Knowledge Base Category -

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

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

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

Welcome to this month’s MAC Talk article. This month before diving into updates from the MACs, I want to highlight Kepro’s  Fall 2020 Case Review Connections newsletter for acute care. The following items are included in this issue:

• Medical Director’s Corner with a focus on the Important Message from Medicare (IM),
• Appeals: Delivering the IM to a Representative,
• A link to KEPRO’s COVID-19 resource page,
• An Immediate Advocacy Success Story,
• FAQs related to the IM,
• Beneficiary Care Management Program, and
• Outreach: Focus on State Health Insurance Assistance Programs.

Note, the Post-acute Care Edition of Case Review Connections provides information about giving a Medicare beneficiary the Notice of Medicare Non-coverage (NOMNC).

 

September MAC Talk: The Local Scene

 

September 8, 2020: WPS GHA Medicare eNews: Prior Authorization for Hospital Outpatient Department Services Unique Tracking Number (UTN) Facts

WPS GHA published the following in their September 8th edition of their Medicare eNews:

“WPS assigns a UTN to each request submitted under the Prior Authorization for HOPD Services program. Providers should keep the following points in mind about the UTN:

• Part A HOPD providers shall include the UTN when submitting their claims for payment. Part B physicians do not need to include it on their claims.
• Once a Nurse Analyst renders a prior authorization decision, the UTN is valid for 120 days.
• The UTN is valid for one-time use.
• If the anticipated date of service changes but remains within the 120 days the UTN is valid, the provider does not need to seek a new UTN for that service.”

September 8, 2020: WPS GHA Medicare eNews: Prior Authorization for Hospital Outpatient Department Services Tips and Reminders

WPS GHA published the following information in their September 8th edition of their Medicare eNews:

“We continue to find errors and omissions on prior authorization requests. These errors and omissions may result in processing delays. Providers should note the following:

• Prior Authorization Request Form
• To be valid the prior authorization request must:
• Include the facility PTAN and NPI
• Include the correct Medicare Beneficiary Identifier (MBI)
• Include medical documentation for review
• Include an applicable CPT or HCPCS code
• Be legible
• To prevent processing delays due to rejections, we encourage providers to use our Prior Authorization (PA) Request Form

• Botulinum Toxin
• Prior authorization requests are only for injection CPT codes 64612 and 64615
• Prior authorization requests must include both the administration site and drug CPT codes
• Units of service for botulinum toxin injections should include the expected units of waste

• Vein Ablation
• Prior authorization requests should clearly identify which extremity and vein(s) the request is for

• Blepharoplasty
• Prior authorization requests should clearly identify which eye the request is for
• Photographs should include patient identifiers 

For additional information, see Prior Authorization for Hospital Outpatient Department Services (HOPD) Overview. Please select J5A or J8A to see the full article.”

September 8, 2020: Palmetto GBA – Medicare Advantage (MA) Plan Overpayments – Update

Palmetto noted on September 8th that CMS has extended the deadline for accepting the agency’s settlement offers to resolve the MA overpayments by several months. You will also find a link to FAQs on their MA Plans Overpayments Update web page. 

September 18, 2020: Kepro Joins YouTube

Kepro, announced their new BFCC-QIO YouTube channel aimed at providing education for providers and Medicare beneficiaries. Here are the first three videos available on their channel:

• Using Kepro's Medical Records Bar Code Fax Cover Sheet: This video talks about the importance of using this cover sheet when you fax medical records to Kepro.
• How to Fill Out and Deliver the Notice of Medicare Non-Coverage: This video will review this Centers for Medicare & Medicaid Services form, which is used for skilled service termination appeals. We will go over how the form must be delivered and how to fill it out.
• Medical Record Documentation for Medicare Hospital Discharge and Skilled Service Termination Appeals: This video will provide you with tips about documentation requirements to help ensure that medical records are complete and contain the appropriate level of documentation to ensure the appropriate appeal outcome.

Palmetto GBA JJ/JM Part A MACtoberfest October 20th and 21st Goes Virtual

Palmetto GBA has announced their first-ever virtual MACtoberfest® - “Shelter in Place. We are Coming to You.” The Palmetto team will be providing the latest information regarding the current state of Medicare. Note, you must sign up for each day separately. Following are just a few of the sessions being offered:

• Discharge Planning – Working with other Entities,
• The Latest COVID-19 News and Reminders,
• Hospital Outpatient Department (OPD) Prior Authorization, and
• Part A Medical Review – Signed, Sealed, and Documented.

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 15th through 22nd.

Resource Spotlight: Billing Guidance for Hospitalization without a Positive COVID-19 Test

CMS first released MLN SE20015 on April 15, 2020. This article was revised for the third time on September 11, 2020 to add guidance on how providers notify their MAC when there is no evidence of a positive laboratory test documented in the patient’s medical record.

As a reminder, for admissions on or after September 1, 2020 to be eligible for the 20 percent increase in the MS-DRG weighting factor there must be a positive COVID-19 laboratory test documented in the patient’s medical record. The following guidance was added to the September 11th update:

“To notify your MAC when there is no evidence of a positive laboratory test documented in the patient’s medical record, enter a Billing Note NTE02 “No Pos Test” on the electronic claim 837I or a remark “No Pos Test” on a paper claim.”

A word of caution, CMS also indicates in the MLN article that they may conduct post-payment medical review and if no documentation is in the medical record they will recoup the additional payment. In fact, in late August, the OIG added auditing whether payments made by Medicare for COVID-19 inpatient discharges billed by hospitals complied with Federal requirements to their Active Work Plan Items. 

September 15, 2020: Bipartisan COVID Relief Framework

The Problem Solvers Caucus (PSC), a group of 25 Democrats and 25 Republicans, released their "March to Common Ground" Bipartisan COVID Relief Framework. With an objective of inspiring negotiators to return to the table, this document addresses the following topics related to COVID-19 by indicating the problem and providing solutions:

• Testing and Healthcare,
• Support for individuals and Families,
• Unemployment Assistance,
• Small Business & Non-Profits,
• Schools and Child Care,
• State and Local Aid,
• Election Aid,
• Broadband, Agriculture, USPS, & Census; and
• Worker and Liability Protections.

 

September 16, 2020: Report from the Independent Coronavirus Commission for Safety and Quality in Nursing Homes (Commission)

CMS announced they had received the final report from the Commission. “To help CMS inform immediate and future actions as well as identify opportunities for improvement, the Commission was created to conduct an independent review and comprehensive assessments of confronting COVID-19. The Commission’s report contains best practices that emphasize and reinforce CMS strategies and initiatives to ensure nursing home residents are protected from COVID-19.”

September 16, 2020: COVID-19 Vaccine Distribution Strategy Released

HHS and the Department of Defense (DoD) announced the release of two documents “outlining the Trump Administration’s detailed strategy to deliver safe and effective COVID-19 vaccine doses to the American people as quickly and reliably as possible.” The Operation Warp Speed, “From the Factory to the Frontlines” document details requirements for vaccine distribution, administration, monitoring, and engagement with a nationwide network of partners. 

September 17, 2020: COVID-19 Lessons Learned & Infectious Disease Surge Annex Template

CMS indicated in the Thursday September 17 edition of MLNConnects that the Office of the Assistant Secretary for Preparedness and Response (ASPR) Technical Resources, Assistance Center, and Information Exchange (TRACIE) have released the following resources related to COVID-19 lessons learned as well as an infectious disease surge annex template:

• “The Exchange, Issue 11: COVID-19 Lessons Learned: Resources on managing patient surge, safety and staff health, operations, telehealth, and what’s next 

• Healthcare Coalition Infectious Disease Surge Annex Template: Voluntary template for developing a surge annex 
• Interim Guidance: SARS-CoV-2 (COVID-19) and Field Trauma Triage Principles: How COVID-19 impacts triage for first responders

For More Information: 

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

September 17, 2020: New Guidance for Safe Visitation in Nursing Homes During COVID-19 Public Health Emergency

CMS has issued revised guidance on ways for nursing homes to safely facilitate visitation during the ongoing COVID-19 pandemic. “CMS recognizes that physical separation from family and other loved ones has taken a significant toll on nursing home residents. In light of this, and in combination with increasingly available data to guide policy development, CMS is issuing revised guidance to help nursing homes facilitate visitation in both indoor and outdoor settings and in compassionate care situations.”

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 8th through the 15th.

Resource Spotlight: COVID-19 Public Reporting Tip Sheets

CMS has created COVID-19 public reporting tip sheets to explain the strategy for CMS quality data exempted from public reporting due to COVID-19 and the impact on Compare website refreshes. Tip Sheets are available for:

• Home health (PDF),
• Hospice (PDF),
• Inpatient Rehabilitation Facility (IRF (PDF)),
• Long-Term Care Hospital (LTCH (PDF)), and
• Skilled Nursing Facility (SNF (PDF)).

 

September 8, 2020: AMA Announces New COVID-19 Related CPT Codes

The American Medical Association (AMA) announced in a Press Release that they have published an update to the CPT® Code Set which “includes two code additions for reporting medical services sparked by the public health response to the COVID-19 pandemic.”

New Category I CPT codes and long descriptors

• CPT 99072: Additional supplies, materials, and clinical staff time over and above those usually included in an office visit or other non-facility service(s), when performed during a Public Health Emergency as defined by law, due to respiratory-transmitted infectious disease
• 86413: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) antibody, quantitative

The AMA notes that they have worked with “50 national medical societies and other organizations” to compile data regarding the costs involved in maintaining a safe medical office during the public health emergency and have provided this information to CMS “to inform payment of code 99072.”

Both codes are effective immediately. In addition to the Press Release you can find additional information about the two new codes, including a clinical example in a CPT® Assistance Special Edition: September Update.  

 

September 9, 2020: Expanding Access to COVID-19 Vaccines

The U.S. Department of Health and Human Services issued a Press Release highlighting the issuance of guidance under the Public Readiness and Emergency Preparedness Act (PREP Act) to expand access to safe and effective COVID-19 vaccines. “This guidance authorizes state-licensed pharmacists to order and administer, and state-licensed or registered pharmacy interns acting under the supervision of the qualified pharmacist to administer, COVID-19 vaccinations to persons ages 3 or older, subject to certain requirements.”

 

September 17 CDC Call: Testing and Treatment of 2020-2021 Seasonal Influenza During the COVID-19 Pandemic

The CDC is hosting a Clinician Outreach and Communication Activity (COCA) Call on Thursday, September 17th from 2:00 pm – 3:00 pm (ET). In the announcement, the CDC indicated the following four objectives that participants will be able to accomplish at the conclusion of the call:

• Review influenza activity since the onset of the COVID-19 pandemic.

1. Provide background on influenza tests and antivirals for influenza.
2. Describe influenza testing guidance for patients with acute respiratory illness for the 2020-2021 season, including during community co-circulation of influenza viruses and SARS-CoV-2.
3. Describe antiviral treatment recommendations for patients with suspected or confirmed influenza for the 2020-2021 season, including during community co-circulation of influenza viruses and SARS-CoV-2.

Additional information about the call and how to join in the session can be found on the CDC website at https://emergency.cdc.gov/coca/calls/2020/callinfo_091720.asp?deliveryName=USCDC_1052-DM37672.

 

September 8, 2020: CDC COVID Data Tracker – United States COVID-19 Cases

• Total Cases: 6,287,362,
• Total Deaths: 188,688
• Deaths per 100,000 people: 57
• Cases in last 7 days: 282, 919
  

September 14, 2020: CDC COVID Data Tracker – United States COVID-19 Cases

• Total Cases: 6,503,030
• Total Deaths: 193,705
• Deaths per 100,000 people: 59
• Cases in last 7 days: 241,814

Link to CDC COVID Data Tracker: https://covid.cdc.gov/covid-data-tracker/?deliveryName=USCDC_2067-DM37553#cases

In a September 3, 2020 Press Release, CMS announced the launch of a new website call Care Compare. “Care Compare provides a single user-friendly interface that patients and caregivers can use to make informed decisions about healthcare based on cost, quality of care, volume of services, and other data. With just one click, patients can find information that is easy to understand about doctors, hospitals, nursing homes, and other health care services instead of searching through multiple tools.”

Care Compare Features:

• One click to find information about doctors, hospitals, nurses, nursing homes, home health service, hospice care, inpatient rehabilitation facilities, long-term care hospitals and dialysis facilities,
• Tool is optimized for mobile and tablet use,
• Updated maps,
• New filters to help you identify the providers right for you, and
• “Consistent design that makes it easier to compare providers and find the information that’s most important to you.”

CMS Administrator Seema Verma noted in the Press Release that “By aggregating all eight of CMS’ quality tools into a single interface, patients can easily research different providers and facilities before they entrust themselves to their care. Today’s launch of Care Compare is the next step in fulfilling our eMedicare promise. Our Administration is committed to ensuring our tools are robust and beneficial to patients.”

While CMS gathers feedback and considers additional improvements to the tool, you will still be able to use the original eight compare tools.

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 1st through the 8th.

 

Resource Spotlight: Travel during the COVID-19 Pandemic

The CDC’s Travel during the COVID-19 Pandemic webpage provides information about:

• Reasons you should not travel,
• Considerations prior to travel,
• What to do if you do travel,
• Considerations for types of travel (i.e., air, bus, care, RV),
• Tips to avoid getting and spreading COVID-19 in common travel situations (i.e., bathrooms and rest stops),
• Anticipating your travel needs, and
• What to do after you have traveled.

 

September 1, 2020: Provider Relief for Assisted Living Facilities (ALFs)

HHS announced that ALFs may now apply for funding under the Provider Relief Fund Phase 2 General Distribution allocation. This funding was made possible through the CARES Act and the Paycheck Protection Program and Healthcare Enforcement Act.

 

September 3, 2020: $2 Billion Provider Relief Fund Nursing Home Incentive Payment Plans

HHS announced “details of a $2 billion Provider Relief Fund (PRF) performance-based incentive payment distribution to nursing homes. This distribution is the latest update in the previously announced $5 billion in planned support to nursing homes grappling with the impact of COVID-19. Last week, HHS announced it had delivered an additional $2.5 billion in payments to nursing homes to help with upfront COVID-19-related expenses for testing, staffing, and personal protective equipment (PPE) needs. Other resources are also being dedicated to support training, mentorship and safety improvements in nursing homes.”

The Press Release provides details regarding:

• Qualifications to participate in the Program,
• The performance and payment cycle, and
• Methodology to measure a facilities performance. Specifically, nursing homes will have their performance measured on their ability to keep new COVID infection rates low among residents and ability to keep COVID mortality low among residents.

 

September 3, 2020: Reported Cases of Multisystem Inflammatory Syndrome in Children (MIS-C) in the United States

The CDC has been tracking reports of MIS-C since mid-May 2020. According to the CDC, this is “a rare but serious condition associated with COVID-19. MIS-C is a new syndrome, and many questions remain about why some children develop it after a COVID-19 illness or contact with someone with COVID-19, while others do not.”

 

MIS-C Cases as of September 3, 2020:

• 792 confirmed cases and 16 deaths in 42 states,
• Most cases are in children between 1 and 14 years old with an average age of 8,
• More than 70% of reported cases have occurred in children who are Hispanic/Latino (276 cases) or Non-Hispanic Black (230 cases),
• 99% of cases (783) tested positive for COVID-19 while the remaining 1% were around someone with COVID-19,
• Most children developed MIS-C 2-4 weeks after COVID-19 infection, and
• 54% of reported cases have been male.

The CDC MIS-C webpage provides additional information about the disease, what they are doing, and information for healthcare professionals.

 

September 8, 2020: CDC COVID Data Tracker – United States COVID-19 Cases

• Total Cases: 6,287,362,
• Total Deaths: 188,688
• Deaths per 100,000 people: 57
• Cases in last 7 days: 282, 919
• Link to CDC COVID Data Tracker: https://covid.cdc.gov/covid-data-tracker/?deliveryName=USCDC_2067-DM37553#cases

CMS released the display copy of the Fiscal Year (FY) 2021 Inpatient Prospective Payment System (IPPS) Final Rule last Wednesday September 2, 2020. As of the release of this article, you have twenty-one days to read and absorb the information as you prepare for the October 1, 2020 start of the 2021 CMS FY.  

At least annually, MS-DRG classifications and relative weights are adjusted to reflect changes in treatment patterns, technology, and other factors that may change the relative use of hospital resources. This week highlights finalized changes to specific MS-DRG Classifications.

 

Pre-MDC: Bone Marrow Transplants

Surgical vs. Medical MS-DRGs

Currently, the Bone Marrow Transplant (BMT) MS-DRGs (MS-DRG 014 (Allogeneic Bone Marrow Transplant), MS-DRG 016 (Autologous Bone Marrow Transplant with CC/MCC or T-Cell Immunotherapy), and MS-DRG 017 (Autologous Bone Marrow Transplant without CC/MCC) are designated as surgical MS-DRGs.

In the proposed rule, a request was made to re-designate these three MS-DRGs as medical MS-DRGs as a Bone Marrow Transplant does not involve a surgical procedure or require the use of an O.R. The requestor noted that this change “would clinically align with the resources utilized in the performance of these procedures.”

Clinical advisors agreed and CMS finalized their proposal to re-designate MS-DRGs 014, 016, and 017 as medical MS-DRGs effective October 1, 2020.

BMT Procedures Designation O.R. vs. Non-O.R.

The requestor also noted that MS-DRGs 016 and 017 includes ICD-10-PCS procedures codes designated as Non-O.R. while the following eight procedures are designated as O.R. Procedures:

• 30230AZ: Transfusion of embryonic stem cells into peripheral vein, open approach
• 30230G0: Transfusion of autologous bone marrow into peripheral vein, open approach
• 30230X0: Transfusion of autologous cord blood stem cells into peripheral vein, open approach
• 30230Y0: Transfusion of autologous hematopoietic stem cells into peripheral vein, open approach
• 30240AZ: Transfusion of embryonic stem cells into central vein, open approach
• 30240G0: Transfusion of autologous bone marrow into central vein, open approach
• 30240X0: Transfusion of autologous cord blood stem cells into central vein, open approach
• 30240Y0: Transfusion of autologous hematopoietic stem cells into central vein, open approach.

CMS finalized the re-designation of these codes from O.R. to Non-O.R. procedures affecting their current MS-DRG assignment.  

Chimeric Antigen Receptor (CAR) T-Cell Therapies: New MS-DRG

In the FY 2020 IPPS Proposed Rule, a request was made to create new MS-DRGs for CAR T-cell therapy. The requestor noted this would improve payment in the inpatient setting. CMS did not believe enough data was available to make a change at that time. However, CMS did seek comments on payment alternatives for CAR-T cell therapies.

In the FY 2020 Final Rule CMS finalized the continuation of the new technology status and add-on payments for FY 2020 for this therapy.

In the FY 2021 proposed rule, the request was again made to create a new MS-DRG as this therapy will no longer be eligible for the new technology add-on payment (NTAP) for FY 2021. CMS responded by noting they now have enough data to consider the development of a new MS-DRG. Further, CMS clinical advisors found a vast discrepancy in resource consumption and clinical differences warranting the creation of new MS-DRG.

In the Final Rule, CMS finalized their proposal to:  

• Assign cases reporting ICD-10-PCS procedure codes XW033C3 or XW043C3 to a new MS-DRG 018 (Chimeric Antigen Receptor (CAR) T-cell immunotherapy, and
• Revise the MS-DRG 016 title to “Autologous Bone Marrow Transplant with CC/MCC.”

The following table highlights the MS-DRG relative weight (RW) and geometric mean length of stay (GMLOS) for the BMT MS-DRGs and the new CAR T-Cell MS-DRG:

‍MDC 1: Diseases and Disorders of the Nervous System

Carotid Artery Stent Procedures: Background

In FY 2020 CMS finalized their proposal to reassign 96 ICD-10-PCS procedures describing dilation of carotid artery with an intraluminal device(s):

• From MS-DRGs 037, 038, and 039 (Extracranial Procedures with MCC, with CC, and without CC/MCC respectively)
• To MS-DRGs 034, 035, and 036 (Carotid Artery Stent Procedures with MCC, with CC, and without CC/MCC respectively)

Carotid Artery Stent Procedures: FY 2021 Proposals

In response to a request, CMS proposed to reassign the following six ICD-10-PCS codes describing dilation of carotid artery with drug eluting intraluminal device(s) using an open approach from MS-DRGs 037, 038, and 039 to MS-DRGs 034, 035, and 036:

• 037H04Z: Dilation of right common carotid artery with drug-eluting intraluminal device, open approach
• 037J04Z: Dilation of left common carotid artery with drug-eluting intraluminal device, open approach
• 037K04Z: Dilation of right internal carotid artery with drug-eluting intraluminal device, open approach
• 037L04Z: Dilation of left internal carotid artery with drug-eluting intraluminal device, open approach
• 037M04Z: Dilation of right external carotid artery with drug-eluting intraluminal device, open approach
• 037N04Z: Dilation of left external carotid artery with drug-eluting intraluminal device, open approach

CMS further reviewed to see if any of the six codes were included in MS-DRGs outside of MDC 1. They found a total of 36 ICD-10 PCS codes for procedures describing dilation of the carotid artery with an intraluminal device with an open approach that are currently assigned to MS-DRG 252 (Other Vascular Procedures with MCC) in MDC 5 (Diseases and Disorders of the Circulatory System). Interestingly, they found 8 claims with one of these 36 ICD-10-PCS codes and a Principal Diagnosis in MDC 1 causing the claims to group to the Extensive O.R. Procedure Unrelated to Principal Diagnosis MS-DRG Group (981, 982, and 983).

CMS finalized the proposal to add the 6 codes as requested and the additional 36 ICD-10-PCS codes they identified as currently being in MDC 5 to the GROUPER logic for MS-DRGs 034, 035, 036 in MDC 1.

As an instructor told me when first learning about the MS-DRG system, this change permits cases with a Principal Diagnosis in MDC 1 to “remain in the family.”

 

MDC 3: Diseases and Disorders of Ear, Nose, and Throat

Temporomandibular Joint Replacements

A request was made to reassign ICD-10-PCS procedures 0RRC0JZ (Replacement of right temporomandibular joint with synthetic substitute, open approach), and 0RRD0JZ (Replacement of left temporomandibular joint with synthetic substitute, open approach):

• From MS-DRGs 133 and 134 (Other Ear, Nose, Mouth and Throat O.R. Procedures with and without CC/MCC, respectively)
• To MS-DRGs 131 and 132 (Cranial and Facial Procedures with and without CC/MCC, respectively) in MDC 03.

The requestor stated that it is inaccurate for these two codes that involve the excision of the TMJ and replacement with a prosthesis to Group to MS-DRGs 133 and 134 when the codes for the TMJ excision alone (0RBC0ZZ (Excision of right temporomandibular joint, open approach) and 0RBD0ZZ (Excision of left temporomandibular joint, open approach) group to the higher weighted MS-DRGs 131 and 132.

CMS undertook a comprehensive review of all procedures currently assigned to MS-DRGs 129, 130, 131, 132, 133, and 134. Based on data analysis and this comprehensive review, CMS Clinical Advisors supported restructuring of these MS-DRGs by assigning procedures based on clinical intensity, complexity of service and resource utilization.

CMS finalized their proposals to:  

• Delete the three MS-DRGs groups with a two-way severity level subgroup (129 & 130, 131 & 132, and 133 & 134)
• Create two new base MS-DRGs with a three-way severity level split:
• MS-DRGs 140, 141, and 142 (Major head and Neck Procedures with MCC, with CC, without CC/MCC respectively), and
• MS-DRGs 143, 144, and 145 (Other Ear, Nose, Mouth, and Throat O.R. Procedures with MCC, with CC, without CC/MCC respectively).

Note, CMS refers readers to Tables 6P.2a, 6P.2b, and 6P.2.c associated with the final rule for the finalized list of procedure codes that define the logic for the finalized MS-DRGs.

 

MDC 5: Diseases and Disorders of the Circulatory System

Left Atrial Appendage Closure (LAAC)

Requests were made to create a new MS-DRG for the LAAC procedure or to map all LAAC procedures to a different MS-DRG with payment rates aligned with procedural costs.  The following table details the current corresponding MS-DRGs for the 9 ICD-10-PCS codes describing LAAC Procedures. Note that currently the procedure map to an MS-DRG based on the approach.

CMS finalized their proposal to reassign the ICD-10-PCS procedure codes for an open approach to MS-DRGs 273 and 274. “Clinical advisors stated this reassignment would allow all LAAC procedures to be grouped to the same MS-DRGs and improve clinical coherence.” The following table highlights the difference in R.W. and GMLOS for FY 2021 for the four MS-DRGs as well the MS-DRG title changes for MS-DRGs 273 and 274:

‍Insertion of Cardiac Contractility Modulation Device

A request was made to review the MS-DRG assignment for cases identifying patients receiving a cardiac contractility modulation (CCM) device system for CHF. “CCM is indicated for patients with moderate to severe heart failure resulting from either ischemic or non-ischemic cardiomyopathy. CCM utilizes electrical signals which are intended to enhance the strength of the heart and overall cardiac performance. CCM delivery device systems consist of a programmable implantable pulse generator (IPG) and three leads which are implanted in the heart. One lead is implanted into the right atrium and the other two leads are inserted into the right ventricle.”

Reasons for this request:

• MS-DRGs 222, 223, 224, 225, 226, and 227 (Cardiac Defibrillator Implant with and without Cardiac Catheterization with and without AMI/HF/Shock with and without MCC, respectively include “code pairs” describing the insertion of contractility modulation devices.
• Currently, GROUPER logic requires the combination of the CCM device codes and a left ventricular lead to map to this group of MS-DRGs.
• Per the requestor, a CCM device is contraindicated in patients with a left ventricular lead. Consequently, no case involving insertion of the CCM system can be appropriately mapped to this group of MS-DRGs.
• Currently, CCM system insertion maps to MS-DRG 245 (AICD Generator Procedures).
• Requester noted to date this procedure has been performed on an outpatient bases but expects that some Medicare patients will receive CCM devices as an inpatient.

CMS analysis found that the ICD-10-PCS procedure code combinations for right ventricular and/or right atrial lead insertion with insertion of CCM devices were inadvertently excluded from this group of MS-DRGs as a result of replicating the ICD-9 based MS-DRGs.

CMS has finalized the following two proposals:

• Add 24 ICD-10-PCS code combinations for CCM devices to this group of MS-DRGs, and
• Delete 12 clinically invalid code combinations from the GROUPER logic of this MS-DRG group describing the insertion of CCM device and the insertion of a cardiac lead into the left ventricle.

 

MDC 8: Diseases and Disorders of the Musculoskeletal System and Connective Tissue

Hip and Knee Joint Replacements

A requestor recommended restructuring MS-DRGs for total joint arthroplasty that utilize oxidized zirconium bearing surface implants in total hip and total knee replacements. They went on to offer three options for restructuring the MS-DRGs.

Based on the request and lengthy data analysis by CMS, CMS proposed and has finalized two new MS-DRGs for hip replacements due to a hip fracture.  The following table highlights the difference in R.W. and GMLOS for FY 2021:

‍Impact on the Comprehensive Care for Joint Replacement (CJR) Model

In the proposed rule CMS acknowledged that the CJR model includes episodes triggered by MS-DRG 469 with hip fracture and MS-DRG 470 with hip fracture. Given the proposal for new MS-DRGs for hip fracture, CMS requested comments on the effect this proposal would have on the CJR model and whether to incorporate the new MS-DRGs into the model if finalized.

CMS notes in the Final Rule that “an interim final rule published in April 6, 2020 extended the CJR model through March 31, 2021, in light of the COVID-19 pandemic, to ensure the continuity of the CJR model operations in participant hospitals during the public health emergency so that we did not create any additional disruptions to the standard of care procedures hospitals have in place during this challenging time. Because the model will continue until at least March 31, 2021, we intend to adopt a policy in the CJR final rule that incorporates MS-DRG 521 and MS-DRG 522 into the CJR model as of the effective date of these new MS-DRGs. We believe such an approach would avoid disruption to the model for the remainder of PY5 (as extended) and thereafter, if our proposal to extend the CJR model to December 31, 2023 is finalized.”

 

MDC 11: Diseases and Disorders of the Kidney and Urinary Tract

Kidney Transplants

Currently, Kidney Transplants group to MS-DRG 652 (Kidney Transplant) in MDC 11. There was a request to re-designate kidney transplants as Pre-MDC MS-DRGs similar to other organ transplants. CMS analysis found that all kidney transplants in MS-DRGs 981 and 982 reported a principal diagnosis in MDC 5 (Diseases and Disorders of the Circulatory System).

Instead of proposing a move to a Pre-MDC MS-DRG, CMS proposed and has now finalized an alternate option “to modify the GROUPER logic for MS-DRG 652 by allowing the presence of a procedure code describing transplantation of the kidney to determine the MS-DRG assignment independent of the MDC of the principal diagnosis in most instances.”

Of note, CMS discussed in the proposed rule how the Pre-MDCs came into existence and that the proposal for kidney transplant procedure code to determine the MS-DRG assignment represent a “first step in investigating” how they may consider shifting transplants out of Pre-MDCs as their clinical advisors have noted that while once considered as being very resource intensive, “treatment practices have shifted since the inception of Pre-MDCs.”

Kidney Transplants and Dialysis during an Inpatient Stay

An additional request was made to create a new MS-DRG for kidney transplant cases where a patient receives dialysis during the inpatient stay and after the date of the transplant. The following three ICD-10-PCS procedure codes identify the performance of hemodialysis:

• 5A1D70Z: Performance of urinary filtration, intermittent, less than 6 hours per day
• 5A1D80Z: Performance of urinary filtration, prolonged intermittent, 6-18 hours per day
• 5A1D90Z: Performance of urinary filtration, continuous, greater than 18 hours per day

CMS indicated in the proposed rule that they believe that creating separate MS-DRGs when hemodialysis is performed either before or after a kidney transplant or simultaneous pancreas/kidney transplant “would appropriately address the differential in resource consumption consistent with the President’s Executive Order on Advancing American Kidney Health (see https://www.whitehouse.gov/presidential-actions/executive-order-advancing-american-kidney-health/).”

CMS has finalized the proposed three new MS-DRGs:

• Pre-MDC MS-DRG 019 (Simultaneous Pancreas/Kidney Transplant with Hemodialysis) for cases describing the performance of hemodialysis during an admission where the patient received a simultaneous pancreas/kidney transplant, and
• MS-DRGs 650 and 651 (Kidney Transplant with Hemodialysis with MCC and without MCC respectively) for cases describing the performance of hemodialysis in an admission where the patient received a kidney transplant in MDC 11.

As part of the logic for the new MS-DRGs, CMS finalized their proposal to change the designation of the above hemodialysis codes from non-O.R. procedures to non-O.R. procedures affecting the MS-DRG.

 

MDC 17: Myeloproliferative Diseases and Disorders, Poorly Differentiated Neoplasms

Inferior Vena Cava Filters

A requestor noted that currently when the procedure code describing the placement of an inferior vena cava (IVC) filter (06H03DZ – Insertion of intraluminal device into inferior vena cava, percutaneous approach) is also reported with the codes describing the introduction of a high dose chemotherapy agent or report a chemotherapy principal diagnosis with a secondary diagnosis describing acute leukemia, the cases are assigned to a lower weighted MS-DRG group than when the IVC filter code is not on the claim.

CMS noted in the proposed rule that “our clinical advisors believe that, given the similarity in factors such as complexity, resource utilization, and lack of a requirement for anesthesia administration between all procedures describing insertion of a device into the inferior vena cava, it would be more appropriate to designate these three ICD-10-PCS codes describing the insertion of an intraluminal device into the inferior vena cava as Non-O.R. procedures. Therefore, we are proposing to remove ICD-10-PCS procedure codes 06H00DZ, 06H03DZ, and 06H04DZ from the FY 2021 ICD-10 MS-DRG Version 38 Definitions Manual in Appendix E--Operating Room Procedures and Procedure Code/MS-DRG Index as O.R. procedures. Under this proposal, these procedures would no longer impact MS-DRG assignment.”

In the Final Rule, CMS clinical advisors concurred with commenters “that while the procedure to insert an IVC filter is not surgical in nature, procedures describing the insertion of an intraluminal device into the inferior vena cava performed via an open or percutaneous endoscopic approach could require greater resources than a procedure describing insertion of an intraluminal device into the inferior vena cave performed via a percutaneous approach.”

For this reason, CMS has indicated they will further examine relevant clinical factors and similarities in resource consumption between procedures describing the insertion of an intraluminal device into the inferior vena cava performed via an open or a percutaneous endoscopic approach.”

CMS finalized the following proposals for FY 2021: 

• ICD-10-PCD procedure code 06H03DZ designation is changing from O.R. to non-O.R. procedure, and
• For now, ICD-10-PCS procedures codes 06H00DX and 06H04DZ will maintain the O.R. designation and continue to impact MS-DRG assignment.

 

Moving Forward

The FY 2021 IPPS Final Rule is scheduled to be published in the Federal Register on September 18, 2020. Until then, you can access the display copy available on the FY 2021 IPPS Final Rule Home Page and watch for additional articles in the Wednesday@One.

 

Resources:

FY 2021 IPPS Final Rule Home Page on CMS website: https://www.cms.gov/medicare/acute-inpatient-pps/fy-2021-ipps-final-rule-home-page#1735

CMS Fact Sheet: Fiscal Year (FY) 2021 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Acute Care Hospital (LTCH) Final Rule (CMS-1735-F): https://www.cms.gov/newsroom/fact-sheets/fiscal-year-fy-2021-medicare-hospital-inpatient-prospective-payment-system-ipps-and-long-term-acute-0