Knowledge Base Category -

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.

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)

Just in case you “aren’t from around here”, the state of Alabama is very divided when it comes to college football. In general, you are either a devoted fan of the Alabama Crimson Tide or the Auburn Tigers. On a personal note, and having been told I was from up North (Tennessee), I root for the Tennessee Vols. Unlike the either or of college football, receiving the COVID-19 vaccine, your annual flu shot, and pneumococcal vaccinations are integral to your personal preventive healthcare playbook.

Did You Know?

According to the CDC, “pneumococcal disease is common in young children, but older adults are at greatest risk of serious illness and death.” Potential “defensive options” have been made available by the FDA approval of five different pneumococcal vaccines.

Prevnar® or PCV7 was the first pneumococcal conjugate vaccine licensed by the FDA in 2000. This vaccine provided protection against seven types of pneumococcal bacteria.

Prevnar 13® (pneumococcal conjugate vaccine or PCV13) is a registered trademark by Wyeth LLC and marketed by Pfizer Inc. This vaccine provides protection against infections caused by 6 more serotypes than PCV7. This vaccine is part of the routine childhood immunization schedule. Additionally, in 2011, it was licensed by the FDA for use in adults 50 years or older. The CDC recommends PCV13 for:

• All children younger than 2 years old, and
• People 2 years or older with certain medical conditions. The CDC advises adults 65 years and older to discuss the need for this vaccine with their health care provider.

Pneumovax23® (pneumococcal polysaccharide vaccine or PPSV23) is a Merck product This vaccine was approved by the FDA in 1983 and helps protect against 23 types of pneumococcal bacteria. The CDC recommends this vaccine for:

• All adults 65 years or older,
• People 2 through 64 years old with certain medical conditions (i.e., diabetes, heart disease or COPD), and
• Adults 19 through 64 years old who smoke cigarettes.

Prevnar 20™ (Pneumococcal 20-valent Conjugate Vaccine) On June 8, 2021, Pfizer announced (link) the FDA approval of the Prevnar 20™ vaccine for adults 18 years or older and noted that it is “the first approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia, including seven responsible for 40% of pneumococcal disease cases and deaths in the U.S.”

Vaxneuvance™ (Pneumococcal 15-valent Conjugate Vaccine) On July 16, 2021, Merck announced (link) the FDA approval of Vaxneuvance™, a new vaccine for the prevention of invasive pneumococcal disease in adults 18 years and older caused by 15 serotypes.

Why It Matters?

With the approval of new vaccines, Medicare has expanded their coverage.

Medicare Coverage of Pneumococcal Vaccines

You can find information about pneumococcal shot and administration in the Medicare Learning Network Educational Tool: Medicare Preventive Services (link). This resource was last updated in September 2021 and indicates that Medicare will cover all patients with no copayment, coinsurance, or deductible for the Prevnar 13® and Pneumovax23® vaccines.

Since September, CMS published the following information related to the Prevnar 20™ Vaccine in the Thursday, October 14, 2021 edition of MLN Connects (link):

“Medicare began covering Pneumococcal conjugate vaccine, 20 valent on October 1. CMS suggests submitting separate claims for this vaccine (HCPCS code 90677).

• Part A Medicare Administrative Contractors (MACs) will hold these claims until the April 2022 system update
• Part B MACs began processing these claims on October 4
• CMS will deny claims for vaccines provided July 1–September 30 (before it was covered by Medicare)”

The CMS has also released Transmittal 11092 (Change Request 12439) and related MLN Matters Article (link) providing claims processing instructions for the new Pneumococcal conjugate vaccine, 20 valent.

What Can You Do?

With the 2021 approval of two new pneumococcal vaccines, the CDC’s Advisory Committee on Immunization Practices (ACIP) has held meetings to discuss considerations for age-based and risk-based use of PCV 15/PCV 20 among adults. The most recent meeting was a couple of weeks ago now on October 20, 2021 (link).

As a healthcare provider, I recommend “scouting” for Medicare guidance related to coverage of the Vaxneuvance™ vaccine. As a healthcare consumer, talk with your physician to come up with the winning play for your vaccination needs.

Resources:

• CDC webpage - Pneumococcal Vaccinations: What Everyone Should Know:
  https://www.cdc.gov/vaccines/vpd/pneumo/public/index.html
• Prevnar 20 FDA webpage:
  https://www.fda.gov/vaccines-blood-biologics/vaccines/prevnar-20
• Vaxneuvance FDA webpage:
  https://www.fda.gov/vaccines-blood-biologics/vaccines/vaxneuvance

Even though, Halloween has come and gone, the shift in your Hospital Readmission Reduction Program penalty for the new CMS Fiscal Year may or may not be a treat.

Did You Know?

It has been a decade since CMS began reducing payments to hospitals for excessive readmissions. The payment reduction is capped at 3 percent (that is, a payment adjustment factor of 0.97). And while your penalty rate is based on unplanned readmissions for the following six conditions, the penalty is applied to all Medicare Fee-for-Service inpatient discharges:

• Acute myocardial infarction (MI),
• Chronic Obstructive Pulmonary Disease (COPD),
• Heart Failure (HF),
• Pneumonia,
• Coronary Artery Bypass Graft (CABG) surgery, and
• Elective primary total hip arthroplasty and/or total knee arthroplasty (THA/TKA).

The CMS unplanned hospital visits provider data was last updated September 22, 2021 and released on October 27, 2021 (link). Note, data for the first and second quarters of 2020 are not included in this release due to the impact of the COVID-19 pandemic. CMS has updated the Medicare Hospital Compare webpage (link) with the latest data release.

Why it Matters?

FY 2022 Readmission Reduction Penalties by the Numbers According to a Kaiser Health News article by Jordan Rau (link):

• 2,499 or 47% of all hospitals will be receiving reduced payments,
• The average penalty is a 0.64% reduction in payment,
• Congress’ Medicare Payment Advisory Commission (MedPAC) has noted that the average fines for a hospital in 2018 was $217,000.
• For FY 2022, 82% of hospitals will receive a penalty. This is nearly the same number of hospitals as last year.

What Can You Do?

I encourage you to read the Kaiser Health News article and access the accompanying Look-Up Tool (link) where you will find a trend of your hospitals Readmission Penalties from FY 2015 through 2022.

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.

Medicare MLN Articles & Transmittals – Recurring Updates

January 2022 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Fields and Revisions to Prior Quarterly Pricing Files

• Article Release Date: October 1, 2021
• What You Need to Know: Billing staff need to be aware of these quarterly updates to Medicare ASP and Not Otherwise Classified (NOC) Part B drug pricing files.
• MLN MM12469: (link)

Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 28.0, Effective January 1, 2022

• Article Release Date: October 1, 2021
• What You Need to Know: Billing staff need to be aware of these quarterly updates to Medicare ASP and Not Otherwise Classified (NOC) Part B drug pricing files.
• MLN MM12469: (link)

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

• Article Release Date: October 1, 2021
• What You Need to Know: Billing staff need to be aware of these quarterly updates to Medicare ASP and Not Otherwise Classified (NOC) Part B drug pricing files.
• MLN MM12469: (link)

New/Modifications to the Place of Service (POS) Codes for Telehealth

• Article Release Date: October 14, 2021
• What You Need to Know: The POS Workgroup has revised the description of existing POS code 2 and added a new POS code 10.
• MLN MM12427: (link)

Claim Status Category and Claim Status Codes Update

• Article Release Date: October 14, 2021
• What You Need to Know: This article updates, as needed, the Claims Status and Claim Status Category Codes approved by the National Code Maintenance Committee.
• MLN MM12299: (link)

April 2022 Update to the Java Medicare Code Editor (MCE) for New Edit 20 – Unspecified Code Edit

• Article Release Date: October 22, 2021
• What You Need to Know: This article tells about system changes needed to update the MCE to accept a new MCE edit 20 (Unspecified Code Edit).
• MLN MM12471: (link)

Revised Medicare MLN Articles & Transmittals

Medicare Clarifies Recognition of Interstate License Compact Pathways

• Article Release Date: Initial article May 5, 2020 – Revision September 16, 2021
• What You Need to Know: The CMS revised this MLN article to clarify recognition of licenses through interstate license compact pathways as valid and full licenses for purposes of meeting federal license requirements.
• MLN SE20008: (link)

Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) Updates for Fiscal Year (FY) 2022

• Article Release Date: August 12, 2021 – Revised October 6, 2021
• What You Need to Know: This MLN article was revised to reflect revised CR 12417 which corrected the fixed dollar loss threshold amount to $16,040.
• MLN MM12417: (link)

National Coverage Determination (NCD 110.24): Chimeric Antigen Receptor (CAR) T-cell Therapy – This CR Rescinds and Fully Replaced CR 11783

• Article Release Date: May 24, 2021 – Revised October 6, 2021
• What You Need to Know: In this fourth iteration of this MLN article, information has been added on the use of the KX modifier on professional claims. Substantive changes are in dark red font.
• MLN MM12177: (link)

Medicare Coverage Updates

September 27, 2021: Final Decision Memo – Home Use of Oxygen and Home Oxygen to Treat Cluster Headaches

The CMS posted a final national coverage determination (NCD) and decision memo ((link) for two separate, but medically related NCDs.

• NCD 240.2.2: Home Oxygen Use to Treat Cluster Headaches (CH)
• CMS is removing this NCD from the Medicare NCD manual,
• Ending Coverage with Evidence Development (CED), and
• Allowing MACs to make coverage determinations regarding the use of home oxygen and oxygen equipment for CH.
• NCD 240.2: Home Use of Oxygen
• CMS is expanding patient access to oxygen and oxygen equipment in the home, and
• Permitting MACs to cover the use of home oxygen and oxygen equipment in order to treat CH and other acute conditions.

I have recently noticed a resurgence of a favorite commercial from my childhood featuring a little boy, Mr. Turtle, Mr. Owl, and a tootsie roll pop (link). Although it’s a given that we will never know how many licks it takes to get to the center of a Tootsie Roll pop, it’s no mystery as to why the OIG believes CMS has paid millions in overpayments for neurostimulator implantation surgeries. Let’s unwrap this OIG report (link) and get to the center of it.

Why This Audit was Conducted

CMS analysis revealed that claims for spinal neurostimulator implantation surgeries increased by nearly 175 percent between 2007 and 2018. “CMS researched possible causes for the increased volume of these procedures that would indicate the services are increasingly necessary, but CMS did not find any plausible reason for the increase in services and concluded that a financial motivation was the most likely cause for the increase.”

Strategic Health Solutions, the first Supplemental Medical Review Contractor (SMRC), was tasked with reviewing post-payment claims of Medicare Part B spinal neurostimulator implantation surgeries. They reviewed claims with dates of service from January through September of 2014 and identified a 72% error rate.

Without a “plausible reason for the increase in services” and the SMRC review’s high error rate, the OIG conducted this review to “determine whether health care providers complied with Medicare requirements when they billed for neurostimulator implantation surgeries.”

What are Neurostimulators?

• What is it? A battery-powered electronic device enclosed in a small metal container that is surgically implanted under a patient’s skin and connected to wires called leads
• Types of Neurostimulators: Spinal cord, deep brain, and vagus nerve stimulator (VNS) devices.
• Conditions that can be treated with neurostimulator: chronic pain, Parkinson’s disease, essential tremor, dystonia, obsessive-compulsive disorder, seizures, and epilepsy.

Medicare Coverage Requirements for Neurostimulators

As noted above, there are several conditions where treatment with a neurostimulator implant may be warranted. Medicare has several National Coverage Determinations (NCDs) related to neurostimulators that detail the indications and limitations of coverage, including:

• NCD 160.2: Treatment of Motor Function Disorders with Electrical Nerve Stimulation,
• NCD 160.7: Electrical Nerve Stimulators,
• NCD 160.18 – Vagus Nerve Stimulation, and
• NCD 160.24 – Deep Brain Stimulation for Essential Tremor and Parkinson’s Disease.

OIG Claims Selection by the Numbers

• 2016-2017: The audit period for this review,
• $1.4 billion: The Medicare payments made to providers during the audit period,
• 58,213: The number of beneficiaries who had at least one neurostimulator implantation during the audit period.
• HCPCS Codes 61885, 61886, or 63685: The codes used to identify beneficiaries who had undergone a neurostimulator implantation surgery.
• 124 claims: The stratified random sample of claims reviewed in this audit.
• $1,000: All claims reviewed were for paid amounts greater than $1,000.
• $3.4 million: The amount paid to 102 providers for the 124 claims in the audit sample.
• Audit sample claim specific indication for neurostimulator:
• 87 claims were for treatment of chronic pain,
• 4 claims were for treatment of seizures, and
• 13 claims were for essential tremors and Parkinson’s disease.
• Note, the remaining two claims involved a neurostimulator implant with an investigational device exemption.

Audit Error Rates

The OIG found that 40% of health care provided did not comply with Medicare requirements. Based in this finding, they estimated that:

• Providers received $636 million in unallowable Medicare payments, and
• Medicare beneficiaries paid $54 million in related unnecessary coinsurance amounts.

An independent contractor reviewed the medical records and determined that 48 (49%) of the 106 claims did not contain documentation supporting compliance with the applicable NCD indications. The OIG report lists types of missing/incomplete documentation by NCD, for example:

• NCD 160.7:
• No documentation of other failed treatment modalities or that other treatment prior to a neurostimulator was felt to be unsuitable or contraindicated, and
• No documentation of the multidisciplinary screening includes a psychological evaluation.

OIG Audit Conclusions & Recommendations

The “tootsie-roll center” of this audit are the OIG’s audit conclusions and recommendations. Both lay the groundwork for steps for providers moving forward. The OIG concluded that:

• Medical records lacked documentation to support the NCD coverage requirements for neurostimulator implants,
• There were limited instances when providers “stated that they did not fully understand these Medicare coverage requirements,”
• These claims did not require prior authorization, nor were they subject to pre-payment reviews, and
• There is no edit in the CMS software to initiate such a review.
• It was not until after the completion of this audit that CMS published the CY 2021 OPPS Final Rule that added prior authorization of spinal neurostimulators to the Prior Authorization for Certain Hospital Outpatient Department Services program effective for services on or after July 1, 2021(link). The OIG notes that this final rule does not include claims for neurostimulator implantation for Parkinson’s disease or seizure disorders.
• Note, in May of 2021, the CMS limited the prior authorization requirement to CPT code 63650 (implantation of spinal neurostimulator electrodes, accessed through the skin).

Based on their conclusions, the OIG recommended that CMS instruct the Medicare Administrative Contractors:

• Recover overpayments,
• Advise applicable providers to exercise reasonable diligence to identify, report, and return over-payments in accordance with the 60-day rule,
• Conduct provider outreach and education regarding Medicare coverage requirements, and
• Require prior authorization for procedures for Parkinson’s disease and seizures.

CMS agreed with all recommendations but indicated that neurostimulator implantation for Parkinson’s disease and seizure disorders are currently on the Medicare Inpatient Only (IPO) Procedure List and their prior authorization authority does not extend to inpatient services. The OIG noted that “CMS’s inability to implement this control for inpatient claims…leaves this area vulnerable to future overpayments.”

Steps Moving Forward

I encourage you to:

• Become familiar with the Medicare coverage requirements at the National and Local MAC level,
• Identify the documentation deficiencies by NCD detailed in this OIG report,
• Work with your Physician’s offices to ensure all documentation needed to support the medical necessity of the procedure is in the medical record, and
• Learn about current MAC specific provider outreach and education activities in a related article in this week’s newsletter.