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 that span from April 23rd through April 30th.  

Coronavirus.gov Website

This week’s COVID-19 resource spotlight is the Coronavirus.gov website at

https://www.coronavirus.gov/. Specifically, there are two resources available on this website that I want to point out. First is the COVID-19 Screening Tool.  This tool can help you understand what to do next about COVID-19. Second, is the State Information where you can choose a state to see COVID-19 specific guidance from that state’s health department. Both of these resources can be found by clicking “Check for Symptoms” on the homepage.  

April 23, 2020: COVID-19 FAQs on Medicare Fee-for-Service (FFS) Billing – Updated

On April 9, 2020 CMS announced in Special Edition MLN Connects that the COVID-19 FAQs have been updated. They advise that you check this resource often as it is updated on a regular basis. They noted that a date is added at the end of an FAQ when it is new or the content has been updated. As of Thursday April 23th this document is now 41 pages. The following list highlights the newest FAQ topics in the document:

• Payment for specimen collection for purposed of COVID-19 testing,
• Diagnostic laboratory services,
• Hospital services,
• Ambulance services,
• Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs),
• NEW: Expansion of Virtual Communication Services for FQHCs/RHCs,
• NEW: Revision of the Home Health Agency Shortage Area Requirement for Visiting Nursing Services Furnished by RHCs and FQHCs,
• Medicare telehealth. (CMS notes this document does not include flexibilities that might be exercised under the CARES Act),
• Physician Services
• Home Infusion Services,
• Accountable Care Organizations (ACO),
• Opioid Treatment Programs,
• Inpatient Rehabilitation Facility services,
• Skilled Nursing Facility services,
• General billing requirements,
• Home Health,
• Drugs and Vaccines under Part B,
• NEW: National Coverage Determinations (NCD),
• Medicare payment to facilities accepting government resources,
• Oxygen,
• NEW: Temporary Department of Defense Sites, and
• NEW: Military Treatment Facilities (MTFs).

April 24, 2020: Alabama Medicaid Alert

Alabama Medicaid indicated in a Provider Alert that all previously published expiration dates related to the COVID-19 emergency are being extended with a new expiration date of May 30, 2020 or at the conclusion of the COVID-19 National emergency, whichever occurs first.

Also included in this Alert is the reminder that “during the COVID-19 emergency, it is important to file claims as quickly as possible to ensure payment from Medicaid is made to Medicaid providers close to the date of service. The Centers for Medicare and Medicaid Services has increased the federal matching percentage for the emergency time frame, but states can only receive the increased match on claims that are paid during the emergency. Providers should include appropriate COVID-19 diagnosis code(s) on claims submitted to help with tracking of COVID-19.”

You can view a listing of prior Provider Alerts and all actions in response to the COVID-19 National emergency on the Agency’s COVID-19 at: https://medicaid.alabama.gov/news_detail.aspx?ID=13729

April 27, 2020: HHS Launches COVID-19 Uninsured Program Portal

In an April 27th media release, the U.S. Department of Health and Human Services (HHS) announced that they have “launched a NEW COVID-19 Uninsured Program Portal, allowing health care providers who have conducted COVID-19 testing or provided treatment for uninsured COVID-19 individuals on or after February 4, 2020 to submit claims for reimbursement.”

About the Program

• Where to Access the Portal
• HHS’ Health Resources and Services Administration (HRSA) COVID-19 Claims Reimbursement to Health Care Providers and Facilities Testing and Treatment of the Uninsured webpage at: https://www.hrsa.gov/coviduninsuredclaim
• HHS’ HRSA has contracted with UnitedHealth Group to administer this program.
• Approximately $1 billion is available to reimburse providers. This money was appropriate through the Families First Coronavirus Response Act.
• Program Timeline:
• April 22: Program Details Launch
• April 27: Sign up period begins for the program
• April 29: On Demand training starts
• May 6: Begin submitting claims electronically
• Mid-May: Begin receiving reimbursement
• Services Eligible for reimbursement:
• Specimen collection, diagnostic and antibody testing.
• Testing-related visits including in the following settings: office, urgent care or emergency room or via telehealth.
• Treatment, including office visit (including via telehealth), emergency room, inpatient, outpatient/observation, skilled nursing facility, long-term acute care (LTAC), acute inpatient rehab, home health, DME (e.g., oxygen, ventilator), emergency ground ambulance transportation, non-emergent patient transfers via ground ambulance, and FDA-approved drugs as they become available for COVID-19 treatment and administered as part of an inpatient stay.
• FDA-approved vaccine, when available.
• For inpatient claims, date of admittance must be on or after February 4, 2020.
• How to learn more:
• HRSA has indicated the Program website will be updated with much more information starting April 27 and to check back often.

April 27, 2020: MLN Matters MM11765: Addition of the QW Modifier to HCPCS Code U0002 and 87635

Provider Types affected by information in MLN MM11765 are facilities with a current Clinical Laboratory Improvement Amendments (CLIA) certificate of waiver. Specifically, the article advised the need for the addition of the QW modifier to:

• HCPCS code U0002 (2019-nCoV Coronavirus, SARS-CoV-2/2019-nCoV (COVID-19), any technique, multiple types or subtypes (includes all targets), non-CDC), and
• 87635 [Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease {COVID-19}, amplified probe technique.]

Medicare will permit the use of Codes U0002QW and 87635QW for claims submitted by facilities with a valid, current CLIA certificate of waiver with dates of service on or after March 20, 2020. The official instruction, CR 11765, issued to your MAC regarding this change is available at https://www.cms.gov/files/document/r10066OTN.pdf.

April, 28 2020: AHA and AHIMA FAQs Regarding ICD-10-CM Coding for COVID-19 Revised

The American Hospital Association and American Health Information Management Association released this joint FAQs regarding ICD-10-CM Coding for COVID-19 document on March 24, 2020. Since then several FAQs have been added with the most recent additions being on April 28, 2020.

MMP encourages you to visit the AHA COVID-19 FAQ webpage often for new information that can be downloaded and shared with your Coders and Clinical Documentation Integrity (CDI) Specialists.

April 28, 2020: Alabama Hospitals allowed to Resume Medical Procedures

Alabama’s Safer At Home Order signed on April 28, 2020 amended the Order of the State Health Officer Suspending Certain Public Gathering Due to the Risk of Infection by COVID-19 document. This is good news for Alabama hospitals as the following information for hospitals regarding resuming medical procedures was included in the amended document:

“Medical procedures. Effective April 30, 2020, at 5:00 P.M., dental, medical, or surgical procedures may proceed unless the State Health Officer or his designee determines that performing such procedures, or any category of them (whether statewide or regionally), would unacceptably reduce access to personal protective equipment or other resources necessary to diagnose and treat COVID-19. Providers performing these procedures shall follow all applicable COVID-19-related rules adopted by a state regulatory board or by the Alabama Department of Public Health. In the absence of such rules, providers should take reasonable steps to comply with applicable COVID-19-related guidelines from the Centers for Medicare and Medicaid Services (CMS) and the CDC, including “Re-opening Facilities to Provide Non-emergent Non-COVID-19 Healthcare: Phase I” from CMS, available at https://www.cms.gov/files/document/covid-flexibility-reopen-essential-non-covid-services.pdf, and “Infection Control Guidance for Healthcare Professionals about Coronavirus (COVID-19)” from the CDC, available at https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control.html.”

April 28, 2020: CMS Issues Letter to Clinicians Regarding New COVID-19 Clinical Trials Improvement Activity to the MIPS

In a letter thanking clinicians for their efforts to treat patients and combat COVID-19, CMS provided additional details on the new Merit-Based Incentive Payment System (MIPS) improvement activity.

Letter (PDF)

April 29, 2020: First Coast eNews: COVID-19: Allowances for Lab Test Codes U0001-U0004 and 87635

In this announcement, First Coast reminds providers that CMS established new codes for lab tests for the novel coronavirus (COVID-19). Further, CMS provided pricing for codes U0001 and U0002, and instructed MACs to develop the allowance for the remaining codes. The following table highlights the Allowance for each code:

‍April 29, 2020: The HHS Office of Civil Rights (OCR) Webinar on HIPAA Privacy and Security Issues Related to COVID-19

In an April 29th announcement the OCR indicated they had hosted a webinar on April 24, 2020, for health IT stakeholders on HIPAA privacy and security issues related to COVID-19 and recent OCR actions related to the pandemic. The following topics were included in this webinar:

• COVID-19 and Permissible Disclosures under the HIPAA Privacy Rule
• Enforcement Discretion and Guidance for Telehealth Remote Communications
• Guidance for Disclosures to First Responders and Public Health Authorities
• Enforcement Discretion for Business Associates to Use and Disclose PHI for Public Health and Health Oversight Activities
• Enforcement Discretion for Community-Based Testing Sites

A recording of this webinar is now available on YouTube: https://youtu.be/2C6iOdS_FR0. 

The slides from this presentation may be viewed at:  https://go.usa.gov/xvExS. 

For more information related to HIPAA and COVID-19, visit the HIPAA, Civil Rights, and COVID-19 webpage.

April 30, 2020: Second Round Sweeping Changes to Support U.S. Healthcare System During COVID-19 Pandemic

In an April 30th Press Release the CMS announced “another round of sweeping regulatory waivers and rule changes to deliver expanded care to the nation’s seniors and provide flexibility to the healthcare system as America reopens.” The CMS indicates “today’s actions are informed by requests from healthcare providers as well as by the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act.”  Included in the Press Release is the reminder that you do need to apply for the blanket waivers and providers and states can begin using the flexibilities immediately. Following are a few of the actions being taken:   

COVID-19 Diagnostic Testing for Medicare and Medicaid Beneficiaries:

• During the Public Health Emergency, COVID-19 test may be covered when ordered by any healthcare professional authorized to do so under state law. To provide broad access to testing related to COVID-19, a written practitioner’s order is no longer required for the COVID-19 test for Medicare payment purposes.
• CMS will pay hospitals and practitioners to assess beneficiaries and collect lab samples for COVID-19 testing, and make separate payment when that is the only service the patient receives.
• CMS announced they will be “covering certain serology (antibody) tests, which may aid in determining whether a person may have developed an immune response and may not be at immediate risk for COVID-19 reinfection. Medicare and Medicaid will cover laboratory processing of certain FDA-authorized tests that beneficiaries self-collect at home.”

CMS Hospitals Without Walls

CMS provided the following examples of ways hospitals are being provided flexibility to increase beds for COVID-19 patients and receive stable Medicare payments:

• Teaching hospitals can increase the number of temporary beds without facing reduced payments for indirect medical education.
• Inpatient Psychiatric and inpatient rehabilitation facilities (IRFs) can admit more patients to alleviate pressure on acute-care hospital capacity without facing reduced teaching status payments.
• Specific for freestanding IRFs, CMS is excepting certain requirements to enable them to accept patients from acute-care hospitals experiencing a surge, even if they do not require rehabilitation care.
• Hospital systems with rural health clinics (RHCs) can increase bed capacity without affecting the RHCs payments.

Outpatient Hospital Services

• Under current law, most provider-based hospital outpatient departments that relocate off-campus are paid at lower rates under the Physician Fee Schedule, rather than the Outpatient Prospective Payment System (OPPS). CMS will allow certain provider-based hospital outpatient departments that relocate off-campus to obtain a temporary exception and continue to be paid under the OPPS. Importantly, hospitals may also relocate outpatient departments to more than one off-campus location, or partially relocate off-campus while still furnishing care at the original site.

Additional flexibilities being made are related to increasing the Healthcare Workforce, decreasing administrative burden for providers, and further expanding telehealth.

You can read more about the new flexibilities and waivers in a related CMS Fact Sheet or the Medicare and Medicaid Interim Final Rule with Comment (IFC): Additional Policy and Regulatory Revisions in Response to COVID-19 Public Health Emergency (CMS-5531 IFC) that can be found on the CMS COVID-19 flexibilities webpage: https://www.cms.gov/about-cms/emergency-preparedness-response-operations/current-emergencies/coronavirus-waivers. 

April 30, 2020: MLN SE20016 New and Expanded Flexibilities for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) During the COVID-19 Public Health Emergency (PHE) Revised

MLN SE20016 was revised to provide the following:

• Additional claims submission and processing instructions,
• Information on cost-sharing related to COVID-19 testing,
• Additional information on telehealth flexibilities, and
• Information on provider-based RHCs exemption to the RHC payment limit.

April 30, 2020: New FAQs on the Emergency Medical Treatment and Labor Act (EMTALA)

CMS has issued FAQs to clarify requirements and considerations for hospitals and other providers related to EMTALA during the COVID-19 pandemic. FAQ topics includes the following:

• Patient Presentation to the Emergency Department,
• Where Does EMTALA Apply,
• Qualified Medical Professionals (QMPs),
• Medical Screening Exam (MSE),
• Transfer and Stabilization of a Patient,
• Telehealth,
• Waivers Under Section 1135 of the Social Security Act, and
• FAQs falling under “Other.”

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates that span from April 20th through April 27th.  

April 20, 2020: FDA’s Daily Roundup: Serological (Antibody) Tests Guidance

On April 20th the Food and Drug Administration (FDA) issued the following information on the use or serological (antibody) tests to help identify people potentially exposed to the SARS-CoV-2 virus or have recovered from the infection:

• Letter to Health Care Providers: Important Information on the use of serological (antibody) tests for COVID-19. This letter opens with the following important statement: “The U.S. Food and Drug Administration (FDA) recommends that health care providers continue to use serological tests intended to detect antibodies to SARS-CoV-2 to help identify people who may have been exposed to the SARS-CoV-2 virus or have recovered from the COVID-19 infection. Health care providers should also be aware of the limitations of these tests and the risks to patients and the community if the test results are used as the sole basis to diagnose COVID-19.”
• FDA Fact Sheet: Serological Testing for Antibodies to SARS-CoV-2 Infection; and
• New Serology/Antibody Test FAQs in the FAQs on Diagnostic Testing for SARS-CoV-2 Infection.

April 20, 2020: CMS Announces Clinicians Can Earn Credit in the Merit-Incentive Payment System (MIPS) when Participating and Attesting to the New COVID-19 Clinical Trials Improvement Activity

In an April 20th Press Release, CMS announced that clinicians who participate in the CMS Quality Payment Program (QPP) may now earn credit in the MIPS for participation in a clinical trial and reporting clinical information by attesting to the new COVID-19 Clinical Trials improvement activity. CMS noted “this action will provide vital data to help drive improvement in patient care and develop innovative best practices to manage the spread of COVID-19 within communities.”

How You Will Receive Credit for Participation

“Clinicians must attest that they participate in a COVID-19 clinical trial utilizing a drug or biological product to treat a patient with a COVID-19 infection and report their findings through a clinical data repository or clinical data registry for the duration of their study.”

More about this Improvement Activity

• There is flexibility in the type of clinical trial, which could include the traditional double-blind placebo-controlled trial, to an adaptive or pragmatic design that flexes to workflow and clinical practice.
• Clinicians who report this activity will automatically earn half of the total credit needed to earn a maximum score in the MIPS improvement activities performance category, which counts as 15 percent of the MIPS final score.
• You can view a database of privately and publicly funded clinical studies currently being conducted on COVID-19 at https://clinicaltrials.gov/

April 21, 2020: COVID-19 Update: FDA Authorizes First Test for Patient At-Home Sample Collection

The U.S. FDA announced  that they had re-issued the emergency use authorization (EUA) for the LapCorp COVID-10 RT-PCR Test to permit testing of samples self-collected by patients at home using LapCorp’s Pixel by LabCorp COVID-19 Test home collection kit. FDA Commissioner Stephen M. Hahn, M.D., notes they “worked with LapCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital or other testing site. With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home.”

The FDA makes it clear this authorization only applies to this LapCorp test and is not a general authorization for at-home collection of patient samples using other collection swabs, media, or tests, or for tests fully conducted at home.

April 21, 2020: CMS Releases Additional Blanket Waivers for Long-Term Care Hospitals, Rural Health Clinics, Federally Qualified Health Center and Intermediate Care Facilities

Additional blanket waivers released on April 21st were related to care for patients in LTCHs, temporary expansion locations of Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs), staffing and training modifications in Intermediate Care Facilities for individuals with Intellectual disabilities, and the limit for substitute billing arrangements (locum tenens). Blanket waiver guidance can be found in the COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers document.

April 21: Memorandum to State Survey Agency Directors: Guidance for Freestanding EDs during COVID-19 Public Health Emergency

According to the Memorandum Summary, “CMS is creating additional flexibilities to allow licensed independent freestanding emergency departments (EDs) to participate in Medicare and Medicaid to help address the urgent need to increase hospital capacity to provide care to patients. The following ways to participate include:

• Becoming affiliated with a Medicare/Medicaid-certified hospital under the temporary expansion 1135 emergency waiver.
• Participating in Medicaid under the clinic benefit if permitted by the State, or
• Enrolling temporarily as a Medicare/Medicaid-certified hospital to provide hospital services.”

April 22, 2020: New Toolkit to Help States Navigate COVID-19 Health Workforce Challenges

An April 22nd CMS Press Release announced that the CMS and the Assistant Secretary of Preparedness and Response (ASPR) released the COVID-19 Healthcare Workforce Toolkit to help state and local healthcare decision makers maximize workforce flexibilities when confronting COVID-19 in their communities. This work was developed by the Healthcare Resilience Task Force and provides helpful information on funding flexibilities, liability protections, and workforce training. It also provides up-to-date best practices making it a go-to resource for decision makers to find out what has been implemented in the field and how it’s working.

The toolkit is housed on the ASPR Technical Resources, Assistance Center, and Information Exchange (TRACIE). This is a healthcare emergency preparedness information gateway ensuring all stakeholders have access to the information. To view the COVID-19 Healthcare Workforce Toolkit, visit: https://asprtracie.hhs.gov/Workforce-Virtual-Toolkit

April 23, 2020: COVID-19 Telehealth Toolkit to Accelerate State Use of Telehealth in Medicaid and CHIP

The Trump Administration announced in a Press Release the release of a new toolkit for states to help accelerate adoption of broader coverage policies in the Medicaid and Children’s Health Insurance Program (CHIP) during the COVID-19 pandemic. The toolkit includes the following issues for states to consider when evaluating their need to expand telehealth capabilities and coverage policies:

• Patient populations eligible for telehealth,
• Coverage and reimbursement policies,
• Providers and practitioners eligible to provide telehealth,
• Technology requirements,
• Pediatric considerations; and
• A compilation of FAQs.

April 23, 2020: Guidance for Infection Control and Prevention Concerning COVID-19 in Home Health Agencies (HHAs) and Religious Nonmedical Healthcare Institutions (RNHCIs)

This guidance was initially released on March 10, 2020 and was subsequently updated on April 23, 2020 to include RNHCI Guidance on COVID-19. The following information was added to the Memorandum Summary:

• HHA Guidance now includes additional information about CMS waivers and regulations, and CDC guidance was added for optimizing personal protective equipment and return to work criteria for healthcare personnel with confirmed or suspected COVID-19.
• Recommendations for Visitation in Residential Facilities not Certified by Medicare: CMS is providing recommendations to home health care personnel who care for patients in residential settings such as assisted and independent living facilities.
• Medicare Participating Religious Nonmedical Healthcare Institutions (RNHCIs) and Actions – CMS is providing additional guidance for RNHCIs related to addressing potential and confirmed COVID cases and mitigating transmission including screening, treatment, and transfer to higher level of care (when appropriate).

April 24, 2020: Nursing Home Five Star Quality Rating System Updates, Nursing Home Staff Counts, and Frequently Asked Questions

An April 24, 2020 Memorandum to State Survey Agency Directors indicates CMS’ commitment to ensuring nursing homes are prepared to respond to the threat of COVID-19. Specific steps outlined in the memorandum summary includes the following:

• The inspection domain of the Nursing Home Compare Five Star Quality Rating System will be held constant temporarily due to the prioritization and suspension of certain surveys, to ensure the rating system reflects fair consumer information.
• CMS will post a list of the surveys conducted after the prioritization of certain surveys, and findings, through a link on the Nursing Home Compare website.
• CMS is publishing a list of the average number of nursing and total staff that work onsite in each nursing home, each day. This information can be used to help direct adequate (PPE) and testing to nursing homes.
• A list of FAQs is being released to clarify certain actions that CMS has taken related to visitation, survey, waivers, and other guidance.

April 26, 2020: CMS Reevaluates Accelerated Payment Program and Suspends Advance Payment Program

On April 26, the Centers for Medicare & Medicaid Services (CMS) announced that it is reevaluating the amounts that will be paid under its Accelerated Payment Program and suspending its Advance Payment Program to Part B suppliers effective immediately. The agency made this announcement following the successful payment of over $100 billion to health care providers and suppliers through these programs and in light of the $175 billion recently appropriated for health care provider relief payments. You can read more about this in the April 26th CMS Press Release.

April 27, 2020: WPS GHA Medicare eNews: Modifier CS and COVID-19 Testing

The following reminder was included in the April 27th edition of WPS’ Medicare eNews:

“A new law waives cost-sharing under Medicare Part B for certain outpatient COVID-19 testing-related services. The CS modified signals the MACs to pay 100% for these services. This applies for claims with dates of service on or after March 18, 2020. Claims submitted without the modifier may be resubmitted.

To learn more, refer to "Families First Coronavirus Response Act Waives Coinsurance and Deductibles for Additional COVID-19 Related Services"   in the CMS MLN Connects Special Edition – Tuesday, April 7, 2020.”

Kaiser Health News and Guardian US Partner to Honor American Health Care Workers Lost on the Frontline of the COVID-19 Pandemic

In recent COVID-19 updates articles MMP has highlighted the Institute for Health Metrics and Education (IHME) COVID-10 Projection Models (link to Project: https://covid19.healthdata.org/projections

) and the Johns Hopkin’s Coronavirus Resource Center where you will find world and U.S. specific numbers as well as critical trends.

This week I want to make our readers aware of the Lost on the Frontline Project that was officially launched on April 15th by KFF’s Kaiser Health News (KHN) and Guardian US. This special project aims to document the life of every health care worker in America who has died from COVID-19 during the pandemic. According to the KHN Announcement, “this includes medical professionals like doctors, nurses and paramedics, and others working at hospitals, nursing homes and other medical facilities, including aides, administrative employees and cleaning and maintenance staff.”

Note, when you go to the Lost on the Frontline website, you are encouraged to share the story of colleagues or loved ones that you know who have died from COVID-19.

KHN and The Guardian are inviting news organizations across the country to partner in the effort. The project will link to local news stories on health care worker deaths, and all content from the series will be available free to other news organizations to republish. The project will reflect the rich diversity of the U.S. health care workforce. The lead partners will translate selected stories into multiple languages and make them available for publication by ethnic media outlets to ensure they reach the many communities in America affected by the pandemic. 

April 10, 2020: AMA Announces Expedited Updates to CPT for COVID-19 Antibody Tests

The CPT Editorial Panel expedited the review of proposed changes and approved them on April 10th. In the Announcement AMA President Patrice A. Harris, M.D., M.A. said that “The expedited approval of new CPT codes for COVID-19 antibody tests is an important step that enhances the reporting of innovative tools now available to advance medicine's overarching goals of reducing the COVID-19 disease burden, improving health outcomes and reducing long-term care costs.”

• Code 86328 has been established for antibody testing using a single step method immunoassay.
• Code 86769 has been established for antibody testing using a multiple step method.

Prior to these two new Category I CPT codes approval, the CPT Editorial Panel approved a new code to report molecular testing to detect the SARS-CoV-2 virus:

• Code 87635 Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique

Note: All AMA COVID-19 Coding Guidance to date is available on the AMA’s COVID-19 Coding and Guidance webpage. 

April 13, 2020: CMS Provides COVID-19 Long-Term Care Transfer Scenarios

CMS released a Memorandum to State Survey Agency Directors. This memorandum provides supplemental information for transferring or discharging residents between facilities for the purpose of cohorting residents based on COVID-19 status (i.e., positive, negative, unknown/under observation). This guidance includes graphics explaining the various scenarios.

April 14, 2020: Novo Nordisk® Offering Free 90-Day Insulin Supply to People Experiencing Financial Hardship due to COVID-19

Novo Nordisk, Inc. announced on April 14th that diabetics using Novo Nordisk insulin who have lost health insurance coverage because of a change in job status due to the COVID-19 pandemic may now be eligible for enrollment in their Diabetes Patient Assistance Program and receive a 90 day supply of insulin free of charge.

April 15, 2020: Special Edition MLNConnects: IPPS Hospitals, LTCHS: Reprocessing Claims for CARES Act

Sections 3710 and 3711 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act implemented changes to increase payments to IPPS Hospitals and Long-Term Care Hospitals (LTCHs). When you submit an IPPS claim for discharges on or after January 27, 2020, or an LTCH claim for admissions on or after January 27, 2020, and we receive it:

• April 20, 2020, and earlier, Medicare will reprocess. You do not need to take any action.
• On or after April 21, 2020, Medicare will process in accordance with the CARES Act.

For more information, see MLN Matters Special Edition Article SE20015.

April 15, 2020: CMS Increases Medicare Payment for High-Production Coronavirus Lab Tests

In a CMS Press Release CMS announced that Medicare will nearly double payments for certain lab tests that use high-throughput technologies to rapidly diagnose large numbers of COVID-19 cases. CMS Administrator Seema Verma said “this is an absolute game-changer for nursing homes, where the risk of Coronavirus infection is high among our most vulnerable.”

Key Facts from this Announcement

• Medicare will pay the higher payment of $100 for COVID-19 clinical diagnostic lab tests making use of high-throughput technologies developed by the private sector.
• High-throughput lab tests can process more than 200 specimens daily.
• High-throughput lab tests use highly sophisticated equipment requiring specially trained technicians and more time-intensive processes to assure quality.
• This increased payment rate became effective April 14, 2020, through the duration of the COVID-19 National Emergency.
• Local Medicare Administrative Contractors (MACs) will continue to be responsible for other COVID-19 lab tests.
• MACs are currently paying approximately $51 for those tests.

CMS reminds readers that for a complete and updated list of  CMS actions, and other information specific to CMS, please visit the Current Emergencies Website.

For more information on this payment announcement, please visit: https://www.cms.gov/files/document/cms-2020-01-r.pdf

April 17, 2020:  MLN SE20016: New and Expanded Flexibilities for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) During the COVID-19 Public Health Emergency (PHE)

Special Edition Article SE20016 highlights changes made to the RHC and FQHC requirements and payments for the duration of the PHE. Also included in this article is a link to the RHC/FQHC COVID-19 FAQs.

April 17, 2020: CDC’s Clinical Outreach & Communications Activity (COCA) Webinar: COVID-19 in the United States: Insights from Healthcare Systems

This past Friday the CDC provided a webinar focused on insights from healthcare care systems in response to the COVID-19 PHE. Specifically, David Reich, MD, President, and Chief Operating Officer of The Mount Sinai Hospital in New York and Amy Compton-Phillips, MD, Executive Vice President, Chief Clinical Office of Providence St. Joseph Health in Washington shared their healthcare systems experience. A replay of the webinar and the transcript and slide presentation are available on the CDC’s COCA Calls/Webinars - 2020. 

Drug Enforcement Administration: Diversion Control Divisions’ Response to COVID-19

The Diversion Control Division of the DEA has been working closely with “Federal partners, DEA registrants, and their representative association to assure that there is an adequate supply of controlled substances in the United States. The DEA will also work to assure that patients will have access to controlled substances.” All of their actions to date are available on their COVID-19 Information Page. Following is one Q&A available on this page regarding drug distribution to “pop-up” hospitals. 

Question: Distributors are being inundated with requests to deliver to what distributors are referring to as "pop-up" hospital/triage locations that are located in a variety of locations, including parking lots, hotels, and convention centers – essentially wherever additional space can be found to set up treatment centers. Distributors are concerned that these alternate locations do not comply with the CSA and the DEA regulations regarding the delivery of controlled drugs. How can distributors obtain expedited approval to deliver to an alternate address for their customers in the event that a pharmacy or healthcare facility is shut down for quarantine or cleaning?

Answer: Before addressing this question, we wish to emphasize that DEA is making every effort to expeditiously review any application for an emergency DEA registration number and intends to expedite the pre-registration process when warranted. The DEA registrant requesting to establish an alternate site should submit a request to DEA's national disaster email, natural.disaster@usdoj.gov, for an emergency DEA registration number for each designated alternate location. The email must include the following information for the alternate location: physical address; security measures; and, the name and complete contact information of the person who will be responsible for the controlled substances at this location.

Please also see the answer to the question and answer regarding what alternate delivery methods will be considered compliant with 21 CFR 1305.13(c) and 1305.22(f) during the COVID-19 public health emergency. In addition, to address the scenario in which, due to COVID-19 related considerations, the purchaser that has recently set up location for which the purchaser's DEA-222 forms do not yet reflect its new location, DEA is issuing an exception to the regulations. This exception is posted at DEA's COVID-19 guidance webpage

April 19, 2020: New Nursing Homes COVID-19 Transparency Efforts

CMS announced new regulatory requirements for nursing homes in a Sunday April 19th Press Release.

New Requirements:

• Nursing homes will be required to inform residents, their families and representatives of COVID-19 cases in their facilities.
• As part of President Trump’s Opening Up America, nursing home will now be required to report COVID-19 case directly to the CDC in accordance with existing privacy regulations and statute.
• Nursing homes will be required to fully cooperate with CDC surveillance efforts around COVID-19 spread. The CDC will be providing a reporting tool to nursing homes that will support Federal efforts to collect nationwide data to assist in COVID-19 surveillance and response. CMS plans to make the data publicly available.

April 19, 2020: Guidelines for Opening Up America Again

In an April 19th Press Release, the CMS announced the issuance of new recommendations specifically targeted to communities that are in Phase 1 of the Guidelines for President Trump’s Opening Up America Again with low incidence or relatively low and stable incidence of COVID-19 cases. The recommendations update earlier guidance provided by CMS on limiting non-essential surgeries and medical procedures. The new CMS guidelines recommend a gradual transition and encourage health care providers to coordinate with local and state public health officials and to review the availability of Personal Protective Equipment (PPE) and other supplies, workforce availability, facility readiness, and testing capacity when making the decision to re-start or increase in-person care.

The new recommendations can be found here: https://www.cms.gov/files/document/covid-flexibility-reopen-essential-non-covid-services.pdf

The Guidelines for Opening Up America Again can be found here: https://www.whitehouse.gov/openingamerica/#criteria 

Medical Review Administrative Relief Related to the Novel Coronavirus (COVID-19) Pandemic

Palmetto GBA has posted the following Notice on their website:

The Centers for Medicare & Medicaid Services (CMS) has authorized nationwide waivers under §1812(f) of the Social Security Act retroactive to March 1, 2020, for those impacted by COVID-19. Medicare Fee-For-Service (FFS) operations will implement the following policies and procedures for all claims, not just for the COVID-19 diagnoses.

Additional Documentation Requests (ADRs)

• For ADRs that have already been issued, Medicare contractors will release the claims for payment and not issue claim denials; providers should not respond to any pending claims as all claims will be released for relief efforts.
• Any claims auto-denied for non-response of an ADR from March 1, 2020, until March 26, 2020, will have the denial reversed and allow payment if an appeal has not been filed. If an appeal has been filed, normal appeals processes will be followed.
• As of March 26, 2020, future ADRs will not be sent until further notice from CMS

Targeted Probe and Education (TPE)

• All current TPE reviews and associated edits are suspended and selected claims released for payment
• MACs will allow TPE medical review education sessions to be rescheduled upon provider request

Note: Providers must resume compliance with normal Medicare fee-for-service rules and regulations as soon as they are able. The waivers or modifications a provider was operating under are no longer available after the termination of the emergency period.

April MAC Talk: The Local Scene

March 17th, 2020: Palmetto GBA JM Posts TPE Progress Updates

It seems a little ironic that in March Palmetto GBA JM began releasing Targeted Probe and Educate (TPE) Progress Updates. Medical Review specific articles include the dates of services reviewed, the volume of probes performed, the charge denial rates, top denial reasons, tips for preventing denials, next steps, and references.

In regards to “Next Steps,” Palmetto GBA indicates that Providers found to be non-compliant (major risk category/denial rate of 21–100%) at the completion of TPE Probe 1 will advance to Probe 2 at least 45 days from completion of the 1:1 post probe education call date. Palmetto GBA offers education at any time for providers. Providers do not have to be identified for TPE to request education.

Following is a list of the specific TPE articles released to date by Palmetto GBA JM:

• March 17, 2020: DRG 682/683 Renal Failure with MCC/CC,
• March 17, 2020: DRG 470 – Major Joint Replacement,
• March 18, 2020: Inpatient Rehab Facility A0604, B0604, C0604 and D0604,
• March 18, 2020: DRG 885 Psychoses,
• March 19, 2020: Therapeutic Exercise 97110,
• March 19, 2020: Skilled Nursing Facility (SNF),
• March 23, 2020: Rituximab J9310/J9312,
• March 23, 2020: Pegfilgrastim J2505,
• March 23, 2020: Neuromuscular Re-education – 97112,
• March 23, 2020: Manual Therapy – 97140,
• March 23, 2020: Infliximab J1745,
• March 23, 2020: HBO Therapy G0277,
• March 23, 2020: DRG 291 Heart Failure and Shock with MCC and DRG 292 Heart Failure and Shock with CC,
• March 23, 2020: Denosumab J0897, and
• March 23, 2020: Bevacizumab J0935.

Links to all of the articles can be found on Palmetto GBA’s JM Target Probe and Educate webpage.

March 20, 2020: First Coast Revises Articles A52571 and A57778

Article A52571: Self-Administered Drug Exclusion List

Effective May 3, 2020, First Coast (JN) has added the following drugs to the self-administered drug (SAD) list:

• Tremfya® (guselkumab) (J1628), and
• Stelara® (ustekinumab) subcutaneous (J3357).

This announcement includes a link to their entire list of SADs.

Article A57778: Billing and Coding Intravenous Immune Globulin

First Coast has added the new FDA approved drug Panzyga® (immune globulin intravenous, human – IFAS) (HCPCS codes C9399 and J1599) to the CPT®/HCPCS Codes/Group 1 Paragraph:/Group 1 codes:” and “ICD-10 Codes that Support Medical Necessity/Group 1 Paragraph:” section.

This change is effective for claims processed on or after March 16, 2020, for services rendered on or after August 2, 2018.

March 24, 2020: Palmetto GBA Daily Newsletter: Self-Administered Drug Exclusion List Article Changes

Palmetto GBA posted information about revisions made to their Self-Administered Drug Exclusion List

Article A53066.

These changes will be effective 4/20/2020. They encourage providers to share this information with their staff.

• Revision 23 (R23): Under Excluded CPT/HCPCS Codes – Table Format the previous revision (R22) that added HCPCS Code J3358 – Stelara®, ustekinumab for intravenous injection, 1mg should be disregarded as this code was inadvertently added. HCPCS code J3557 – Stelara®, ustekinumab for subcutaneous injection, 1mg has been added.

March 25, 2020: Palmetto GBA JJ Posts TPE Progress Updates

A little over a week after Palmetto GBA released TPE Progress Updates for Jurisdiction M they began posting findings for Jurisdiction J. Review specific articles follow the same format as articles released for JM. Following is a list of specific TPE articles released to date by Palmetto GBA JJ:

• March 25, 2020: HBO Therapy G0277,
• March 25, 2020: JJ Part A Skilled Nursing Facility (SNF),
• March 25, 2020: Therapeutic Exercise 97110,
• April 3, 2020: DRG 885 Psychoses; and
• April 3, 2020: DRG 470 Major Joint Replacement,
• April 10, 2020: Manual Therapy 97140,
• April 10, 2020: Inpatient Rehabilitation Facility (IRF) A0604-D0604
• April 10, 2020: Pegfilgrastim J205,
• April 10, 2020: DRGs 291 and 292: Heart Failure and Shock with MCC and with CC,
• April 11, 202: Rituximab J9310,
• April 11, 2020: Infliximab J1745,
• April 11, 2020: Denosumab J0897, and
• April 11, 2020: Bevacizumab J9035.

Links to all of the articles can be found on Palmetto GBA’s JJ Target Probe and Educate webpage.

March 30, 2020: CGS Posts Notice Medical Review Update

On January 31, 2020, Secretary Azar of the Department of Health & Human Services (HHS) declared a nationwide public health emergency.  On March 13, 2020, Secretary Azar authorized waiver and modifications under §1135 of the Social Security Act retroactive to March 1, 2020. CGS understands the effect of COVID-19 on our provider community. In response to questions received regarding Medical Review Additional Document Requests (ADRs) and Targeted Probe and Educate (TPE) activity, at this time, CGS has temporarily suspended TPE reviews. Our medical review and provider outreach and education staff will continue to be available to conduct education sessions and provide answers to questions to ensure that providers understand regulatory guidelines to prevent improper payment. To reschedule a TPE educational session, request an educational session related to medical review topics, or for medical review general TPE questions please contact us at one of the email addresses below or contact the appropriate provider contact center (PCC) at: https://www.cgsmedicare.com/help/index.html.

• Part A Medical Review: J15AprobeandEducation@cgsadmin.com
• Part B Medical Review: J15BPROBEANDEDUCATION@cgsadmin.com
• HHH Medical Review: J15HHprobeandEducation@cgsadmin.com

April 1, 2020: NGS News COVID-19 Update: Important Information Regarding Part A and B Second-Level Appeals
NGS provided the following “information at the request of the Qualified Independent Contractor (QIC), C2C Innovative Solutions, Inc. (C2C). C2C conducts second-level Medicare Part A and B Fee-for-Service claims appeals submitted in Jurisdiction K Part A and B as well as Jurisdiction 6 home health and hospice for New York, New Jersey, Puerto Rico and the U.S. Virgin Islands. If you appeal to C2C as the Part A and B East QIC, they are limiting their on-site mail room operations in response to the COVID-19 public health emergency. During this public health emergency, providers and Medicare beneficiaries falling into the above categories are encouraged to submit new second-level Medicare appeals and related correspondence via fax or the electronic portal. For additional information including the QIC fax numbers and a link to their portal, please visit the C2C website.”

April 6, 2020: NGS Posts Update Regarding Pricing of HCPCS G2066

NGS News and Alerts

On 3/12/2020 NGS posted an article on their website regarding a fee adjustment for HCPCS G2066 (Interrogation device evaluation(s), (remote) up to 30 days; implantable cardiovascular physiologic monitor system, implantable loop recorder system, or subcutaneous cardiac rhythm monitor system, remote data acquisition(s), receipt of transmissions and technician review, technical support and distribution of results).

While NGS recognizes its authority to periodically review and adjust pricing as warranted of any “Contractor Priced“ codes, the adjustment in payment for HCPCS G2066 will not go into effect during this PHE, as scheduled on April 24, 2020.

HCPCS G2066 was created by the CMS for 2020 to replace the retired code of CPT 93299. Therefore, the fee for G2066 will remain the same as the prior 2019 fee for CPT 93299.

At such time as the PHE is deemed over, HCPCS G2066 will be reviewed for pricing based on other MAC fees; a thorough review of this service; and further input from stakeholders.

April 8, 2020: Palmetto GBA Claims Payment Issue: Medically Unlikely and Procedure-to-Procedure Edit Updates Due to COVID-19

Palmetto GBA identified the following Issue on April 3, 2020:

As a result of the CMS expansion of telehealth services in response to COVID-19, CMS updated certain Medically Unlikely Edits (MUEs) and Procedure-to-Procedure (PTP) edits for CPT and HCPCS codes, retroactive to January 1, 2020. Palmetto GBA advises that they will implement the CMS replacement files and adjust affect claims with dates of service on or after March 6, 2020. Additionally, any appeals already started by Palmetto GBA that related to MUE or PTP denials will be prioritized for review using the replacement files for claims with dates of service on or after March 6, 2020.

April 9, 2020: NGS Daily News: A Message from Our Medical Review Team: Targeted Probe and Educate Medical Reviews
In the wake of the public health emergency related to COVID-19, National Government Services (NGS) is in the process of pausing Targeted Probe and Educate (TPE) Medical Reviews. At this time, they are unable to provide additional clarity on when or how TPE reviews will resume, but will share information as it’s made available. They will work with providers who previously scheduled educational sessions to reschedule them.

NGS is contacting providers to let them know claims were released and there is no need to respond to an additional development request (ADR) for medical records. Effective 3/1/2020, claims that auto-denied for nonresponse or late response to the ADR will be reversed and allowed for payment unless an appeal has already been filed. In that case, the appeal will follow the normal appeals process.

NGS’ dedicated email address remains available for questions specific to medical reviews

• Jurisdiction 6 Part A:  j6probeandeducate@anthem.com
• Jurisdiction 6 Part B: J6Bprobeandeducate@anthem.com
• Jurisdiction K Part A: ngs-jkmedicalreview@anthem.com
• Jurisdiction K Part B: educate@anthem.com">Jkbprobe&educate@anthem.com

April 9, 2020: Palmetto GBA Update: MACs to Host Multi-jurisdictional Contractor Advisory Committee (CAC) Meeting Regarding Facet Joint & Medical Nerve Branch Procedures on May 28, 2020 from 1-3 p.m. CT

Due to the COVID-19 Pandemic, the decision has been made to hold the meeting via Teleconference/Webinar ONLY. All other information remains the same.

The purpose of the meeting is to obtain advice from CAC members and subject matter experts (SMEs) regarding the strength of published evidence on Facet Joint and Medial Nerve Branch Procedures. In addition to discussion, the CAC and SME panel will vote on pre-distributed questions. The public is invited to attend as observers.

The meeting will be hosted by seven Medicare Administrative Contractors and will be held via Teleconference/Webinar. There will be a panel of experts discussing the Facet Joint and Medial Nerve Branch Procedures. CAC panels do not make coverage determinations, but MACs benefit from their advice.

Complete details will be available by May 14, 2020 (background material, questions, and agenda).

Link to Announcement:
https://www.palmettogba.com/palmetto/providers.nsf/DocsR/JJ-Part-A"BMYQLA2250

April 13, 2020: WPS J8A Medical Review (MR) Targeted Probe & Educate (TPE) Quarterly Update

WPS provided the common errors identified by their Medical Review staff throughout the first quarter of 2020. Specific for hospitals was the following guidance regarding wound care.

• Wound Care (CPT 11042): Denials for Documentation Not Supporting Sharp Debridement: WPS reminds Providers that documentation should provide a clear rationale for the excisional debridement. Additionally, the documentation should include a certified plan of care that includes the potential to heal and goals. The WPS Local Coverage Determination (LCD) L37228outlines coverage criteria for wound care.

April 13, 2020: WPS eNews: Inpatient Psychiatric Facility (IPF) – CERT Errors

A WPS Announcement indicated that the Comprehensive Error Rate Testing (CERT) Contractor has assessed for errors for IPF services and found that in most cases there was missing documentation to support payment based on Medicare guidelines. The announcement details information that should be submitted in a response to a Medicare request and provides a link to additional information in Chapter 2: Inpatient Psychiatric Hospital Services of the Medicare Benefit Policy Manual.

April 13, 2020: OIG Releases Report : An Estimated 87 Percent of Inpatient Psychiatric Facility Claims with Outlier Payments Did Not Meet Medicare’s Medical Necessity or Documentation Requirements

The OIG focus for this audit was claims resulting in outlier payments with an objective of determining whether Inpatient Psychiatric Facilities (IPFs) complied with Medicare coverage, payment, and participation requirements. OIG Findings from the 160 sampled claims:

• 25 claims did not meet Medicare medical necessity requirements,
• 142 claims had missing or inadequate medical record elements, including physician certification, and
• 12 of the 142 claims did not clearly support that the IPF had protected the patient’s right to make informed decisions regarding care.

Ultimately, the OIG estimated that Medicare overpaid IPFs $93 million for FYs 2014 and 2015 for stays that were non-covered or partially non-covered and resulted in outlier payments. 

April 16, 2020: CGS Announces Retirement of LCD L34093: Chemotherapy and Biologicals

• Effective June 7, 2020: CGS will be retiring LCD L34093: Chemotherapy and Biologicals
• Effective June 8, 2020: LCD L34093 will be replaced with Article A58113: Off-Label Use of Anti-Cancer Drugs and Biologicals
• CGS Notes in the announcement that, “This is a change from how we currently handle chemotherapy and biological drugs. While there will no longer be a local policy in place with attached billing and coding articles, we will be using the coverage indications as listed in the Centers for Medicare & Medicaid Services (CMS) Internet Only Manual (IOM) 100-02, Chapter 15, section 50.4.1 and 50.4.5 which is the basis for the current policy. CGS will cover these types of drugs based on FDA label indications and for off label use if listed in one of the five CMS approved compendia’s (NCCN, Micromedex Drug DEX, Lexi-Drugs, AHFS, or Clinical Pharmacology).”
• You can read the entire announcement at:   https://www.cgsmedicare.com/parta/pubs/news/2020/04/cope16807.html

April 17, 2020: First Coast eNews: TPE Announcement

“Targeted probe and educate (TPE) reviews have been temporarily postponed due to the public health emergency (PHE) declared as a result of the 2019 novel coronavirus (COVID-19). We encourage providers to focus on patient care and defer discussions related to these reviews after the PHE. First Coast will reach out to providers after the pandemic to offer education based upon prior reviews. In the event providers would like to receive education during this time, we are prepared to provide educational sessions. Please feel free to reach out to the nurse assigned to your case to arrange an educational call.”

“I am convinced that acupuncture is going to be one of the greatest contributions that any group of people has made to the future of all medicine, if it is handled correctly by the people of the Western World.”

• 1972 Quote by Dr. W. Kenneth Riland, Personal Physician to President Nixon

Background

In May 1980, CMS issued a national non-coverage determination for acupuncture (NCD30.3). Since then they have issued non-coverage determinations for acupuncture for fibromyalgia (NCD 30.3.1) and acupuncture for osteoarthritis (NCD 30.3.2).

In a July 15, 2019, Press Release, CMS announced their proposal to cover acupuncture for chronic low back pain (cLBP) as a potential alternative to opioid use, while data is collected on patient outcomes. HHS Secretary Alex Azar noted, “Defeating our country’s epidemic of opioid addiction requires identifying all possible ways to treat the very real problem of chronic pain, and this proposal would provide patients with new options while expanding our scientific understanding of alternative approaches to pain.”

On January 15, 2020, CMS released the Final Decision memo for acupuncture for cLBP (CAG-00452N).

CMS indicated in a related Press Release they had “conducted evidence reviews and examined coverage policies of private payers to inform today’s decision.”

MLN Matters MM11691: April 2020 Update of the Hospital Outpatient Prospective Payment System (OPPS)

MLN MM11691 describes changes to and billing instructions for various payment policies implemented in the April 2020 Hospital OPPS update. Included in the update is guidance about the change in status indicators for acupuncture as a result of NCD 30.3.3. Following is an excerpt from the article specific for Acupuncture:

Effective January 21, 2020, Medicare covers acupuncture and dry needling for beneficiaries with chronic low back pain…Based on this recent coverage determination, CMS revised the OPPS status indicator and APC assignment for the CPT codes describing acupuncture and dry needing services from “E1” (Not paid by Medicare when submitted on outpatient claims (any outpatient bill type) to “S” (Paid under OPPS, separate APC payment) and “N” (Paid under OPPS; payment is packaged into payment for other services. Thus, there is no separate APC payment.)

Table 2 – Acupuncture and Dry Needling CPT Codes for Newly Covered by Medicare

You can learn more about what is covered, what is noncovered, and who can furnish acupuncture for the Medicare Fee-for-Service population as detailed in NCD30.3.3 in a related MMP article.

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week’s updates span from April 2nd through April 13th.

Johns Hopkin’s Coronavirus Resource Center

In last week’s COVID-19 updates article we highlighted the Institute for Health Metrics and Education (IHME) COVID-10 Projection Models (link to Project: https://covid19.healthdata.org/projections). This week I want to make readers aware of the Johns Hopkin’s Coronavirus Resource Center where you will find world and U.S. specific numbers as well as critical trends.

April 2, 2020: CDC Posts Guidance on How to Certify Deaths due to COVID-19

The National Centers for Health Statistics (NCHS) is responding to COVID-19 with new resources to monitor and report deaths. On April 2nd the document Guidance for Certifying Deaths Due to Coronavirus Disease 2019 (COVID-19) was posted on the CDC’s National Vital Statistics System (NVSS) Coronavirus Disease (COVID-19) Death Data and Reporting Guidance webpage. This document provides guidance to death certifiers on proper cause-of-death certification for cases where confirmed or suspected COVID-19 infection resulted in death. You can also find provisional death counts for COVID-19 (updated daily Monday through Friday) and NVSS COVID-19 Alerts on this webpage.

April 3, 2020: Lessons Learned from the Front Lines: COVID-19

On April 3, CMS Administrator Seema Verma, Deborah Birx, MD, White House Coronavirus Task Force, and officials from the FDA, CDC, and FEMA participated in a call on COVID-19 Flexibilities. Several physician guests on the front lines presented best practices from their COVID-19 experiences. You can listen to the conversation here.

April 3, 2020: Palmetto GBA updates COVID-19 Accelerated Payment Hotline FAQs

Following is an example of one question available in this FAQs document:  

• Question: How many months will we be able to ask for help?
• Answer: CMS' payment provision at this time is for a three-month or six-month operating period, depending upon your provider type.
  

Note: Hospital sub-units are eligible for payment for a three-month operating period. Only Inpatient acute care hospitals, children's hospitals, certain cancer care hospitals, and critical access hospitals are eligible for payment for a six-month operating period at this time.

April 4, 2020: CDC Post: Cloth Face Covers Guidance to Help Slow the Spread of COVID-19

The CDC posted guidance regarding cloth face covers including the following:

• Recommendations regarding the use of cloth face coverings,
• How to wear a face cloth,
• Sew and no sew instructions for a face cloth, and
• Cloth face covers FAQs.

April 6, 2020: FDA Coronavirus Daily Update: Diagnostics Update to Date

• The FDA has worked with more than 270 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect COVID-19.
• To date, 28 emergency use authorizations have been issued for diagnostic tests.
• The FDA has been notified that more than 145 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
• The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.

April 6, 2020: OIG Issues Policy Statement and FAQs Regarding Application of Certain Administrative Enforcement Authorities Due to Declaration of COVID-19 Outbreak

The OIG issued the Policy Statement to “notify interested parties that OIG will exercise its enforcement discretion not to impose administrative sanctions under the Federal anti-kickback statute for certain remuneration related to COVID-19 covered by the Blanket Waivers of Section 1877(g) of the Social Security Act (the Act) issued by the Secretary on March 30, 2020 (the Blanket Waivers), subject to the conditions specified herein.”

The OIG also provided a link to a related FAQ webpage where they encourage providers to submit questions regarding how OIG would view an arrangement that is directly connected to the public health emergency. Currently, OIG offers an answer to the following question:

• Can health care providers and practitioners furnish services, not to exceed their scope of practice, for free or at a reduced rate, to assist skilled nursing facilities (SNFSs) or other long-term-care providers that are facing staffing shortages due to the COVID-19 outbreak?

April 7, 2020: Eli Lilly Announces New $35 Co-Pay Available

Eli Lilly introduced the Lilly Insulin Value Program. Mike Mason, president, Lilly Diabetes noted in the announcement that “too many people in the U.S. have lost their jobs because of the COVID-19 crises, and we want to make sure that no one goes without their Lilly insulin…we’ve been providing affordability solutions for a long time, but more is needed to help people during this unprecedented period.” About the Program

• The program became effective on April 7th and covers most Lilly insulins including all Humalog® (insulin lispro injection 100 units/mL) formulations.
• This Program is for people with commercial insurance and those without insurance to be able to fill their monthly prescription of Lilly insulin for $35.
• The savings can be obtained by calling the Lilly Diabetes Solution Center at (833) 808-1234. The Center is open 8 am to 8 pm (EDT) Monday through Friday.

April 7, 2020: CMS Waivers and COVID-19 Response Call

During this call the CMS provided updates on recent CMS actions taken to address the COVID-19 public health emergency. You can view the call slide deck at https://www.cms.gov/files/document/cms-waivers-and-covid-19-response.pdf.

April 7, 2020: CMS Letter to Clinicians

CMS posted a Letter outlining a summary of actions taken by CMS to ensure clinicians have maximum flexibility to provide patient care during the COVID-19 outbreak. This summary includes information about telehealth and virtual visits, accelerated and advanced payments, and recent waiver information.

April 7, 2020: CMS Updates Non-Emergent, Elective Medical Services, and Treatment Recommendations Document

CMS initially announced in a March 18th Press Release that all elective surgeries, non-essential medical, surgical, and dental procedures be delayed during the 2019 Novel Coronavirus (COVID-19) outbreak.

Working with medical societies and association, CMS announced on April 7th that the recommendations to limit medical services that can be deferred. “A tiered framework is recommended to prioritize services and care to those who require emergent or urgent attention to save a life, manage a severe disease, or avoid further harms from an underlying condition.”

April 8, 2020: CMS Issues New Wave of Infection Control Guidance

Based on CDC guidelines, CMS announced in April 8th Press Release a new wave of infection control guidance for several health settings. “For hospitals, psychiatric hospitals and CAHs, the revised guidance, for example, provides expanded recommendations on screening and visitation restrictions, discharge to subsequent care locations for patients with COVID-19, recommendations related to staff screening and testing, and return-to-work policies.”

April 9, 2020: CMS Temporarily Suspends a Number of Rule to Boost Frontline Medical Staff

Changes affecting doctors, nurses, and other clinicians were announced focusing “on reducing supervision and certification requirements so that practitioners can be hired quickly and perform work to the fullest extent of their licenses. The new waivers sharply expand the workforce flexibilities CMS announced on March 30.” This Press Release provides a link to a complete list of waivers announced today and in recent weeks.

April 9, 2020: COVID-19 FAQs on Medicare Fee-for-Service (FFS) Billing – Updated

CMS announced in Special Edition MLN Connects that the COVID-19 FAQs have been updated. They advise that you check this resource often as it is updated on a regular basis. They noted that a date is added at the end of an FAQ when it is new or the content has been updated. As of Monday April 13th this 38 page document included FAQs related to the following topics:

• Payment for specimen collection for purposed of COVID-19 testing,
• Diagnostic laboratory services,
• Hospital services,
• Ambulance services,
• Rural Health Clinics and Federally Qualified Health Centers,
• Medicare telehealth. (CMS notes this document does not include flexibilities that might be exercised under the CARES Act),
• Physician Services
• Home Infusion Services,
• Accountable Care Organizations,
• Opioid Treatment Programs,
• Inpatient Rehabilitation Facility services,
• Skilled Nursing Facility services,
• General billing requirement,
• Home Health,
• Drugs and Vaccines under Part B,
• Medicare payment to facilities accepting government resources, and
• Oxygen

April 10, 2020: MLN SE20011 Medicare Fee-for-Service Response to the Public Health Emergency on the Coronavirus (COVID-10) Revised

Following is a list of revisions made to this MLN article:

• Link to all the blanket waivers related to COVID-19,
• Provide place of service coding guidance for telehealth claims,
• Link to the Telehealth Video for COVID-19,
• Add information on the waiver of coinsurance and deductibles for certain testing and related services,
• Add information on the expanded use of ambulance origin/destination modifiers,
• Provide new specimen collection codes for clinical diagnostic laboratories billing, and
• Add guidance regarding delivering notices to beneficiaries.

April 10, 2020: Special MLNConnects – Sequestration Adjustment Suspended

CMS announced in an April 10th Special Edition MLNConnects that Section 3709 of the CARES Act temporarily suspends the 2% payment adjustment currently applied to all Medicare Fee-for-Service (FFS) claims due to sequestration. The suspension is effective for claims with dates of service from May 1 through December 31, 2020.

April 11, 2020: Expanded Coverage for Essential Diagnostic Services amid COVID-19 Public Health Emergency

The CMS and the Departments of Labor and the Treasury announced in a CMS Press Release that guidance has been issued ensuring Americans with private health insurance have coverage of COVID-19 diagnostic testing and certain other related services, including antibody testing, at no cost. The guidance is made available in the format of an FAQ Document. Following are just a few of the questions that are answered in the guidance:

• The types of group health plans and health insurance that are subject to this guidance,
• What plans are insurers are required to comply with and for how long, and
• What items and services plans and insurers must provide.

April 13, 2020: United Healthcare Waiving CMS Originating Site Restriction & Audio-Video Requirement

The UnitedHealthcare Telehealth webpage was most recently updated on April 13, 2020. Included on this page is the announcement that they will be waiving the CMS originating site restriction and audio-video requirement for Medicare Advantage, Medicaid, and Individual and Group Market health plan members from March 18, 2020 until June 18, 2020. You can read the entire announcement on the UnitedHealthcare COVID-19 Telehealth webpage at: https://www.uhcprovider.com/en/resource-library/news/Novel-Coronavirus-COVID-19/covid19-telehealth-services/covid19-telehealth-services-telehealth.html.

April 13, 2020: Immediate Infusion of $30 Billion into the Health Care System

Late Monday afternoon I started receiving the following notice in my inbox from different MACs around the country:

“Recognizing the importance of delivering funds in a fast and transparent manner, $30 billion is being distributed immediately through a program administered by the Department of Health and Human Services – with payments arriving via direct deposit beginning April 10, 2020 – to eligible providers throughout the American health care system. These payments are unrelated to the Accelerated and Advanced Payments you may have requested from Medicare.

The automatic payments will come from Optum Bank with "HHSPAYMENT" as the payment description. Find more information about these payments at http://www.hhs.gov/provider-relief/index.html.”

When you access the hhs.gov webpage, the announcement includes the following bolded sentence: These are payments, not loans, to healthcare providers, and will not need to be repaid.

March 30, 2020: OIG Released Strategic Plan for the Next Five Years (2020-2025)

On March 30th, the OIG published their Strategic Plan for the next five years (2020-2025).  Christi A. Grimm, Principal Deputy Inspector General, notes that this “plan is dynamic to accommodate a rapidly changing health and human services environment, including emergent threats and vulnerabilities. This Strategic Plan is a roadmap to guide our entire multidisciplinary workforce in planning and conducting the most consequential oversight work, optimizing use of our available resources and delivering results for our stakeholders. To support our workforce, OIG will continue to prioritize investment in data analytics, technology, expertise, and training. This strengthens OIG’s modern approach to oversight that allows us to quickly adapt to emerging risks, including the corona virus disease 2019 (COVID-19) pandemic.”

The Strategic Plan includes examples of past accomplishments related to their three stated Goals.

Goal 1: Fight Fraud, Waste and Abuse

Past Accomplishment: Nationwide Brace Scam

• April 2019: With law enforcement partners, OIG dismantled one of the largest fraud schemes involving telemedicine and medically unnecessary back, shoulder, wrist and knee braces.
• Impact: Twenty-four defendants were charged for allegedly participating in the scheme, in which over $1.7 billion in Medicare claims were fraudulently submitted.

Goal 2: Promote Quality, Safety and Value

Past Accomplishment: Identifying and Combating Potential Abuse and Neglect of Beneficiaries

• OIG issued an early alert followed by two June 2019 reports identifying thousands of Medicare claims that indicate abuse and neglect of Medicare beneficiaries.
• Impact: CMS has provided details about actions taken and plans to take ensuring incidents of potential abuse or neglect in SNFs are identified and reported.

Goal 3: Advance Excellence and Innovation

Past Accomplishment: Data at OIG’s Fingertips

• Self-service data and analytics tools empower OIG to use data proactively.
• Impact: OIG has created portals offering access to data analytics tools used to oversee the Medicare programs and also enable grants oversight work.

April 3, 2020: OIG Report – Hospital Experiences Responding to the COVID-19 Pandemic: Results of a National Pulse Survey March 23 – 27, 2020

On April 3rd, the OIG provided their findings from a survey they conducted with a goal of being able to provide decision makers “with a national snapshot of hospitals’ challenges and needs in responding to the coronavirus 2019 (COVID-19) pandemic. The information represents brief telephone interview (“pulse surveys”) conducted March 23-27, 2020 with hospital administrators from 323 hospitals across 46 States, the District of Columbia, and Puerto Rico. The rate of contact with this random sample was 85 percent.

If you have been following the barrage of COVID-19 news available via television, radio, internet, it shouldn’t surprise you that the following list represents the most significant challenges reported by hospitals:

• Severe shortages of testing supplies and extended waits for results,
• Widespread shortages of Personal Protective Equipment (PPE),
• Difficulty maintaining adequate staffing and supporting staff,
• Difficulty maintaining and expanding hospital capacity to treat patients,
• Shortages of critical supplies, materials, and logistic support,
• Anticipated shortages of ventilators,
• Increased costs and decreased revenue, and
• Changing and sometimes inconsistent guidance.

It is important to note that there are five different instances in this report where the OIG reminds the reader “the hospital input and suggestions in this report reflect a specific point in time- March 23-27, 2020. We recognize that HHS is also getting input from hospitals and other frontline responders and has already taken and continues to take actions” related to findings in this report. 

On April 6, 2020 Rick Pollack, President and CEO of the American Hospital Association (AHA), released a Statement on HHS OIG Report. In the statement, he opened by noting this report is important and timely and “the HHS Office of the Inspector General accurately captures the crisis that hospitals and health systems, physicians and nurses on the front lines face of not having enough personal protective equipment (PPE), medical supplies and equipment in their fight against COVID-19.” He ends the AHA Statement with the following: “The AHA continues to urge that all possible levers be used by both the government and the private sector to ensure front line heroic providers battling against COVID-19 have what they need for protection and to provide care for their patients and communities -- countless lives are depending on it.”

A Full Summary and the Report are available on the OIG website.

April 8, 2020: OIG Releases Notice of Recently Added OIG Work Plan Items

Just five days after the Pulse Survey Report was released, the OIG updated their OIG Work Plan with the following items related to COVID-19:

You can access the entire OIG Work Plan at: https://go.usa.gov/xvjmP.

COVID-19 Portal

In addition to the Strategic Plan, Survey and Work Plan, the OIG has also created a COVID-19 Portal on their website. The portal provides links to information about COVID-19 Fraud, Infectious Disease Preparedness and Response and Policy Statements and Guidance. Additionally, you can find links to resources, recent new put out by the OIG and the opportunity to submit questions regarding OIG’s authorities during the COVID-19 public health emergency.

On March 26, 2019, the National Coverage Determination (NCD) 20.4: Implantable Cardiac Defibrillators (ICDs) was updated to reflect changes in the February 15, 2018 Final Decision Memo (CAG-00157R4).  Almost a year later, on March 3, 2020, CMS released MLN Matters article SE2006 updating provider on Medicare coverage rules and policies for NCD 20.4.

Background

This MLN article addresses concerns that CMS has received related to the following three indications in the NCD 20.4:

• Patients with a prior Myocardial Infarction (MI) and a measured left ventricular ejection fraction (LVEF) ≤30,
• Patients who have severe ischemic dilated cardiomyopathy but no personal history of sustained ventricular tachycardia (VT) or cardiac arrest due to ventricular fibrillation (VF), and have NYHA Class II or II heart Failure, LVEF ≤ 35 percent, and
• Patients who have severe non-ischemic dilated cardiomyopathy but no personal history of cardiac arrest or sustained VT, NYHA Class II or III heart failure, LVEF ≤ 35 percent, and been on optimal medical therapy for at least 3 months.
  

Response to Concerns

Concern: Heart Failure ICD-10 Codes Requirement

“CMS believes that perhaps some have misinterpreted correct coding principles with respect to the use of” the ICD-10 heart failure diagnosis codes (I150.21, I50.22, I50.23, I50.41, I50.42, and I50.43).

CMS Response: CMS agrees that patients do not have to have “active heart failure” to qualify for an ICD and notes that patients “also do not have to have “active heart failure” in order to append one of these codes as required based on NCD language. CMS notes when a patient has had to undergo treatment at some time in the past for clinical signs and symptoms of heart failure and his or her left ventricular function is still impaired, it would be appropriate to code a heart failure code. 

Concern: CMS has received a suggestion that the unspecific heart failure code (I50.9) should be added to the covered codes for this NCD.

CMS Response: CMS disagrees with the addition of this code as “one cannot determine what type of heart failure may be, or may have been present.”

Concern: Related articles outlining the coding requirements (including heart failure codes) are more restrictive than the NCD.

MMP Reminder: CPT/HCPCS and ICD-10 Codes are not published in NCD 20.4. Rather, they can be found in the following related Medicare Administrative Contractor Articles:

• First Coast JN (A56341)
• NGS J6/JK (A56326)
• Noridian JE (A56340)
• Noridian JF (A56342)
• Novitas JH/JL (A56355)
• Palmetto JJ/JM (A56343)
• WPS J5/J8 (A56391)

CMS Response: CMS disagrees and asserts that the articles are not more restrictive. They do agree that “the NCD does not specifically use the terms encompassed by the heart failure code descriptors.”

CMS concludes this MLN article ends with the following statement:

“It is incumbent upon the provider to select the proper code(s). We believe the listed covered codes encompass the various clinical scenarios that occur for patients who meet the NCD coverage requirements and are provided, not to write additional parameters into the NCD, but to ensure there is an appropriate code for the covered indications.”

You can read more about specific changes made in the Final Decision Memo in a related MMP article at http://www.mmplusinc.com/news-articles/item/ncd-20-4-implantable-cardiac-defibrillators-icds. 

Resources

NCD 20.4: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=110

MLN Matters SE20006: https://www.cms.gov/files/document/se20006.pdf

MMP remains committed to continuously monitoring COVID-19 updates specific to our reader base. As such, following is a time-line of key announcements occurring within the last week including sweeping regulatory changes announced by CMS after 5pm on Monday March 30th.   

March 23, 2020: CMS Updates FAQs on Coding & Billing COVID-19

This updated FAQ document addresses questions related to the following:

• Diagnostic Lab Services,
• Physicians’ Services,
• Home Health,
• Hospital Services,
• Drugs and Vaccines Under Part B,
• Ambulance Services, and
• Medicare Payments to Facilities Accepting Government Resources.

March 23, 2020: CMS Posts ICD-10 MS-DRG Version 37.1 R1 Effective April 1, 2020

The CDC and National Center for Health Statistics is implementing the new diagnosis code, U07.1, COVID-19, into the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) effective April 1, 2020. The ICD-10 MCE Version 37.1 R1 uses edits for the ICD-10 codes reported to validate correct coding on claims for discharges on or after April 1, 2020. The ICD-10 MS-DRG Grouper software package to accommodate this new code, Version 37.1R1, is effective for discharges on or after April 1, 2020. Assignment of new ICD-10-CM diagnosis code U07.1, COVID-19, is as follows:

 This announcement also indicates that if diagnosis code U07.1, COVID-19, is reported as a principal diagnosis, it will only exclude itself from acting as a MCC under the CC Exclusion List.

March 23, 2020: Cigna Waives Prior Authorization for Transfer of non-COVID-19 customers to In-Network LTACHs

On March 23rd Cigna announced that “Effective today, Cigna will waive prior authorizations for the transfer of its non-COVID-19 customers from acute inpatient hospitals to in-network LTACHs. In place of prior authorizations, Cigna will require notification from the LTACH on the next business day following the transfer. This policy will remain in place through May 31, 2020 and applies to Cigna commercial and Medicare Advantage plans. Cigna has also waived prior authorizations for the transfer of its patients to other in-network subacute facilities, including skilled nursing facilities and acute rehab centers.” This is the latest effort made by Cigna to protect customers against COVID-19. You can read about additional efforts over the past two weeks in the Announcement.

March 24, 2020: United Healthcare Reduces Prior Authorization Requirements

On March 24th, UnitedHealthcare posted an Announcement about efforts in response to COVID-19. The following provision related to post-acute care settings is in this announcement:

• Suspension of prior authorization requirements to a post-acute care setting effective March 24, 2020 through May 31, 2020. Details:
• Waiving prior authorization for admissions to: long-term care acute facilities (LTAC), acute inpatient rehabilitation (AIR), and skilled nursing facilities (SNF).
• Consistent with existing policy, the admitting provider must notify us within 48 hours of transfer and penalties still apply.
• Length of stay reviews still apply, including denials for days that exceed approved length.
• Discharges to home health will not require prior authorization.
• Prior authorization is not required for COVID-19 testing and COVID-19 testing related visits.

This announcement also provides detail regarding suspension of prior authorization requirements when a member transfers to a new provider and a link to a surgical code list of procedures in which site of service reviews are being suspended until April 30th, 2020.  

March 24, 2020: OIG FAQs - Waiving Telehealth Cost-Sharing During COVID-10 Outbreak

On March 17, 2020, OIG issued “OIG Policy Statement Regarding Physicians and Other Practitioners That Reduce or Waive Amounts Owed by Federal Health Care Program Beneficiaries for Telehealth Services During the 2019 Novel Coronavirus (COVID-19) Outbreak.”

Since the issuance of the Policy Statement, OIG has received questions regarding the scope of the Policy Statement. The OIG has compiled responses to frequently asked questions related to the Policy Statement in an FAQ document and reports they will update the FAQ document as they receive additional questions.

March 24, 2020: Activation of Systematic Validation Edits for OPPS Providers with Multiple Service Locations – Delayed Until Further Notice

On September 5, 2019 CMS announced a delay of full implementations until April 2020. You can read more about this requirement in a related MMP article at http://www.mmplusinc.com/news-articles/item/claim-edits-for-reporting-of-service-locations.

On March 24th, 2020, CMS announced a delay until further notice for the activation of Systematic Validation Edits for OPPS Providers with Multiple Service Locations. While this is not specifically COVID-19 related, I imagine the delay until further notice is in response to the COVID-19 pandemic.

• MLN SE189007: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE19007.pdf

March 24, 2020: Notice of Emergency Use Authorization Declaration

In a March 24, 2020 Federal Register, post the Secretary of Health and Human Services made the “determination of a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves the novel (new) coronavirus, SARS-CoV-2.”

Based on this determination the Secretary “declared that circumstances exist justifying the authorization of emergency use of medical devices, including alternative products used as medical devices, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.”

March 24, 2020: Cost Report Filing Extensions

Palmetto GBA updated providers about Cost Report filing extensions through the following Q&A:  

Question: Will CMS delay the filing deadline of Fiscal Year End (FYE) December 31, 2019 cost reports due at the end of May due to the Covid-19 outbreak?
Answer: Yes, 42 CFR § 413.24 (f) (2) (ii) allows this flexibility. CMS is currently authorizing delay for the following FYE dates.
 
The filing deadline for the following cost reports are now June 30, 2020:

• FYE October 31, 2019 due by March 31, 2020
• FYE November 30, 2019 due by April 30, 2020

The filing deadline for FYE December 31, 2019 is now July 31, 2020. This is a blanket extension; you do not need to send a request.

March 24, 2020: AHA and AHIMA FAQs Regarding ICD-10-CM Coding for COVID-19 Revised

This FAQ Document was jointly developed and approved by the American Hospital Association Central Office on ICD-10-CM/PCS and the American Health Information Management Association. MMP encourages you to share this information with your Coders and Clinical Documentation Integrity (CDI) Specialists.

March 25, 2020: CDC Posts ICD-10-CM April 1, 2020 Addenda

The April 1, 2020 Addenda posted by the CDC on March 25th includes guidance for the new Vaping Related Disorder as well as COVID-19.

March 25, 2020: OIG Coronavirus Portal

The OIG announced the creation of a Portal for all information and announcements related to COVID-19. The portal can be accessed from OIG’s main website or directly at oig.hhs.gov/coronavirus. The OIG is asking for feedback from individuals or entities who need clarification on its oversight authorities during the coronavirus (COVID-19) pandemic.

March 26, 2020: CMS News Alert

CMS summarized recent actions they have taken in response to COVID-19 in a March 26, 2020 Press Release . “To keep up with the important work the Task Force is doing in response to COVID-19, click here www.coronavirus.gov. For information specific to CMS, please visit the CMS News Room and Current Emergencies Website.”

March 26, 2020: Special Thursday Edition MLNConnects: Beneficiary Notices Delivery Guidance

In a special MLNConnects notice CMS has finally provided hospitals with guidance on how to handle providing beneficiary notices to patients with suspected or confirmed COVID-19. Specifically, “CMS encourages the provider community to be diligent and safe while issuing the following beneficiary notices to beneficiaries receiving institutional care:

• Important Message from Medicare   (IM)_CMS-10065
• Detailed Notices of Discharge   (DND)_CMS-10066
• Notice of Medicare Non-Coverage   (NOMNC)_CMS-10123
• Detailed Explanation of Non-Coverage   (DENC)_CMS-10124
• Medicare Outpatient Observation Notice   (MOON)_CMS-10611
• Advance Beneficiary Notice of Non-Coverage   (ABN)_CMS-R-131
• Skilled Nursing Advance Beneficiary Notice of Non-Coverage   (SNFABN)_CMS-10055
• Hospital Issued Notices of Non-Coverage   (HINN)

In light of concerns related to COVID-19, current notice delivery instructions provide flexibilities for delivering notices to beneficiaries in isolation. These procedures include: 

• Hard copies of notices may be dropped off with a beneficiary by any hospital worker able to enter a room safely. A contact phone number should be provided for a beneficiary to ask questions about the notice, if the individual delivering the notice is unable to do so. If a hard copy of the notice cannot be dropped off, notices to beneficiaries may also delivered via email, if a beneficiary has access in the isolation room. The notices should be annotated with the circumstances of the delivery, including the person delivering the notice, and when and to where the email was sent.
• Notice delivery may be made via telephone or secure email to beneficiary representatives who are offsite. The notices should be annotated with the circumstances of the delivery, including the person delivering the notice via telephone, and the time of the call, or when and to where the email was sent.

CMS encourages providers to review all of the specifics of notice delivery, as set forth in Chapter 30 of the Medicare Claims Processing Manual. https://www.cms.gov/media/137111”

CMS also included the following two FAQ Documents in this special MLNConnects edition:

• 2019-Novel Coronavirus (COVID-19) Medicare Provider Enrollment Relief FAQ, and
• Enforcing Open Payment Deadlines FAQ.

March 27, 2020: CMS Provides Additional Instructions RE: Relief in Quality Reporting Programs

CMS initially announced relief for clinicians, providers, hospitals and facilities participating in quality reporting programs in response to the 2019 Novel Coronavirus (COVID-19). On March 27th CMS provided a Memorandum and Fact Sheet as supplements providing additional guidance to health care providers.

March 23, 2020: CMS Approves Medicaid Section 1135 Waivers for 11 Additional States in Response to COVID-19

The Centers for Medicare & Medicaid Services (CMS) approved an additional 11 state Medicaid waiver requests under Section 1135 of the Social Security Act (Act), bringing the total number of approved Section 1135 waivers for states to 13. States approved waivers include the following states:

• Alabama,
• Arizona
• California
• Illinois
• Louisiana
• Mississippi
• New Hampshire
• New Jersey
• New Mexico
• North Carolina
• Virginia

Examples of waivers available under section 1135 of the Act include:

• Temporarily suspend prior authorization requirements;
• Extend existing authorizations for services through the end of the public health emergency;
• Modify certain timeline requirements for state fair hearings and appeals;
• Relax provider enrollment requirements to allow states to more quickly enroll out-of-state or other new providers to expand access to care, and
• Relax public notice and submission deadlines for certain COVID-19 focused Medicaid state plan amendments, enabling states to make changes faster and ensure they can be retroactive to the beginning of the emergency.

These section 1135 waivers are effective March 1, 2020 and will end upon termination of the public health emergency, including any extensions. Last week, CMS approved COVID-19 related state Medicaid section 1135 waiver requests for Florida and Washington. Link to Press Release: https://www.cms.gov/newsroom/press-releases/cms-approves-medicaid-section-1135-waivers-11-additional-states-response-covid-19

March 27, 2020: CMS Approves Additional 1135 Waivers Bringing Total Number of Waivers to 29

New York, Colorado, Hawaii, Idaho, Massachusetts and Maryland have also been granted 1135 waivers. In this announcement CMS also issued important Clinical Laboratory Improvement Amendments (CLIA) Guidance. You can find additional details here: https://www.cms.gov/newsroom/press-releases/cms-news-alert-march-27-2020

March 27, 2020: 34th State Request for Medicaid Emergency Waivers

Included in this Press Release is “guidance to states on how to apply for Section 1135 waivers through the Medicaid Disaster Response Tool Kit, which can be found here. To further the agency’s efforts, CMS has developed checklists and tools to expedite  COVID-19 virus requests and approvals for waivers and other commonly requested flexibilities during the current public health emergency.  Home and community based program resources can be found here.”

March 28, 2020: CMS Expands Accelerated and Advanced Payment Program

In a March 28 Press Release, CMS announced an expansion of its accelerated and advance payment program for Medicare participating health care providers and suppliers. This expansion includes changes from the recently enacted Coronavirus Aid, Relief, and Economic Security (CARES) Act.

Accelerated and advance Medicare payments provide emergency funding and addresses cash flow issues based on historical payments when there is disruption in claims submission and/or claims processing. These expedited payments are typically offered in natural disasters to accelerate cash flow to the impacted health care providers and suppliers. In this situation, CMS is expanding the program for all Medicare providers throughout the country during the public health emergency related to COVID-19.  The payments can be requested by hospitals, doctors, durable medical equipment suppliers and other Medicare Part A and Part B providers and suppliers.

To qualify for accelerated or advance payments, the provider or supplier must:

• Have billed Medicare for claims within 180 days immediately prior to the date of signature on the provider’s/ supplier’s request form,
• Not be in bankruptcy,
• Not be under active medical review or program integrity investigation, and
• Not have any outstanding delinquent Medicare overpayments.

Medicare will start accepting and processing the Accelerated/Advance Payment Requests immediately. CMS anticipates that the payments will be issued within seven days of the provider’s request. 

CMS has established COVID-19 hotlines at each MAC to assist providers with their accelerated payment requests. MAC hotline numbers as well Details on the eligibility and the request process and MAC hotline numbers can be found in a related Fact Sheet.  The expansion of this program is only for the duration of the public health emergency.

March 29, 2020: Trump Administration Engages America’s Hospitals in Unprecedented Data Sharing

On Sunday March 29th CMS announced that letters had been sent to the nation’s hospitals on behalf of Vice President Pence requesting data in connection with their efforts to fight COVID-19 be reported to CMS. Following is what data CMS is requesting:

• Hospitals report COVID-19 testing to the U.S. Department of Health and Human Services (HHS),
• Daily reporting regarding bed capacity and supplies to the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) COVID-19 Patient Impact and Hospital Capacity Module.

To ensure patient privacy, data reported will be not include personal identifying information.

CMS Administrator Seema Verma notes in the announcement, “the nation’s nearly 4,700 hospitals have access to testing data that’s updated daily. This data will help us better support hospitals to address their supply and capacity needs, as well as strengthen our surveillance efforts across the country…America’s hospitals are demonstrating incredible resilience in this unprecedented situation and we look forward to partnering with them going forward.”

March 30, 2020: CMS Makes Sweeping Waivers

At 5:32 PM on March 30th, CMS updated their Coronavirus Waivers and Flexibilities webpage by posting provider-specific fact sheets on new waivers and flexibilities for the following providers:

• Physicians and Other Practitioners (PDF)
• Ambulances (PDF)
• Hospitals (PDF)
• Teaching Hospitals, Teaching Physicians and Medical Residents (PDF)
• Long Term Care Facilities (Skilled Nursing Facilities and/or Nursing Facilities) (PDF)
• Home Health Agencies (PDF)
• Hospices (PDF)
• Inpatient Rehabilitation Facilities (PDF)
• Long Term Care Hospitals & Extended Neoplastic Disease Care Hospitals (PDF)
• Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) (PDF)
• Laboratories (PDF)
• End Stage Renal Disease (ESRD) Facilities (PDF)
• Durable Medical Equipment (PDF)
• Participants in the Medicare Diabetes Prevention Program (PDF)
• Medicare Advantage and Part D Plans (PDF)

The document specific to hospitals indicates that “the Trump Administration is issuing an unprecedented array of temporary regulatory waivers and new rules to equip the American healthcare system with maximum flexibility to respond to the 2019 Novel Coronavirus (COVID-19) pandemic. Made possible by President Trump’s recent emergency declaration and emergency rule making, these temporary changes will apply immediately across the entire U.S. healthcare system for the duration of the emergency declaration.” Following are a few examples of waivers and flexibilities specific to Hospitals:

Limit Discharge Planning for Hospital and CAHs: To allow hospitals and CAHs more time to focus on increasing care demands, discharge planning will focus on ensuring that patients are discharged to an appropriate setting with the necessary medical information and goals of care. CMS is waiving detailed regulatory requirements to provide information regarding discharge planning, as outlined in 42 CFR §482.43(a)(8), §482.61(e), and 485.642(a)(8). The hospital, psychiatric hospital, and CAH must assist patients, their families, or the patient’s representative in selecting a post-acute care provider by using and sharing data that includes, but is not limited to, home health agency (HHA), skilled nursing facility (SNF), inpatient rehabilitation facility (IRF), and long term care hospital (LTCH) data on quality measures and data on resource use measures. The hospital must ensure that the post-acute care data on quality measures and data on resource use measures is relevant and applicable to the patient’s goals of care and treatment preferences. During this public health emergency, a hospital may not be able to assist patients in using quality measures and data to select a nursing home or home health agency, but must still work with families to ensure that the patient discharge is to a post-acute care provide that is able to meet the patient’s care needs.

Utilization review: CMS is waiving these requirements at 42 CFR §482.1(a)(3) and 42 C.F.R §482.30, that requires that hospitals participating in Medicare and Medicaid to have a utilization review plan that meets specified requirements. CMS is waiving the entire Utilization Review CoP at §482.30, which requires that a hospital must have a utilization review (UR) plan with a UR committee that provides for review of services furnished to Medicare and Medicaid beneficiaries to evaluate the medical necessity of the admission, duration of stay, and services provided. These flexibilities should be implemented so long as they are not inconsistent with a State or pandemic/emergency plan. Removing these administrative requirements will allow hospitals to focus more resources on providing direct patient care.

Nursing services: CMS is waiving the provision at 42 CFR 482.23(b)(4), 42 CFR 482.23(b)(7), and 485.635(d)(4), which requires the nursing staff to develop and keep current a nursing care plan for each patient, and the provision that requires the hospital to have policies and procedures in place establishing which outpatient departments are not required under to have a registered nurse present. These waivers allow nurses increased time to meeting the clinical care needs of each patient and allows for the provision of nursing care to an increased number of patients. In addition, we expect that hospitals will need relief for the provision of inpatient services and as a result, the requirement to establish nursing-related policies and procedures for outpatient departments is likely unnecessary. These flexibilities apply to both hospitals and CAHs, and should be implemented so long as they are not inconsistent with a State or pandemic/emergency plan.

I strongly encourage hospitals take the time to read this entire ten page document.

Background

Last June CMS released a Final Decision Memo (CAG-00430R) for Transcatheter Aortic Valve Replacement (TAVR) Procedures. This procedure is for the treatment of symptomatic aortic valve stenosis where a biprosthetic valve is inserted percutaneously using a catheter and implanted in the orifice of the native aortic valve.

Final Decision Memo: What Did Not Change

Coverage under Evidence Development

The requirement that a procedure be performed under Coverage with Evidence Development (CED) did not change in the Final Decision Memo. CED means that the service is only covered in the context of a clinical trial (such as a national registry or a clinical study). This allows limited coverage for Medicare beneficiaries in a controlled environment while determining the efficacy, risks, and outcomes of the procedure. Once a new technology or procedure is proven to be safe and effective, CMS may remove the CED requirement and cover the procedure outright within set criteria.

• TAVR is covered according to CMS criteria when the procedure is furnished with a complete aortic valve and implantation system that has received FDA premarket approval (PMA) for that system’s FDA approved indication and the heart team and hospital are participating in a prospective, national, audited registry.
• TAVR is covered for uses that are not expressly listed as an FDA-approved indication when performed within a clinical study that fulfills criteria set forth in the decision memo.

Link to CMS TAVR CED webpage: https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/TAVR

The Heart Team

• The patient (preoperatively and postoperatively) is under the care of a heart team: a cohesive, multi-disciplinary, team of medical professionals:
• The heart team’s interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TAVR; and
• TAVR must be furnished in a hospital with the appropriate infrastructure.

Final Decision Memo: What Did Change

Pre-Procedure Patient Evaluation Requirements

Historically, the TAVR National Coverage Determination (NCD) 20.32 required a face-to-face evaluation of a patient’s suitability for TAVR surgery by two cardiac surgeons. The most recent Final Decision Memo changed the requirement from two cardiac surgeons to a cardiac surgeon and an interventional cardiologist. This change is in line with the requirement of the heart team’s interventional cardiologist(s) and cardiac surgeon(s) jointly participating in the intra-operative technical aspects of TAVR. Following is specific guidance from the Final Decision Memo:

• “The heart team includes the following:
• Cardiac surgeon and an interventional cardiologist experienced in the care and treatment of aortic stenosis who have:
• Independently examined the patient face-to-face, evaluated the patient’s suitability for surgical aortic valve replacement (SAVR), TAVR or medical or palliative therapy;
• Documented and made available to the other team members the rationale for their clinical judgement.
• Providers from other physician groups as well as advanced patient practitioners, nurses, research personnel and administrators.”

Note, in general, I have seen most denials from Medicare Contractors for this procedure being due to a lack of documentation of a face-to-face encounter by two surgeons. What I have found in performing claim reviews for MMP clients is that often there was documentation from a surgeon and an interventional cardiologist which now meets the face-to-face requirement.

Hospital Specific Procedure Volumes

The prior version of the NCD and Final Decision memo both required certain volumes of procedures for the hospital and the heart team based on whether they had previous TAVR experience or not.

For example, hospitals with no previous TAVR experience, the volume of Aortic Valve Replacements has decreased while a specific volume of open heart surgeries and having at least one physician with interventional cardiology privileges has been added to the NCD. Whether or not you currently perform TAVR procedures or are in the planning phase of performing these procedures, I encourage you to review the new requirements in NCD 20.32.

August 16, 2019 FDA Announcement:  FDA Expands Indication for Several Transcatheter Heart Valves to Patients at Low Risk for Death or Major Complications Associated with Open-Heart Surgery

Last August, “the U.S. Food and Drug Administration today approved an expanded indication for several transcatheter heart valves to include patients with severe aortic valve stenosis (a narrowing of the heart’s aortic valve that restricts blood flow to aorta, the body’s main artery) who are at low risk for death or major complications associated with open-heart surgery to replace the damaged valves. These transcatheter valves – Sapien 3, Sapien 3 Ultra, CoreValve Evolut R and CoreValve Evolut PRO – were previously indicated only for patients at intermediate or higher risk for death or major complications during open-heart surgery.

In low risk patients, open-heart surgery has been the standard-of-care for aortic valve replacement. However, the procedure to insert a transcatheter heart valve is less invasive, and involves a smaller incision and shorter recovery time than open-heart surgery. The FDA is the first medical products regulatory body in the world to expand the indication for these devices to patients at low risk for death or major complications associated with open-heart surgery.”

Final Decision Memo Changes are Now Effective

• Effective Date: June 21, 2019
• Implementation Date: June 12, 2020.

As always, with Decision Memos, the requirements are not effective until the NCD is updated and implemented. However, NCD revisions generally revert to the effective date of the Decision Memo, which is in this case June 21, 2019.

On Friday March 13th CMS published Change Request (CR) 11660  informing Medicare Administrative Contractors (MACs) that effective June 21, 2019, CMS will continue to cover TAVR under CED when the procedure is furnished for the treatment of symptomatic aortic stenosis and according to an FDA approved indication for use with an approved device, in addition to the coverage criteria outlined in the NCD manual. The Implementation date is June 12, 2020.

On Tuesday 3/24/2020 CMS published related MLN Matters Article MM11660.

TAVR Hospital “To Do” List

• Read the updated NCD carefully, making sure you are following all of Medicare’s requirements.
• Ensure your medical record contains documentation of the face-to-face patient examinations by a cardiac surgeon and an interventional cardiologist (experienced in the care and treatment of aortic stenosis) evaluated the patient’s suitability for SAVR, TAVR or medical or palliative therapy;
• Ensure your hospital has the appropriate infrastructure for the procedure;
• Assess your hospital and heart team volumes to be sure you meet the requirements for performing the procedure under the new Decision Memo; and
• Ensure the patient is under the care of a heart team and the heart team’s interventional cardiologist(s) and cardiac surgeon(s) jointly participate in the intra-operative technical aspects of TAVR.