Knowledge Base Category -

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

In general, my day-to-day focus as it relates to Medicare Fee-for-Service guidance, is the acute hospital inpatient and outpatient setting. Last week, CMS issued Christmas in July gifts, in the form of 4 final FY 2022 payment rules. While not my day-to-day focus, highlights, and links to information about the final rules are important enough to share with you, our readers, who may be impacted.

FY 2022 Skilled Nursing Facility (SNF) Prospective Payment System (CMS-1746-F)

Major provisions in this final rule are highlighted in a related CMS Fact Sheet (link) and includes:

• FY 2022 Updates to the SNF Payment Rates,
• Methodology for Recalibrating the Patient Driven Patient Model (PDPM) Parity Adjustment,
• Rebase and Revise the SNF Market Basket by using the 2018-based SNF market basket to update the PPS payment rates, instead of the 2014-based SNF market basket,
• Section 134 of the Consolidated Appropriations Act, 2021 – New Blood Clotting Factor Exclusion from SNF Consolidated Billing,
• Changes in the PDPM ICD-10 Code Mappings,
• SNF Quality Reporting Program (SNF QRP) update, and
• SNF Value-Based Purchasing (SNF VBP) Program.

FY 2022 Hospice Payment Rate Update Final Rule (CMS-1745-F)

Major provisions highlighted in a related CMS Fact Sheet (link) includes:

• FY 2022 Routine Annual Rate Setting Changes,
• Other Medicare Hospice Payment Policies,
• Changes to the Hospice Conditions of Participation (CoPs) in response to the COVID-19 Public Health Emergency (PHE),
• Hospice Quality Reporting Program, and
• Home Health Quality Reporting Program.

FY 2022 Inpatient Rehabilitation Facility (IRF) Prospective Payment System (PPS) Final Rule (CMS-1748-F)

Major provisions in this final rule in a related CMS Fact Sheet (link) includes:

• Updates to IRF Payment Rates,
• IRF Quality Reporting Program (IRF QRP) Updates, and
• Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Policy Issues.

FY 2022 Inpatient Psychiatric Facility (IPF) Prospective Payment System Final Rule (CMS-1750-F)

Major provisions highlighted in a related CMS Fact Sheet (link) includes:

• FY 2022 Updates to the IPF Payment Rates,
• Updates to the IPF Teaching Policy, and
• IPF Quality Reporting Program (IPF QRP) Updates.

Question

In last week’s article about the OPPS and ASC Proposed Rule you indicated that CMS has proposed to remove 258 procedures that were added to the ASC covered procedure list in CY 2021. What procedures are remaining on the ASC list?

Answer

In the CY 2021 Final Rule, the finalized additions to the ASC Covered Procedure List were separated into two tables:

• Table 59 listed procedures added under the standard review process, and
• Table 60 listed procedures added under the second alternative proposal considered for CY 2021.

The procedures proposed for removal from the ASC list for CY 2022 are from Table 60. The procedures listed in Table 59 were not proposed for removal from the ASC list and includes the following CPT/HCPCS codes:

• 0266T: Implantation or replacement of carotid sinus baroreflex activation device; total system (includes generator placement, unilateral or bilateral lead placement, intra-operative interrogation, programming, and repositioning, when performed),
• 0268T: Implantation or replacement of carotid sinus baroreflex activation device; pulse generator only (includes intra-operative interrogation, programming, and repositioning, when performed),
• 0404T: Transcervical uterine fibroid(s) ablation with ultrasound guidance, radiofrequency,
• 21365: Open treatment of complicated (e.g., comminuted or involving cranial nerve foramina) fracture(s) of malar area, including zygomatic arch and malar tripod; with internal fixation and multiple surgical approaches,
• 27130: Arthroplasty, acetabular and proximal femoral prosthetic replacement (total hip arthroplasty), with or without autograft or allograft,
• 27412: Autologous chondrocyte implantation, knee,
• 57282: Colpopexy, vaginal; extra-peritoneal approach (sacrospinous, iliococcygeus),
• 57283: Colpopexy, vaginal; intra-peritoneal approach (uteroscacral, levator myorrhaphy),
• 57425: Laparoscopy, surgical, colpopexy (suspension of vaginal apex),
• C9764: Revascularization, endovascular, open or percutaneous, and vessel(s); with intravascular lithotripsy, includes angioplasty within the same vessel(s), when performed, and
• C9766: Revascularization, endovascular, open or percutaneous, any vessel(s); with intravascular lithotripsy and atherectomy, includes angioplasty within the same vessel(s), when performed.

Resources:

• CY 2021 OPPS Final Rule and ASC Payment System Final Rule [CMS-1736-FC]: https://www.cms.gov/medicaremedicare-fee-service-paymenthospitaloutpatientppshospital-outpatient-regulations-and-notices/cms-1736-fc
• CY 2022 OPPS and ASC Payment System Proposed Rule {CMS-1753-O]
  Note, see table 45 for procedures proposed for removal from the ASC Covered Procedures List. (link)
• Related MMP Article: CY 2022 OPps and ASC Proposed Rule – Inpatient Only List and ASC Covered Procedure List (link)

Medicare MLN Articles & Transmittals – Recurring Updates

July Quarterly Update for 2021 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Fee Schedule

• Article Release Date: July 2, 2021
• What You Need to Know: This article provides information about changes to the DMEPOS fee schedule that is updated on a quarterly basis. Key points in Change Request 12345 are related to The Coronavirus Aid, Relief, and Economic Security (CAREs) Act, 2020 as it relates to DMEPOS.
• MLN MM12345: (link)

October 2021 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files

• Article Release Date: July 15, 2021
• What You Need to Know: This article talks about the ASP methodology, which CMS bases on quarterly data submitted to them by manufacturers.
• MLN MM12342: (link)

Changes to the Laboratory National Coverage Determination (NCD) Edit Software for October 2021

• Article Release Date: July 15, 2021
• What You Need to Know: This article is related to Change Request 12384 which announced the changes that will be included in the October 2021 quarterly release of the edit module for clinical diagnostic laboratory services.
• MLN MM12384: (link)

Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 27.3, Effective October 1, 2021

• Article Release Date: July 14, 2021
• What You Need to Know: Change Request (CR) 12340 provides quarterly updated to the NCCI PTP edits.
• MLN MM12340: (link)

Other Medicare MLN Articles & Transmittals

Section 50 in Chapter 30 of Publication (Pub.) 100-04 Manual Updates: ABNs

• Article Release Date: July 14, 2021
• What You Need to Know: This article alerts providers about key changes being made to Chapter 30, Section 50 of the Medicare Claims Processing Manual related to Advance Beneficiary Notices of Non-coverage (ABNs). One key revision listed is the period of effectiveness of the ABN for repetitive or continuous non-covered care.
• MLN MM12242: (link)

Revised Medicare MLN Articles & Transmittals

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

• Article Release Date: Initial article May 24, 2021 – 2nd Revision July 21, 2021
• What You Need to Know: The revised change request added CPT code C9076 (Breyanz). The implementation date was also revised to September 20, 2021. Breyanz joins a list of other CAR T-cell therapies including Kymriah®, Yescarta®, Tecartus™, and ABECMA®.
• MLN MM12177: (link)

Medicare Coverage Updates

July 12, 2021: National Coverage Analysis (NCA) for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease

July 12, 2021: National Coverage Analysis (NCA) for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease On June 7, 2021, The FDA approved, using accelerated approval, aducanumab (brand name Aduhelm™) with an indication for the treatment of Alzheimer’s disease. Aducanumab is a monoclonal antibody directed against amyloid beta to reduce amyloid accumulations. CMS has initiated a national coverage determination (NCD) analysis (link) and is requesting public comments to several questions.

Medicare Educational Resources

Critical Access Hospital MLN Booklet Revised

JCMS recently revised the MLN Booklet (link) to include changes related to the COVID-19 Public Health Emergency (PHE). Specifically:

• CAH temporary emergency coverage without a qualifying hospital stay due to COVID-19 PHE, and
• Waiving the limitation on number of swing beds (25) and Length of Stay of 96 hours during the COVID-19 PHE.

COVID-19 Updates

Medicare COVID-19 Snapshot Updates

CMS updated their Medicare COVID-19 Data Snapshot slides (link) on June 30, 2021, to provide insight on the Medicare population from January 1, 2020 – April 24, 2021. With this update, data shows that there have been over 4.3 million COVID-19 cases and over 1.2 million COVID-19 hospitalizations.

OIG Fraud Alert: COVID-19 Scams

On July 21, 2021, the OIG updated their Fraud Alert: COVID-19 Scam’s webpage (link). You can find a short YouTube video highlighting 5 things about COVID-19 fraud and tips to protect yourself. For example, “offers to purchase COVID-19 vaccination cards are scams. Valid proof of COVID-19 vaccination can only be provided to individuals by legitimate providers administering vaccines.”

July 19, 2021: COVID-19 PHE Extended

In case you missed it in a recent Wednesday@One article, On July 19, 2021, Xavier Becerra, Secretary of Health and Human Services, renewed the PHE effective July 20, 2021 (link).

Other Updates

CY 2022 Medicare Physician Fee Schedule Proposed Rule

CMS issued this proposed rule on July 13, 2020 (link). Examples of what is being proposed includes:

• Proposals related to telehealth services added during the COVID-19 PHE and a proposal to require use of a new modifier for telehealth services furnished using audio-only communications,
• Proposal to make direct payments to Physician Assistants (PAs) for professional services furnished under Part B beginning January 1, 2022, and
• Proposal to begin the payment penalty phase of the Appropriate Use Criteria (AUC) Program on the later of January 1, 2023, or the January 1 that follows the declared end of the PHE for COVID-19.

You can read additional highlights from the proposed rule in a related CMS Fact Sheet (link).