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Is a New Long-Acting Monoclonal Antibodies for Pre-Exposure Prevention of COVID-19 an Option for You?
Published on Jan 12, 2022
20220112

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.”

Beth Cobb

December & Early January 2022 COVID-19 and Other Medicare Updates
Published on Jan 05, 2022
20220105

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.”

Beth Cobb

December & Early January 2022 Medicare Transmittals and Coverage Updates
Published on Jan 05, 2022
20220105

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)

Beth Cobb

December 2021 Medicare Transmittals and Coverage Updates
Published on Dec 15, 2021
20211215

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).

Beth Cobb

Therapy Threshold Amounts for 2022
Published on Dec 08, 2021
20211208
Question:

Are there any updates for rehabilitative therapy services’ threshold amounts for the coming year?

Answer:

Yes. MLN MM12470 (link) details updates to the annual per-beneficiary incurred expenses amounts now call the KX modifier thresholds and related policy for CY 2022. These thresholds were previously known as “therapy caps.” For CY 2022, the KX modifier threshold amounts are:

  1. $2,150 for Physical Therapy (PT) and Speech-Language Pathology (SLP) services combined, and
  2. $2,150 for Occupational Therapy (OT) services.

Providers can track a patient’s year-to-date therapy amounts on Medicare eligibility screens. The KX modifier must be appended to therapy services’ line-items on the claim for medically necessary therapy services above the threshold amounts. The medical necessity of services beyond the threshold amount must be justified by appropriate documentation in the medical record. Services provided beyond the threshold that are not billed with the KX modifier will be denied with Claim Adjustment Reason Code 119 - Benefit maximum for this time period or occurrence has been reached

There is also a therapy threshold related to the targeted medical review process, now known as the Medical Record (MR) threshold amount. This threshold remains at $3,000 for PT and SLP combined and a separate $3,000 for OT until CY 2028. Not all therapy services exceeding the $3,000 thresholds will be reviewed. CMS will analyze data to select claims exceeding this threshold for review.

Beth Cobb

November 2021 Medicare MLN Articles and Transmittals
Published on Dec 01, 2021
20211201

Medicare MLN Articles & Transmittals – Recurring Updates

Fiscal Year (FY) 2022 Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) PPS Changes
  • Article Release Date: October 27, 2021
  • What You Need to Know: This article provides highlights to changes in the FY 2022 IPPS Final Rule.
  • MLN MM12373: (link)
New Waived Tests
  • Article Release Date: November 1, 2021
  • What You Need to Know: This article provides information about CLIA requirements, new CLIA waived tests approved by the FDA and the use of modifier QW for CLIA-waived tests.
  • MLN MM12504: (link)
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: November 1, 2021
  • What You Need to Know: This article highlights updates to NCDs. The implementation date for updates is November 23, 2021, and the effective date is April 1, 2022.
  • MLN MM12480: (link)
International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs) – April 2022 (CR 2 of 2)
  • Article Release Date: November 1, 2021
  • What You Need to Know: This article highlights updates to NCDs. The implementation date for the updates is December 2, 2021, and the effective date April 1, 2022.
  • MLN MM12482: (link)
2022 Annual Update to the Therapy Code List
  • Article Release Date: November 12, 2021
  • What You Need to Know: 5 CPT codes have been added to this list for CY 2022. This article details some of the requirements for using these codes.
  • MLN MM12446: (link)
The Supplemental Security Income (SSI)/Medicare Beneficiary Data for Fiscal Year (FY) 2019 for Inpatient Prospective Payment System (IPPS) Hospitals, Inpatient Rehabilitation Facilities (IRFs), and Long Term Care Hospitals (LTCHs)
  • Article Release Date: November 16, 2021
  • What You Need to Know: You will find information about updated data available that decides the Disproportionate Share (DSN) adjustments for IPPS Hospitals, Low-Income Patient (LIP) for IRFs and payments for LTCH discharges.
  • MLN MM12516: (link)
Summary of Policies in the Calendar Year (CY) 2022 Medicare Physician Fee Schedule (MPFS) Final Rule, Telehealth Originating Site Facility Fee Payment Amount and Telehealth Services List, CT Modifier Reduction List, and Preventive Services List
  • Article Release Date: November 17, 2021
  • What You Need to Know: This article summarizes policies in the CY 2022 MPFS.
  • MLN MM12519: (link)
Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code (CARC), Medicare Remit Easy Print (MREP) and PC Print Update
  • Article Release Date: November 18, 2021
  • What You Need to Know: Make sure your billing staff know about the latest updates to the code sets, what you must do if you use MREP or PC Print and where to find the official code lists.
  • MLN MM12478: (link)

Revised Medicare MLN Articles & Transmittals

Skilled Nursing Facility (SNF) Claims Processing Updates
  • Article Release Date: Initial article August 11, 2021 – Revised November 5, 2021
  • What You Need to Know: This article was updated to add guidance regarding an emergency room claim falling within a covered SNF Part A or Swing Bed Stay.
  • MLN MM12344: (link)
Medicare Part B CLFS: Revised Information for Laboratories on Collecting & Reporting Data for the Private Payor Rate-Based Payment System
  • Article Release Date: Initial article February 27, 2019 – most recent revision November 4, 2021
  • What You Need to Know: This article was updated to note that for CDLTs that are not ADLTs, the data reporting is delayed by one year and includes information about the Online Data Collection System.
  • MLN SE19006: (link)

Beth Cobb

November 2021 Medicare Updates
Published on Dec 01, 2021
20211201

Other Updates

Amount in Controversy Threshold Requirement for ALJ Hearing for CY 2022

Beginning in January 2005, the established amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and reviews in the Federal District court, is to be adjusted annually. The amounts are to remain the same in CY 2022 as they have been in CY 2021:

  • ALJ hearing requests - $180
  • Federal District Court reviews - $1,760

This information was posted in the Thursday, September 30, 2021 Federal Register (link).

October 27, 2021: OIG Report – 2021’s Top Unimplemented Recommendations

The full title of this report is 2021 OIG’s Top Unimplemented Recommendations: Solutions to Reduce Fraud, Waster, and Abuse in HHS Programs (link). In this year’s iteration of this annual report, the OIG focuses on “the top 25 unimplemented recommendations that, in OIG’s view, would most positively affect HHS programs in terms of cost savings, public health and safety, and program effectiveness and efficiency, if implemented.”

The CMS noted in a related Fact Sheet (link) to the Final Rule that among other things, this “rule finalizes modifications to the ESRD Treatment Choices (ETC) Model policies to encourage certain health care providers to decrease disparities in rates of home dialysis and kidney transplants among ESR patients with lower socioeconomic status. This makes the model one of the agency’s first CMS Innovation Center models to directly address health equity.”

November 3, 2021: CMS Appropriate Use Criteria (AUC) Program Update

The CMS has updated the AUC Program webpage with the following notice: “The EDUCATIONAL AND OPERATIONS TESTING PERIOD for the AUC Program has been extended beyond CY 2021. There are no payment consequences associated with the AUC program during the Educational and Operations Testing Period. We encourage stakeholders to use this period to learn, test and prepare for the AUC program. The payment penalty phase will begin on the later of January 1, 2023 or the January 1 that follows the declared end of the public health emergency (PHE) for COVID-19. For more information please review the CY 2022 Physician Fee Schedule Final Rule: (link) see pp. 661-716.”

November 10, 2021: Automatic Exception Policy for MIPS Individual Physicians

CMS announced they will be applying an automatic extreme and uncontrollable circumstances (EUC) policy to all individual Merit-based Incentive Payment System (MIPS) eligible clinicians for the 2021 MIPS performance year. A QPP COVID-19 Response Fact Sheet is available on the CMS Quality Payment Program webpage (link).

November 12, 2021: CMS Fact Sheet Medicare Parts A & B Premiums and Deductibles for 2022

CMS issued a Fact Sheet (link) announcing the 2022 premiums, deductibles, and coinsurance amounts for the Medicare Part A and Part B programs, and the 2022 Medicare Part D income-related monthly adjustment amounts. CMS notes that the increases in part are due to the uncertainty regarding the potential use of the new Alzheimer’s drug, Aduhelm™ which costs $56,000 per person, per year.

November 12, 2021: Nursing Home Visitation Guidance during the COVID-19 PHE Revised & COVID-19 Survey Activities

CMS published a revised memorandum regarding nursing home visitation and COVID-19 (link). Specifically, the following statement has been added to the memorandum summary, “visitation is now allowed for all residents at all times.” While noting that current nursing home COVID-19 data shows approximately 86% of residents and 74% of staff after fully vaccinated, CMS continues to emphasize the importance of maintaining infection prevention practices.

CMS also published a second memo, Changes to COVID-19 Survey Activities which includes steps to assist State Survey Agencies (SAs) to address the backlog of facility complaint and recertification surveys. You can read about both memos in a related CMS News Alert (link).

November 19, 2021: COVID-19 Booster Shots Expanded to All Adults

The FDA announced (link) an amended the emergency use authorization (EUA) for the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccinations.

Beth Cobb

November 2021 Medicare Coverage Updates & Education Resources
Published on Dec 01, 2021
20211201

Medicare Coverage Updates

National Coverage Determination (NCD) 270.3 Blood-Derived Products for Chronic, Non-Healing Wounds
  • Article Release Date: September 15, 2021 – Revised November 12, 2021
  • What You Need to Know: This article lets providers know that CMS will nationally cover autologous Platelet-Rich Plasma (PRP) for the treatment of chronic non-healing diabetic wounds under specific conditions. It was updated to reflect a revised implementation date of November 23, 2021 for MACs.
  • MLN MM12403: (link)
October 28, 2021: Transvenous (Catheter) Pulmonary Embolectomy Final Decision Memo

CMS published a Final Decision Memo (link) and is removing the National Coverage Determination (NCD) for Transvenous (Catheter) Pulmonary Embolectomy (NCD 240.6) and permitting coverage determinations to be made by Medicare Administrative Contractors (MACs).

November 12, 2021: CMS Repeals MCIT/R&N Rule

CMS announced they have rescinded the Medicare Coverage and Innovative Technology and Definition of “Reasonable and Necessary” (MCIT/R&N) final rule that was published January 14, 2021. CMS notes in a related Press Release (link) that they plan “to work with the FDA, Agency for Healthcare Research and Quality (QHRQ), medical device manufacturers, and other stakeholders to develop and expeditious process to cover innovative devices that benefit Medicare patients, and intends to hold at least two stakeholder public meetings in CY 2022 to inform our future policy-making in this space.”

November 17, 2021: Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) Proposed Decision Memo

CMS posted Proposed Decision Memo (CAG-00439R) (link) which would update the eligibility criteria for a LDCT. Two key changes are decreasing the age of eligibility from 55 years to 50 years and the history of smoking in pack-years from 30 to 20 years. CMS is accepting comments through December 17, 2021.

December 12, 2021: Future Effective Palmetto GBA LCD and Article: Cardiac Resynchronization Therapy (CRT)

CMS published a final Decision Memo, February 15, 2018, related to NCD 20.4 (Implantable Cardioverter Defibrillators). Changes made to this policy included removal of the Class IV Heart Failure requirements for CRT. At that time, CMS noted that coverage determinations for CRT devices are currently made by local Medicare Administrative Contractors (MACs) and not currently subject to an NCD.

Currently, First Coast Services Options, the JN MAC is the only MAC with a CRT coverage policy (LCD L33271 / A57634). That will soon change as Palmetto GBA the JJ and JM MAC has published LCD DL39080 with associated coding and billing article A58821 with a future effective date of December 11, 2021. Palmetto notes in the LCD that it “does not address the decision-making between CRT-pacemaker (CRT-P) or CRT-defibrillator (CRT-D) options other than to emphasize that those patients receiving CRT-D must not only meet coverage criteria in this policy but also meet the NCD for Implantable Automatic Defibrillators (20.4) criteria for the defibrillator portion of their therapy in order to be considered for coverage.”

Medicare Educational Resources

CMS MLN Fact Sheet: Medicare Billing: 837P & Form CMS-1500 Updated

CMS has recently updated this MLN Fact Sheet (link) by adding a new Test Transaction Tool and information about late claims exceptions, new electronic filing exceptions and new waiver requests criteria.

Beth Cobb

COVID-19 Updates November 2021
Published on Nov 17, 2021
20211117

It has been a while since we have published an article solely focused on COVID-19 issues. However, November has been a busy month related to COVID-19 vaccines, Medicare Contractor COVID-19 specific audits, telehealth, and a shift in treatment payment from Medicare Fee-for-Service to Medicare Advantage Plans for their enrollees. As we have reiterated so often since the beginning of the COVID-19 Public Health Emergency (PHE), MMP is thankful to all front-line workers who have and continue to provide care to patients diagnosed with COVID-19 and emotional support to their families.

October 29, 2021: FDA Authorizes COVID-19 Vaccine for Emergency Use for Children

The FDA announced (link) emergency use authorization for Pfizer-BioNTech COVID-19 Vaccines for children 5 to 11 years of age. The announcement includes key points for parents and caregivers. For example, “Safety: The vaccine’s safety was studied in approximately 3,100 children ages 5 through 11 who received the vaccine and no serious side effects have been detected in the ongoing study.”

CMS including the following information related to vaccinations for children in the Thursday, November 4th edition of MLN Connects (link):

CMS now covers the Pfizer-BioNTech COVID-19 Vaccine for children ages 5 – 11. Health care providers and other entities administering COVID-19 vaccines:

  • Must provide vaccines regardless of the patient’s health coverage
  • Cannot charge patients for the vaccine or administering it, including deductibles and coinsurance

More Information:

  • CDC COVID-19 Vaccination Program Provider Requirements and Support (link)
  • CMS COVID-19 Provider Toolkit (link)
  • CMS Press Release (link)
October 29, 2021: Supplemental Medical Review Contractor (Noridian) Posts New Project: Audio Only Telehealth Services During the PHE

The CMS released this Final Rule and notes in a related Fact Sheet (link) this final rule “would accelerate the shift from paying for Medicare home health services based on volume to a system that pays for value.” CMS finalized making permanent current blanket waivers related to home health aide supervision and the use of telecommunications in conducting assessment visits that are currently in place due to the COVID-19 public health emergency. The CMS does note that “while we are finalizing the limited use of telecommunications technology when performing the 14-day supervisory visit requirement when a patient is receiving skilled services, we expect that in most instances, the HHAs would plan to conduct the 14-day supervisory assessment during an on-site, in person visit, and that the HHA would use interactive telecommunications systems option only for unplanned occurrences that would otherwise interrupt scheduled in-person visits.”

November 4, 2021: MA Plans to Begin Payment for COVID-19 Vaccine and Monoclonal Antibody Products

CMS announced (link) that effective for dates of service on or after January 1, 2022, Original Medicare will no longer being paying claims for COVID-19 vaccination and monoclonal antibody products for beneficiaries enrolled in a Medicare Advantage (MA) Plan. Providers will need to submit claims to the MA Plan. More information is available on the following CMS webpages:

  • Medicare Billing for COVID-19 Vaccine Shot Administration (link)
  • Monoclonal Antibody COVID-19 Infusion (link)
November 4, 2021: Supplemental Medical Review Contractor (Noridian) Project 01-043 DRG COVID 20% Add-On Payment Review Results Posted

The SMRC posted review results of claims related to the add-on payment for COVID-19 (link). Claims reviewed were for dates of service from April 1, 2020, through August 30, 2020, and the denial rate was 1%. Noteworthy is the fact that as of September 1, 2020, CMS requires that claims eligible for the 20 percent increase in the MS-DRG weighting factor have a positive COVID-19 lab test documented in the record. While the SMRC review results were low, I believe that this may remain a review focus by the SMRC or another Medicare review contractor for claims on or after September 1, 2020.

November 5, 2021: Medicare and Medicaid Programs; Omnibus COVID-19 health Care Staff Vaccination Interim Final Rule with Comment Period

November 5, 2021, The effective date for this Interim Final Rule with Comment Period (IFC) (link) is November 5, 2021. Along with the IFC, CMS has published the following related resources:

  • CMS Press Release: (link)
  • CMS Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule: (link)
  • Slides and Video from National Stakeholder Call are available on the CMS Current Emergencies COVID-19 webpage: (link)

Beth Cobb

October 2021 Medicare Education and COVID-19 Updates
Published on Oct 27, 2021
20211027

Medicare Educational Resources

MLN Booklet: Transitional Care Management Services Revised

This MLN Booklet (link) focuses on covered services, location, who may provide services, supervision, billing services, documenting services and service benefits specific to Transitional Care Management. With the most recent updates, the CMS has added codes health care professionals can bill concurrently with Transitional Care Management services and added language about auxiliary personnel providing services under supervision.

WPS GHA YouTube: CERT Errors – Transitional Care Management (TCM)

WPS has published a YouTube video (link) focused on two Comprehensive Error Rate Testing (CERT) errors on Transitional Care Management (TCM) services. The errors concern the patient record for the:

  • Medical decision-making complexity
  • Interactive contact
MLN Booklet: Medicare Mental Health (MLN1986542)

This MLN booklet (link) was updated this month and includes information on covered and non-covered services, eligible professionals, Medicare Advantage and Medicare drug plan coverage, and medical record documentation and coding guidance.

COVID-19 Updates

COVID-19 Booster Shots for Eligible Consumers

From late September to mid-October, there have been several updates related to COVID-19 booster shots, for example:

  • September 24, 2021: CMS to Pay for COVID-19 Booster Shots: (link)
  • FDA Bulletin Announcing Booster Shot Authorization: (link)
  • September 28, 2021: CDC Call: What Clinicians Need to Know About the Latest CDC Recommendations for Pfizer-BioNTech COVID-19 Booster Vaccination: (link)
  • October 7, 2021: CDC Guidance: Who is Eligible for a COVID-19 Booster Shot? (link)
  • October 20, 2021: FDA Takes Additional Actions on the Use of a Booster Dose: (link)
  • October 21, 2021: CDC Expands Eligibility for COVID-19 Booster Shots: (link)
  • October 22, 2021: CMS Reminds Eligible Consumers They Have Coverage for COVID-19 Booster Shot as No Cost: (link)
  • October 26, 2021: CDC Clinician Outreach Call – What Clinician’s Need to Know About COVID-19 Booster Recommendations: (link)
September 30, 2021: OCR Issues Guidance on HIPAA, COVID-19 Vaccinations, and the Workplace

HHS and the Office of Civil Rights (OCR) announced their release of guidance (link) to help the public understand when the HIPAA Privacy Rule applies to information about a person’s COVID-19 vaccination status. The “guidance addresses common workplace scenarios and answers questions about whether and how the HIPAA Privacy Rule applies.”

October 5, 2021: Getting Your CDC COVID-19 Vaccination Record Card

The CDC has updated their webpage Getting Your CDC COVID-19 Vaccination Record Card (link). Of note, the “CDC does not maintain vaccination records or determine how vaccination records are used, and CDC does not provide the white CDC-labeled COVID-19 Vaccination Record card to people. These cards are distributed to vaccination providers by state health departments.” The CDC advises you to contact your state health departments if you have additional questions about your vaccination records. This webpage includes a link to help you find information about your state health department.

October 15, 2021: COVID-19 Public Health Emergency (PHE) Extended

Xavier Becerra, Secretary of Health and Human Services, renewed the Public Health Emergency (PHE) due to the COVID-19 pandemic (link). This declaration will last for the duration of the emergency or 90 days and may be extended again by the Secretary. Continuation of the PHE means that 1135 Blanket Waivers for health care providers will remain in place too (link).

Other Updates

September 30, 2021: Requirements Related to Surprise Billing; Part II

The CMS announced the issuance of an interim final rule with comment period to further implement the No Surprises Act (link). In addition to this second interim final rule, CMS launched new online information at www.cms.gov/nosurprises. In this Fact Sheet, CMS reminds you that the rules will take effect on January 1, 2022 and that “more information on how the rule impacts various types of health plans, providers, and organizations supporting payment dispute processes is described in a related fact sheet (link).

October 10, 2021: MLN Connects – Drugs & Biologics

CMS noted in the October 10th edition of MLN Connects (link) that they have published the third quarter 2021 HCPCS Application Summaries and Coding Decisions for Drugs and Biologics. Of the fourteen requests to establish a new HCPCS Level II code, eight new codes were established with an effective date of January 1, 2022.

Beth Cobb

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