Knowledge Base Category -

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.”

Did You Know?

Malnutrition and more specifically, severe malnutrition has been in the audit spotlight for several years. Historically, the OIG completed a series of reviews of hospitals with claims that included the ICD-9 diagnosis code for Kwashiorkor (260). In a December 2017 Report Brief (link), the OIG “reviewed the medical records for 2,145 inpatient claims at 25 providers and found that all but 1 claim incorrectly included the diagnosis code for Kwashiorkor, resulting in overpayments in excess of $6 million.”

They identified a discrepancy in the ICD-CM coding classification between the tabular list and the alpha index on the use of diagnosis code 260 and stated “CMS did not have adequate policies and procedures in place to address this discrepancy, resulting in a total potential loss of approximately $102 million during CYs 2006 through 2015. Even though CMS was aware of the discrepancy, it did not take any separate action to address it.”

In July 2020, the OIG published a Report Brief (link), looking at ICD-10-CM severe malnutrition diagnosis codes E41 (nutritional marasmus) and E43 (unspecified severe protein calorie malnutrition). The OIG found that 164 of 200 claims had billing errors resulted in net overpayments of $914,128 and stated, “the errors occurred because hospital used severe malnutrition diagnosis codes when they should have used codes for other forms of malnutrition or no malnutrition diagnosis code at all.” Based on the sample of claims reviewed, the OIG estimated hospitals received overpayments of $1 billion for FYs 2016 and 2017.

Most recently, in November 2021, the OIG added a review of Medicaid inpatient hospital claims with severe malnutrition to their Work Plan (link). The Work Plan issue description, indicates “adding an MCC to a claim can result in an increased payment by causing the claim to be coded in a higher diagnosis-related group.”

In addition to the OIG, the Q3 Fiscal Year (FY) 2021 Program for Evaluation Payment Patterns Electronic Report (PEPPER) became available and includes the new risk area, severe malnutrition. More specifically, this new PEPPER Target Area focuses on DRGs assigned based on an MCC with one of the following malnutrition ICD-10-CM diagnosis codes as the only MCC:

• E40: Kwashiorkor
• E41: Nutritional Marasmus
• E42: Marasmic kwashiorkor
• E43: Unspecific severe protein-calorie malnutrition

The Thirty-Fourth Edition of the Short-Term Acute Care PEPPER User’s Guide (link) provides the following guidance for hospitals that are high outliers for this new risk area:

“This could indicate that there are coding errors related to unsubstantiated coding of one of the severe malnutrition codes (i.e., E40, E41, E42, or E43) as the only MCC. A sample of medical records with a severe malnutrition code as the only MCC should be reviewed to determine whether coding errors exist. A diagnosis of severe malnutrition must be determined by the physician. A coder should not code based on laboratory findings or nutritional consultation without seeking physician determination of the clinical significance of the abnormal findings.”

Severe Malnutrition by the Numbers

As severe malnutrition has been and continues to be a focus of audit, I turned to our sister company RealTime Medicare Data (RTMD) to try and understand how often one of the above severe malnutrition ICD-10-CM diagnosis codes continues to be the only MCC coded on a record. RTMD data is Medicare Fee-for-Service specific and includes inpatient discharges, outpatient services, and CMS 1500 Professional services. It is full-census, non-modeled, and typically available 90 days post-payment.

The data provided by RTMD for this article includes calendar years (CYs) 2019 and 2020 inpatient claims for the entire RTMD footprint. Here is what I found.

CY 2019 and 2020 combined:

• 188,383 total claims paid where a severe malnutrition code was the only MCC on the claim.
• Actual Total Payment: Just over $2.9 billion
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• The five states with the highest number of claims for both CYs included Florida, California, New York, Texas, and Illinois.

CY 2019:

• 102,874 total paid claims
• Actual Total Payment: $1,543,413,978
• Volume of claims by ICD-10-CM diagnosis code:
• E40 Kwashiorkor – 13 claims
• E41 Nutritional Marasmus – 235 claims
• E42 Marasmic Kwashiorkor – 4 claims
• E43 Unspecified severe protein-calorie malnutrition – 102,622 claims
• Claims where one of the four severe malnutrition codes was the only secondary diagnosis on the claim:
• 8,506 claims
• Actual Total Payment: $114,480,291

CY 2020

• 85,509 claims
• Actual Total Payment: $1,367,094,959
• Volume of claims by ICD-10-CM diagnosis code:
• E40 Kwashiorkor – 12 claims
• E41 Nutritional Marasmus – 117 claims
• E42 Marasmic Kwashiorkor – 10 claims
• E43 Unspecified severe protein-calorie malnutrition – 85,370 claims
• Claims where one of the four severe malnutrition codes was the only secondary diagnosis on the claim:
• 8,101 claims
• Actual Total Payment: $114,246,389

Moving Forward

• Make sure key stakeholders (i.e., Physicians, Coding Professionals, Clinical Documentation Integrity Specialists, and Registered Dieticians) at your facility are familiar with the 2012 ASPEN/AND criteria and the 2018 Global Leadership Initiative on Malnutrition (GLIM) criteria,
• Partner with your medical staff to standardize the criteria your hospital uses to define the types of malnutrition (i.e., Kwashiorkor, Nutritional Marasmus),
• Monitor your quarterly PEPPER to see if your hospital is an outlier in this risk area,
• Respond in a timely manner to medical record requests made by auditing entities.

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).

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.

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.

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.