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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

October MAC Talk: The Local Scene

September 28, 2020: Noridian Provider Outreach & Education Webinar: Compliance Program – What Every Provider Needs to Know

Noridian’s Provider Outreach and Education (POE) will be hosting the Compliance Program webinar next Wednesday October 28, 2020 at 3 p.m. CT. Topics to be covered include:

• What is the Compliance Program,
• Compliance Fundamental Elements,
• Compliance Laws and Statues,
• Documentation and Functions of Medical Records, and
• Noteworthy Information and Resources.

Link to Webinar Announcement: https://med.noridianmedicare.com/web/jfa/article-detail/-/view/10529/compliance-program-what-every-provider-needs-to-know-webinar-october-28-2020

September 29, 2020: Novitas Solutions Reminds Providers about Requirements to be Eligible for 20 Percent Increase in MS-DRG Weighting Factor

This Novitas article opens by reminding the reader that the CARES Act established a 20 percent increase in the relative weight of the diagnosis related group (DRG) billed for a Medicare fee-for-service inpatient hospitalization during the COVID-19 public health emergency. They go on to reinforce that effective for admissions on after September 1, 2020 that without documentation of a positive COVID-19 test in the record, the hospital is not eligible to receive the 20 percent increase. I encourage you to read this article as it goes on to provide coding and billing guidance.

September 29, 2020: Palmetto GBA Article: Cardiovascular Disease and Intensive Behavioral Therapy

Palmetto highlights the fact that hypertension (HTN), coronary artery disease (i.e., myocardial infarction and angina pectoris), heart failure and stroke are all Cardiovascular Disease (CVD) diagnoses. This article reminds health care providers that CMS believes “Intensive Behavioral Therapy (IBT) for CVD is reasonable and necessary for the prevention or early detection of illness or disability, and is appropriate for” Medicare beneficiaries. This article highlights risk factors for CVD, the HCPCS code for IBT for CVD (G0446), discusses the components of IBT and provides resources including a link to the National Coverage Determination (NCD) 210.11 Intensive Behavioral Therapy for Cardiovascular Disease.

October 1, 2020: Novitas Solutions: Prior Authorizations for hospital Outpatient Department Tips and Reminders

Similar to WPS, Novitas released an article including tips and reminders to assist you in avoiding a delay or dismissal of a prior authorization request (PAR).

October 2, 2020: Palmetto GBA Article: TPE Notifications Coming to eServices!

Palmetto GBA announced the addition of TPE notification letters to their eServices portal beginning October 10, 2020. At that time, letters will be issued as before through standard mail for non-eServices Users or the new option of electronically for eService Users. At the end of this announcement, Palmetto reminds providers that TPE reviews are on hold due to the COVID-19 pandemic and you will be notified when it TPE reviews do resume.

October 2, 2020: Palmetto GBA Article: Procedure Codes that Require Additional Documentation

This article  opens by reminding providers that “the submission of additional documentation is required only when certain CPT/HCPCS codes are billed or when additional documentation is needed for Palmetto GBA to process and/or price a service.” Palmetto GBA has included a list of codes requiring additional documentation in the article.

October 6, 2020: Novitas Article: Change to Amount in Controversy (AIC) for Appeals in 2021

This Novitas article provides updated information to the AIC for Appeals filed on or after January 1, 2021, includes the AIC amount, explains how the AIC is calculated and provides examples.

October 6, 2020: Palmetto GBA Article: General Appeals Information

Palmetto GBA reminds providers that you have the right to request an appeal if you disagree with an initial claim determination. This article walks through the five levels of Medicare Fee-for-Service appeals including time limits to appeal, minimum amounts in controversy (AIC) and notes providing additional guidance at the first three levels of appeal.

October 13, 2020: Palmetto GBA Article: Consider Reopening a Claim Instead of a Written Redetermination

Palmetto GBA advises, in the opening of this article, that “there is no need to appeal a claim if you have made a minor error or omission in filing the claim, which in turn caused the claim to be denied. In the case where a minor error or omission is involved, you may request that Palmetto GBA reopen the claim so the error or omission can be corrected rather than going through the written appeals process.” The article goes on to provide examples of what is considered a minor error or omission that can be reopened, modifiers considered simple claims corrections, and provide answers to questions about the process.

October 15, 2020: First Coast Services Options Prior Authorization for Certain Outpatient (OPD) Services FAQs and Retroactive Authorization for Services in the ED

First Coast has recently posted two documents providing information about the Prior Authorization for Certain OPD Services program that began in July of this year.

• FAQ Document based on questions posed during webinars: https://medicare.fcso.com/Prior_authorization/0466250.asp, and
• Retroactive Services in the Emergency Department: https://medicare.fcso.com/Prior_authorization/0474891.asp

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

Q:

How would you code a foreign body that is intentionally left in the body during an operation since the ICD-10-CM codes are for situations where the foreign body was unintentionally left behind?

A:

The answer to this question comes from Coding Clinic, First Quarter 2014, page 21.  We are not to assign a complication code for something left intentionally during surgery. Coding Clinic made this change to reflect The National Quality Forum revised information on Serious Reportable Events in Healthcare.

Reference:

Coding Clinic, First Quarter 2014, page 21 

Q:

Given the ongoing COVID-19 Pandemic, has CMS delayed the start date for the Hospital Price Transparency requirement?

A:

There has been no delay in this requirement. CMS actually reaffirmed the January 1, 2020 effective date by including the following information in their Thursday October 1, 2020 MLNConnects newsletter:

Hospital Price Transparency: Requirements Effective January 1

Starting January 1, 2021, each hospital operating in the United States is required to provide clear, accessible pricing information online about the items and services they provide in two ways:

• Comprehensive machine-readable file with all items and services
• Display of shoppable services in a consumer-friendly format

Is your organization prepared to be compliant? Visit the new Hospital Price Transparency website for resources to help you prepare:

• Final Rule
• FAQs (PDF)
• 8 Steps to a Machine-Readable File (PDF)
• 10 Steps to a Consumer-Friendly Display (PDF)
• Quick Reference Checklists (PDF)

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

MEDICARE TRANSMITTALS – RECURRING UPDATES

October 2020 Update of the Hospital Outpatient Prospective Payment System (OPPS)

• Article Release Date: August 31, 2020
• What You Need to Know: This article informs providers about changes to and billing instructions for various payment policies implemented in the October 2020 OPPS update.
• MLN MM11905: https://www.cms.gov/files/document/mm11905.pdf

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

• Article Release Date: August 28, 2020
• What You Need to Know: This article provides information about the October 2020 version of the I/OCE instructions and specifications that Medicare uses.
• MLN MM11944: https://www.cms.gov/files/document/mm11944.pdf

Annual Clotting Factor Furnishing fee Update 2021

• Article Release Date: August 28, 2020
• What You Need to Know: The annual clotting factor furnishing fee for 2021 is $0.238 per unit.
• MLN MM11932: https://www.cms.gov/files/document/mm11932.pdf

2021 Annual Update for the Health Professional Shortage Area (HPSA) Bonus Payments

• Article Release Date: August 28, 2020
• What You Need to Know: Section 413(b) of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 mandated an annual update to the automated HPSA bonus payment file. This article lets providers know that CMS will provide MACs with files for the automated payments of HPSA bonuses for dates of service January 1, 2021 through December 31, 2021.
• MLN MM11852: https://www.cms.gov/files/document/mm11852.pdf

October Quarterly Update for the 2020 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule

• Article Release Date: August 28, 2020
• What You Need to Know: This article provides details about the changes to the DMEPOS fee schedules that Medicare updates quarterly, when necessary, to implement fee schedule amounts for new and existing codes, as applicable, and apply changes in payment policies. Specific to the ongoing Public Health Emergency (PHE) due to the COVID-19 pandemic, “the October 2020 DMEPOS and PEN fee files continue to include the non-rural contiguous non-CBA 75/25 blended fees required by Section 3712(b) of the CARES Act signed into law on March 27, 2020.
• MLN MM11956: https://www.cms.gov/files/document/mm11956.pdf

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

• Article Release Date: August 28, 2020
• What You Need to Know: This article informs providers that Medicare will update its claims processing systems based on the Committee on Operating Rules for Information Exchange (CORE), Code Combination List, which will be published on or about October 1, 2020.
• MLN Matters MM11881: https://www.cms.gov/files/document/mm11881.pdf

Update to Hospice Payment Rates, Hospice Cap, Hospice Wage Index and Hospice PRICER for FY 2021

• Article Release Date: August 31, 2020 – Revised September 10, 2020
• What You Need to Know: This article provides updates in Change Request (CR) 11876 to hospice payment rates, wage index, PRICER, and aggregate cap amounts for Fiscal Year (FY) 2021. Note, this article was revised on September 10th to correct two typos. All other information remained the same.
• MLN Matters MM11876: https://www.cms.gov/files/document/mm11876.pdf

Claim Status Category and Claim Status Codes Updates

• Article Release Date: August 28, 2020
• What You Need to Know: This article informs providers of updates to the Claim Status and Claims Status Category Codes used for the Accredited Standards Committee (ASC) X12 276/277 Health Care Claim Status Request and Response and ASC X12 277 Health Care Claim Acknowledgement transactions. Code changes during the September/October 2020 National Code Maintenance Committee (NCMC) meeting will be posted on or about November 1, 2020.
• MLN Matters MM11796: https://www.cms.gov/files/document/mm11796.pdf

2021 Annual Update of Healthcare Common Procedure Coding System (HCPCS) Codes for Skilled Nursing facility (SNF) Consolidated Billing (CB) Update

• Article Release Date: September 16, 2020
• What You Need to Know: This articles provides information regarding changes to HCPCS codes and Medicare Physician Fee Schedule (MPFS) designations that Medicare uses to revise Common Working File (CWF) edits to allow MACs to make appropriate payments.
• MLN Matters MM11968: https://www.cms.gov/files/document/mm11968.pdf

Fiscal Year (FY) Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) PPS Changes

• Article Release Date: September 22, 2020
• What You Need to Know: This article provides FY 2021 update to the IPPS and LTCH PPS.
• MLN MM11879: https://www.cms.gov/files/document/mm11879.pdf

Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 27.0, Effective January 1, 2021

• Article Release Date: September 25, 2020
• What You Need to Know: CR 11984 provides quarterly updates to the NCCI PTP edits. A test file will be available around November 2, 2020 with a final file available on or about November 17, 2020.
• MLN MM11984: https://www.cms.gov/files/document/mm11984.pdf

OTHER MEDICARE TRANSMITTALS

Updates to Chapter 23 – Fee Schedule Administration and Coding Requirements

• Change Request Release Date: August 28, 2020
• What You Need to Know:
• CR 11941 (Transmittal 10320): https://www.cms.gov/files/document/r10320cp.pdf
• Effective Date: December 1, 2020
• Implementation Date: December 1, 2020

Internet Only Manual Update to Pub. 100-04, Chapter 16, Section 60.1.2 and Pub. 100-04, Chapter 26, Section 10.4, Item 19

• Article Release Date: September 4, 2020
• What You Need to Know: CMS has removed the reference to Electrocardiogram (EKG) services in the Medicare Claims Processing Manual, Chapter 16, Section 60.1.2 and Chapter 26, Section 10.4, Item 19. This change only clarifies existing content.
• MLN Matters MM11935: https://www.cms.gov/files/document/mm11935.pdf

Update to the Medicare Claims Processing Manual

• Article Release Date: September 18, 2020
• What You Need to Know: This article provides information regarding updated to the Medicare Claims Processing Manual, Chapters 12 and 23.
• MLN Matters MM111958: https://www.cms.gov/files/document/mm11958.pdf

REVISED MEDICARE TRANSMITTALS

National Coverage Determination (NCD 30.3.3): Acupuncture for Chronic Low back Pain (cLPB)

• Article Release Date: May 13, 2020 – Revised September 1, 2020
• What You Need to Know: This MLN article was revised to reflect an updated Change Request (CR) 11755 that provides revised messaging (page 3 in the article). It also revised the Claims Processing Manual at Section 410.4.
• MLN Matters MM11755: https://www.cms.gov/files/document/MM11755.pdf

Update to the Model Admission Questions for Providers to Ask Medicare Beneficiaries

• Article Release Date: September 4, 2020 – Revised September 15, 2020
• What You Need to Know: This article provides information about CMS modifying and streamlining the model admission questions for providers to ask Medicare beneficiaries or authorized representatives upon admission or start of care.
• Note, this article was revised on September 15th to reflect the CR revision adding part of sentence that had been left out of manual Section 20.2.2 of the Medicare Secondary Payer Manual.
• MLN Matters MM11945: https://www.cms.gov/files/document/mm11945.pdf

October 2020 Update of the Ambulatory Surgical Center (ASC) Payment System

• Article Release Date: September 11, 2020 – Revised September 24, 2020
• What You Need to Know: This article is based on Change Request (CR) 11963 which provides information about changes to and billing instructions for various payment policies implemented in the October 2020 ASC payment system update.
• Note, this article was revised to reflect the updated CR revision to HCPCS code C9066 in Table 2 in the CR.
• MLN MM11963: https://www.cms.gov/files/document/mm11963.pdf

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

• Article Release Date: August 7, 2020 – Latest Revision September 24, 2020
• What You Need to Know: This article informs laboratories of changes from the quarterly update to the clinical laboratory fee schedule. Now in its third iteration, this article was most recently updated to add new COVID-19 code (86413) and ADLT code (0090U).
• MLN MM11937: https://www.cms.gov/files/document/mm11937.pdf

Change to the Payment of Allogeneic Stem Cell Acquisition Services

• Article Release Date: July 13, 2020 – Revised September 24, 2020
• What You Need to Know: This article was revised to reflect a revised CR issued on September 24, 2020. All other information remains the same.
• MLN MM11729: https://www.cms.gov/files/document/mm11729.pdf

October 2020 Update of the Hospital Outpatient Prospective Payment System (OPPS)

• Article Release Date: August 31, 2020 – Revised September 25, 2020
• What You Need to Know: This article has been revised to reflect an updated CR 11960 that made several changes including adding a new COVID-19 CPT code, 86413, to Table 1.
• MLN MM11960: https://www.cms.gov/files/document/mm11960.pdf

MEDICARE COVERAGE UPDATES

National Coverage Determination (NCD 90.2): Next Generation Sequencing (NGS) for Medicare Beneficiaries with Germline (Inherited) Cancer

• Article Release Date: September 15, 2020
• What You Need to Know: CMS “has determined that NGS, as a diagnostic laboratory test, is reasonable and necessary and covered nationally for patients with germline (inherited) cancer when performed in a CLIA-certified laboratory, when ordered by a treating physician, and when specific requirements are met.
• NCD Implementation Date: November 13, 2020
• NCD Effective Date: January 27, 2020
• MLN MM11837: https://www.cms.gov/files/document/mm11837.pdf

OTHER MEDICARE UPDATES

August 27, 2020: OIG Report – Medicare Contractors Were Not Consistent in How They Reviewed Extrapolated Overpayments in the Provider Appeals Process

• Link to Report: https://oig.hhs.gov/oas/reports/region5/51800024.pdf

Proposed Rule: Medicare Program; Modernizing and Clarifying the Physician Self-Referral Regulations Extension of Timeline for Publication of Final Rule

Link to notice in Federal Register: https://www.govinfo.gov/content/pkg/FR-2020-08-27/pdf/2020-18867.pdf

September 2, 2020: FY 2021 IPPS Final Rule released.

September 3, 2020: Medicare Preventive Services Tool and Poster Revised

CMS noted in their September 3rd edition of MLNConnects that the Medicare Preventive Services Medicare Learning Network Educational Tool and Poster have been revised. The tool is extremely useful to understand Coding, Coverage, and Copayment/coinsurance and deductible requirements for Preventative Services covered by Medicare.

• Link to Revised Tool: Medicare Preventive Services
• Link to Revised Poster: Medicare Preventive Services Poster

September 10, 2020: OIG Report: Billions in Estimated Medicare Advantage Payments from Diagnoses Reported Only on Health Risk Assessments Raise Concerns

The OIG performed this review due to concerns that Medicare Advantage Organizations may use Health Risk Assessments (HRAs) to inappropriately increase risk adjusted payments. The key takeaway highlighted in the Report Brief is that “billions in estimated risk-adjusted payments supported solely through HRAs raise concerns about the completeness of payment data, validity of diagnoses on HRAs, and quality of care coordination for beneficiaries.”

September 11, 2020: Community Health Access and Rural Transformation (CHART) Model CMS Fact Sheet

CMS announced the CHART Model in a Fact Sheet, indicating that “the approximately 57 million Americans living in rural communities, including millions of Medicare and Medicaid beneficiaries, face unique challenges when seeking health care services, such as limited transportation options, shortages of health care services, and an inability to fully benefit from technological and care-delivery innovations.” CMS goes on to highlight the following three items to be accomplished through this model:

• “Increase financial stability for rural health care providers through multiple new funding approaches, including the use of up-front investments and predictable, capitated payments that pay for quality and patient outcomes over volume;

• Provide the necessary operational and regulatory flexibilities to allow health care providers and CMS to test the Model in their local communities and successfully transform themselves; and
• Support local rural communities’ transformation efforts by being directly engaged at CMS, offering real-time technical expertise and other learning when needed to foster success.”

New Understanding Your Remittance Advice Reports MLN Booklet (MLN8788099)

CMS has published a new MLN Booklet providing information to:

• Help you learn which types of Remittance Advice (RA) are available,
• What information is included in an RA,
• How to view an RA, and
• Frequently Asked Questions.

Checking Medicare Eligibility MLN Booklet (MLN8816413 September 2020)

CMS advises providers, in this MLN Booklet, “to ensure you are billing appropriately for Medicare-covered supplies and services, check for eligibility. Regularly review your patients’ eligibility information.” This booklet provides guidance on who may be eligible for Medicare and how to check for eligibility.

September 15, 2020: New Roadmap for States to Accelerate Adoption of Value-Based Care (VBC) through Medicaid

CMS sent a letter to State Medicaid Directors on September 15, 2020 “to provide information on how states can advance value-based care (VBC) across the healthcare systems, with a particular emphasis on Medicaid populations, and to share pathways for adoption of such approaches with interested states.

CMS noted in a related Fact Sheet, that just as they have made a “strong commitment to advancing VBC in Medicare for its 61.7 million enrollees” guidance released on September 15, 2020 “is designed to ensure that this same commitment can be made at the state level through Medicaid with its nearly 74 million beneficiaries.”

September 18, 2020: CMS Announces New Model of Care for Medicare Beneficiaries with Chronic Kidney Disease

CMS has finalized the End-Stage Renal Disease (ESRD) Treatment Choices (ETC) Model, “to improve or maintain the quality of care and reduce Medicare expenditures for patients with chronic kidney disease” (CKD). CMS notes in a Press Release that the model is set to be implemented January 1, 2021, will impact approximately 30 percent of kidney care providers, and the estimated savings from the model is $23 million over five and half years.

September 18, 2020: CMS Announced Radiation Oncology Model

CMS has finalized the Radiation Oncology (RO) Model which is “expected to improve the quality of care for cancer patients receiving radiotherapy and reduce Medicare expenditures through bundled payments that allow providers to focus on delivering high-quality treatments.” CMS notes in a Press Release that the RO Model is set to begin January 1, 2021 and the estimated savings is $230 million over five years.

September 21, 2020: OIG Report (A-07-17-01176) Incorrect Acute Stroke Diagnosis Codes Increased Payments to Medicare Advantage Organizations

In this audit, the OIG focused on Medicare eligible patients who were covered under traditional Medicare one year and the following year chose a Medicare Advantage Plan. Data mining enabled them to identify several diagnosis codes at high risk of being miscoded. Specifically for this audit, the OIG focused on the acute stroke diagnosis codes reported on one physician’s claim without being reported on the corresponding inpatient claim. The objective being to determine if selected acute stroke codes submitted by physicians under traditional Medicare were later used by CMS to make payments to MA organizations complied with Federal Requirements. The OIG found that in 580 of 582 claims, the record did not support the acute stroke diagnosis codes. In turn, this meant the ischemic stroke codes used as HCC’s were not valid. CMS estimated just over $14.4 million inaccurate payments were made to MA Plans.

September 22, 2020: CMS Expands Ambulance Program Integrity Model Nationwide

CMS announced the expansion of the Medicare Prior Authorization Model for Repetitive, Scheduled Non-Emergent Ambulance Transport (RSNAT) nationwide. CMS notes in the Press Release that the model has saved Medicare $650 million over four years.

The initial model began for transports on or after December 15, 2014 and is scheduled to end in all model states on December 1, 2020, based on date of service. You can read more about this model in Special Edition MLN article SE1514. Information is also available on the Prior Authorization of Repetitive, Scheduled Non-Emergent Ambulance Transport CMS webpage.

September 24, 2020: Importation of Prescription Drugs FDA Final Rule

This Final Rule was issued “to implement a provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow importation of certain prescription drugs from Canada. Under this final rule, States and Indian Tribes, and in certain future circumstances pharmacists and wholesalers, may submit importation program proposals to the Food and Drug Administration (FDA, the Agency, or we) for review and authorization…The purpose of the final rule is to achieve a significant reduction in the cost of covered products to the American consumer while posing no additional risk to the public’s health and safety.”

• Final Rule 4164.01-P: https://www.hhs.gov/sites/default/files/importation-final-rule.pdf
• FDA News Release: https://www.fda.gov/news-events/press-announcements/fda-takes-actions-help-lower-us-prescription-drug-prices?utm_medium=email&utm_source=govdelivery

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 22nd through 30th.

Resource Spotlight: FDA Video – Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments

The FDA announced in their September 21, 2020 COVID-19 Daily Roundup the release of a new video, Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments, explaining “there are currently no FDA-approved drugs or vaccines to treat or prevent COVID-19. Products that fraudulently claim to cure, treat, diagnose, or prevent COVID-19 haven’t been evaluated by the FDA for safety and effectiveness for such use, and they might be dangerous to you and your family.”

September 22, 2020: Deaths in U.S. Tops 200,000

The American Hospital, American Medical Association and American Nurses Association released a joint statement marking this “somber milestone” and urging everyone to get their flu shot early.

September 23, 2020: $200 Million from Centers for Disease Control and Prevention (CDC) to Jurisdictions for COVID-19 Vaccine Preparedness

The Department of Health and Human Services (HHS) announced the CDC’s action of providing $200 million to 64 jurisdictions for COVID-19 vaccine preparedness to help states prepare for the COVID-19 vaccine.  “Notices of Awards will be issued on September 23, 2020, and all 64 jurisdictions will receive funding, with the amount each jurisdiction receives determined by a population-based formula.”

September 23, 2020: CMS Call to Action – Drastic Decline in Care for Children in Medicaid and CHIP due to COVID-19

CMS preliminary Medicaid and Children’s Health Insurance Program (CHIP) data analysis reveals that, during the COVID-19 public health emergency (PHE), rates for vaccinations, primary and preventative services have steeply declined. Specifically, compared to the same time period in 2019:

• 22% fewer (1.7 million) vaccinations received by beneficiaries up to age 2,
• 44% fewer (3.2 million) child screening services assessing physical and cognitive development, and
• 69% fewer (7.6 million) dental services.

CMS indicates in a Press Release that they are “releasing this preliminary data to raise awareness of the vital services Medicaid and CHIP provides, and calling on stakeholders to take action to make services more readily available so that we can begin closing the gap in care for children.”

September 23, 2020: FDA Authorizes First Point-of-Care Antibody Test for COVID-19

First authorized for emergency use by certain labs in July, the FDA reissued the Emergency Use Authorization (EUA) for the Assure COVID-19 IgG/IgM Rapid Test Device for Point of Care (POC) use using finger stick blood samples. FDA Commissioner Stephen M. Hahn, M.D. noted in the FDA

News Release that “Authorizing point-of-care serology tests will enable more timely and convenient results for individuals who want to understand if they have previously been infected with the virus that causes COVID-19.”

September 24, 2020: MLNConnects COVID-19 Resources

CMS announced in the September 24th MLNConnects newsletter that “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:  

• Maintaining Healthcare Safety During the COVID-19 Pandemic: Health care professionals share their experiences
• Critical Care Load-Balancing Operational Template and Considerations for Assessing Regional Patient Effects: Resources to help jurisdictions manage Coronavirus Disease 2019 (COVID-19) patient surge
• Behavioral Health Compendium: Grants; online resources and trainings; waivers and flexibilities; and data sources for regional emergency coordinators, federal, and state planners.”

September 25, 2020: New Tools to Streamline Certification for Labs Testing for COVID-19

CMS announced the release of new tools for labs seeking Clinical Laboratory Improvement Amendments (CLIA) certification to test for COVID-19. The announcement includes a link to a quick-start guide outlining the steps that must be followed to apply for and receive CLIA certification.

CDC COVID Data Tracker – United States COVID-19 Cases