Included in the SODF notice was a link to the SODF Presentation (link) and the No Surprises Act CMS webpage (link).