Knowledge Base Category -

2020 has been a very long and challenging year. In addition to caring for the influx of COVID-19 patients, hospitals have been bombarded with information on how to code and bill for COVID-19. Included in last week’s newsletter was an FAQ detailing the requirement that documentation of a positive COVID-19 test be in the medical record for hospitals to receive the additional 20% payment for the duration of the COVID-19 public health emergency (PHE).

In March, CMS suspended most Medicare Fee-for-Service (FFS) medical reviews because of the COVID-19 pandemic. However, to add to the challenge for hospitals, medical reviews resumed in August. This article focuses on COVID-19 related reviews being conducted by the Office of Inspector General (OIG) and the Supplemental Medical Review Contractor (SMRC).  

Completed OIG Work Plan Reviews Related to COVID-19

As of November 6, 2020, the OIG’s Office of Evaluation and Inspections has issued reports for two Work Plan items related to the COVID-19 PHE.  

COVID-19 Hospital Response Report (OEI-06-20-00300)

In this report, the OIG notes that feedback from hospitals reflects “perspectives at a point in time-March 23-27, 2020.” At that time, the most significant challenges reported by hospitals was related to testing and caring for patients with COVID-19 and keeping staff safe. From anecdotal conversations with our clients, these challenges remain eight months later.

Highlights of OIG’s Emergency Preparedness Work: Insights for COVID-19 Response Reports

Prior to the COVID-19 PHE, the OIG had published several reports about community and health care facility emergency preparedness and response. The OIG developed the following two toolkits “to assist communities in responding to the current pandemic and to other emergencies as they arise.”

• Toolkit: Insights for Communities From OIG’s Historical Work on Emergency Response (OEI-09-20-00440), and
• Toolkit: Insights for Health Care Facilities from OIG’s Historical Work on Emergency Response (OIE-06-20-00470) OEI-06-20-00470

Active OIG Work Plan Reviews Related to COVID-19

Currently, thirteen of thirty Active Work Plan Items that are related to COVID-19 fall under the Centers for Medicare and Medicaid Services. The following table lists when each of these thirteen items were added to the Work Plan and the Titles of the Item.

I want to call your attention to the August 2020 Item: Audit of Medicare Payments for Inpatient Discharges Billed by Hospitals for Beneficiaries Diagnosed with COVID-19. Specifically, the following summary description for this Work Plan Item:

“Section 3710 of the Coronavirus Aid, Relief, and Economic Security Act directs the Secretary to increase the weighting factor that would otherwise apply to the assigned diagnosis-related group by 20 percent for an individual who is diagnosed with COVID-19 and discharged during the COVID-19 public health emergency period.”  We will audit whether payments made by Medicare for COVID-19 inpatient discharges billed by hospitals complied with Federal requirements.”

It is not clear the claims dates of service that the OIG will request. For claims requested with a date of service on or after September 1, 2020 keep in mind that CMS mandated that a positive COVID-19 test within 14 days of admission must be documented in the record to receive the 20% additional payment. If you receive a notice for records from the OIG and the dates of service are on or after September 1 you should verify whether or not a note for “No Pos Test” was submitted to your MAC. If not, be sure to submit the COVID-19 test results when submitting the record to the OIG. 

Supplemental Medical Review Contractor (SMRC)

Noridian Health Solutions, LLCL (Noridian) is the current SMRC. At the direction of CMS, Noridian conducts nationwide medical reviews for Medicare FFS Part A, Part B and Durable Medical Equipment (DME). On October 15, 2020, Noridian posted a Notification of Medical Review titled DRG COVID 20% Add On Payment.

This project will consist of post-payment reviews of Medicare Part A acute care inpatient hospital claims billed on dates of service from April 1, 2020 through August 30, 2020. Documentation requirements to be included in each Additional Documentation Request (ADR) are listed in Noridian’s notification. Included in this list is “Lab/Diagnostic reports, if applicable, including any that support the COVID-19 diagnosis.” Note, the claims being reviewed are prior to the CMS requirement of a positive COVID-19 test result be in the record to receive the 20% additional payment. This will be important to keep in mind in case you receive a denial based solely on the lack of this documentation being in the record.

CMS announced the release of the Transparency in Coverage Final Rule [CMS-9915-F] on October 28, 2020. According to a related CMS Fact Sheet, “This final rule is a historic step toward putting health care price information in the hands of consumers and other stakeholders, advancing the Administration’s goal to ensure consumers are empowered with the critical information they need to make informed health care decisions.”

Figuring out the plot to a mystery novel involves asking questions and looking for answers to basic questions asked when gathering information (who, what, when, where, and why). CMS Final Rules can at first glance seem like a mystery and require the same process of asking and answering these questions. This article asks key questions and provides you with answers to help you figure out what is included in the Transparency in Coverage Final Rule.

Who is required to Disclose Cost-Sharing Information? 

Group Health Plans and Health Insurance issuers in the Individual and Group Markets.

• Note, the term group health plan includes both insured and self-insured group health plans.

What Type of Cost-Sharing Information is required to be disclosed?

• An estimate of the individual’s cost-sharing liability for covered items or services furnished by a particular provider.
• In-network provider negotiated rates,
• Historical out-of-network allowed amounts, and
• Drug pricing information

What is the required format for Disclosure of Cost-Sharing Information?

• This information must be available on an internet website in machine-readable files, and
• If requested, in paper form.

How many and what type of machine-readable files are required?

Plans and issuers must disclose pricing information in three machine-readable files

• One file will disclosure of payment rates negotiated between plans or issuers and providers for all covered items and services,
• A second file will disclose unique amounts a plan or issuer allowed, as well as associated billed charges, for covered items or services furnished by out-of-network providers during a specific time period.
• A third file will include pricing information for prescription drugs.

How often will issuers be required to update the machine-readable files?

“The final rules adopt, as proposed, the requirement for a plan or issuer to update the information required to be included in each machine-readable file monthly. The final rules clarify that this requirement to update the machine-readable files monthly applies to all three machine-readable files being finalized through the final rules: the In-network Rate File, the Allowed Amount File, and the Prescription Drug File”

What are the benefits of Disclosing Cost-Sharing Information?

CMS indicates in the Final Rule that “by requiring the dissemination of price and benefit information directly to consumers and to the public, the transparency in coverage requirements will provide the following consumer benefits:

• enables consumers to evaluate health care options and to make cost-conscious decisions;
• strengthens the support consumers receive from stakeholders that help protect and engage consumers;
• reduces potential surprises in relation to individual consumers’ out-of-pocket costs for health care services;
• creates a competitive dynamic that may narrow price dispersion for the same items and services in the same health care markets; and
• Puts downward pressure on prices which, in turn, potentially lowers overall health care costs.”

Where can you find a list of the 500 Items and Services Identified by the Departments?

This information is included in the Final Rule in Table 1: 500 Items and Services List. The table includes the applicable HCPCS/CPT code with the code description and a plain language description. For example, the first item in the list is J0702: BETAMETHASONE ACET&SOD PHOS with the plain language description being “Injection to treat reaction to a drug.”

Where can you find definitions of key terms in the Final Rule?

There is a Transparency in coverage – Definitions section towards the end of the final rule. Here you will find definitions for the following key terms:

• Accumulated amounts,
• Beneficiary,
• Billed charge,
• Billing code,
• Bundled payment arrangement,
• Copayment assistance,
• Cost-sharing liability,
• Cost-sharing information,
• Covered items and services,
• Derived amount,
• Historical net price,
• In-network provider,
• Items or services,
• Machine-readable file,
• National Drug Code,
• Negotiated rate,
• Out-of-network allowed amount,
• Out-of-network provider,
• Out-of-pocket limit,
• Plain language,
• Prerequisite, and
• Underlying fee schedule rate.

What are the CMS Intended Outcomes from implementation of this Final Rule?

• Informed Consumers,
• Consumers may become more cost conscious,
• Timely payment of medical bills, and
• Increase competition among Providers

When will the regulations in this Final Rule go into effect?

“The final rules adopt a three-year, phased-in approach with respect to the scope of the requirement to disclose cost-sharing information. Plans and issuers must make cost-sharing information available for 500 items and services identified by the Departments for plan years (in the individual market, for policy years) beginning on or after January 1, 2023, and must make cost-sharing information available for all items and services for plan years (in the individual market, for policy years) beginning on or after January 1, 2024.”

How will Requirements in the Final Rule be enforced?

“States will generally be the primary enforcers of the requirements imposed upon health insurance issuers by the final rules. 233 The Departments expect to work closely with state regulators to design effective processes and partnerships for enforcing the final rules.”

Of note, this final rule also includes amendments to the Department of Health and Human Services (HHS) medical loss ratio (MLR) program “to allow issuers offering group or individual health insurance coverage to receive credit in their MLR calculations for savings they share with enrollees that result from the enrollees shopping for, and receiving care from, lower-cost, higher-value providers.”

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from October 27th – November 2nd.

Resource Spotlight: November 2, 2020 - CDC Adds to List of Medical Conditions Putting Patients at Risk for Severe Illness due to COVID-19

The CDC webpage People with Certain Medical Conditions has once again been updated to add sickle cell disease and chronic kidney disease to the conditions that might increase the risk of severe illness among children. As we approach the holiday season, this webpage also provides guidance regarding what to consider before being around people and things to consider to help make personal and social activities as safe as possible.

October 28, 2020: FDA Enforcement Policy for Non-Invasive Remote Monitoring Devices during COVID-19 PHE (Revised)

The FDA initially issued guidance in June 2020 “to provide a policy to help expand the availability and capability of non-invasive remote monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to COVID-19 for the duration of the COVID-19 public health emergency.” They note in this October 28, 2020 Announcement that the guidance has been updated and that it is intended to remain in effect only for the duration of the Public Health Emergency (PHE) related to COVID-19.

October 28, 2020: Fourth COVID-19 Interim Final Rule with Comment Period (IFC-4) – Eliminating Barriers, Flexibilities, Extension CJR Model,

CMS announced, in an October 28 Press Release, the release of a fourth COVID-19 Interim Final Rule. In a related Fact Sheet, CMS indicates that this final rule, “removes administrative barriers to eliminate potential delays to patient access to a lifesaving vaccine. In addition, the rule:

• Creates flexibilities for states maintaining Medicaid enrollment during the COVID 19 PHE;
• Establishes enhanced Medicare payments for new COVID-19 treatments;
• Takes steps to ensure price transparency for COVID-19 tests, and
• Provides an extension of Performance Year 5 for the Comprehensive Care for Joint Replacement (CJR) model; and
• Creates flexibilities in the public notice requirements and post-award public participation requirements for a State Innovation Waiver under Section 1332 of the Patient Protection and Affordable Care Act during the COVID-19 PHE.”

October 28, 2020: Fourth COVID-19 Interim Final Rule with Comment Period (ICF-4): New COVID-19 Treatments Add-On Payment (NCTAP)

As a segue to the new add-on payment, Section D. of ICF-4 reviews section 3710 of the CARES Act and the IPPS New Technology Add-On Payment process before transitioning to the FDA Coronavirus Treatment Acceleration Program created for possible coronavirus therapies. One aspect of this program is the issuance of Emergency Use Authorizations (EUAs) during the COVID-19 Public Health Emergency (PHE). “CMS has determined that it is appropriate for CMS to consider drug and biological products which are authorized for emergency use for COVID-19, with letters of authorization, and are used to treat COVID-19 disease, to fall within the drugs and biologicals” Medicare benefit category.

CMS believes that as “drugs or biological products become available and are authorized or approved by FDA for the treatment of COVID-19 in the inpatient setting, it would be appropriate to increase the current IPPS payment amounts to mitigate any potential financial disincentives for hospitals to provide these new treatments during the PHE.”

CMS indicates effective with the date of ICF-4 and until the end of the PHE, when a therapy meets specific criteria it will be eligible for NCTAP. They also note that currently there are only two drug and biological products that meet the criterion. The following table highlights the two products and the ICD-10-PCS codes assigned to the products.

“CMS is setting the NCTAP amount for a case that meets the NCTAP eligibility criteria equal to the lesser of: (1) 65 percent of the operating outlier threshold for the claim or (2) 65 percent of the amount by which the costs of the case exceed the standard DRG payment, including the adjustment to the relative weight under section 3710 of the CARES Act. As with the new technology add-on payment and outlier payments, the costs of the case are determined by multiplying the covered charges by the operating cost-to-charge ratio. In addition, the NCTAP will not be included as part of the calculation of the operating outlier payments.”

To date, no drug or biological product has a EUA for treatment of COVID-19 patients in the outpatient setting. However, this Interim Final Rule includes the criteria for separate payment for New COVID-19 Treatments in the Outpatient Setting for the remainder of the PHE if and when a product is granted EUA.

October 28, 2020: Incentive Payments to Nursing Home Curing COVID-19 Deaths and Infections

Over 10,000 nursing homes will be receiving money from the approximately $333 million in first round performance payments to be made by HHS through the Health Resources and Services Administration (HRSA). HHS Secretary Alex Azar indicated in an HHS Press Release that "These $333 million in performance payments are going to nursing homes that have maintained safer environments for residents between August and September. We've provided nursing homes with resources and training to improve infection control, and we're rapidly providing incentives to those facilities that are making progress in the fight against COVID-19."

October 30, 2020: CDC Morbidity & Mortality Report: COVID-19 Exposure and Infection Among Health Care Personnel

The CDC’s Morbidity and Mortality Weekly Report (MMWR) for October 30th focused on COVID-19 exposure and infection among health care professionals in Minnesota from March 6th through July 11, 2020. The report summary acknowledges that it is already known that health care personnel (HCP) are at increased risk for COVID-19 from workplace exposures. The authors of this report found that “HCP in congregate living and long-term care setting experience considerable risk and post a transmission risk to residents. Improved access to personal protective equipment, flexible medical leave and testing is needed.”

October 30, 2020: CMS Announces Launch of the Nursing Home Resource Center

CMS announced the launch of this new online platform which “consolidates all nursing home information, guidance and resources into a user-friendly, one-stop-shop that is easily navigable so providers and caregivers can spend less time searching for critical answers and more time caring for residents. Moreover, the new platform contains features specific to residents and their families, ensuring they have the information needed to make empowered decisions about their healthcare.”

The Resource Center includes information for Providers & CMS Partners and Patients & Caregivers. Resource Topics specific to Providers and CMS Partners includes the following:

• Regulations & Guidance,
• Training & Resources,
• Technical Information,
• COVID-19 Data & Updates, and
• Payment Policy Information.

October 30, 2020: Supply Kits to Safely Administer COVID-19 Vaccines to Americans

An HHS news release indicates that they have “recently contracted with McKesson Corporation to produce, store and distribute these vaccine ancillary supply kits on behalf of the Strategic National Stockpile. Each kit will contain enough supplies to administer up to 100 doses of vaccine and will include:

• Needles (various sizes for the population served by the ordering vaccination provider)
• Syringes
• Alcohol prep pads
• Surgical masks and face shields for vaccinators
• COVID-19 vaccination record cards for vaccine recipients
• Needle information card”

October 31, 2020: BinaxNOW COVID-19 Tests Distribution

HHS announced that in ongoing efforts to prevent COVID-19 outbreaks in high risk communities, 389,040 Abbott BinaxNOW COVID-19 rapid tests have been distributed at no cost to 83 Historically Black Colleges and Universities (HCBU’s) in 24 states. “The Abbott BinaxNOW test is the only rapid point of care test that does not require instrumentation – is easy to use, produces COVID-19 test results within fifteen minutes and costs just five dollars. In addition to responding quickly to flash outbreaks, these tests are ideally suited for the screening and ongoing surveillance of underserved demographic groups and in congregate settings such as group homes, nursing homes, K-12 schools and institutions of higher learning.”

CDC COVID Data Tracker – United States COVID-19 Cases

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from October 20th through October 26th.

Resource Spotlight: Tips for Voters

As we are just days away from the election, the CDC has created a Tips for Voters to Reduce Spread of COVID-19 webpage which includes 6 steps to follow before you vote and 6 steps to take the day you vote. For those of you who plan to vote in person, the CDC provides a checklist of recommended items to bring with you to your voting site, including:

• Necessary documentation such as your identification (check with your voting site),
• A mask,
• An extra mask,
• Tissues,
• Hand sanitizer with at least 60% alcohol,
• Water,
• Black ink pen, and
• Bring prepared items with you (e.g., registration forms, sample ballots)

October 20, 2020: New FAQs added to COVID-19 FAQs on Medicare Fee-for-Service (FFS) Billing

Three new FAQs were added to this now 150 page document on October 20, 2020. Two pertain to Medicare Telehealth (questions 46 and 47 in the Medicare Telehealth section of this document). The third FAQ is related to Medicare beneficiary SNF benefits as follows:

“Question: If a new benefit period was granted pursuant to the section 1812(f) waiver, and the PHE ends in the middle of that new benefit period, would the beneficiary be entitled to the full 100 days of renewed SNF benefits, or would that entitlement end on the day the PHE ends?

Answer: If a beneficiary has qualified for the special one-time renewal of SNF benefits under the benefit period aspect of the section 1812(f) waiver while the section 1812(f) waiver is in effect, that reserve of 100 additional SNF benefit days would remain available for the beneficiary to draw upon even after the waiver itself has expired.

New: 10/20/20”

As a reminder, Secretary Azar issued the most recent continuation of the Public Health Emergency (PHE) due to the COVID-19 pandemic on October 2, 2020 with an effective date of October 23, 2020.

October 21, 2020: CDC Guidance: Test for Current Infection Updated

The CDC webpage Test for Current Infection has been updated and lists the following considerations for who should get tested:

• People who have symptoms of COVID-19,
• People who had had close contact (within 6 feet of an infected person for a total of 15 minutes or more) with someone with confirmed COVID-19,
• People who have been asked or referred to get testing by their healthcare provider, local or state health department.

October 21, 2020: Expanding Access to COVID-19 Tests and Vaccines

HHS issued guidance under the Public Readiness and Emergency Preparedness Act (PREP Act) authorizing qualified pharmacy technicians and State-authorized pharmacy interns to administer, childhood vaccines, COVID-19 Vaccines when available, and COVID-19 tests. All those authorized to administer tests and vaccines are subject to several requirements. HHS provides a link to the guidance document in their Press Release.

October 22, 2020: Nursing Home COVID-19 Preparedness for Fall & Winter Web-Based Training

The Thursday October 22nd edition of the CMS MLNConnects newsletter informs providers about web-based training available to Nursing Homes to help them prepare for COVID-19, provide resident-centered care, and prevent and control infection. You can visit the Quality, Safety & Education Portal to access free scenario-based trainings for managers and frontline staff. See the flyer for more information.

October 22, 2020: FDA Approved First Treatment for COVID-19

The FDA announced their approval of the “antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Veklury is the first treatment for COVID-19 to receive FDA approval.” 

Reminder, effective August 1, 2020, CMS implemented 12 new ICD-10-PCS codes related to COVID-19 became effective, including the administration of Remdesivir.

October 22, 2020: Relief Fund Eligibility Expansion and Updated Reporting Requirements

Relief Fund Eligibility Expansion: HHS announced the expansion of Providers eligible to receive Phase 3 Provider Relief Funding. The announcement includes a list of eligible providers “regardless of whether they accept Medicaid or Medicare.” Note, applicants have until 11:59PM EST on November 6, 2020 to submit an application for payment consideration.

Reporting Requirement Update: An update to the reporting requirements was also included in the announcement. “In response to concerns raised, HHS is amending the reporting instructions to increase flexibility around how providers can apply PRF money toward lost revenues attributable to coronavirus. After reimbursing healthcare related expenses attributable to coronavirus that were unreimbursed by other sources, providers may use remaining PRF funds to cover any lost revenue, measured as a negative change in year-over-year actual revenue from patient care related sources.” Note, this announcement includes links to a policy memorandum and the amended reporting requirements.

CDC COVID Data Tracker – United States COVID-19 Cases

MEDICARE TRANSMITTALS – RECURRING UPDATES

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

• Article Release Date: October 9, 2020
• What You Need to Know: This article informs providers about updates to the Quarterly ASP Medicare Part B Pricing Files and informs you of revisions, if needed to prior quarterly pricing files.
• MLN MM12020: https://www.cms.gov/files/document/MM12020.pdf

OTHER MEDICARE TRANSMITTALS

 New Waived Tests

• Article Release Date: October 5, 2020 – Revised October 15, 2020
• What You Need to Know: This article tells you of new Clinical Laboratory Improvement Amendments of 1988 (CLIA) waived tests approved by the FDA. CMS notes that “MACs will not search their files to either retract payment or retroactively pay claims, however, MACs should adjust claims if you bring those claims to their attention.”
• Note, this article was revised to correct a date for one of the codes for 87804QW.
• MLN Matters MM11982: https://www.cms.gov/files/document/mm11982.pdf

Ambulance Inflation Factor (AIF) for Calendar Year (CY) 2021 and Productivity Adjustment

• Article Release Date: October 16, 2020
• What You Need to Know: This article provides the CY 2021 AIF for determining the payment limit for ambulance services.
• MLN MM12031: https://www.cms.gov/files/document/mm12031.pdf

REVISED MEDICARE TRANSMITTALS

October 2020 Integrated Outpatient Code Editor (I/OCE) Specifications Version 21.3

• Article Release Date: August 28, 2020 – Revised October 5, 2020
• What You Need to Know: This article was revised to reflect changes made to CR 11944 including adding several items to the Summary of Quarterly Release Modifications table.
• MLN Matters MM11944: https://www.cms.gov/files/document/mm11944.pdf

Update to Hospice Payment Rates, Hospice Cap, Hospice Wage Index and Hospice Pricer for FY 2020

• Article Release Date: August 31, 2020 – Revised September 24, 2020
• What You Need to Know: This article was revised to reflect a revised CR 11876 which changed the hourly Continuous Home Care rates in the hospice tables.
• MLN Matters MM11876: https://www.cms.gov/files/document/mm11876.pdf

Change to the Payment of Allogeneic Stem Cell Acquisition Services

• Article Release Date: July 13, 2020 – Revised October 21, 2020
• What You Need to Know: This article was revised to reflect the revised CR 11729 issued on October 20, 2020. This revision did not impact the substance of the article.
• MLN Matters: MM11729: https://www.cms.gov/files/document/mm11729.pdf

MEDICARE COVERAGE UPDATES

October 22, 2020: MCD Overview Page and Advanced Search Function Going Away

CMS has posted the following alert on the Medicare Coverage Database (MCD) Notice Board:

“On December 11, 2020, the Overview page of the Medicare Coverage Database (MCD) application will be removed in an effort to streamline the site. The website address will remain cms.gov/medicare-coverage-database but users will be directed to the Search page by default, instead of the Overview page.

On April 30, 2021, the Advanced Search function of the MCD application will be removed. All features related to the Advanced Search were incorporated into the new Search function, which was released on September 3, 2020. The new Search function is both faster and easier to use than the Advanced Search, so please switch to the new Search if you haven't already. Bookmarks to advanced-search.aspx and search-results.aspx will no longer work after April 30, 2021.”

MEDICARE EDUCATIONAL RESOURCES

September 28, 2020: MLN Fact Sheet: ICD-10-CM, ICD-10-PCS, CPT, and HCPCS Code Sets

• What You Need to Know: CMS released this educational tool to give “health care providers, suppliers, medical coders, billing and claims staff an easy reference to information on the code sets used to bill Medicare claims.” CMS advises using this tool when submitting inpatient and outpatient diagnoses, procedures, and supplies on Medicare claims.
• ICN MLN900943 September 2020: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/ICD9-10CM-ICD10PCS-CPT-HCPCS-Code-Sets-Educational-Tool-ICN900943.pdf

October 2020: Medicare Quarterly Provider Compliance Newsletter

This CMS quarterly newsletter provides information on how to avoid common billing errors and includes top issues of a particular quarter. The October 2020 edition of the newsletter highlights Recovery Auditor Findings related to the following two issues:

Issue #0070: Critical Care Billed on the Same Day as Emergency Room Services: Unbundling

• Provider Types Affected: Physicians and Non-Physician Practitioners (NPPs)
• Problem: “Hospital emergency department services are not payable for the same calendar date as critical care services when billed for the same beneficiary, on the same date of service and by the same service provider (based on Tax ID and Provider Specialty Code).
• Affected Codes: 99281, 99282, 99283, 99284, 99285
• Type of Review: Automated Review

Issue #0131: Pneumatic Compression Device (PCD): Medical Necessity and Documentation Requirements.

• Provider Types Affected: Durable Medical Equipment (DME) Suppliers, including physicians who supply DME
• Problem: When providing PCDs to patients, be sure the patient meets all Medicare coverage criteria.
• Affected codes: E0650, E0651, E0652, E0656, E0657, E0667, E0668, E0669 and E0670.
• Type of review: Complex Review

Link to newsletter: https://www.cms.gov/outreach-and-educationmedicare-learning-network-mlnmlnproductsmln-publications/mln5230120

OTHER MEDICARE UPDATES

September 28, 2020: CMS Guidance Related to the Emergency Preparedness Testing Exercise Requirements – COVID-19

CMS posted a Memo to State Surveyors on their website which included the following summary statements and a link to the memorandum:

“CMS regulations for Emergency Preparedness require specific testing exercises be conducted to validate the facility’s emergency program. During or after an actual emergency, the regulations allow for an exemption to the testing requirements based on real world actions taken by providers and suppliers.

This worksheet presents guidance for surveyors, as well as providers and suppliers, with relevant scenarios on meeting the testing requirements in light of many of the response activities associated with the COVID-19 Public Health Emergency (PHE).”

September 28, 2020: CY 2021 Annual Amount In Controversy (AIC) Adjustments

CMS published the AIC Adjustments for CY 2021 in the Federal Register:

• Administrative Law Judge (ALJ) hearings AIC threshold: $180, and
• Judicial Review AIC threshold: $1,760.

October 5, 2020: Compliance with Residents’ Rights Requirement related to Nursing Home Residents’ Right to Vote

CMS sent this Memorandum to State Survey Agency Directors on October 5, 2020. Following are the three Memorandum Summary bullets:

• The Centers for Medicare & Medicaid Services (CMS) is affirming the continued right of nursing home residents to exercise their right to vote.
• While the COVID-19 Public Health Emergency has resulted in limitations for visitors to enter the facility to assist residents, nursing homes must still ensure residents are able to exercise their Constitutional right to vote.
• States, localities, and nursing home owners and administrators are encouraged to collaborate to ensure a resident’s right to vote is not impeded.

Additionally, CMS has published a letter to be sent to nursing home residents or family members.

October 8, 2020: CMS Press Release: Medicare Advantage and Medicare Part D Quality Ratings

CMS indicates in this Press Release that “according to the latest data, quality ratings of Medicare Advantage and Medicare Part D drug plans remain strong. Most Medicare beneficiaries – about 77 percent – who enroll in Medicare Advantage plans with drug coverage will be in plans with four or more stars in 2021.”

October 9, 2020: New National Action Plan for Combating Antibiotic-Resistant Bacteria

The CDC announced the release of the next National Action Plan for Combating Antibiotic-Resistant Bacteria for 2020-2025. They note in the announcement that antibiotic-resistant infections kill more than 35,000 people in the United States each year.

October 19, 2020: Palmetto GBA Outpatient Department (OPD) Prior Authorization (PA) Alert!

Palmetto GBA included in the following Alert in their October 21, 2020 Daily eNewlsetter:

“As of October 9, 2020, if you are a physician/NPP (Part B provider), you are required to provide two (2) fax numbers to receive your Outpatient Department (OPD) Prior Authorization (PA) decision. If a second fax number is not provided, your OPD PA will be rejected. 

If the requestor is a representative of the Hospital Outpatient Facility, only one (1) fax number is required.

Did you know?
...that the when requesting an OPD PA you must include both the hospital and the requestor’s fax number if the requestor is the physician/NPP (Part B provider)? If not, your PA will be rejected.

Did you know?
...that if the requestor is a representative of the Hospital Outpatient Facility, only one fax number is required.”

October 21, 2020: CMS Announcement, Radiation Oncology Model Delayed

CMS posted the following update to the CMS Radiation Oncology Model webpage:

“UPDATE: (10/21/2020) - CMS has received feedback from a number of stakeholders about the challenges of preparing to implement the RO Model by January 1, 2021. Based on this feedback, CMS intends to delay the RO Model start date to July 1, 2021. We are pursuing rulemaking to make this change.” Note, slides for two recent events related to this model as well as an FAQ document are also available on the Radiation Oncology Model webpage.

October 2020 C2C Innovative Solutions, Inc. Quarterly Newsletter Released

C2C Innovative Solutions Inc. (C2C), the Qualified Independent Contractor (QIC) for Medicare Part A for 26 eastern states, Washington D.C. and two U.S. territories, has released its quarterly newsletter.

October 21, 2020: Alabama Medicaid Alert: National Changes for Office Visit Procedure Codes

The Alabama Medicaid Agency issued an Alert reminding providers about the upcoming changes for Evaluation and Management (E&M) Procedure Codes effective January 1, 2021. This Alert includes links to National Information and Additional Resources about the changes.

Pre-orders have started for Apple’s soon to be released iPhone 12. Imagine what it would be like for devoted iPhone fans if the time from placing a pre-order to when you could actually hold one in your hands followed the CMS timeline for approval for new healthcare technologies. This would definitely not be the timeline for creating and maintaining a consumer base of people wanting the latest technology available in an iPhone.

In September, CMS released the proposed rule Medicare Coverage of Innovative Technology (MCIT) and Definition of Reasonable and Necessary Proposed Rule (CMS-3372-P). Per a related CMS Press Release, “Under current rules, FDA approval of a device is followed by an often lengthy and costly process for Medicare coverage. The lag time between the two has been called the “valley of death” for innovative products, with innovators spending time and resources on FDA approval, only to be forced to spend additional time and money on the Medicare coverage process.” Further, U.S. Department of Health and Human Services (HHS) Secretary Alex Azar, stated 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.”

FDA Breakthrough Devices Program

The Breakthrough Devices Program is specifically for medical devices and device-led combination products meeting the following two criteria:

• The device provides more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.
• The device must satisfy one of the following elements:
• It represents a breakthrough technology;
• No approved or cleared alternatives exist; or
• It offers significant advantages over existing approved or cleared alternatives.

Current Medicare Coverage Pathways

The MCIT pathway is being proposed because the prescribed statutory timeframes for the National Coverage Determination (NCD) process limits CMS’ ability to institute immediate national coverage policies for new, innovative medical devices. NCDs and Local Coverage Determinations (LCDs) take, on average, 9 to 12 months to finalize.

CMS details current Medicare coverage pathways in this proposed rule. Each pathway is highlighted in the following table. 

‍Proposed MCIT Coverage Pathway

The MCIT Coverage Pathway would be specifically for Medicare coverage of devices that are designated as part of the FDA Breakthrough Devices Program and are FDA market authorized. The pathway would involve a coordinated effort by CMS, the FDA and manufacturers as medical devices move through the FDA regulatory process for Breakthrough devices. This simultaneous effort will ensure Medicare coverage on the date of FDA market authorization for all devices that fall within a Medicare benefit category.

MCIT Pathway Proposals:

• The pathway would be voluntary and be initiated when a manufacturer notifies CMS of its intention to utilize the MCIT pathway.
• To be part of the MCIT Pathway, the device must be used in accordance with its FDA approved or cleared indication for use.
• Unlike the pathways in the above table, CMS is proposing that that MCIT Pathway would allow for immediate national coverage upon the date of FDA market authorization (that is the date the medical device received Premarket Approval (PMA); 510K clearance; or the granting of a De Novo classification request) for the breakthrough device.
• If CMS has issued an NCD for a specific breakthrough device, it would not be eligible for the MCIT pathway.
• Coverage would continue for up to 4 years, unless CMS determines the device does not have a Medicare benefit category as determined as part of the pathway process.
• Reasons that the MCIT pathway may end prior to 4 years includes circumstances where a device becomes subject to an NCD, regulation, statute, or if the device can no longer be lawfully marketed.

CMS intends to list MCIT pathway covered devices on the CMS website to ensure all stakeholders will be aware of what is covered through this pathway.

When an MCIT Coverage Pathway Ends, What Next?

At the end of the 4-year MCIT pathway, coverage of a device would be subject to one of the following three possible outcomes:

• NCD affirmative coverage, which may include facility or patient criteria;
• NCD non-coverage; or
• MAC discretion (claim-by-claim adjudication or NCD).

CMS encourages interested manufacturers to submit an NCD request during the third year of MCIT to allow time for NCD development. They are also seeking comments on whether or not a National Coverage Analysis should be opened if a MAC has not issued an LCD within 6 months of the expiration date of the MCIT period.

MCIT Device Eligibility

CMS is proposing that devices having received Breakthrough Device designation within 2 years of the date this proposed rule is finalized will be eligible for coverage for claims submitted on or after the effective date of the final rule. This group of devices would not be eligible for all 4 years of MCIT coverage as the 4 year period starts on the date of FDA market authorization. CMS anticipates two MCIT pathway participants in the first year based on the number of medical devices that received FY 2020 NTAP and were non-covered in at least one MAC jurisdiction by LCDs and related articles.

Proposal to Codify Definition of “Reasonable and Necessary”

In addition to the proposed MCIT Pathway, CMS is proposing to “codify in regulations the Program Integrity Manual definition of ‘‘reasonable and necessary’’ with modifications, including to add a reference to Medicare patients and a reference to commercial health insurer coverage policies.”

Proposal: “An item or service would be considered ‘‘reasonable and necessary’’ if it is— (1) safe and effective; (2) not experimental or investigational; and (3) appropriate for Medicare patients, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it is:

• Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member;
• Furnished in a setting appropriate to the patient’s medical needs and condition;
• Ordered and furnished by qualified personnel;
• One that meets, but does not exceed, the patient’s medical need; and
• At least as beneficial as an existing and available medically appropriate alternative.”

Proposal: An item or service would be “appropriate for Medicare patients” under (3) if it is covered in the commercial insurance market, except where evidence supports that there are clinically relevant differences between Medicare beneficiaries and commercially insured individuals.

Proposal: An item or service deemed appropriate for Medicare coverage based on commercial coverage would be covered on that basis without also having to satisfy the bullets listed above.

CMS Seeking Comments to the Proposed Rule

In the world of CMS proposed rules, this one makes for a quick read at just 13 pages in the Federal Register. CMS is seeking comments on many aspects of this proposed rule and comments must be received by CMS no later than 5 p.m. on November 2, 2020.

Resources

CMS Press Release: CMS Acts to Spur Innovation for America’s Seniors https://www.cms.gov/newsroom/press-releases/cms-acts-spur-innovation-americas-seniors

CMS Fact Sheet: Proposed Medicare Coverage of Innovative Technology (CMS-3372-P)

https://www.cms.gov/newsroom/fact-sheets/proposed-medicare-coverage-innovative-technology-cms-3372-p

Proposed Rule (CMS-3372-P)

https://www.federalregister.gov/documents/2020/09/01/2020-19289/medicare-program-medicare-coverage-of-innovative-technology-mcit-and-definition-of-reasonable-and

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from October 13th through October 19th.

Resource Spotlight: Hypertension Control Call to Action by Surgeon General

On October 8, 2020, Surgeon General, VADM Jerome M. Adams, M.D., M.P.H., “issued a Call to Action urging Americans to recognize and address hypertension control as a national, public health priority. The Surgeon General's Call to Action to Control Hypertension - PDF* provides strategies for those on the frontlines of health care and public health to address this costly, dangerous and far too common chronic health condition.”

This HHS Press Release includes a video by the Surgeon General and goes on to note that “currently, there are limited data and information about the impact of underlying medical conditions – including hypertension – on the risk for severe illness from COVID-19. While our understanding of COVID-19 is still improving and evolving, we know that people with hypertension may be at an increased risk for severe illness from COVID-19.”

October 8, 2020: CMS Halt to Advance Payment Applications

CMS updated the Fact Sheet: Repayment Terms for Accelerated and Advance Payments Issued to Providers and Suppliers During COVID-19 Emergency. New to this Fact Sheet is the following statement: “Please note that, as of October 8, 2020, CMS will no longer accept applications for accelerated or advance payments as they relate to the COVID-19 PHE, although CMS will continue to monitor the ongoing impacts of COVID-19 on the Medicare provider and supplier community.”

You can also read more about the Accelerated/Advance Payment (AAP) Repayment process in an FAQ document posted to Palmetto GBA’s website on October 14, 2020.

October 9, 2020: Trick or Treating and Other Halloween Activities

With just a little over one week until October 31st, the CDC has created the webpage Trick or Treating and Other Halloween Activities.  On this page you find guidance on the following topics for this spookiest of nights:

• Make trick-or-treating safer,
• Wear a mask,
• Stay at least 6 feet away from others who do not live with you,
• Wash your hands,
• Steps to take for Other Halloween Activities,
• Decorate and carve pumpkins,
• Visit an orchard, forest, or corn maze. Attend a scavenger hunt, and
• Links to posters in pdf format with all of the information on this webpage.

October 14, 2020: AHIP Blog: Health Insurance Providers Respond to Coronavirus (COVID-19)

The America’s Health Insurance Plans (AHIP) national association has compiled an A to Z listing of some health insurance providers who are taking action to ensure Americans have access to the prevention, testing, and treatment needed for COVID-19.

https://www.ahip.org/health-insurance-providers-respond-to-coronavirus-covid-19/

October 14, 2020: List of Covered Telehealth Services Covered During the COVID-19 PHE Expanded

CMS announced in a Press Release the expansion of telehealth services to be covered during the COVID-19 Public Health Emergency (PHE) for Medicare Fee-for-Service beneficiaries. Effective immediately, CMS will begin paying for the new telehealth services for the duration of the PHE.

CMS also announced, in the same Press Release, the release of a supplement to its State Medicaid & CHIP Telehealth Toolkit: Policy Considerations for States Expanding Use of Telehealth, COVID-19 Version that provides numerous new examples and insights into lessons learned from states that have implemented telehealth changes.

October 15, 2020: CMS Changes Medicare Payment for COVID-19 Diagnostic Testing

CMS announced changes to Medicare payment to laboratories for high throughput diagnostic tests effective January 1, 2021. The following highlights the timeline of changes:

• April 2020: CMS increased Medicare payment from approximately $50 to $100 per test.
• Effective January 1, 2021:
• Medicare will pay $100 only to laboratories who can complete COVID-19 diagnostic tests within two days of the specimen collection.
• Medicare will pay $75 for laboratories taking longer than two days.

You will also find a link to CMS’ document, COVID-19 FAQs on Medicare Fee-for-Service Billing, at the end of the Press Release. Note, CMS has added a new section, D. High Throughput COVID-19 Testing, (see pages 12 through 16 of the document). 

October 15, 2020: Supplemental Medical Review Contractor (SMRC) Medical Review Notification: DRG COVID-19 20% Add On Payment

Noridian Healthcare Solutions, the current SMRC added Project 01-043 to their list of active projects on October 15, 2020. They will be conducting post-payment Medicare Part-A acute inpatient reviews of claims billed with dates of service from April 1, 2020 through August 30, 2020. Following is the background information included in this Notification:

“Medicare Severity Diagnosis Related Group (MS-DRG) is a system used to classify various diagnoses and procedures for acute care inpatient hospital stays so Medicare can accurately reimburse the hospital under the Inpatient Prospective Payment System (IPPS). In response to the declaration of the COVID-19 outbreak as a Public Health Emergency (PHE), the Coronavirus Aid, Relief, and Economic Security (CARES) Act (Public Law 116-136), was enacted on March 27, 2020. Section 3710 of the CARES Act directs the Secretary to increase the weighting factor of the assigned Diagnosis-Related Group (DRG) by 20 percent for an individual diagnosed with COVID-19 discharged during the COVID-19 PHE period. Discharges of an individual diagnosed with COVID-19 will be identified by the presence of appropriate International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnosis codes. Notably, in August of 2020, the Office of Inspector General (OIG) placed an “Audit of Medicare Payments for Inpatient Discharges Billed by Hospitals for Beneficiaries Diagnosed With COVID-19” on its active work plan.”

October 16, 2020: Medicare Fee-for-Service (FFS) Response to the Public Health Emergency on the Coronavirus (COVID-19) MLN Article Revised

MLN SE20011 was originally released March 16, 2020. This latest revision to the article clarifies HCPCS codes that Critical Access Hospitals (CAHs) should use in the, Families First Coronavirus Act Waives Coinsurance and Deductibles for Additional COVID-19 Related Services section. The Skilled Nursing Facility (SNF) Benefit Waiver Period section, now clarifies that the SNF waiver applies to swing-bed services in rural hospitals and CAHs.

October 16, 2020: Special Edition MLNConnects: Enforcement Discretion Relating to Certain Pharmacy Billing

CMS announced that in order to provide onsite COVID-19 vaccines to Skilled Nursing Facility (SNF) residents, CMS is exercising discretion during this global emergency to “allow Medicare-enrolled immunizers, including but not limited to pharmacies working with the United States, to bill directly and receive direct reimbursement from the Medicare program for vaccinating Medicare SNF residents.”

In a related Press Release, the U.S. Department of Health and Human Services (HHS) also announced on October 16th “agreements with CVS and Walgreens to provide and administer COVID-19 vaccines to residents of long-term care facilities (LTCF) nationwide with no out-of-pocket costs.”

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from October 6th through October 12th.

Resource Spotlight: CDC Updates Guidance on How Coronavirus Spreads

On October 5th, the CDC updated their guidance on how Coronavirus spreads. The CDC’s How COVID-19 Spreads webpage opens by noting the spread of COVID-19 is mainly through close contact (within about 6 feet) and that people who are infected but asymptomatic can also spread the virus. The next sentence in the opening paragraph reminds the reader how much is still unknown about this disease as the CDC states “we are still learning about how the virus spreads and the severity of illness it causes.”

New to this page is the fact that the CDC is now on record as stating they believe “COVID-19 can sometimes be spread by airborne transmission” The following example provided by the CDC brings to mind the choir practice in March that resulted in multiple people testing positive for COVID-19, including three patients being hospitalized and two dying.

“There is evidence that under certain conditions, people with COVID-19 seem to have infected others who were more than 6 feet away. These transmissions occurred within enclosed spaces that had inadequate ventilation. Sometimes the infected person was breathing heavily, for example while singing or exercising.

• Under these circumstances, scientists believe that the amount of infectious smaller droplet and particles produced by the people with COVID-19 became concentrated enough to spread the virus to other people. The people who were infected were in the same space during the same time or shortly after the person with COVID-19 had left.”

September 29, 2020: CMS Updates COVID-19 Testing Methodology for Nursing Homes

Although this update occurred in late September. After talking with my mother, who is now a permanent resident of an Assisted Living Community where a Skilled Nursing Unit (SNF) is housed on the opposite side of the building, I felt it was important to share. Especially after my mom mentioning during a phone conversation that she is getting testing weekly for COVID-19 and the employees are getting tested twice a week.

The September 29th updated guidance came about in response to CMS receiving concerns from some governors of rural states that the frequency guidelines were not working well for some rural areas and updates the August 26th guidance.

October 6, 2020: CMS Interim Final Rule (IFC) –Requirements & Enforcement Process for Reporting COVID-19 Data Elements

CMS summarized the IFC as follows:

“CMS is committed to continuing to take critical steps to ensure America’s healthcare facilities are prepared to respond to the Coronavirus Disease 2019 (COVID-10) Public Health Emergency (PHE). On September 2, 2020, the Federal Register published an interim final rule with comment period (IFC) (85 FR 54820). CMS has released new regulatory requirements for all hospitals and critical access hospitals (CAHs) at 42 C.F.R. §§482.42(e) and 485.640(d), respectively, to report information in accordance with a frequency and in a standardized format as specified by the Secretary during the PHE for COVID-19. Failure to report the specified data needed to support broader surveillance of COVID-19 may lead to the imposition of the remedy to terminate a provider’s participation from the Medicare and Medicaid programs.”

You will find a link to the memorandum sent to CMS Locations State Agencies, Hospitals/CAHs, and other stakeholders as well as Hospital Mandatory COVID-19 Reporting Enforcement Workflow pdf document on this CMS webpage.

October 6, 2020: FDA Launches New Webpage: COVID-19 Vaccines

In their October 6, 2020 COVID-19 Daily Roundup, the FDA announced the launch of a new webpage, COVID-19 Vaccines, to highlight new information as it becomes available. On this webpage, Stephen M. Hahn, M.D., FDA Commissioner, and Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research indicate that “We are committed to expediting the development of COVID-19 vaccines, but not at the expense of sound science and decision making. We will not jeopardize the public’s trust in our science-based, independent review of these or any vaccines. There’s too much at stake.”

October 7, 2020: Regeneron Seeks Emergency Use Authorization Request

Regeneron announced their submission to the FDA for an Emergency Use Authorization (EUA) for their REGN-COV2 investigational antibody combination for COVID-19. The announcement goes on to indicate that “if an EUA is granted the government has committed to making these doses available to the American people at no cost and would be responsible for their distribution. At this time, there are doses available for approximately 50,000 patients, and we expect to have doses available for 300,000 patients in total within the next few months.”

October 7, 2020: FDA Recommendations on Instructions for Patients Self-Collecting Nasal Samples for COVID-19 Testing

In an FDA Letter to Health Care Providers, the FDA is recommending that “providers provide visual (written or video) step-by-step instructions, in addition to verbal instructions, to patients who, in a health care setting, are self-collecting anterior nares (nasal) samples for SARS-CoV-2 testing…the instructions provided to patients should incorporate the following information:

• The entire tip of the swab (usually ½ to ¾ of an inch) should be placed inside the nose, and the side of the swab tip should be rubbed with moderate pressure against as much of the wall of the anterior nares region as possible, moving the tip through a large circular path inside the nose.
• At least four of these sweeping circles should be performed in each nostril using the same swab. This should take approximately 10-15 seconds per nostril.
• Simply twirling the swab against one part of the inside of the nose or leaving the swab in the nose for 10-15 seconds, is not proper technique and may result in an insufficient sample.”

The letter also includes links to additional resources and how to report problems with SARS-COV-2 testing to the FDA.

October 7, 2020: AMA Press Release – New CPT codes for Multi-Virus Tests Detect COVID-19 and Flu – Approved for Immediate Use

The AMA announced an update to the Current Procedural Terminology (CPT®) code set including “new code additions and editorial revisions for reporting medical services sparked by the public health response to the COVID-19 pandemic.”

The following two new codes allow for detection of COVID-19 and common viral infections, including influenza A/B and respiratory syncytial virus.

• 87636 - Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) and influenza virus types A and B, multiplex amplified probe technique
• 87637- Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), influenza virus types A and B, and respiratory syncytial virus, multiplex amplified probe technique

It is important to note that revisions to the code set have been approved for immediate use.

October 8, 2020: New Repayment Terms for Medicare Loans made to Providers during COVID-19

The recently enacted “Continuing Appropriations Act, 2021 and Other Extensions Act” amended the repayment terms for the Expanded Accelerated and Advance Payments (AAP) Program. CMS released a Special Edition MLNConnects providing details regarding the new recoupment terms giving providers and suppliers one additional year to start their loan repayments. “CMS issued $106 billion in payments to providers and suppliers in order to alleviate the financial burden health care providers faced while experiencing cash flow issues in the early stages of combating the Coronavirus Disease 2019 (COVID-19) public health emergency.” This article includes links to a Fact Sheet (PDF) and FAQs (PDF) document providing more information about the repayment terms.

Palmetto GBA, the Medicare Administrative Contractor (MAC) for Jurisdictions J and M also released an

Article on October 8th letting providers know that they will be issuing “letters to any provider or facility that received an APP with full details regarding repayment of their accelerated or advanced payment. The letter will include a list of the provider’s accelerated or advance payment(s), including the amount(s), the date(s) that repayment will begin, and the related Accounts Receivable (AR) number(s). If a provider received accelerated or advance payment(s) in multiple disbursements, each disbursement amount will be listed, along with the corresponding date that repayment for each disbursement will begin.”

October 8, 2020: MLNConnects Notification – COVID-19: Optimizing PPE and Child Health and Wellness

CMS provided the following information in their Thursday October 8th edition of MLNConnects:

The Office of the Assistant Secretary for Preparedness and Response (ASPR) Technical Resources, Assistance Center, and Information Exchange (TRACIE) released:

• Optimizing Healthcare PPE and Supplies Webinar Q&A: Read responses to questions from the September 24 webinar
• PPE Preservation Planning Toolkit: Reuse, repurpose, or reduce the use of Personal Protective Equipment (PPE)
• Crisis Standards of Care  in Post-Acute and Long-Term Care Facilities: Respond to crisis standards of care
• Child Health and Wellness Webinar Recording: Listen to the first webinar in the Hidden Consequences: How the COVID-19 Pandemic is Impacting Children series

For More Information:

• ASPR TRACIE Fact Sheet
• ASPR TRACIE website
• ASPR TRACIE Novel Coronavirus Resources webpage

October 8, 2020: SNF and LTCH Quality Reporting Programs: COVID-19 Public Reporting – Revised

Also included in the Thursday October 8th edition of MLNConnects, are updated COVID-19 public reporting tip sheets for Skilled Nursing Facilities (SNFs) and Long-Term Care Hospitals (LTCHs).

October 9, 2020: CMS Takes Action to Protect Integrity of COVID-19 Testing

CMS notes in an October 9th Press Release that “since August 12, 2020, CMS issued 171 cease and desist letters to entities across the U.S. that were testing for COVID-19 without an appropriate CLIA certificate. Of those 171 letters, 34 percent went to facilities conducting laboratory testing without a CLIA certificate and 66 percent were issued to laboratories performing COVID-19 testing outside the scope of the existing CLIA certification. The letters ordered these laboratories to stop immediately to safeguard the integrity of COVID-19 testing, and protect patients from potential endangerment if provided inaccurate or unreliable test results. Following receipt of the letter, laboratories are required to provide CMS an attestation certifying they have ceased testing.”

CDC COVID Data Tracker – United States COVID-19 Cases

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from September 28th through October 5th.

Resource Spotlight: CDC Guidance on Personal and Social Activities

Fall is my favorite time of year as there are so many opportunities to gather with friends and family. Unfortunately, this year is like no other in my lifetime. As you consider activities with friends and family, review guidance on the CDC website regarding personal and social activities which includes among other activities, hosting gatherings or cook-outs.

September 28, 2020: Alabama Medicaid COVID-19 Relief Grants

The state of Alabama is offering cash grants up to $15,000 for Alabama Health Care and Emergency Response Providers that meet eligibility requirements. Key things to note in this Alabama Medicaid Alert are:

• Disbursements will be awarded on a first-come, first-served basis up to $35 million aggregate cap,
• The application period for the Alabama Health Care and Emergency Response Provider Grant Program will be open on noon October 5, 2020 and end at noon October 16, 2020, and
• Eligible providers for this grant program include:
• Health care providers including primary care clinics, ambulance/EMS service providers, pharmacies, physician offices, dentist offices, outpatient care centers, medical and diagnostic laboratories, home health care businesses, assisted living facilities, physical therapy offices, and other provider types.
• Emergency response providers including rescue squad organizations, volunteer fire departments, 911 boards, and other provider types.

September 29, 2020: OIG Report – National Snapshot of State Agency Approaches to Child Care During the COVID-19 Pandemic

The objective of this Audit was to identify what measures Child Care and Development Fund (CCDF) program lead agencies have undertaken “to ensure access to safe child care as well as to protect the providers rendering the care in their CCDF programs in response to the COVID-19 pandemic.” The OIG compiled responses to a questionnaire and follow-up interviews conducted with State agencies between April 30 and June 16, 2020. Not surprising to parents, the OIG found that nationally about 63 percent of child care centers and 27 percent of family child care providers had closed during the COVID-19 pandemic. The OIG made no recommendations. Instead they note that the Administration for Children and Families (AFC) should “use this report to support State agencies as they work to address ongoing issues that could impede access to child care as a result of the COVID-19 pandemic.”

October 1, 2020: HHS & The Rockefeller Foundation to Share Best Practices for Increased COVID-19 Testing

HHS announced their agreement with the Rockefeller foundation “to identify and share effective approaches for using rapid point-of-care (POC) antigen tests to screen for COVID-19 in communities, with a focus on safely reopening K-12 schools.”

October 1, 2020: Remdesivir Now Available Directly from Distributor

HHS announced in a Press Release that beginning October 1, 2020, American hospitals can purchase Veklury (remdesivir) directly from the drug’s distributor. What you need to know:

• Also on October 1st, the FDA revised the Emergency Use Authorization for Veklury removing the U.S. government’s role in directing the allocation of the drug,
• The current supply of the drug exceeds the market demand,
• The cost of the drug will not change in the transition away from U.S. government oversight. Hospitals will continue to pay no more than Gilead’s wholesale acquisition price (WAC), approximately $3,200 per treatment course, and
• AmerisourceBegen will remain the sole distributor through the end of 2020 to ensure a smooth distribution process.

October 1, 2020: MLNConnects Notification – Optimizing Health Care PPE and Supplies

The Office of the Assistant Secretary for Preparedness and Response (ASPR) Technical Resources, Assistance Center, and Information Exchange (TRACIE) released an Express message with new resources:  

• COVID-19: Optimizing Healthcare Personal Protective Equipment (PPE) and Supplies webinar recording: Hear from public and private sector partners

• COVID-19 Response Assistance Field Observations webpage: Learn about institutions of higher learning, K-12 schools, minority/vulnerable populations, and critical infrastructure
• Maintaining Healthcare Safety During the COVID-19 Pandemic speaker series: Listen to health care professionals share their experiences

For More Information:

• ASPR TRACIE Fact Sheet

• ASPR TRACIE website
• ASPR TRACIE Novel Coronavirus Resources webpage

October 1, 2020: $20 Billion in New Phase 3 Provider Relief Funding

The Department of Health and Human Services (HHS) announced $20 billion in new funding for providers and can begin applying for funds on Monday October 5th and can apply through November 6, 2020. Under this Phase 3 General Distribution allocation eligibility has expanded to the following:

• Providers who have already received Provider Relief Fund payments are invited to apply for additional funding,
• Previously ineligible providers, such as those who began practicing in 2020 will be invited to apply, and
• An expanded group of behavioral health providers confronting mental health and substance issues exacerbated by the pandemic will also be eligible for relief payments.

“HHS is urging all eligible providers to apply early; do not wait until the last day or week of the application period. Applying early will help to expedite HHS’s review process and payment calculations, and ultimately accelerate the distribution of all payments.”

October 2, 2020: Public Health Emergency Renewed

The Secretary of Health and Human Services, Alex M. Azar II, has renewed the Public Health Emergency (PHE) due to the COVID-19 pandemic effective October 23, 2020. The extension of the PHE means that current waivers will remain in place.

• Renewal of Public Health Emergency: https://www.phe.gov/emergency/news/healthactions/phe/Pages/covid19-2Oct2020.aspx
• CMS Coronavirus Waivers & Flexibilities webpage: https://www.cms.gov/about-cms/emergency-preparedness-response-operations/current-emergencies/coronavirus-waivers

CDC COVID Data Tracker – United States COVID-19 Cases

CMS released the display copy of the Fiscal Year (FY) 2021 Inpatient Prospective Payment System (IPPS) Final Rule on Wednesday September 2, 2020. Time has a way of marching on as tomorrow is the start of FY 2021. This article focuses on New Technology Add-On Payments (NTAP) for FY 2021.

New Technology Add-On Payment Traditional Pathway

“A new medical service or technology may be considered for new technology add-on payment if, based on the estimated costs incurred with respect to discharges involving such service or technology, the DRG prospective payment rate otherwise applicable to such discharges under this subsection is inadequate.”

In general, there are three criteria for determining when a new medical service or technology would warrant additional payment:

• The medical service or technology must be new.
• The medical service or technology must be costly such that the DRG rate otherwise applicable to discharges involving the medical service or technology is determined to be inadequate (Note, “no add-on payment will be made if a new technology is assigned to a DRG that most closely approximates it’s costs); and
• The service or technology must demonstrate a substantial clinical improvement over existing services or technologies.

Alternative Inpatient New Technology Payment Pathways

New for FY 2021, “certain transformative new devices and Qualified Infectious Disease Products (QIDPs) may qualify for new technology add-on payment under alternative pathway” as finalized in the FY 2020 IPPS/LTCH Final Rule.

A technology is not required to have a specified FDA designation at the time the application for NTAP is made. Instead, “CMS will review the application based on the information provided under by the applicant under the alternative pathway specified by the applicant. However, to receive approval for the new technology add-on payment under that alternative pathway, the technology must have the applicable designation and meet all other requirements in the regulations in § 412.87(c) and (d), as applicable.”

Certain Antimicrobial Products Alternative Pathway

For FY 2021, the alternative pathway for QIDPs has been expanded to include products approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) pathway. In the Final Rule, CMS finalized policy to refer more broadly to “certain antimicrobial products” rather than specifying specific FDA programs for antimicrobials (i.e. QIDPs and LPADs).

Products approved through this pathway will be considered new and not substantially similar to an existing technology and will not need to demonstrate that it meets the substantial clinical improvement criterion. However, the technology will need to meet the cost criterion.

Certain Transformative New Devices Alternative Pathway

Beginning in FY 2021, “if a medical device is part of FDA’s Breakthrough Devices Program and received FDA marketing authorization, it will be considered new and not substantially similar to an existing technology for purposes of the new technology add-on payment under the IPPS.” However, the new device must meet the cost criterion and must receive marketing authorization for the indication covered by the Breakthrough Device Program designation.

Additional Payment for NTAP’s

Payment for an NTAP is based on the cost to hospitals for the new medical service or technology. As set forth in § 412.88(b)(2), unless the discharge qualifies for an outlier payment, the additional Medicare payment will be limited to the following:

• For “Traditional Pathway” and “Certain Transformative New Devices”, Medicare will make an add-on payment equal to the lesser of: (1) 65 percent of the costs of the new medical service or technology; or (2) 65 percent of the amount by which the costs of the case exceed the standard DRG payment.
• For Certain Antimicrobial NTAPs (QIDPs and LPADs), Medicare will make an add-on payment equal to the lesser of: (1) 75 percent of the costs of the new medical service or technology; or (2) 75 percent of the amount by which the costs of the case exceed the standard DRG payment.

Coding NTAPs

Section X is the New Technology section that was added to ICD-10-PCS effective October 1, 2015.

CMS has indicated that Section X was created in response to public comments received regarding New Technology proposals presented at ICD-10 Coordination and Maintenance Committee Meetings, and general issues facing classification of new technology procedures. The public had opposed many requests to add new codes to the existing ICD-10-PCS sections for the use of specific drugs, devices, or supplies in an inpatient setting, even when the code related to an application for New Technology add-on payments.

NTAPs for FY 2021 by the Numbers

• 10 Technologies approved for NTAP in FY 2020 which will continue in FY 2021
• 6 New technologies were approved for FY 2021 under the Traditional Pathway
• 8 New technologies were approved for FY 2021 under the Alternative Pathway of Certain Antimicrobial Products or Certain Transformative New Devices
• $874 million is CMS estimate for FY 2021 Medicare spending on NTAPs. This is nearly a 120% increase over the FY 2020 spending.

CMS Policy for Continuing NTAP Status 

“Our policy is that a medical service or technology may continue to be considered “new” for purposes of new technology add-on payments within 2 or 3 years after the point at which data begin to become available reflecting the inpatient hospital code assigned to the new service or technology. Our practice has been to begin and end new technology add-on payments on the basis of a fiscal year, and we have generally followed a guideline that uses a 6-month window before and after the start of the fiscal year to determine whether to extend the new technology add-on payment for an additional fiscal year. In general, we extend new technology add-on payments for an additional year only if the 3-year anniversary date of the product’s entry onto the U.S. market occurs in the latter half of the fiscal year (70 FR 47362).”

FY 2020 NTAPs Approved for Continued NTAP Status for FY 2021

The following Summary Table from the Final Rule highlights which NTAPs have been discontinued or continued for FY 2021.

Source: Federal Register / Vol. 85, No. 182 / Friday, September 18, 2020 / Rules and Regulations / page 58619 at https://www.govinfo.gov/content/pkg/FR-2020-09-18/pdf/2020-19637.pdf

FY 2021 Approved Applications for NTAP (Traditional Pathway)  

ContaCT

• New Technology Description: According to Viz.ai Inc., ContaCT is a radiological computer-assisted triage and notification software system intended for use by hospital networks and trained clinicians. ContaCT analyzes computed tomography angiogram (CTA) images of the brain acquired in the acute setting, sends notifications to a neurovascular specialist(s) that a suspected large vessel occlusion (LVO) has been identified, and recommends review of those images.

• ICD-10-PCS Procedure Code: 4A03X5D (Measurement of arterial flow, intracranial, external approach)

• Maximum Add-on Payment: $1,040 (65% of the costs of the new technology)

Eluvia™ Drug-Eluting Vascular Stent System (Eluvia)

• New Technology Description: Eluvia™, a drug-eluting stent for the treatment of lesions in the femoropopliteal arteries, received FDA premarket approval (PMA) September 18, 2018. According to the applicant, Boston Scientific, the Eluvia™ system is a sustained release drug-eluting stent indicated for the treatment of lesions in the femoropopliteal arteries and is designed to restore blood flow in the peripheral arteries above the knee – specifically the superficial femoral artery (SFA) and proximal popliteal artery (PPA).

• ICD-10-PCS Procedure Codes: See table on page 58647 of the Final Rule (total 16 codes)

• Maximum Add-on Payment: $3,646.50 (65% of the costs of the new technology)

Hemospray® Endoscopic Hemostat (Hemospray)

• New Technology Description: According to the applicant, Cook Medical, Hemospray is indicated by the FDA for hemostasis of nonvariceal gastrointestinal bleeding. Using an endoscope to access the gastrointestinal tract, the Hemospray delivery system is passed through the accessory channel of the endoscope and positioned just above the bleeding site without making contact with the GI tract wall. The Hemospray powder, bentonite, is propelled through the application catheter, either a 7 or 10 French polyethylene catheter, by release of CO2 from the cartridge located in the device handle and sprayed onto the bleeding site. According to the applicant, bentonite can rapidly absorb 5 to 10 times its weight in water and swell up to 15 times its dry volume, becoming cohesive to itself and adhesive to tissue forming a physical barrier to aqueous fluid (for example, blood). Hemospray powder is not absorbed by the body and does not require removal as it passes through the GI tract within 72 hours. Hemospray is single-use and disposable.

• ICD-10-PCS Procedure Codes:
• XW0G886 (Introduction of mineral-based topical hemostatic agent into upper GI, via naturel or artificial opening endoscopic, new technology group 6), and
• XW0H886 (Introduction of mineral-based topical hemostatic agent into lower GI, via natural or artificial opening endoscopic, new technology group 6)

• Maximum Add-on Payment: $1,625.00 (65% of the costs of the new technology)

IMFINZI® (durvalumab) and TECENTRIQ® (Atezolizumab)

• New Technology Description: Two manufacturers, AstraZeneca PLC and Genentech, Inc., submitted separate applications for new technology add-on payments for FY 2021 for IMFINZI® (durvalumab) and TECENTRIQ® (atezolizumab), respectively. Both of these technologies are programmed deathligand 1 (PD-L1) blocking antibodies used for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).

The applications were considered separately in the Proposed Rule. Since then, CMS has determined the two are substantially similar and as such evaluated both technologies as one application for NTAP.

• ICD-10-PCS procedure codes for TECENTRIQ®
• XW033D6 (Introduction of atezolizumab antineoplastic into peripheral vein, percutaneous approach, new technology group 6), and
• XW043D6 (Introduction of atezolizumab antineoplastic into central vein, percutaneous approach, new technology group 6)
• ICD-10-PCS procedure codes for IMFINZI®
• XW03336 (Introduction of durvalumab antineoplastic into peripheral vein, percutaneous approach, new technology group 6), and
• XW04336 (Introduction of durvalumab antineoplastic intro central vein, percutaneous approach, new technology group 6)

• Maximum Add-on Payment: $6,875.90 (65% of the costs of the new technology)

Soliris® (eculizumab)

• New Technology Description: Soliris® is approved for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. According to the applicant, Alexion, Inc., NMOSD is a rare and severe condition that attacks the central nervous system without warning. The applicant explained that NMOSD attacks, also referred to as relapses, can cause progressive and irreversible damage to the brain, optic nerve and spinal cord, which may lead to long-term disability, and in some instances, the damage may result in death.

• ICD-10-PCS Procedure Codes:
• XW033C6 (Introduction of eculizumab into peripheral vein, percutaneous approach, new technology group 6), and
• XW043C6 (Introduction of eculizumab into central vein, percutaneous approach, new technology group 6).
• Maximum Add-on Payment: $21,199.75 (65% of the costs of the new technology)

The SpineJack® Expansion Kit (SpineJack® System)

• New Technology Description: The applicant, Stryker, Inc., describes the SpineJack® system as an implantable fracture reduction system, which is indicated for use in the reduction of painful osteoporotic vertebral compression fractures (VCFs) and is intended to be used in combination with Stryker VertaPlex and VertaPlex High Viscosity (HV) bone cement.

• ICD-10-PCS Procedure Codes:
• XNU0356 (Supplement lumbar vertebra with mechanically expandable (paired) synthetic substitute, percutaneous approach, new technology group 6), and
• XNU4356 (Supplement thoracic vertebra with mechanically expandable (paired) synthetic substitute, percutaneous approach, new technology group 6)
• Maximum Add-on Payment: $3,654.72 (65% 0f the costs of the new technology)

FY 2021 Approved NTAP Alternative Pathway for Breakthrough Devices

BAROSTIME NEO® System

• New Technology Description: According to the applicant, CV Rx, the BAROSTIM NEO® System is indicated for the improvement of symptoms of heart failure – quality of life, six-minute hall walk and functional status – for patients who remain symptomatic despite treatment with guideline-directed medical therapy, are NYHA Class III or Class II (who had a recent history of Class III), have a left ventricular ejection fraction ≤ 35%, a NT-proBNP < 1600 pg/ml and excluding patients indicated for Cardiac Resynchronization Therapy (CRT) according to AHA/ACC/ESC guidelines.

• ICD-10-PCS Procedure codes:
• 0JH60MZ (insertion of stimulator generator into chest subcutaneous tissue and fascia, open approach) in combination with
• 03HK0MZ (Insertion of stimulator lead into right internal carotid artery, open approach), OR
• 03HL0MZ (Insertion of stimulator lead into left internal carotid artery, open approach).

• Maximum Add-on Payment: $22,750 (65% of the average cost of the technology)

Optimizer® System (QFV)

• New Technology Description: Impulse Dynamics submitted an application for The Optimizer® System (QFV). It is intended for the treatment of chronic heart failure in patients with advanced symptoms that have normal QRS duration and are not indicated for cardiac resynchronization therapy.

• ICD-10-PCS Procedure codes to identify the Optimizer System
• 0JH60AZ (Insertion of contractility modulation device into chest subcutaneous tissue and fascia, open approach),
• 0JH63AZ (Insertion of contractility modulation device into chest subcutaneous tissue and fascia, percutaneous approach),
• 0JH80AZ (Insertion of contractility modulation device into abdomen subcutaneous tissue and fascia, open approach), and
• 0JH83AZ (Insertion of contractility modulation device into abdomen subcutaneous tissue and fascia, percutaneous approach)

• Maximum Add-on Payment: $14,950 (65% of the average cost of the technology)

FY 2020 Approved NTAP Alternative Pathway Certain Antimicrobial Products (i.e. QIDPs and LPADs)

Cefiderocol (Fetroja)

• Product Description: Cefiderocol is an injectable β-lactam antibiotic indicated for the treatment of complicated urinary tract infections (cUTI), including Pyelonephritis, caused by the following susceptible Gram-negative (GN) pathogens: Escherichia coli (including with concurrent bacteremia), Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Citrobacter freundii, Enterobacter cloacae, Morganella morganii, and Serratia marcescens.

Per the applicant, Shionogi & Co. Ltd (Company), Cefiderocol should be used to treat infections where limited or no alternative treatment options are available and where Cefiderocol is likely to be an appropriate treatment option, which may include use in patients with infections caused by documented or highly suspected carbapenem-resistant (CR) and/or multidrug-resistant GN pathogens.

• ICD-10-PCS Procedure Codes:
• XW03366 (Introduction of Lefamulin Anti-infective into Peripheral Vein, Percutaneous Approach, New Technology Group 6), or
• XW04366 (Introduction of Lefamulin Anti-infective into Central Vein, Percutaneous Approach, New Technology Group 6)

• Maximum Add-on Payment: $7,919.86 (75% of the average cost of the technology)

CONTEPO™ (fosfomycin for injection)

• Product Description: IV fosfomycin for injection (ZTI-01) is for the treatment of patients 18 years and older with cUTI including Acute Pyelonephritis (AP) caused by designated susceptible bacteria. The applicant, Nabriva Therapeutics, notes that once approved, CONTEPO will represent the first FDA-approved IV epoxide antibiotic in the United States.

• ICD-10-PCS Procedure Codes:
• XW033K5, (Introduction of Fosfomycin anti-infective into peripheral vein, percutaneous approach, new technology group 5), and
• XW043K5 (Introduction of Fosfomycin anti-infective into central vein, percutaneous approach, new technology group 5)

• Maximum Add-on Payment: $2,343.75 (75% of the average cost of the technology)

NUZYRA® for injection (omadacycline)

• Product Description: According to the applicant, Paratek Pharmaceuticals, NUZYRA® for Injection is a tetracycline class antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms:
• Community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus methicillin susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.
• Acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible microorganisms: Staphylococcus aureus (methicillin susceptible and resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Enterococcus faecalis, Enterobacter cloacae, and Klebsiella pneumoniae.

• ICD-10-PCS Procedure Codes:
• XW033B6 (Introduction of omadacycline anti-infective into peripheral vein, percutaneous approach, new technology group 6), or
• XW043B6 (Introduction of omadacycline anti-infective into peripheral vein, percutaneous approach, new technology group 6).

• Maximum Add-on Payment: $1,552.50 (75% of the average cost of the technology)

RECARBRIO™

• Product Description: RECARBRIOTM is a fixed-dose combination of imipenem, a penem antibacterial; cilastatin, a renal dehydropeptidase inhibitor; and relebactam, a novel β-lactamase inhibitor (BLI). According to the applicant, Merck, RECARBRIOTM is intended for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) for patients 18 years of age and older. RECARBRIOTM is administered via intravenous infusion. Per RECARBRIOTM’s prescribing information, the recommended duration of treatment with RECARBRIOTM is 4 days to 14 days.

• ICD-10-PCS Procedure Codes:
• XW033U5 (Introduction of imipenem-cilastatin-relebactam anti-infective into peripheral vein, percutaneous approach, new technology group 5) or
• XW043U5 (Introduction of imipenem-cilastatin-relebactam antiinfective into central vein, percutaneous approach, new technology group 5)

• Maximum Add-on Payment: $3,532.78 (75% of average cost of the technology)

XENLETA

• Product Description: Nabriva Therapeutics submitted an application for XENLETA, a pleuromutilin antibacterial agent representing the first intravenous (IV) and oral treatment option from a novel class of antibiotics for community-acquired bacterial pneumonia (CABP). XENLETA is indicated for the treatment of adults with CABP caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae. Per the applicant, XENLETA also has in vitro activity against methicillin resistant Staphylococcus aureus.

• ICD-10-PCS Procedure Codes:
• XW03366 (Introduction of lefamulin anti-infective into peripheral vein, percutaneous approach, new technology group 6),
• XW04366 (Introduction of lefamulin anti-infective into central vein, percutaneous approach, new technology group 6) or
• XW0DX66 (Introduction of efamulin anti-infective into mouth and pharynx, external approach, new technology group 6)

• Maximum Add-on Payment: $1,275.75 (75% of the average cost of the technology)

ZERBAXA® (ceftolozane and tazobactam)

• Product Description: ZERBAXA® is a combination of ceftolozane, a cephalosporin antibacterial; and tazobactam, a β-lactamase inhibitor (BLI), indicated in patients 18 years or older for the treatment of the following infections caused by designated susceptible microorganisms:
• Complicated Intra-abdominal Infections (cIAI), used in combination with metronidazole;
• Complicated Urinary Tract Infections (cUTI), Including Pyelonephritis;
• Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP).

Note, CMS has indicated that the NTAP for FY 2021 is specific to treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) is eligible for NTAP for FY 2021, because the other indications approval is beyond the 3-year newness period.

• ICD-10-PCS Procedure Codes:
• XW03396 (Introduction of Ceftolozane/Tazobactam Anti-infective into Peripheral Vein, Percutaneous Approach, New Technology Group 6), or
• XW04396 (Introduction of Ceftolozane/Tazobactam Anti-infective into Central Vein, Percutaneous Approach, New Technology Group 6)

• Maximum Add-on Payment: $1,836.98 (75% of the average cost of the technology)

Appendix A – Effects of Policies Relating to New Medical Service and technology Add-On Payments (page 2056)

CMS estimates the payment amounts for new technology add-on payments in the Final Rule based on the applicant’s estimates. This amount and the estimated number of patients is highlighted in the following table: 

‍Moving Forward

The number of new technologies has increased from 18 in FY 2020 to 24 in FY 2021. With this increase, the estimated number of patients to receive a new technology during an inpatient stay has increased from 71,659 in FY 2020 to 259,101 for FY 2021. Identifying and coding new technologies is an opportunity not to be missed for those hospitals providing these services. That said, some questions come to mind for you to think about:

• Is your hospital providing any of these medical services or technology?
• Who needs to be aware of what the new technologies are? (i.e. Physicians, Pharmacy, Coding Professionals, Clinical Documentation Integrity Specialists, Case Managers)
• What process do you have in place to alert your Coding Staff of the need to code the new technologies?

Resources:

CMS September 2, 2020 Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/fiscal-year-fy-2021-medicare-hospital-inpatient-prospective-payment-system-ipps-and-long-term-acute-0

FY 2021 IPPS CMS webpage: https://www.cms.gov/medicare/acute-inpatient-pps/fy-2021-ipps-final-rule-home-page

MM11879 – Fiscal Year (FY) 2021 Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) PPS Changes: https://www.cms.gov/files/document/mm11879.pdf