Knowledge Base Category -

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).

MMP’s Protection Assessment Report (P.A.R.) combines current Medicare Fee-for-Service review targets (i.e. MAC, RAC, OIG, etc.) with hospital specific paid claims data made possible through a collaboration with RealTime Medicare Data (RTMD). Monthly, our newsletter spotlights current review activities. This month we highlight recent CMS and Medicare Administrative Contractor (MAC) eNews reminders for Providers.

P.A.R. PRO TIPS: eNews Reminders for Providers

November 29, 2021: WPS J8 eNews: Prior Authorization for Hospital Outpatient Department Services Tips and Reminders

After noting they continue to find errors, including omissions, on prior authorization requests that may result in processing delays, WPS offered the following tips and reminders related to the CME Prior Authorization for Hospital Outpatient Department Services Program (link) in their daily eNews:

Vein Ablation

• Prior authorization requests should clearly identify which extremity and vein(s) the request is for, and
• Documentation should include conservative measures and the length of time the conservative measures were tried.

Implantation of Spinal Neurostimulators

• The Unique Tracking Number (UTN) assigned to an affirmed implantation of spinal neurostimulators trial is the same UTN that shall be used for the permanent implantation,
• A new UTN for the permanent implantation is only required if more than 120 days have passed since the trial UTN was issued or if the trial and permanent Provider Transaction Numbers (PTANs) are different, and
• Documentation should include a psychiatric evaluation and support of tried and failed conservative treatment.

WPS provides a more detailed article on their website about this program (link)

December 1, 2021: Palmetto GBA eNews: Aftercare, Musculoskeletal System and Connective Tissue Diagnosis Related Groups (DRGs)

“This article (link) includes a description of the DRG codes for Aftercare, Musculoskeletal System and Connective Tissue and a list of Principal Diagnosis Tips. Please review this information and share it with your staff.” For example, Palmetto advises that ICD-10-CM Diagnosis code M48.4 (Fatigue fracture of vertebra, should not be used for acute traumatic fracture.

Comprehensive Error Rate Testing (CERT) Question & Answer Fact Sheet

A second article of interest (link) in Palmetto’s December 1st eNews answers who, what and how questions about the CERT. For example:

• Question: “Are healthcare providers required to comply with CERT’s request for medical records?
• Answer: Yes, the CERT is a federally mandated program. Non-submission of medical records will result in a denial of all services billed on the claim.”

December 2, 2021: CMS MLN Connects eNews: Skilled Nursing Care & Skilled Therapy Services to Maintain Function or Prevent or Slow Decline

CMS included the following reminder to providers in the December 2nd edition of MLN Connects (link):

“Medicare covers skilled nursing care and skilled therapy services under skilled nursing facility, home health, and outpatient therapy benefits when a beneficiary needs skilled care to maintain function or to prevent or slow decline, as long as:

• The beneficiary requires skilled care for the services to be provided safely and effectively
• An individualized assessment of the patient's condition demonstrates that the specialized judgment, knowledge, and skills of a qualified therapist are needed for a safe and effective maintenance program

Visit the Jimmo Settlement Agreement webpage for more information.”

December 2, 2021: Palmetto GBA eNews: Responding to CERT Documentation Request

As a follow-up to the previously mentioned CERT FAQ document, Palmetto published an article (link) detailing why you are required to respond to CERT requests, what you need to send, and where to send the documentation to.

December 7, 2021: Novitas Solutions JL eNews: Prior Authorization: Cervical fusion with disc removal

Novitas noted in their eNews that the A/B MAC Prior Authorization Collaboration Workgroup has published an article (link) about cervical fusions with disc removal and reminds providers that this procedure is part of the prior authorization program for certain hospital outpatient department services.

December 10, 2021: Protecting Medicare and American Farmers from Sequester Cuts Act

President Biden signed this Act into law on December 10th (link) and while this is not a Pro Tip, passage of this Act does impact hospitals. Among other items in the Act, it amends the CARES Act to extend the 2 percent sequestration suspension until March 31, 2022. Beginning April 1, 2022, and ending June 30, 2022, the sequestration payment reduction will be 1.0 percent. The full 2 percent Medicare sequester cut will begin again on July 1, 2022.

In response to the ongoing COVID-10 public health emergency, CDC’s National Center for Health Statistics (NCHS) will be implementing new ICD-10 diagnosis and procedures codes. The three new ICD-10-CM diagnosis codes are for reporting an individual’s vaccination status.

New Diagnosis Codes

• Z28.310: Unvaccinated for COVID-19
• Z28.311: Partially vaccinated for COVID-19
• Z28.39: Other underimmunization status

There are also seven new ICD-10-PCS procedure codes to describe the introduction or infusion or therapeutics, including vaccines for COVID-19 treatment. In the CMS announcement related to the procedure codes, providers are reminded that “for hospitalized patients, Medicare pays for the COVID-19 vaccines and their administration separately from the Diagnosis-Related Group rate. As such, Medicare expects that the appropriate CPT codes will be used when a Medicare beneficiary is administered a vaccine while a hospital patient.”

New Procedure Codes

• XW013V7: Introduction of COVID-19 vaccine dose 3 into subcutaneous tissue, percutaneous approach, new technology group 7
• XW013W7: Introduction of COVID-19 vaccine booster into subcutaneous tissue, percutaneous approach, new technology group 7
• XW023V7: Introduction of COVID-19 Vaccine dose 3 into muscle, percutaneous approach, new technology group 7,
• XW023W7: Introduction of COVID-19 Vaccine booster into muscle, percutaneous approach, new technology group 7,
• XW0DXR7: Introduction of fostamatinib into mouth and pharynx, external approach, new technology group 7,
• XW0G7R7: Introduction of fostamatinib into upper GI, via natural or artificial opening, new technology group 7, and
• XW0H7R7: Introduction of fostamatinib into lower GI, via natural or artificial opening, new technology group 7.

All ten new codes will become effective April 1, 2022.

Resource: CMS’ MS-DRG Classifications and Software webpage (link), see ICD-10 MS-DRGs V39.1 Effective April 1, 2022 Zip file under “Latest News”

Did You Know?

Between 2010 and 2020, the CDC estimates (link) that flu has resulted in

• Nine million – forty-one million illnesses,
• 140,000 – 710,000 hospitalizations, and
• 12,000 – 52,000 deaths annually.

Why This Matters?

According to the CDC, “flu activity often starts to increase in October, most commonly peaks in February and can last into May.” The best way to prevent the spread of flu and widespread flu illnesses is for people to get a flu vaccine.

What Can You Do?

If you are a healthcare provider, CMS has put together a Flu Shot Toolkit (link) which includes information about payment for the 2021-2022 season, frequency and coverage, billing, coding, and additional resources.

The CDC recommends annual flu shots for everyone 6 months or older by the end of October or as soon as possible each flu season. As a healthcare consumer, if you have not already received your flu shot, there is still time to get one.

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.

Did You Know?

• Lung cancer is the third most common cancer and the leading cause of cancer deaths in the United States,
• In 2021, the National Cancer Institute (NCI) estimated that the number of new lung cancer cases is over 235,000, with a median age at diagnosis of 71 years; and
• Cancer of the lung and bronchus accounted for over 130,000 deaths in 2021 (more than the total number of estimated deaths from colon, breast and prostate cancer combined), with a median age at death of 72 years.
Source: CMS Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) Proposed Decision Memorandum (CAG-00439R)

According to the CDC’s Lung Cancer Awareness webpage (link):

• Lung Cancer is the leading cause of cancer death among both men and women in the United States, and
• Different people have different symptoms for lung cancer. Most people do not have symptoms until the cancer is advanced.

Why Should You Care?

You can be your own advocate to lower your lung cancer risks:

• If you smoke, quit!
• Stay away from secondhand smoke,
• Get your house tested for Radon,
• If appropriate, get screened for Lung Cancer with LDCT.

Lung cancer screening with LDCT is a covered Medicare Preventive Service and is covered annually with no copayment, coinsurance, or deductible when you meet the Medicare coverage requirements (link).

On November 17, 2021, the CMS posted proposed National Coverage Determination (NCD) and Decision Memorandum (CAG-00439R) (link) for NCD 210.14 Screening for Lung Cancer with Low Dose Computed Tomography (LDCT).

Beneficiary Eligibility criteria:
Proposed changes to the eligibility criteria include expanding the age eligibility from 55 to 50 years and decreasing the tobacco smoking history in pack-years from thirty pack-years to twenty pack years.

Counseling and Shared Decision-Making Visit
Before a beneficiary’s first LDCT screening, the beneficiary must receive a counseling and shared decision-making visit meeting all criteria outlined in the Proposed Decision Memo.

CMS is proposing “to remove the specificity regarding the type of provider who must furnish the counseling and shared decision-making…we do not believe there is an evidentiary reason to continue to limit the shared decision-making visit to physician and non-physician practitioners. We note that this expansion can allow for this service to be furnished “incident to” a physician’s professional service. Removing the specification for the type of practitioner should expand the individuals that can conduct shared decision-making to other health care practitioners, such as health educators and others beyond physicians or non-physician practitioners. This proposed change may broaden access to LDCT screening.”

Reading Radiologist Eligibility Criteria :
CMS notes that the proposed Decision Memo “reduces the eligibility criteria for the reading radiologist and removes the radiology imaging facility eligibility criteria (including removes the requirement that facilities participate in a registry).”

What Can You Do?

As a healthcare provider, be familiar with the Medicare coverage requirements and as a healthcare consumer, you can visit the CDC’s Lung Cancer Awareness webpage (link) to learn about ways to lower your lung cancer risk, take a lung cancer screening quiz, and identify if you are an appropriate candidate for screening with LDCT.

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)

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.

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.