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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)

Thursday August 12, 2021

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).

Friday August 13, 2021

The 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). They go on to note in the announcement that they will be sharing information in the coming days related to billing and coding.

Monday August 16, 2021

The CMS released a Special Edition MLN Connects noting that “effective August 12, 2021, CMS will pay to administer additional doses of COVID-19 vaccines consistent with the FDA EUAs, using CPT code 0003A for the Pfizer vaccine and CPT code 0013A for the Moderna vaccine (link). We’ll pay the same amount to administer this additional dose as we did for other doses of the COVID-19 vaccine (approximately $40 each).

We’ll hold and then process all claims with these codes after we complete claims system updates (no later than August 27).”

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

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).

Medicare Educational Resources

Revised MLN Fact Sheet: Medicare Disproportionate Share Hospital

CMS issued a revised edition of the Medicare Disproportionate Share Hospital MLN Fact Sheet (link). Specifically, the Fact Sheet includes information about how CMS calculates uncompensated care payments for FY 2021 and FY 2022.

Revised MLN Fact Sheet: Medicare Billing for Cardiac Device Credits

This revised Fact Sheet (link) includes the following two changes highlighted in dark red font in the text:

• When a hospital gets a replaced device credit 50% or greater than the device’s cost, report the amount in the claim’s FD code value portion.
• Beginning in 2020, Medicare applies a device offset cap to the Ambulatory Payment Classification (APC) claims that require implantable devices and have significant device offset (greater than 30%) based on the FD value code’s listed credit amount.”

MLN Educational Tool: Medicare Preventive Services Revised

CMS updated this Education Tool (link) in May. Information available in this tool includes:

• Link to National Coverage Determination (NCD) services webpage when applicable to a service,
• HCPCS and CPT codes,
• Prolonger Prevention Services information,
• ICD-10-CM diagnosis codes,
• Billing for telehealth during COVID-19,
• Coverage Requirement,
• Frequency Requirements,
• Patient liability, and
• Telehealth eligibility.

COVID-19 Updates

June 3, 2021: Myths and Facts about COVID-19 Vaccines

The CDC developed this webpage (link) to help stop common myths and rumors such as:

• The COVID-19 vaccine can make you be magnetic,
• The COVID-19 vaccine will alter my DNA, or
• The COVID-19 vaccine will make me sick with COVID-19.

June 9, 2021: Medicare to Increase Payment for Medicare Vaccination Administration in the Home

In a Special Edition MLN Connects, CMS announced additional payment for administering in-home COVID-19 vaccinations to Medicare beneficiaries (link). A related infographic (link) was also updated to include this information.

June 17, 2021: CMS MLN Connects – Emergency Use Authorization (EUA) for Monoclonal Antibody Updates

CMS noted that on May 26, 2021, the FDA released an EUA for the COVID-19 monoclonal antibody product sotrovimab. Coinciding with the FDA release, CMS created new HCPCS codes also effective May 26th for sotrovimab. This drug can be administered in health care setting and the home. The following is an excerpt from the MLN Connects newsletter:

Q0247

• Long descriptor: Injection, sotrovimab, 500 mg
• Short descriptor: Sotrovimab
• Price: The government won’t provide this drug for free; visit the COVID-19 Vaccines and Monoclonal Antibodies webpage for pricing information (available soon)

M0247

• Long Descriptor: Intravenous infusion, sotrovimab, includes infusion and post administration monitoring
• Short Descriptor: Sotrovimab infusion
• Price: $450.00 per infusion

M0248

• Long Descriptor: Intravenous infusion, sotrovimab, includes infusion and post administration monitoring in the home or residence; this includes a beneficiary’s home that has been made provider-based to the hospital during the COVID-19 public health emergency
• Short Descriptor: Sotrovimab inf, home admin
• Price: $750.00 per infusion

On June 3rd, the FDA released a revised EUA for Regnereon’s COVID-19 monoclonal antibody combination product casirivimab and imdevimab. Updates includes new dosing regimen and allows a new route of administration. “In response to this change, CMS created a new HCPCS code, effective June 3, and updated the short and long code descriptors. This information is detailed in the MLN Connects newsletter (link).

Other Medicare Updates

July 1, 2021: Interim Final Rule Banning Surprise Billing and Certain Out-of-Network Charges

HHS issued the interim final rule, “Requirements Related to Surprise Billing: Part 1,” that will restrict surprise billing for insured patients that receive emergency care, non-emergency care from out-of-network providers at their in-network facility, and air ambulance services from out-of-network providers. One way this helps patient, as noted in a Related CMS Fact Sheet (link), is that “if your health plan provides or covers any benefits for emergency services, this rule requires emergency services to be covered:

• Without any prior authorization (meaning you no not need to get approval beforehand).
• Regardless of whether a provider or facility is in-network.”

This rule will take effect on January 1, 2022. CMS is excepting written comments through 5 p.m. 60 days after the rule is displayed in the Federal Register. At the time of this article, the interim final rule had not been published in the Federal Register. You can learn more about the interim rule requirements in another CMS Fact Sheet (link).

Medicare MLN Articles & Transmittals – Recurring Updates

Addition of the QW Modifier to Healthcare Common Procedure Coding System (HCPCS) Codes 0240U, 0231U and 87637

• Article Release Date: June 11, 2021
• What You Need to Know: The FDA has issued Emergency Use Authorizations (EUAs) for the COVID-19 tests represented by these three HCPCS codes. “For Medicare to recognize these tests performed under a CLIA certificate of waiver or a CLIA certificate for provider-performed microscopy procedures, you must add the modifier QW.”
• MLN MM12318: (link)

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

• Article Release Date: June 14, 2021
• What You Need to Know: This article provides a summary of changes to and billing instructions for payment policies to be implemented by CMS on July 1, 2021.
• MLN MM12316: (link)

July 2021 Update of the Ambulatory Surgical Center [ASC] Payment System

• Article Release Date: June 25, 2021
• What You Need to Know: For the July 2021 Update there are 8 new CPT Category III codes, a new device pass through code, new HCPCS codes for drugs and biologicals, a change to a skin substitute HCPCS code from the low to the high-cost skin substitute group and a new technology HCPCS code as been established to describe the technology associated with vaginal colpopexy by sacrospinous ligation fixation.
• MLN MM12341: (link)

Revised Medicare MLN Articles & Transmittals

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

• Article Release Date: February 23, 2021 – Most recent revision June 3, 2021
• What You Need to Know: In the third iteration of this MLN article, important information about the use of the QW modifier was added in red print on page 10 of this document.
• MLN MM12131: (link)

International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs) – July 2021

• Article Release Date: May 18, 2021 – Revised June 3, 2021
• What You Need to Know: This article was revised to reflect NCD specific changes made in a revised Change Request (CR) 12124.
• MLN MM12124: (link)

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

• Article Release Date: April 27, 2021 – Revised June 8, 2021
• What You Need to Know: This article was revised to reflect a revised CR 12244 which added language about Section 405 of the Consolidated Appropriates Act, 2021.
• MLN MM12244: (link)

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

• Article Release Date: May 24, 2021 – Revised June 15, 2021
• What You Need to Know: This article was revised due to a revised Change Request (CR) 12885 which included the addition of new codes to the national HCPCS file.
• MLN MM12285: (link)

Medicare Coverage Updates

June 10, 2021: NGS Reminder Regarding General Anesthesia, Conscious Sedation and Facet Joint Interventions

NGS posted a reminder regarding the recent revision to Local Coverage Determination (LCD) (L35936) “Facet Joint Interventions for Pain Management” and Local Coverage Article (LCA) (A57826) “Billing and Coding: Facet Joint Interventions for Pain Management.” As of April 25, 2021, one Limitation of LCD L359356 (link) indicates that “general anesthesia is considered not reasonable and necessary for facet joint interventions.” Neither conscious sedation nor monitored anesthesia care (MAC) is routinely necessary for intraarticular facet joint injections or medial branch blocks are not routinely reimbursable. Individual consideration may be given on redetermination (appeal) for payment in rare, unique circumstances if the medical necessity of sedation is unequivocal and clearly documented in the medical record. Frequent reporting of these services together may trigger focused medical review.”

National Coverage Determination (NCD) 20.9.1 Ventricular Assist Devices (VADs)

• Article Release Date: June 11, 2021
• What You Need to Know: Effective December 1, 2020, CMS covers VADs under certain criteria. Change Request (CR) 12290 revises NCD 20.9 in the Medicare NCD Manual and Chapter 32, Section 320 of the Medicare Claims Processing Manual.
• MLN MM12290: (link)

July 2, 2021: Proposed Decision Memo for Home Use of Oxygen and Home Oxygen Use to Treat Cluster Headaches

CMS issued Proposed Decision Memo CAG-00296R2 (link). Two changes being proposed includes:

• Remove NCD 240.2.2 of the Medicare NCD Manual, ending coverage with evidence development, and allow the Medicare Administrative Contractors (MACs) to make coverage determinations regarding the use of home oxygen and oxygen equipment for cluster headaches (CH), and
• Modify NCD 240.2 Home Use of Oxygen to expand patient access to oxygen and oxygen equipment in the home, and to permit MACs to cover the use of home oxygen and equipment in order to treat CH and other acute conditions.

You can submit comments through August 1, 2021. The related National Coverage Analysis (NCA) Tracking Sheet for this Decision Memo CAG-00296R2 (link) will enable you to follow the progress of this proposal.

MMP and RealTime Medicare Data (RTMD) have collaborated to highlight Health Awareness Month topics throughout the year with an infographic spotlight on Medicare Fee-for-Service (FFS) paid claims data comparatives and a related article. June is Cataract Awareness Month. The American Academy of Ophthalmology notes that “cataract is one of blindness in the United States. If not treated, cataracts can lead to blindness. In addition, the longer cataracts are left untreated, the more difficult it can be to successfully remove the cataract and restore vision. During Cataract Awareness Month in June, the American Academy of Ophthalmology reminds the public that early detection and treatment of cataracts is critical to preserving sight.”

Did You Know?

According to Medicare.gov (link) the average amount that a patient pays for extracapsular lens removal with insertion of intraocular lens prosthesis (CPT 66984) is $316 in the Ambulatory Surgery Center (ASC) setting and $524 in a Hospital Outpatient Department.

Several Medicare Administrative Contractors (MACs) have Local Coverage Determinations (LCDs) and Local Coverage Articles (LCAs) related to cataract removal.

Why Does this Matter?

The CERT, Recovery Auditors and a two of the MACs are reviewing cataract procedure records. Reviews include the ASC and Hospital Outpatient Department Settings.

Comprehensive Error Rate Testing (CERT)

In the 2020 Medicare Fee-for-Service Supplemental Improper Payment Data (link), the CERT review contractor indicates they reviewed 209 Part B claims and identified a 6% improper payment rate that equates to a projected improper payment amount of $111,696,441.

Recovery Auditors

There are currently three approved RAC issues related to cataracts:

• Issue 0002: Cataract Removal: Medical Necessity & Documentation Requirements,
• Issue 0083: Cataract Removal: Excessive Units (partial), and
• Issue 0084: Cataract Removal: Partial Payment.

Provider Types they have been approved to review includes ASC, Outpatient Hospitals and specific to Issue 0083 and 0084 Professional Services.

CGS MAC for Jurisdiction 15 (J15)

Prior to CMS temporarily pausing the Targeted Probe and Educate (TPE) Program, reviewing Medicare Part A claims for cataract removal was part of CGS’, the MAC for Kentucky and Ohio, list of review topics. A Cataract Extraction with IOL ADR Checklist (link) is available on the CGS website.

Palmetto GBA JJ and JM

Palmetto GBA, the MAC for Jurisdictions J (Alabama, Georgia, and Tennessee) and M (North and South Carolina, Virginia and West Virginia) recently published service-specific post payment probe review results of CPT 66984, Extracapsular Cataract Removal with insertion for both Jurisdictions. Both articles include state specific findings, reasons for claims denials and recommendations to prevent future denials.

• April 14, 2021, Palmetto GBA JJ Part B results (link): 680 claims were reviewed, with 110 (16.17%) claims being completely or partially denied. The charge denial rate of 15.65% equated to $59,466.77 in denials.
• May 11, 2021, Palmetto GBA, JM Part B results (link): 2,508 claims were reviewed, with 128 (5.1%) claims being completely or partially denied. The charge denial rate of 5.13% equated to $76,598.10 in denials.

Based on their findings, Palmetto plans to continue post-payment reviews of CPT 66984 in both Jurisdictions.

What You Can Do About It?

• Identify whether there is an applicable LCD and LCA for your MAC jurisdiction.
• Read Palmetto GBA’s Cataract Removal article (link) which provides conditions or circumstances when lens extraction is considered medically necessary and therefore covered by Medicare.
• Share this information with Providers performing these procedures at your facility.
• Review a sample of your cataract claims for documentation supporting the medical necessity of the service.

Resource

• CMS MLN Matters SE1319: Cataract Removal, Part B: (link)

As described in the Welcome to the PAR article, MMP Associates monitor websites monthly to identify new Medicare Fee-for-Service review targets and review results. Invariably, we will come across useful “Did You Know” information that we will be sharing in this monthly PAR Pro Tips article.

Pro Tip: MACs Post-Payment Reviews Expanded

In 2020, in response to the COVID-19 Public Health Emergency (PHE), CMS put a halt to the Medicare Administrative Contractor (MAC) Targeted Probe and Education (TPE) Program. In August 2020, CMS advised MACs to resume post-payment reviews with dates of service before March 2020. Most recently, CMS announced in the Thursday June 3, 2021 MLN Connects (link), that MACs can now begin conducting post-payment reviews for claims after March 2020.

Pro Tip: New April 2021 Medicare Quarterly Provider Compliance Newsletter

Also, in the June 3rd MLN Connects newsletter, CMS announced the release of the April 2021 Medicare Quarterly Provider Compliance Newsletter. Per the introduction of this newsletter, it aims to “help health care professionals to understand the latest findings identified by MACs and other contractors such as Recovery Auditors and the Comprehensive Error Rate Testing (CERT) review contractor, in addition to other governmental organizations as the Office of Inspector General (OIG).” Two RAC Issues detailed in the newsletter includes acute care hospitals claims review

Recovery Auditor (RAC Issue 0067): Inpatient Psychiatric Facility Services: Medical Necessity and Documentation Requirements

RAC Issue 0067 (link) was approved by CMS for the RACs to review on September 1, 2018 for provider types Inpatient Hospital and Inpatient Psychiatric Facility (IPF). The April newsletter includes a discussion of the problem, background information and guidance, and resources to assist providers in meeting medical necessity and documentation requirements for providing psychiatric services.

Did You Know?

• Palmetto JJ, Palmetto JM, and WPS J5 are currently conducting post-payment reviews of MS-DRG 885 (Psychoses) claims,
• Six of the twelve MACs have published a Local Coverage Determination (LCD) and Local Coverage Article (LCA) specific to psychiatric services, and
• MS-DRG 885 claims have been a focus by the CERT review contractor since 2011. The annual improper payment rate reported by the CERT for this MS-DRG has been as high as 14.4% with the lowest rate being 2.9% in 2020.

Recovery Auditor (RAC Issue 0074): Drugs and Biologicals: Incorrect Units Billed (Single-Dose Vials)

RAC Issue 0067 RAC Issue 0074 (link) was approved by CMS for the RACs to review on December 21, 2017 for provider types Outpatient Hospital and Professional Services.

The RACs performed “complex reviews for single dose vials to assure compliance with Medicare policy. They reviewed claims to determine the actual amount administered and the correct number of billable/payable units.” You can find case examples in CMS’ newsletter.

Pro Tip: Q2 2021 Medicare Fee-for-Service Payments Integrity Scorecard

PaymentAccuracy.gov (link) is an official website of the U.S. government. This website is “a gateway to ensuring federal funds reach the right recipients, preventing improper payments, and reducing fraud, waste, and abuse.” You will find “Program Scorecards”, “The Numbers” and “Resources” on this website.

The most recent Medicare Fee-for-Service Scorecard available is Q2 2021 (link). The Scorecard shares three HHS accomplishments in Reducing Monetary Loss:

• HHS continued the process of adding two additional services (cervical fusion with disc removal and implanted spinal neurostimulator) to the Prior Authorization for Certain Hospital Outpatient Department Services Program effective July 1, 2021. You can read more about this in a related MMP article (link),
• HHS continued RAC and MAC post-payment reviews based on data analysis and the CERT findings, and
• HHS continued to use the Supplemental Medical Review Contractor (SMRC) to complete projects in relation to the Public Health Emergency, recent OIG reports, and CERT findings.

SMRC Project 01-043: DRG COVID 20% Add-On Payment

Specific to the PHE, the SMRC is conducting post-payment reviews of Medicare Part A COVID-19 inpatient claims with dates of service from April 1, 2020, through August 30, 2020. In general, in the inpatient setting, a diagnosis code documented at the time of discharge as being “possible”, “probable”, “suspected”, “likely”, “questionable”, or “still to be ruled out”, is coded as if the condition existed.

One exception to this guidance is coding for COVID-19. The ICD-10-CM Official Coding Guidelines (link) for COVID-19 advises coders to code only confirmed cases “as documented by the provider, documentation of a positive COVID-19 test, result, or a presumptive positive COVID-19 test result.”

While beyond the dates of service of the SMRC Project, it is worth noting that in August 2020, CMS revised MLN article SE20015 (link) by adding guidance “to address potential Medicare program integrity risks, effective with admissions occurring on or after September 1, 2020, claims eligible for the 20 percent increase in the MS-DRG weighting factor will also be required to have a positive COVID-19 laboratory test documented in the patient’s medical record. Positive tests must be demonstrated using only the results of viral testing (i.e., molecular or antigen), consistent with CDC guidelines. The test may be performed either during the hospital admission or prior to the hospital admission.”

One last reminder, the add-on payment for COVID-19 claims will end when the COVID-19 PHE ends. While the Biden Administration has indicated the PHE will likely be in place until December 31, 2021, the current PHE declaration will expire in July.

Medicare Coverage Updates

May 18, 2021: CMS Initiates National Coverage Analysis for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT)

• Coverage Analysis Issue: The United States Preventive Services Task Force (USPSTF) recently published an updated recommendation for certain persons at high risk for lung cancer based on age and smoking history for screening for lung cancer with LDCT.
• CMS Actions: CMS received a complete, formal request to reconsider the National Coverage Determination 210.14 and are soliciting public comment. The public comment period ends on June 17, 2021.
• Resources
• March 9, 2021 USPSTF Lung Cancer Screening Recommendation Statement: (link)
• Coverage Analysis (CAG-00439R): (link)
• NCD 210.14: (link)

National Coverage Determination (NCD) Removal

• Article Release Date: May 24, 2021
• What You Need to Know: 6 NCDs are being removed from the NCD Manual based on rulemaking in the Calendar Year 2021 Medicare Physician Fee Schedule.
• NCD 20.5 Extracorporeal Immunoadsorption (ECI) Using Protein A Columns,
• NCD 20.5 Extracorporeal Immunoadsorption (ECI) Using Protein A Columns,
• NCD 100.9 Implantation of Gastrointestinal Reflux Devices,
• NCD 110.19 Abarelix for the Treatment of Prostate Cancer,
• NCD 220.2.1 Magnetic Resonance Spectroscopy, and
• NCD 220.6.16 FDG PET for Inflammation and Infection.
• MLN MM12254: (link)

National Coverage Determination (NCD 110.24) Chimeric Antigen Receptor (CAR) T-cell Therapy

• Article Release Date: May 24, 2021
• What You Need to Know: Effective for claims with dates of service on or after August 7, 2019, CMS covers autologous treatment for cancer with T-cells expressing at least 1 CAR when administered at healthcare facilities:
• MLN MM12177: (link)

National Coverage Determination (NCD) 210.3 – Screening for Colorectal Cancer (CRC) – Blood-Based Biomarker Tests

• Article Release Date: May 26, 2021
• What You Need to Know: Effective January 19, 2021, CMS determined that the blood-based biomarker test is an appropriate CRC screening test once every three years for Medicare patients when performed in a CLIA certified lab, ordered by a treating physician, and the patient is:
• Aged 50-85 years, and
• Asymptomatic (no signs or symptoms of colorectal disease including but not limited to lower gastrointestinal pain, blood in stool, positive guaiac fecal occult blood test, or fecal immunochemical test); and, • At average risk of developing CRC (no personal history of adenomatous polyps, or inflammatory bowel disease, including Crohn’s Disease and ulcerative colitis; no family history of CRCs or adenomatous polyps, familial adenomatous polyposis, or hereditary nonpolyposis CRC).
• MLN MM12280: (link)

Medicare Educational Resources

Revised MLN Booklet: Behavioral Health Integration Services

CMS issued a revised version of this MLN Booklet (link) to add CY 2021 MPFS Final Rule CMS-1734-F Updates and add new HCPCS code G2214 (Initial or subsequent psychiatric collaborative care management, first 30 minutes in a month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional).

Revised MLN Booklet: Medicare Mental Health

CMS issued a revised version of this MLN Booklet (link) to include a new outpatient psychiatric services medical records checklist, an acute care hospital section, and CPT codes updates and additions.

Revised MLN Fact Sheet: Complying with Medicare Signature Requirements

CMS issued a revised version of this MLN Fact Sheet (link) to include information about signing documentation written by a medical student.

Revised MLN Booklet: Medicare Diabetes Prevention & Diabetes Self-Management Training

CMS issued a revised version of this MLN Booklet (link) to add information about flexibilities extended in the March 1, 2020, COVID-19 Interim Final Rule and the CY 2021 Physician Fee Schedule Final Rule to all patients receiving services as of March 31, 2020. They also spotlight that in January 2020, the American Association of Diabetes Educator (AADE) changed their name to the Association of Diabetes Care & Education Specialists (ADCES).

National Osteoporosis Month

National Osteoporosis Month falls in May each year. Following is information CMS provided in their Thursday May 6th edition of MLN Connects:

“Medicare covers bone mass measurements, and your patients pay nothing if you accept assignment. During National Osteoporosis Month, talk to your Medicare patients about their risk factors and bone health.

More Information:

• Medicare Preventive Services educational tool (link)
• Preventive Services webpage (link)
• CDC Osteoporosis webpage (link)
• National Osteoporosis Foundation website (link)
• Information for your patients on bone mass measurements” (link)

MLN Booklet: Outpatient Rehabilitation Therapy Services: Complying with Documentation Requirements

The Thursday May 13, 2021 edition of the CMS e-newsletter, MLN Connects (link), included the following information related to complying with Medicare billing requirements for outpatient rehabilitation therapy services:

“An Office of Inspector General report (link) found that payments for physical therapy services didn’t comply with Medicare billing requirements. Review the Outpatient Rehabilitation Therapy Services: Complying with Documentation Requirements (PDF) (link) booklet to help you bill correctly, reduce common errors, and avoid overpayments. CMS listed additional resources in the newsletter.

April 2021 MLN Fact Sheet: Medical Record Maintenance & Access Requirements

This MLN Fact Sheet (link) provides information on updated documentation maintenance and access requirements for billing services to Medicare patients. It also includes how long providers are to keep the documentation and who is responsible for providing access.

Medicare MLN Articles & Transmittals – Recurring Updates

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

• Article Release Date: April 27, 2021
• What You Need to Know: This article includes quarterly updates effective July 1, 2021 for ASP and Not Otherwise Classified (NOC) drug pricing files for Medicare Part B drugs.
• MLN MM12244: (link)

International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs) – July 2021

• Article Release Date: May 18, 2021
• What You Need to Know: You will find information about updated ICD-10 conversions and coding updates specific to NCDs as a result of newly available code, coding revisions to NCDs released separately and coding feedback received.
• MLN MM12124: (link)

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

• Article Release Date: May 21, 2021
• What You Need to Know: July 2021 updates to the 2021 MPFS are detailed in this MLN article.
• MLN MM12289: (link)

Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code (CARC), Medicare Remit Easy Print (MREP) and PC Print Update

• Article Release Date: May 21, 2021
• What You Need to Know: MACs perform updates to the RARC and CARC based on the code update schedule and occur around March 1, July 1, and November 1.
• MLN MM12220: (link)

Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code (CARC), Medicare Remit Easy Print (MREP) and PC Print Update

• Change Request Release Date: May 21, 2021
• What You Need to Know: This recurring transmittal is a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. Two NCDs specific to this update are NCD 30.3.3 Acupuncture for Chronic Low-Back Pain (cLBP), and NCD 20.33 Transcatheter Mitral Valve Repair/Transcatheter Edge-to-Edge Repair (TMVR/TEER).
• Change Request (CR) 12279: (link)

Other Medicare MLN Articles & Transmittals

New Waived Tests

• Article Release Date: April 27, 2021
• What You Need to Know: This article highlights newly FDA approved Clinical Laboratory Improvement Amendments of 1988 (CLIA) waived tests.
• MLN MM12204: (link)

Waiver of Coinsurance and Deductible for Hepatitis B Preventive Service Vaccine Code, Section 4104 of the Patient Protection and Affordable Health Care Act (the Affordable Care Act), Removal of Barriers to Preventive Services in Medicare

• Article Release Date: May 11, 2021
• What You Need to Know: The Hepatitis B vaccine (HCPCS 90739) has been added to the preventive services recommended by the U.S. Preventive Services Task Force. Consequently, coinsurance and deductibles won’t apply for this code. Medicare will make a reasonable cost reimbursement for Types of Bill (TOB) 012X, 013X, 022X, and 034X.
• MLN MM12230: (link)

Addition of the Shared System CWF to the Business Requirements for the Healthcare Common Procedure Coding System (HCPCS) Codes U0002QW and 87635QW Mentioned in Change Request 11765

• Article Release Date: May 20, 2021
• What You Need to Know: For labs billing MACs for COVID-19 testing services, this article informs you about a revision to CR 11765 that requires changes to Medicare Common Working File (CWF) for:
• o HCPCS U0002QW [2019-nCoV Coronavirus, SARS-CoV-2/2019-nCoV (COVID-19), any technique, multiple types or subtypes (includes all targets), non-CDC], and
• o 87635 [Infectious agent detection by nucleic acid (DNC or RNA0; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique].
• MLN MM12294: (link)

Other Medicare Updates

New CMS Hospital Star Ratings

On April 28th, CMS updated the Hospital Compare Overall Hospital Quality Ratings (link). Hospital specific scores are based on performance for 5 measure groups (Mortality, Safety of Care, Readmission, Patient Experience and Timely & Effective Care). April 2021 results:

• 455 hospitals received the highest rating of 5 stars,
• 1,018 hospitals received 3 stars, and
• 204 hospitals received a 1 star rating.

Clinical Diagnostic Laboratory Resources about the Private Payor Rate-Based CLFS

CMS posted the following information in the Thursday April 29, 2021 edition of MLN Connects (link): “If you’re a laboratory, including an independent laboratory, a physician office laboratory, or hospital outreach laboratory that meets the definition of an applicable laboratory under the Clinical Laboratory Fee Schedule (CLFS), you must report information, including laboratory test HCPCS codes, associated private payor rates, and volume data.” You can find links to updated resources and the data collection and reporting timeline in the MLN Connects post.

April 29, 2021: CJR Three-Year Extension Final Rule

CMS released the Comprehensive Care for Joint Replacement Model Final Rule which extends the model through December 31, 2021 by adding an additional 3 performance years (PYs). This final rule also revises the episode of care definition, the target price calculation, the reconciliation process, the beneficiary notice requirements and the appeals process. The episode of care definition was revised to include outpatient Total Knee and Total Hip Arthroplasty (TKA/THA) procedures. You can read more about this Model on the CJR CMS webpage (link).

May 7, 2021: Advance Copy of Hospital Interpretive Guidelines for Admission, Discharge and Transfer Notification Requirements

CMS issued a memorandum (link) to State Survey Agency Directors providing an advance copy of the hospital interpretive guidelines for the admission, discharge, and transfer notification requirements outlined in the Interoperability and Patient Access final rule. This guidance is for Hospitals, Psychiatric Hospitals and Critical Access Hospitals and it will also be published in an updated Appendix A of the State Operations Manual.

May 2021: United Healthcare Sepsis Claims Review Change Effective July 1, 2021

While this article focuses on Medicare updates, I believe it is important for Clinical Documentation Integrity Specialists and Utilization Review staff to be aware of this notice. United Healthcare (UHC) has announced (link) that “effective July 1, 2021, Medicare Advantage and commercial claims for sepsis-related treatment may be reviewed on a pre-payment or post payment basis.” UHC will use their Sepsis Clinical Guidelines which includes using Sepsis-3.

May 10, 2021: University of Miami to Pay $22 Million to Settle Claims Involving Medically Unnecessary Laboratory Tests and Fraudulent Billing Practices

This Department of Justice release (link) indicates that the University of Miami (UM):

• Knowingly engaged in improper billing relating to its Hospital Facilities,
• Billed federal health care programs for medically unnecessary laboratory tests for patients who received kidney transplants at the Miami Transplant Institute (MTI) – a transplant program operate by UM and Jackson Memorial Hospital (JMH) and
• Caused JMH to submit inflated claims for reimbursement for pre-transplant laboratory testing conducted at the MTI.

This settlement resolves allegations made in three lawsuits filed under the qui tam (whistleblower) provisions of the False Claims Act.

May 18, 2021: CMS Delays Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” Final Rule

MMP first wrote about this Proposed Rule in October 2020 (link). CMS published a notice further delaying this final rule until December 15, 2021 (link). They note this additional time provides “an opportunity to address all of the issues raised by stakeholders, especially Medicare patient protections, evidence criteria and lack of coordination between coverage, coding and payment.”