Knowledge Base Category -

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

Resource Spotlight: Tips for Voters

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

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

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

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

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

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

New: 10/20/20”

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

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

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

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

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

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

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

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

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

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

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

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

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

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

CDC COVID Data Tracker – United States COVID-19 Cases

October MAC Talk: The Local Scene

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Resource Spotlight: Hypertension Control Call to Action by Surgeon General

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

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

October 8, 2020: CMS Halt to Advance Payment Applications

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Resource Spotlight: CDC Updates Guidance on How Coronavirus Spreads

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

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

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

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

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

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

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

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

CMS summarized the IFC as follows:

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

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

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

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

October 7, 2020: Regeneron Seeks Emergency Use Authorization Request

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

For More Information:

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

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

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

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

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

CDC COVID Data Tracker – United States COVID-19 Cases

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

Resource Spotlight: CDC Guidance on Personal and Social Activities

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

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

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

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

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

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

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

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

October 1, 2020: Remdesivir Now Available Directly from Distributor

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

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

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

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

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

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

For More Information:

• ASPR TRACIE Fact Sheet

• ASPR TRACIE website
• ASPR TRACIE Novel Coronavirus Resources webpage

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

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

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

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

October 2, 2020: Public Health Emergency Renewed

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

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

CDC COVID Data Tracker – United States COVID-19 Cases

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

New Technology Add-On Payment Traditional Pathway

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

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

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

Alternative Inpatient New Technology Payment Pathways

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

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

Certain Antimicrobial Products Alternative Pathway

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

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

Certain Transformative New Devices Alternative Pathway

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

Additional Payment for NTAP’s

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

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

Coding NTAPs

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

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

NTAPs for FY 2021 by the Numbers

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

CMS Policy for Continuing NTAP Status 

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

FY 2020 NTAPs Approved for Continued NTAP Status for FY 2021

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

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

FY 2021 Approved Applications for NTAP (Traditional Pathway)  

ContaCT

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

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

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

Eluvia™ Drug-Eluting Vascular Stent System (Eluvia)

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

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

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

Hemospray® Endoscopic Hemostat (Hemospray)

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

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

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

IMFINZI® (durvalumab) and TECENTRIQ® (Atezolizumab)

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

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

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

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

Soliris® (eculizumab)

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

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

The SpineJack® Expansion Kit (SpineJack® System)

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

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

FY 2021 Approved NTAP Alternative Pathway for Breakthrough Devices

BAROSTIME NEO® System

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

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

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

Optimizer® System (QFV)

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

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

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

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

Cefiderocol (Fetroja)

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

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

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

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

CONTEPO™ (fosfomycin for injection)

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

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

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

NUZYRA® for injection (omadacycline)

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

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

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

RECARBRIO™

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

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

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

XENLETA

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

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

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

ZERBAXA® (ceftolozane and tazobactam)

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

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

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

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

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

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

‍Moving Forward

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

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

Resources:

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

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

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

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from September 22nd through 30th.

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

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

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

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

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

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

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

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

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

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

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

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

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

September 24, 2020: MLNConnects COVID-19 Resources

CMS announced in the September 24th MLNConnects newsletter that “the Office of the Assistant Secretary for Preparedness and Response (ASPR) Technical Resources, Assistance Center, and Information Exchange (TRACIE) released an Express message with new resources:  

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

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

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

CDC COVID Data Tracker – United States COVID-19 Cases

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from September 15th through 22nd.

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

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

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

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

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

September 15, 2020: Bipartisan COVID Relief Framework

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

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

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

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

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

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

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

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

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

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

For More Information: 

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

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

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

CDC COVID Data Tracker – United States COVID-19 Cases

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

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

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

September MAC Talk: The Local Scene

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

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

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

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

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

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

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

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

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

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

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

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

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

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

September 18, 2020: Kepro Joins YouTube

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

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

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

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

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

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

Care Compare Features:

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

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

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