Knowledge Base Category -

Medicare Coverage Updates

August 20, 2021: Closing the Gap: Left Atrial Appendage Closure Module

Palmetto GBA, the Medicare Administrative Contractors for Jurisdictions J and M, published this module (link) to provide an overview of required documentation to support billing of these claims. This interactive model covers the following:

• Left Atrial Appendage Closure (LAAC) overview,
• Indications & Coverage Criteria,
• Registries & Studies, and
• How to Prevent Denials.

Palmetto GBA offers the following tip to preventing denials, “facilities may want to consider implementing a process of requiring the patient’s history and physical with utilization review prior to scheduling the procedure or have designated staff analyze the beneficiary records for national coverage determination (including shared decision-making [SDM]) compliance before allowing the procedure to be scheduled.”

September 8, 2021: Change Request 12361: Claims Processing Instructions for NCD 20.33 – Transcatheter Edge-to-Edge [TEER] for Mitral Valve Regurgitation

NCD 20.33, TEER for Mitral Valve Regurgitation was previously named Transcatheter Mitral Valve Repair (TMVR). CR 12361 (link) informs MACs that on January 1, 2021 (Effective Date), CMS expanded coverage of mitral valve TEER procedures for the treatment of functional mitral regurgitation (MR) and maintained coverage of TEER for the treatment of degenerative MR through coverage with evidence development (CED) with mandatory registry participation.

CMS notes in the CR summary of changes that “NCDs are binding on the MACs who review and/or adjudicate claims, make coverage determinations, and/or payment decisions, and also binds quality improvement organizations, qualified independent contractors, the Medicare appeals council, and Administrative Law Judges (ALJs) (see 42 Code of Federal Regulations (CFR) section 405.1060(a)(4) (2005)). An NCD that expands coverage is also binding on a Medicare advantage organization.”

A related MLN Article MM12361 (link) was released on September 14, 2021. This article includes the procedure and diagnosis codes on claim lines that the MACs will accept for TEER services. CMS notes that “your MAC won’t search for TEER claims they processed before implementation of CR 12361. They will adjust such claims you bring to their attention.” The implementation date is October 8, 2021.

You can read more about the changes and new requirements for NCD 20.33 in a related MMP article (link).

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

• Article Release Date: September 15, 2021
• What You Need to Know: Effective for claims with dates of service on or after April 13, 2021, CMS will nationally cover autologous Platelet-Rich Plasma (PRP) for the treatment of chronic non-healing diabetic wounds under specific conditions. CMS notes that claims should contain HCPCS code G0460, an ICD-10 diagnosis code for diabetes mellitus and an ICD-10 diagnosis code for chronic ulcer. This article provides a link to a list of acceptable diabetes mellitus and chronic ulcer diagnosis codes.
• MLN MM12403: (link)

Medicare Educational Resources

MLN Educational Tool: Medicare Payment Systems

With the beginning of new Prospective Payment System Final Rules just a couple days away now, I want to make our readers aware of a fairly new MLN Education Tool )https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/html/medicare-payment-systems.html#Intro">link) where CMS has combined information about Medicare Payment Systems for Acute Care Hospitals, Hospice, Skilled Nursing, Ambulatory Surgery Centers, Hospital Outpatient, Inpatient Psychiatric Facilities, Inpatient Rehabilitation Facilities and Long-Term Care Hospitals.

July 2021 Medicare Quarterly Provider Compliance Newsletter

CMS announced the release of the July newsletter (link) in the Thursday September 9, 2021, edition of MLN Connects. This newsletter’s aim is to provide guidance to address billing errors.

MLN Booklet: Independent Diagnostic Testing Facility (IDTF)

This MLN Booklet (link) was updated in September. Updates are bolded in red. Of note, guidance for IDFTs related to the COVID-19 Public Health Emergency has been added to this booklet.

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 professional can bill concurrently with Transitional Care Management services and added language about auxiliary personnel providing services under supervision.

Medicare & You 2022

Medicare & You is the official U.S. government Medicare handbook. The 2022 is now available (link). New and important information about COVID-19-related items & services, cognitive assessment & care plan services, and blood-based biomarker testing have been added to the latest edition of this handbook.

Medicare MLN Articles & Transmittals – Recurring Updates

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

• Article Release Date: August 25, 2021
• What You Need to Know: This article providers ICD-10 updates specific to NCDs resulting from newly available codes, separate NCD coding revisions and coding feedback received. Note, one of the updated NCDs is 20.4 Implantable Automatic Defibrillator. As CMS has added codes to this NCD, Novitas and First Coast have both retired their AICD Coding and Billing Articles.
• MLN MM12399: (link)

Implement Operating Rules – Phase III Electronic Remittance Advice (ERA) Electronic Funds Transfer (EFT): Committee on Operating Rules for Information Exchange (CORE) 360 Uniform Use of Claim Adjustment Reason Codes (CARC), Remittance Advice Remark Codes (RARC) and Claim Adjustment Group Code (CAGC) Rule – Update from Council for Affordable Quality Health Care (CAQH) Core

• Article Release Date: September 8, 2021
• What You Need to Know: This article alerts billing staff that the next version of the Code Combination List will be published on or about October 1, 2021. Updates are based on a market-based review conducted once every two years to fit in code combinations that Medicare and other health plans are now using.
• MLN MM12428: (link)

Annual Clotting Factor Furnishing Fee Update 2022

• Article release date: September 8, 2021
• What You Need to Know: Make sure your billing staff knows the clotting factor furnishing fee for 2022 is $0.239 per unit.
• MLN MM12420: (link)

Influenza Vaccine Payment Allowances – Annual Update for 2021-2022 Season

• Article release date: September 9, 2021
• What You Need to Know: This article includes a link to the CMS Seasonal Influenza Vaccines Pricing webpage and reminds all physicians, non-physician practitioners, and suppliers who give the flu shot that they must take assignment on the claim for the shot.
• MLN MM12421: (link)

2022 Annual Update for the Health Professional Shortage Area (HPSA) Bonus Payments

• Article Release Date: September 9, 2021
• What You Need to Know: This article informs providers that the MACs will be receiving files for the automated payments of HPSA bonuses for dates of service from January 1, 2022, through December 31, 2022.
• MLN MM12367: (link)

Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) – October 2021 Update

• Change Request (CR) 12422 released: September 8, 2021
• What You Need to Know: This CR amends the payment files issued to contractors based upon the 2021 Medicare Physician Fee Schedule (MPFS) Final Rule.
• Related MLN MM12422: (link)

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

• Article Release Date: September 10, 2021
• What You Need to Know: This article provides information about quarterly updates to the CLFS, effective October 1, 2021.
• MLN MM12435: (link)

October 2021 Update of the Hospital Outpatient Prospective Payment System (OPPS)

• Article Release Date: September 16, 2021
• What You Need to Know: Changes to and billing instructions for various payment policies are included in this Change Request. Information related to COVID-19 in this update includes:
• New COVID-19 CPT Administration Codes,
• New COVID-19 HCPCS Vaccine Administration Code for Administering in the Beneficiary’s Home, and
• Changes for COVID-19 Monoclonal Antibody Therapy Product and Administration Codes.
• Change Request (CR) 12436: (link)

October 2021 Update of the Ambulatory Surgical Center (ASC) Payment System

• Article Release Date: September 17, 2021
• What You Need to Know: This article highlights HCPCS updates included in the October 2021 ASC payment system update.
• MLN MM12451: (link)

Revised Medicare MLN Articles & Transmittals

Medicare FFS Response to the PHE on COVID-19

• Article Release Date: Initial article March 16, 2020 – 19th iteration September 8, 2021
• What You Need to Know: The latest revision to this MLN Special Edition article includes more information about Skilled Nursing Facility (SNF) waivers. Substantive changes are in dark red font on page 13 of this document. Specifically, CMS reminds providers that while the 3-day qualifying hospital stay is being waived prior to transfer to a SNF, “these emergency measures don’t waive or change any other existing requirements for SNF coverage under Part A such as the SNF level of care criteria, which remain in effect under the emergency.”
• MLN SE20011: (link)

COVID-19 Updates

August 20, 2021: CMS COVID-19 Flexibilities Reminders: Prior Authorization Process, Utilization Management and Medical Necessity

The CMS issued a letter (link) to Medicare Advantage Organizations (MAOs) noting that with the recent COVID-19 delta variant surge resulting in increased hospitalizations, they encourage MA Plans “to waive or relax plan prior authorization requirements and utilization management processes to facilitate the movement of patients from general acute-care hospitals to post-acute care” settings (i.e., skilled nursing facilities, inpatient rehabilitation facilities, inpatient rehabilitation facilities and home health agencies).

Of note, CMS goes on to remind MAOs that “while they and their contract providers are not required to follow Original Medicare’s documentation requirements or policies for establishing medical necessity, the methods implemented…to determine medical necessity cannot result in coverage standards that are more stringent than standards that apply in Fee-For-Service Medicare.”

August 27, 2021: FAQs Regarding ICD-10-CM/PCS Coding for COVID-19 Updated

The FAQ document jointly developed and approved by the American Hospital Association’ Central Office on ICD-10-CM/PCS and the American health Information Management Association provides answers to questions related to Coding COVID-19. This document (link) was most recently revised August 27, 2021.

September 2, 2021: Resumption in Use and Distribution of Bamlanivimab/Etesevimab in all U.S. States, Territories, and Jurisdictions

In late August, use of this COVID-19 monoclonal antibody treatment was revised to authorize use only in areas where the combined frequency of variants resistant to both treatments administered together was less than or equal to 5%. On September 2nd, the FDA announced (link) that based on most recently available data, Bamlanivimab and Etesevimab, administered together, can be used in all U.S. states, territories, and jurisdictions under the condition of authorization for EUA 94.

September 9, 2021: CDC Clinician Outreach and Communications Activity Call: 2021-2022 Influenza Vaccination Recommendations and Guidance on Coadministration with COVID-19 Vaccines

The CDC held this call on Thursday, September 9, 2021. Presenters provided updates on the Advisory Committee on Immunization Practices (ACIP) recommendations for the 2021-2022 influenza vaccination season and guidance for co-administration of influenza and COVID-19 vaccines. One key take away is that COVID-19 vaccines may be administered without regard to timing of other vaccines. For those that missed this call, you can visit the CDC webpage specific to this call (link) to download a copy of the slides.

September 10, 2021: FDA Statement – COVID-19 Vaccines for Young Children

Acting FDA Commissioner Janet Woodcock M.D., and Peter Marks, M.D, Ph.D., director the FDA’s Center for Biologics Research and Education, released a statement (link) providing an update detailing steps being taken to ensure the safety and efficacy of COVID-19 vaccines for young children. The statement ends with the following advice, “Until we authorize or approve a vaccine for this younger population, it’s especially important that parents and others who interact closely with children under 12 years of age get vaccinated, wear masks, and follow other recommended precautions so that we can protect those who cannot yet protect themselves through vaccination.”

September 10, 2021: HHS Announced $25.5 Billion in COVID-19 Provider Funding

The HHS announced (link) that funding from the American Rescue Plan (ARP) and Provider Relief Fund (PFR) totaling $25.5 billion is being made available for health care providers affected by the COVID-19 pandemic. HHS Secretary Xavier Bacerra noted that “this funding critically helps health care providers who have endured demanding workloads and significant financial strains amidst the pandemic…the funding will be distributed with an eye towards equity, to ensure providers who serve our most vulnerable communities will receive the support they need.”

September 30, 2021: CDC COCA Call: Evaluating and Supporting Patients Presenting with Fatigue Following COVID-19

The CDC will be holding a Clinician Outreach and Communication Activity (COCA) call Thursday September 30, 2021, in which presenters will discuss post-COVID conditions (PCC), “an umbrella term for the wide range of health consequences present four or more weeks after infection with SARS-CoV-2, which includes Long-COVID.” If you are unable to attend, call materials will be available on the CDC specific webpage for this call (link).

September 9, 2021: Outpatient Clinic Visit Services at Excepted Off-Campus Provider-Based Departments: Payment Update

CMS included the following updated information in the Thursday September 9, 2021 edition of MLN Connects (link):

“By November 1, 2021, CMS will begin reprocessing claims for outpatient clinic visit services provided at excepted off-campus Provider-Based Departments (PBDs) so they’re paid at the same rate as non-excepted off-campus PBDs for those services under the Physician Fee Schedule (PFS). This affects certain claims with dates of service between January 1 - December 31, 2019. You don’t need to do anything; we’ll reprocess all affected claims. You must refund the coinsurance difference to patients (or payers) who paid the higher coinsurance rates based on new remittance advice information.

Background:

• November 21, 2018: The Calendar Year (CY) 2019 Outpatient Prospective Payment System (OPPS) Rule (link) finalized payment for certain outpatient clinic visit services provided at excepted off-campus PBDs at the same rate that we pay non-excepted off-campus PBDs for those services under the PFS. Previously, CMS and Medicare patients often paid more for the same type of clinic visit in the hospital outpatient setting than in the physician office setting.
• In 2019: We reduced payment to 70% of the full OPPS rate in off-campus PBDs. In 2020, this rate changed to 40%.
• September 17, 2019: The U.S. District Court for the District of Columbia declared invalid the CY 2019 payment rule that provided for the reduction for clinic visits provided at excepted off-campus PBDs.
• January 1 – July 2020: We reprocessed CY 2019 claims paid at the reduced payment rate of 70% to restore the 100% payment rate in accordance with the district court decision.
• July 17, 2020: The U.S. Court of Appeals for the D.C. Circuit reversed the district court ruling, upholding our volume control site-neutrality payment policy for off-campus outpatient hospital clinic visits.”

September 13, 2021: Proposal to Fully Repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” Final Rule

On September 1, 2020, the CMS released the Proposed Rule Medicare Coverage of Innovative Technology (MCIT) and Definition of Reasonable and Necessary Proposed Rule (CMS-3372-P). At that time, then Medicare HHS Secretary Alex Azar stated in a related press release that “this new proposal would give Medicare beneficiaries faster access to the latest lifesaving technologies and provider more support for breakthrough innovations by finally delivering Medicare reimbursement at the same time as FDA approval.” A Final Rule was published in the Federal Register on January 14, 2021, with a stated effective date of March 14, 2021. The effective date has since been delayed until December 15, 2021.

On Wednesday September 15, 2021, the CMS issued a Notice of Proposed Rule Making to fully repeal this final rule. (link). The repeal includes a public comment period through October 15, 2021. CMS’s intent is “to conduct future rulemaking to explore an expedited coverage pathway for innovative technologies (balanced with evidence development to ensure beneficial health outcomes for beneficiaries) and a regulatory definition of the Reasonable and Necessary standard for Medicare coverage.”

September 15, 2021: Department of Justice News: Orlando Cardiologist Pays $6.75 Million to Resolve Allegations

In a recent announcement (link), the DOJ indicated that an Orlando Cardiologist paid $6.75 million to resolve allegations that he performed medically unnecessary ablations and vein stent procedures. Specific allegations included:

• Ablations and stent procedures were performed on veins that did not qualify for treatment under accepted standards of medical practice,
• Dr. Pal made misrepresentations in patient records to justify the procedures, including overstating the degree of reflux and diameter of veins, and falsely documenting patient symptoms, and
• In many instances, the ablations were performed either exclusively or primarily by one or more ultrasound technicians outside their scope of practice.”

September 17, 2021: DOJ News – National Healthcare Fraud Enforcement Action

The DOJ announced (link) criminal charges against 138 defendants, including 42 doctors, nurses, and other licensed medical professionals in 31 federal districts across the U.S. for alleged participation in health care fraud schemes resulting in approximately $1.4 billion in alleged losses. Specifically, charges targeted approximately $1.1 billion in fraud committed using telemedicine, $29 million in COVID-19 health care fraud, $133 million connected to substance abuse treatment facilities, and $160 million connected to other health care fraud and illegal opioid distribution schemes.

Welcome to this month’s edition of MMP’s P.A.R. Pro Tips. For those new to the Wednesday@One, MMP has collaborated with RealTime Medicare Data (RTMD), to develop a proprietary Protection Assessment Report (P.A.R.). This report is a combination of current Medicare Fee-for-Service review targets with hospital specific Medicare Fee-For-Service paid claims data. As a bonus to our Wednesday@One readers, we have begun to provide useful “Did You Know” information that we come across in our ongoing review of key websites (i.e., Medicare Administrative Contractors (MACs), OIG, Recovery Auditors, etc.)

Did You Know?

Late last month, we reported that CMS had given the green light for Medicare Administrative Contractors (MACs) to resume the Targeted Probe and Educate (TPE) Program. This program had been on hold since March of 2020 due to the COVID-19 Public Health Emergency (PHE).

MACs are now reporting that effective September 1, 2021, they will discontinue sending post-payment additional documentation requests (ADR) and will resume reviews conducted under the TPE Medical Review Strategy.

Pro Tip: MAC Education

MACs nationwide have been releasing information about the resumption of the TPE Program.

CGS (Jurisdiction 15)

CGS has posted a letter to providers (link) walking through the TPE process and providing links to resources. At the time this article was written, CGS Part A Medical Review Activity Log (link) indicated that the TPE review types were still paused.

First Coast Service Options, Inc. (Jurisdiction N)

First Coast’s TPE webpage (link) you will find a link to a Targeted Probe and Educate Manual with guidance ranging from what is TPE to filing appeals.

Noridian (Jurisdiction E)

Noridian held a Targeted Probe and Educate (TPE) A/B webinar this past Friday, September 10, 2021. Topics included in the webinar included the TPE process, initiating reviews, providing notification, and completing and closing files. If you missed it, you can sign up for an October 14, 2021 webinar that will cover the same information (link).

Noridian (Jurisdiction F)

Following is an excerpt from an announcement (link) that Noridian posted on their website on September 8, 2021, “CMS has authorized the Medicare Administrative Contractors (MACs) to conduce a 20-40 claim preview for A/B providers utilizing the normal TPE process. If the Round One results in an acceptable error rate, no further action is required, and the TPE review will be closed.”

Novitas Solutions Jurisdiction (Jurisdiction H)

Novitas most recently updated their TPE webpage (link) on September 7, 2021, where you will find links to TPE Q&As, current TPE activities, historical TPE reviews, and documentation checklists. As of 9/7/2021, the only listed TPE Topic list is Therapy Services.

Palmetto GBA (Jurisdiction J)

Palmetto GBA was one of the first to update their Active Medical Review list (link), they note that TPE cases that remained open during the PHE have been closed.

WPS (Jurisdiction 5)

CMS issued the following notice on August 30, 2021, “CMS has authorized WPS to resume the TPE program effective September 1, 2020. Providers selected for review based on data analysis aberrancies will receive notification prior to the start of their TPE review.” Topics under review listed on their website (link) includes:

• Inpatient Psychiatric Facility (IPF),
• Inpatient Rehabilitation Services,
• Routine Foot Care, and
• Wound care in a Critical Access Hospital (CAH).

What Can You Do?

Make sure that employees involved with the TPE program at your facility are aware of the resumption of the program and make sure someone is checking your MAC’s websites on an ongoing basis for any updates, new review targets and TPE review results.

COVID-19 Booster Shots

On August 18, 2021, HHS released a statement, (link), indicating that “the available data make very clear that protection against SARS-CoV-2 infection begins to decrease over time following the initial doses of vaccination, and in association with the dominance of the Delta variant, we are starting to see evidence of reduced protection against mild and moderate disease. Based on our latest assessment, the current protection against severe disease, hospitalization, and death could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout. For that reason, we conclude that a booster shot will be needed to maximize vaccine-induced protection and prolong its durability.” HHS goes on to indicate they have a plan to begin offering booster shots this fall of a third dose of the Pfizer and Moderna mRNA vaccines, “beginning the week of September 20 and starting 8 months after an individual’s second dose.”

HHS also anticipates the need for a booster shot for individuals that received the Johnson & Johnson (J&J) vaccine. They note that “administration of the J&J vaccine did not begin in the U.S. until March 2021, and we expect more data on J&J in the next few weeks. With those data in hand, we will keep the public informed with a timely plan for J&J booster shots as well.”

COVID-19 Third Dose of Moderna and Pfizer-BioNTech CPT Codes

Concurrent to the recommendation that individuals receive a third Moderna or Pfizer-BioNTech COVID-19 vaccine, the AMA published the following CPT codes.

• Moderna Third Dose
• Effective for Emergency Use Authorization (EUA) as of August 12, 2021.
• Administration code 0013A
• Pfizer-BioNTech Third Dose
• Effective for EUA as of August 12, 2021
• Administration code 0003A

You can find a summary of the SARS-CoV-2 related CPT codes on the AMA website (link).

COVID-19 Myths and Facts

The CDC has a webpage (link) dedicated to dispelling myths about COVID-19 vaccines. For example:

• Yes, the Pfizer-BioNTech and Moderna mRNA vaccines trigger an immune response inside your body and are considered vaccines. The CDC notes that “this type of vaccine is new, but research and development on it has been under way for decades.”
• No, COVID-19 vaccines do not contain microchips.
• No, receiving a COVID-19 vaccine will not make you magnetic.

The World Health Organization (WHO) also has a webpage (link) dedicated to dispelling myths about COVID-19 in general by providing the facts, for example:

• COVID-19 is caused by a virus, not by bacteria. The virus that causes COVID-19 is in a family of viruses called Coronaviridae.
• The COVID-19 virus can spread in hot and humid climates, and
• 5G mobile networks DO NOT spread COVID-19. COVID-19 is a virus and is spread through respiratory droplets when an infected person coughs, sneezes or speaks. People can also be infected by touching a contaminated surface and then their eyes, mouth, or nose.

September is Prostate Cancer Awareness Month. A related RealTime Medicare Data (RTMD) infographic in this week’s newsletter focuses on Medicare Fee-for-Service claims data related to screening for Prostate Cancer.

Did You Know?

According to the CDC:

• 13 out of every 100 American men will get prostate cancer during their lifetime, and
• 2 to 3 men will die from prostate cancer,
• If you are African American or have a family history of prostate cancer you are at increased risk for getting or dying from prostate cancer.

The NIH National Cancer Institute indicates that based on 2011-2017 data, there is a 97.5% 5-year relative survival rate for men diagnosed with prostate cancer.

Why Does this Matter? Know the Symptoms

The CDC advises that if you are having any of the following symptoms, you need to see your doctor right away:

• Difficulty starting urination.
• Weak or interrupted flow of urine.
• Frequent urination, especially at night.
• Difficulty emptying the bladder completely.
• Pain or burning during urination.
• Blood in the urine or semen.
• Pain in the back, hips, or pelvis that doesn’t go away.
• Painful ejaculation.

The NIH National Cancer Institute indicates that based on 2011-2017 data, there is a 97.5% 5-year relative survival rate for men diagnosed with prostate cancer.

What You Can Do About It? Screening for Prostate Cancer

There are two tests commonly used to screen for prostate cancer:

• A blood test called a prostate specific antigen (PSA) test and
• A digital rectal examination (DRE).

The U.S. Preventive Services Task Force recommendation is that men aged 55 to 69 years should participate in a shared decision making process with their physician by discussing the potential benefits and harms of screening with a PSA test and incorporating their values and preferences in the decision.

This recommendation applies to men who:

• Are at average risk for prostate cancer,
• Are at increased risk for prostate cancer,
• Do not have symptoms of prostate cancer, and
• Have never been diagnosed with prostate cancer.

Medicare Preventive Service: Prostate Cancer Screening – Coverage & Coding

HCPCS & CPT Codes

• G0102 (Prostate cancer screening; digital rectal exam): A patient’s copayment or coinsurance, and deductible will apply.
• G0103 (Prostate cancer screening; prostate specific antigen test): there is no copayment, coinsurance, or deductible for the patient.

Resources:

• CDC website: https://www.cdc.gov/cancer/prostate/
• NIH National Cancer Institute Cancer Stat Facts: Prostate Cancer: https://seer.cancer.gov/statfacts/html/prost.html
• U.S. Preventive Services Task Force Final Recommendation Statement for Prostate Screening: https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/prostate-cancer-screening
• CMS MLN Educational Tool (MLN006559 May 2021): Medicare Preventive Services at https://www.cms.gov/medicare/prevention/prevntiongeninfo/medicare-preventive-services/mps-quickreferencechart-1.html#PNEUMO

COVID-19 Updates

August 12, 2021: FDA Authorized Additional Vaccine Dose for Certain Immunocompromised Individuals

The FDA has amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID- 19 Vaccine and the Moderna COVID-19 Vaccine to allow for additional doses “in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.” (link). CMS updated their COVID-19 webpage on August 13, 2021 (link), to reflect that they will pay the same amount to administer this additional dose as they did for the other doses (approximately $40 each). .

August 16, 2021: Actemra® (Tocilizumab) Supply Shortage

Genentech released a statement (link) indicating that due to “the unprecedented surge in worldwide demand and supply constraints driven by Delta variant spikes in much of the rest of the world that preceded the current situation in the U.S., has led to a global shortage of Actemra® (tocilizumab) supply for at least the next several weeks…This new wave of the pandemic has led to Genentech experiencing an unprecedented demand for Actemra IV-- well-over 400% of pre-COVID levels over the last two weeks alone and it continues to increase.”

August 18, 2021: COVID-19 Booster Shots

The U.S. Department of Health and Human Services (HHS) published a Press Release (link) regarding the need for COVID-19 booster shots. Specifically, data has shown that protection from vaccination begins to decrease over time and they have a plan to begin offering booster shots “subject to FDA conducting an independent evaluation and determination of the safety and effectiveness of a third dose of the Pfizer and Moderna mRNA vaccines and CDC’s Advisory Committee on Immunization Practices.”

Other Updates

July 19, 2021: CY 2022 Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule (CMS-1753-P) – Hospital Price Transparency

The September 17, 2021 deadline to comment on the CY 2022 OPPS and ASC Payment System Proposed Rule is fast approaching. In a related CMS Fact Sheet (link), CMS noted several proposed “modifications designed to increase compliance and reduce hospital burden beginning January 1, 2022.” One key proposal for hospitals to be aware of is the proposed increase in Civil Monetary Penalties (CMP) for non-compliance with the Hospital Price Transparency rule. Specifically, CMS has proposed the following:

• Set a minimum CMP of $300/day that would apply to smaller hospitals with a bed count ≤30, and
• Apply a penalty of $10/bed/day for hospitals with a bed count >30, not to exceed a maximum daily dollar amount of $5,500.

Under the proposed increases, the new penalty for a full year of noncompliance would be a minimum of $109,500 per hospital and a maximum total penalty of $2,007,500 per hospital.

August 11, 2021: Hospital Price Transparency Stakeholder Webinar

This CMS webinar focused on how to meet the requirements of the Hospital Price Transparency Final Rule (link) for posting standard charge information in a comprehensible machine-readable file (link). CMS experts reviewed 8 steps to a Machine-Readable File of All & Services and provided hospital compliance examples. For those that missed this event, a pdf copy of this presentation is available on the Hospital Price Transparency Resources web page (link). (link)

Medicare MLN Articles & Transmittals – Recurring Updates

New Waived Tests

• Article Release Date: August 9, 2021
• What You Need to Know: This MLN article lists the six latest tests approved by the FDA as waived tests under CLIA. CMS reminds you that the CPT codes for the new tests must have the modifier QW to be recognized as a waived test.
• MLN MM12381: (link)

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

• Article Release Date: August 12, 2021
• What You Need to Know: This article highlights key changes in the FY 2022 IPF PPS.
• MLN MM12417: (link)

Medicare Part A Skilled Nursing Facility (SNF) Prospective Payment System (PPS) Pricer Update FY 2022

• Article Release Date: August 10, 2021
• What You Need to Know: This article provides information related to the SNF payment for rates for FY 2022.
• MLN MM12366: (link)

Inpatient Rehabilitation Facility (IRF) Annual Update: Prospective Payment System (PPS) Pricer Changes for FY 2022

• Article Release Date: August 12, 2021
• What You Need to Know: This article includes information regarding rate updates for PPS IRFs for FY 2022.
• MLN MM12364: (link)

Other Medicare MLN Articles & Transmittals

Modifications/Improvements to Value-Based Insurance Design (VBID) Model – Implementation

• Article Release Date: August 9, 2021
• What You Need to Know: This article alerts you to Change Request (CR) 11754 – Transmittal 10170, which replaces the May 8, 2020, Transmittal 10127. This was done to add a note to the effective date and to revise the background section and business requirements, 11754.3. All other information remains the same.
• MLN MM 12349: (link)

Update of Internet Only Manual (IOM), Pub. 100-04, Chapter 8 – Outpatient ESRD Hospital, Independent Facility, and Physician/Supplier Claims

• Article Release Date: August 9, 2021
• What You Need to Know: This article provides a quick summary of updates to the Medicare Claims Processing Manual, Chapter 8 – Outpatient ESRD Hospital, Independent Facility, and Physician/Supplier Claims. Complete reviews can be found in related Change Request (CR) 12079.
• MLN MM12079: (link)

Internet Only Manual Updates to Publication (Pub.) 100-02 to Implement Updates to Policy and Correct Errors and Omissions (Inpatient Rehabilitation Facility (IRF))

• Article Release Date: August 9, 2021
• What You Need to Know: This article tells you about updates to Chapter 1, Section 110 (IRF Services) of the Medicare Benefit Policy Manual.
• MLN MM12353: (link)

Internet Only Manual Updates to Pub. 100-01, 100-02, and 100-04 to Implement Consolidated Appropriations Act Changes and Correct Errors and Omissions (SNF)

• Article Release Date: August 9, 2021
• What You Need to Know: Changes made clarify existing content. CMS notes in this MLN article that no policy, processing, or system changes are anticipated.
• MLN MM12009: (link)

Implementation of the GV Modifier for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) for Billing Hospice Attending Physician Services

• Article Release Date: August 11, 2021
• What You Need to Know: Effective January 1, 2022, an RHC or FQHC can bill and receive payment under the RHC All-Inclusive Rate (AIR) or FQHC Prospective Payment System (PPS), respectively, when their employed and designated attending physician provides services during a patient’s hospice election. This article provides detail regarding the required modifier to receive payment in both settings.
• MLN MM12357: (link)

Skilled Nursing Facility (SNF) Claims Processing Updates

• Article Release Date: August 11, 2021
• What You Need to Know: This article highlights changes to correct claims processing edits applicable to the FISS and CWF in CR 12344.
• MLN MM12344: (link)

Revised Medicare MLN Articles & Transmittals

National Coverage Determination (NCD) Removal

• Article Release Date: Initial article May 24, 2021 – 3rd Revision August 3, 2021
• What You Need to Know: The MLN Article was revised to reflect the CR 12254 revisions made to the spreadsheet for NCD 20.5 and NCD 220.6.16.
• MLN MM12254: (link)

Medicare Coverage Updates

August 11, 2021: Proposed Decision Memo for Transvenous (Catheter) Pulmonary Embolectomy (CAG-00457R)

The CMS released Proposed Decision Memo CAG-00457R (link) proposing to remove the NCD for Transvenous Pulmonary Embolectomy (NCD 240.6) and allow for Medicare coverage determinations to be made by Medicare Administrative Contractors (MACs). The public comment period ends on September 10, 2021. You can follow the progress of this proposed decision memo on the related National Coverage Analysis (NCA) tracking sheet (link).

August is National Immunization Awareness Month (NIAM). A related RealTime Medicare Data (RTMD) infographic in this week’s newsletter focuses on Medicare Fee-for-Service claims data related to the treatment costs of Pneumonia.

Did You Know?

According to CDC data for the United States in 2017

• 3 million people were diagnosed with pneumonia in an emergency department, and
• Approximately 50,000 people died from pneumonia.

Why Does this Matter?

In general, people affected by pneumonia in the United States are adults. Per the CDC, vaccines, and appropriate treatment (like antibiotics and antivirals) could prevent many of these deaths.

What You Can Do About It? Wash Your HandsWhy Does this Matter?

In general, people affected by pneumonia in the United States are adults. Per the CDC, vaccines, and appropriate treatment (like antibiotics and antivirals) could prevent many of these deaths.

What You Can Do About It? Wash Your Hands

Handwashing is one of the most important things you can do. In fact, it’s so important that annually there is a Global Handwashing Day on October 15th and the first week of December in the U.S. is National Handwashing Week. You can download a CDC poster educating people on knowing when and how to wash your hands (link).

When to Wash Your Hands?

• After using the bathroom,
• Before, during, and after preparing food,
• Before eating food,
• Before and after caring for someone at home who is sick with vomiting or diarrhea,
• After changing diapers or cleaning up a child what has used the toilet,
• After blowing your nose, cough, or sneezing,
• After touching an animal, animal feed, or animal waste,
• After handling pet food or pet treats, and
• After touching garbage.

How to Wash Your Hands? Wet, Lather, Scrub, Rinse and Dry

• Wet your hands with clean running water (warm or cold), turn off the tap and apply soap,
• Lather your hands by rubbing them together with the soap. Be sure to lather the backs of your hands, between your fingers, and under your nails,
• Scrub your hands for at least 20 seconds. Need a timer? Hum the “Happy Birthday” song from beginning to end twice,
• Rinse hands well under running water, and
• Dry hands using a clean towel or air-dry time.

What You Can You Do About It? Get Your Pneumonia Vaccine(s)

Did you know that there are two different pneumonia vaccines? Further, did you know they cannot be given at the same time?

According to the CDC (link), if you are recommended to or want to receive both vaccines get Prevnar13® first and talk to your doctor about when to come back to get the Pneumovax23. If you’ve already received the Pneumovax23 vaccine, wait at least a year after that shot to get the Prevnar13® vaccine.

Prevnar13® Pneumococcal conjugate vaccine (PCV13)
This vaccine was approved in 2010. It is approved for adults 18 years of age and older for the prevention of pneumococcal pneumonia and invasive disease caused by 13 Streptococcus pneumoniae strains.

Pnuemovax23 (Pneumococcal Vaccine Polyvalent)
This vaccine was approved by the FDA in 1983 and has been available for over 35 years. It helps protect against 23 types of pneumococcal bacteria, some of which are common and often cause serious illness.

The CDC recommends this vaccine for:

• All adults 65+, even if you already had a different pneumococcal vaccine, and
• Those 19-64 years old who have certain chronic conditions such as diabetes, heart disease or COPD.

Pneumococcal Shot Administration Coverage
As of September 19, 2014, Medicare Part B covers:

• All adults 65+, even if you already had a different pneumococcal vaccine, and
• Those 19-64 years old who have certain chronic conditions such as diabetes, heart disease or COPD.

There is no copayment, coinsurance, or deductible for Medicare beneficiaries.

HCPCS & CPT Codes

• CPT 90670 – Pneumococcal conjugate vaccine, 13 valent (PCV13), for intramuscular use
• CPT 90732 – Pneumococcal polysaccharide vaccine, 23-valent (PPSV23), adult or immunosuppressed patient dosage, when administered to individuals 2 years or older, for subcutaneous or intramuscular use
• HCPCS G0009 – Administration of pneumococcal vaccine.

Medicare covers all patients receiving pneumonia vaccines and there is no copayment, coinsurance, or deductible.

What Vaccines are Recommended for You?

In addition to pneumonia vaccines, there are additional immunizations that all adults need. Do you know what vaccines you have had or should have? If not, the CDC offers an Adult Vaccine Assessment Tool for all adults 19 years or older (link).

Resources:

• CDC website: https://www.cdc.gov/handwashing/index.html
• CMS MLN Educational Tool (MLN006559 May 2021): Medicare Preventive Services at https://www.cms.gov/medicare/prevention/prevntiongeninfo/medicare-preventive-services/mps-quickreferencechart-1.html#PNEUMO
• MerckVaccines.com®: https://www.pneumovax23.com/
• Prevnar13® website: https://adult.prevnar13.com/about-prevnar13