Knowledge Base Category -

The ICD-10-CM Officials Guidelines “have been developed to assist both the healthcare provider and the coder in identifying those diagnoses that are reported. The important of consistent, complete documentation in the medical record cannot be overemphasized. Without such documentation accurate coding cannot be achieved. The entire record should be reviewed to determine the specific reason for the encounter and the conditions treated.”

The Guidelines for FY 2021 were released at the beginning of July and can be found on the CDC ICD-10-CM webpage as well as the 2021 ICD-10-CM CMS webpage. This article highlights changes to already current sections in the guidelines as well as new sections for EVALI and COVID-19.

Documentation by Clinicians Other than the Patient’s Provider: Social Determinants of Health (SDOH)

Over the past several years this section of the Guidelines has included more and more instances when “code assignment may be based on medical record documentation from clinicians who are not the patient’s provider.” These instances include: Body Mass Index (BMI), depth of non-pressure chronic ulcers, pressure ulcer stage, coma scale, NIH stroke scale (NIHSS), and social determinants of health codes found in categories Z55-Z65.

The 2021 Guidelines adds the following statement regarding assignment of social determinant codes:

“Patient self-reported documentation may also be used to assign codes for social determinants of health, as long as the patient self-reported information is signed-off by and incorporated into the health record by either a clinician or provider.”

Coding COVID-19

Chapter 1 of the Guidelines, Certain Infectious and Parasitic Diseases, includes a new section for Coronavirus infections. Coders are advised to “code only a confirmed diagnosis of the 2019 novel coronavirus disease (COVID-19) as documented by the provider or documentation of a positive COVID-19 test result. For a confirmed diagnosis, assign code U07.1, COVID-19. This is an exception to the hospital inpatient guideline Section II, H. In this context, “confirmation” does not require documentation of a positive test result for COVID-19; the provider’s documentation that the individual has COVID-19 is sufficient.”

If the provider documents “suspected,” “possible,” “probable,” or “inconclusive” COVID-19, do not assign code U07.1. Instead, code the signs and symptoms reports. See guideline I.C.I.g.I.g.”

This new COVID-19 section also provides guidance for the following coding issues:

• Sequencing of codes,
• Acute respiratory manifestations of COVID-19,
• Non-respiratory manifestations of COVID-19,
• Exposure to COVID-19,
• Screening for COVID-19,
• Signs and Symptoms without definitive diagnosis of COVID-19,
• Asymptomatic individuals who test positive for COVID-19,
• Personal history of COVID-19,
• Follow-up visits after COVID-19 infection has resolved, and
• Encounter for antibody testing.

New coding guidance related to COVID-19 is also included in chapters 15 and 16 (“Pregnancy, Childbirth, and the Puerperium” and “Infection in Newborn, respectively”).

Diabetes Mellitus and the Use of Insulin, Oral Hypoglycemics, and Injectable Non-Insulin Drugs

Lately, it seems like every time I turn on the television there is a commercial for a new “long-acting” drug to treat diabetes. For this reason, it is very timely that the following guidance has been added to the FY 2021 Guidelines:

“If the patient is treated with both insulin and an injectable non-insulin antidiabetic drug, assign codes Z79.4, Long-term (current) use of insulin, and Z79.899, Other long term (current) drug therapy. If the patient is treated with both oral hypoglycemic drugs and an injectable non-insulin antidiabetic drug, assign codes Z79.84, Long-term (current) use of oral hypoglycemic drugs, and Z79.899, Other long-term (current) drug therapy.”

Note, this same guidance has been added to the section Secondary diabetes mellitus and the use of insulin or oral hypoglycemic drugs.

Mental and Behavioral Disorders Due to Psychoactive Substance Use

In the “psychoactive substance use, unspecified,” the guidelines previously advised that “as with all other unspecified diagnoses, the codes for unspecified psychoactive substance use…should only be assigned based on provider documentation and when they meet the definition of a reportable diagnosis.”

New for FY 2021, the following bolded guidance has been added:

“These codes are to be used only when the psychoactive substance use is association with a physical disorder included in chapter 5 (such as sexual dysfunction and sleep disorder), or a mental or behavioral disorder, and such a relationship is documented by the provider.”

Hypertensive Heart and Chronic Kidney Disease

FY 2020 Guidance: “If a patient has hypertensive chronic kidney disease and acute renal failure, an additional code for the acute renal failure is required.”

FY 2021 Guidance: “If a patient has hypertensive chronic kidney disease and acute renal failure, the acute renal failure should also be coded. Sequence according to the circumstances of the admission/encounter.”

Vaping-Related Disorders

It is hard to believe that this time last year the CDC, FDA, and state health authorities were diligently working to identify the cause of the national outbreak of e-cigarette, or vaping, product use-associated lung injury (EVALI). According to the CDC webpage devoted to this disease, as of February 18, 2020 a total of 2,807 hospitalized EVALI cases or deaths had been reported to the CDC from all 50 states, the District of Columbia, and two U.S. territories (Puerto Rico and U.S. Virgin Islands).

Initial vaping coding guidance was released in 2019 and a new ICD-10-CM code was implemented on April 1, 2020. Information about both can be downloaded from the CDC ICD-10-CM webpage at https://www.cdc.gov/nchs/icd/icd10cm.htm.

Specific to the Coding Guidelines, the following has been added for FY 2021:

“For patients presenting with condition(s) related to vaping, assign code U07.0, Vaping-related disorder, as the principal diagnosis. For lung injury due to vaping, assign only code U07.0. Assign additional codes for other manifestations, such as acute respiratory failure (subcategory J96.0-) or pneumonitis (code J68.0).

Associated respiratory signs and symptoms due to vaping, such as cough, shortness of breath, etc., are not coded separately, when a definitive diagnosis has been established. However, it would be appropriate to code separately any gastrointestinal symptoms, such as diarrhea and abdominal pain.”

Puerperal Sepsis

For FY 2021, the guidelines advise that “Code O85 should not be assigned for sepsis following an obstetrical procedure (See Section I.C.1.d.5.b., Sepsis due to a postprocedural infection).”

Chapter 21: Factors Influencing Health Status and Contact with Health Services (Z00-Z99) – Observation

The three observation z code categories “are for use in very limited circumstances when a person is being observed for a suspected condition that is ruled out. The observation codes are not for use if an injury or illness or any signs or symptoms related to the suspected condition are present. In such cases the diagnosis/symptom code is used with the corresponding external code cause.”

FY 2020 Guidance: “The observation codes are to be used as principal diagnosis only. The only exception to this is when the principal diagnosis is required to be a code from category Z38, Liveborn infants according to place of birth and type of delivery.”

FY 2021 Guidance: “The observation codes are primarily to be used as a principal/first-listed diagnosis. An observation code may be assigned as a secondary diagnosis code when the patient is being observed for a condition that is ruled out and is unrelated to the principal/first-listed diagnosis (e.g., patient presents for treatment following injuries sustained in a motor vehicle accident and is also observed for suspected COVID-19 infection that is subsequently ruled out).”

Chapter 22: Codes for Special Purposes (U00-U85) NEW

This new chapter for FY 2021 includes the Vaping-related disorder code, U07.0 and COVID-19 code, U07.1. The reader is referenced back to prior sections in the Guidelines for guidance on coding both of these conditions.

While I have highlighted updates for FY 2021, I believe the Guidelines are an essential annual read for Coding and Clinical Documentation Integrity (CDI) Professionals. As I think of school systems struggling with the decision of whether to and when to reopen schools, you can consider reading the FY 2021 Coding Guidelines your required summer reading for the coming Fiscal Year.

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from July 21st through July 27th.    

Resource Spotlight: CDC Natural Disasters, Severe Weather, and COVID-19

Earlier this month the CDC launched the new webpage Natural Disasters, Severe Weather, and COVID-19.  They note that “planning and preparing for hurricanes and other natural disasters can be stressful, even more so during the COVID-19 pandemic. Know how the COVID-19 pandemic can affect disaster preparedness and recovery, and what you can do to keep yourself and others safe.”

You can find guidance on the following topics is available on this webpage:

• Preparing for Hurricanes & COVID-19; Follow tips to help you and your family stay safe during hurricane season this year,
• Public Disaster Shelters & COVID-19: Follow tips to help you prepare and lower your risk of getting sick with COVID-19 while staying in a shelter, and
• Professionals & Emergency Workers: Know how to keep your community safe during and after a natural disaster amid the COVID-19 pandemic.

July 15, 2020: Resuming Elective Orthopedic Surgery During the COVID-19 Pandemic

This article can be found in the July 15, 2020 Issue of The Journal of Bone and Joint Surgery. The guidelines for resuming elective surgery was developed by the International Consensus Group (ICM). Specifically, seventy-seven expert physicians in orthopaedic surgery, infectious disease, microbiology and virology, and anesthesia were involved in this effort. The stated purpose for providing this list of recommendations is to reduce the COVID-19 “pathogen transfer during the reintroduction of elective orthopaedic surgical procedures.” At the outset of this article the authors acknowledge the guidelines are based on current available scientific evidence and may require being altered as new evidence emerges.

July 20, 2020: HHS Protect - Frequently Asked Questions

For a while now, to facilitate the public health response to COVID-19, hospitals have been reporting daily data reports on testing, capacity and utilization, and patient flows. Initially hospitals were advised to send this information to the CDC National Healthcare Safety Network (NHSN). 

Effective July 15, 2020 reporting to the NHSN was no longer an option. Instead, hospitals were to begin submitting data directly to the Federal Government through one of the methods outlined in the COVID-19 Guidance for Hospital Reporting document that was updated on July 10, 2020.

In a July 20, 2020 Press Release, HHS provides Frequently Asked Questions about HHS Protect, “a secure data ecosystem powered by eight commercial technologies for sharing, parsing, housing, and accessing COVID-19 data and driven by four principles: transparency, sharing, privacy, and security.”

July 22, 2020: New Resources to Protect Nursing Home Residents Against COVID-19

Several new initiatives designed to protect nursing home residents was announced in a July 22nd CMS Press Release. CMS Administrator Seema Verma indicates “as caseloads continue to increase in areas around the country, it has never been more important that nursing homes have what they need to maintain a sturdy defense against the virus. These measures will help them do exactly that.”

New Initiatives

• New Funding: HHS will devote $5 billion of the Provider Relief Fund authorized in the CARES Act to Medicare-certified long term care facilities and state veterans’ home (“nursing homes”), to build nursing home skills and enhance nursing response to COVID-19, including infection control.
• Enhanced Testing: Rapid point-of-care diagnostic testing devices will be distributed to nursing homes. Along with the deployment of more than 15,000 testing devices over the next few months, “CMS will being requiring, rather than recommending, that all nursing homes in states with a 5% positivity rate or greater test all nursing home staff each week.”
• Additional Technical Assistance and Support:
• Task Force Strike Teams were deployed in 18 nursing homes in Illinois, Florida, Louisiana, Ohio, Pennsylvania and Texas between July 18 and July 20 with a focus on the following four key areas of support:
• Keeping COVID-19 out of facilities,
• Detecting COVID-19 cases quickly,
• Preventing transmission, and
• Managing staff.
• Nursing Home COVID-19 Training: An online, self-paced, on-demand Nursing Home COVID-19 Training consisting of 23 modules will be made available to all 15,400 nursing homes nationwide. In order for nursing homes to be able to receive additional funding from the Provider Relief Fund Program, participation in this Training is required.
• Weekly Data on High Risk Nursing Home: “The White House and CMS will release a list of nursing homes with an increase in cases that will be sent to states each week as part of the weekly Governor’s report.”

July 23, 2020: COVID-19 Public Health Emergency Declaration to Renew on July 25th

Alex M. Azar II, Secretary of Health and Human Services declared an initial Public Health Emergency due to the COVID-19 pandemic on January 31, 2020. A PHE lasts for the duration of the emergency or 90 days and may be extended by the Secretary. On July 25, 2020, the PHE due to COVID-19 has been extended for the second time. You can learn more about Public Health Emergency Declarations in a CMS

Q&A document.

July 24, 2020: Addition of the QW Modifier to Healthcare Common Procedure Coding System (HCPCS) Code 87426

MLN Article MM11927 provides information about the addition of the QW modifier to HCPCS code 87426] (Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], immunochemiluminometric assay [IMCA]) qualitative or semiqualitative, multiple-step method; severe acute respiratory syndrome coronavirus 9eg, SARS-CoV, SARS-CoV-2 [COVID-19]]/

At the end of this MLN article CMS includes the following note:

“Providers should be aware that MACs will not search their files to either retract payment for claims already paid or to retroactively pay claims. However, MACs will adjust claims that you bring to their attention.”

July 24, 2020: Medicare Fee-For-Service (FFS) Response to the Public Health Emergency on the Coronavirus (COVID-19)

MLN Article SE20011 has now been revised for the eleventh time. In this latest revision, CMS has added clarifying language to the Families First Coronavirus Response Act Waives Coinsurance and Deductibles for Additional COVID-19 Related Services section to show it applies to lab tests regardless of the HCPCS codes used to report those tests.

July 27, 2020: FDA Reiterates Warning about Dangerous Alcohol-Based Hand Sanitizers Containing Methanol

In a Press Announcement, FDA Commissioner Stephen M. Hahn, M.D. notes that “Practicing good hand hygiene, which includes using alcohol-based hand sanitizer if soap and water are not readily available, is an important public health tool for all Americans to employ. Consumers must also be vigilant about which hand sanitizers they use, and for their health and safety we urge consumers to immediately stop using all hand sanitizers on the FDA’s list of dangerous hand sanitizer products….We remain extremely concerned about the potential serious risks of alcohol-based hand sanitizers containing methanol. Producing, importing and distributing toxic hand sanitizers poses a serious threat to the public and will not be tolerated. The FDA will take additional action as necessary and will continue to provide the latest information on this issue for the health and safety of consumers.”

The agencies do-not-use list of dangerous hand sanitizer products is being updated regularly. It is important to note that the FDA has indicated that “In most cases, methanol does not appear on the product label.”

Welcome to this month’s MAC Talk article. Before diving into updates from the MACs, there are two issues I want to alert readers about. First, a reminder about the updated ABN form. Second, CMS’ indication that Medicare Contractor can resume medical reviews as of August 3, 2020.

New Fee-For-Service (FFS) Advanced Beneficiary Notice of Noncoverage (ABN) Form CMS-R-131

On June 24th the FFS ABN CMS webpage was modified to add the following statement:

“The ABN, Form CMS-R-131, and form instructions have been approved by the Office of Management and Budget (OMB) for renewal.  The use of the renewed form with the expiration date of 06/30/2023 will be mandatory on 8/31/2020.  The ABN form and instructions may be found in the download section.”

Link to webpage: https://www.cms.gov/Medicare/Medicare-General-Information/BNI/ABN

Medical Review during the COVID-19 Public Health Emergency

On July 6, 2020, CMS released the document Coronavirus Disease 2019 (COVID-19) Provider Burden Relief Frequently Asked Questions (FAQs). The very first FAQ addresses Medicare Fee-for-Service medical reviews.

Q. Is CMS suspending most Medicare Fee-For-Service (FFS) medical review during the Public Health Emergency (PHE) for the COVID-19 pandemic?

A. On March 30 CMS suspended most Medicare Fee-For-Service (FFS) medical review because of the COVID-19 pandemic. This included pre-payment medical reviews conducted by Medicare Administrative Contractors (MACs) under the Targeted Probe and Educate program, and post-payment reviews conducted by the MACs, Supplemental Medical Review Contractor (SMRC) reviews and Recovery Audit Contractor (RAC). As states reopen, and given the importance of medical review activities to CMS’ program integrity efforts, CMS expects to discontinue exercising enforcement discretion beginning on August 3, 2020, regardless of the status of the public health emergency. If selected for review, providers should discuss with their contractor any COVID-19-related hardships they are experiencing that could affect audit response timeliness. CMS notes that all reviews will be conducted in accordance with statutory and regulatory provisions, as well as related billing and coding requirements. Waivers and flexibilities in place at the time of the dates of service of any claims potentially selected for review will also be applied.

Link to document: https://www.cms.gov/files/document/provider-burden-relief-faqs.pdf

July MAC Talk: The Local Scene

June 16, 2020: Palmetto GBA Article: Botulinum Toxin Injections

In this article, Palmetto provides detail from their Local Coverage Determination (L33458) including dosage and frequency of botulinum toxin injections, documentation expectations for coverage of the services provided, and a checklist to ensure documentation requirements are in the medical record.

This was timely information in advance of the July 1, 2020 implementation date for the Prior Authorization Program for Certain Hospital Outpatient Department (OPD) Services.

June 29, 2020: CGS J15

CGS posted the following information to their website on June 29th:

On April 6, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment (CMS-1744-IFC) instructing the DME MACs to suspend or not enforce various requirements found in local coverage determinations and related policy articles. On May 8, 2020, CMS published CMS-5531-IFC extending non-enforcement of the clinical indications for coverage to therapeutic continuous glucose monitors (CGMs). These changes are effective for claims with dates of service on or after March 1, 2020 and for the duration of the COVID-19 Public Health Emergency (PHE). Please see the full details regarding DME MAC implementation of CMS-1744-IFC and CMS-5531-IFC in the article here.”

July 2, 2020: Noridian JF Article: The Difference Between and Appeal and a Rebuttal

“When a provider does not agree with an overpayment determination, they may appeal the decision. An appeal disputes the overpayment and provides documentation to show medical necessity for the procedures in question. The limitation on recoupment provision mandates that no recoupment begins when a valid and timely request for a first level or second level appeal is received.

A rebuttal does not dispute the amount of the overpayment, nor does it dispute the overpayment determination. A rebuttal permits the provider a vehicle to indicate why the proposed recoupment should not be taken at the designated time. This allows providers to submit a statement advising if the recoupment occurs, it will cause financial hardship for their facility. The contractor, based on the rebuttal statement, determines whether to delay or begin recoupment. The rebuttal process is not an appeal and does not change anything regarding the debt owed.”

Internet Only Manual, (IOM), Publication 100-06, Chapter 3, Section 200.1.4: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/fin106c03.pdf 

Link to Noridian JF webpage: https://med.noridianmedicare.com/web/jfa/article-detail/-/view/10529/the-difference-between-an-appeal-and-a-rebuttal

July 6, 2020: WPS GHA eNews - Prior Authorization (PA) for Hospital Outpatient Department Services Facts

Effective June 17, 2020, providers billing on a 13x Type of Bill (TOB) should submit a PA request to their MAC before providing the following services:

• Blepharoplasty

• Botulinum toxin injections
• Panniculectomy
• Rhinoplasty
• Vein Ablation 

Providers should note the following:

• Prior authorization requests for botulinum toxin injections are only for injection CPT codes 64612 and 64615

• Prior authorization requests for botulinum toxin injections must include both the administration site and drug CPT codes
• Units of service for botulinum toxin injections should include the expected units of waste
• Each date of service requires its own prior authorization request
• CPT code 21235 no longer requires a prior authorization request
• Prior authorization is for dates of service July 1, 2020, and after
• Expedited requests must include justification that the standard review time for making a decision would seriously risk the health of the beneficiary
• Requests are not valid if they do not have the facility PTAN and NPI for the Hospital Outpatient Department 

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

July 6, 2020: Noridian JF to Host ABN Webinar – August 6, 2020

Noridian announced they will be hosting an ABN webinar on August 6th at 11 a.m. CT. This event includes:

• The new ABN form
• ABN Basics
• ABN Completion
• ABN Tips
• ABN Resources
• Noteworthy information

The Noridian announcement provides a link to sign up for this webinar.

July 9, 2020: New and Improved ST PEPPER Format for Short-Term (ST) Acute Care Hospital PEPPER

The PEPPER Team sent a notice about a “new and improved” format for the PEPPER Report. Hospitals will notice changes with the release of the Q1FY20 report scheduled to be available on July 15th.

The PEPPER Team noted in the announcement that “while all of the data and information that you are used to seeing in your PEPPER will still be available, the new format will include the following improvements:

• Greater accessibility
• Cleaner presentation
• Improved readability.

To help introduce Providers to the new format of PEPPER, the PEPPER Team prepared a recorded webinar demonstration of the new PEPPER, which is available on the PEPPER website.

July 13, 2020: First Coast JN Prior Authorization for Certain Hospital Outpatient Department Services Tips and Reminders

First Coast has posted the following information on their website regarding this program:

The PA team has been receiving and processing prior authorization requests (PAR) for certain hospital OPD services. View the following reminders prior to submitting your request:

• Providers are reminded that the PAR must include a PAR coversheet along with appropriate documentation. 
• Providers are asked to make sure the PAR hospital outpatient procedures Medicare fax/mail coversheet is being used and that all fields on the PAR coversheet are completed.
• Remember that PA is only required for procedures on the CMS list

• The PA is only required for the hospital outpatient department (OPD) who will be billing on the type of bill (TOB) 13X
• PA for hospital OPD does not apply to Ambulatory Surgical Centers (ASCs)

• PAR resubmissions must include the following:
• A copy of the initial PAR cover sheet and all documentation from the initial submission
• Any additional information/documentation

Click here to view additional information related to the prior authorization program.

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from July 14th – July 20th.   

Resource Spotlight: CDC COVID-19 One-Stop Shop Toolkits

The CDC has compiled a COVID-19 One-Stop Shop Toolkits webpage where you will find videos, social media, public service announcements, print resources, checklists, FAQs, and web resources for the following audiences:

• Young Adults: 15 – 21,
• Childcare Programs & Summer Camps,
• Youth Sports,
• K-12 Schools,
• Businesses & Workplaces,
• Community & Faith-Based Organizations,
• General Public,
• Domestic Travelers,
• Shared & Congregate Housing, and
• Parks & Recreational Facilities.

July 14, 2020: FDA COVID-19 Daily Roundup – FDA Posts Hand Sanitizer Quiz

Hand sanitizer has been and continues to be a hot commodity during the COVID-19 Pandemic. Do you know where to store and not store hand sanitizer? Is hand sanitizer a drug? When should you consider a hand sanitizer to be expired? These are questions you will find answers to in a Hand Sanitizer Quiz posted by the FDA in their July 14th COVID-19 Daily Roundup. The FDA indicates the quiz provides answers to frequently asked questions and “can help consumers learn how to correctly use hand sanitizer.”

July 14, 2020: Department of Health and Human Services (HHS) Initiative for More and Faster COVID-19 Testing in Nursing Homes

HHS announced “a one-time procurement of devices and tests targeted to facilitate on-site testing among nursing home residents and staff. Through this crucial action, nursing homes will be able to augment their current capacity for coronavirus testing, bolstering their response and helping to prevent the spread of SARS-CoV-2, the virus that causes COVID-19.”

Nursing Home Numbers as of July 9, 2020 according to CMS:

• 200,000: The number of confirmed of suspected cases of COVID-19,
• 35,000: The number of COVID-19 deaths.

“The Centers for Disease Control and Prevention recommends that nursing homes perform baseline testing of all residents and staff, followed by regular screening and surveillance through routine testing to detect potential outbreak situations early and reduce morbidity and mortality.”

July 15, 2020: HHS Makes Changes to COVID-19 Daily Data Reporting for Hospitals

Vice President Pence sent a letter to hospital administrators on March 29, 2020 requesting daily data reports on testing, capacity and utilization, and patient flows be sent to the CDC National Healthcare Safety Network (NHSN) to facilitate the public health response to COVID-19.

Effective July 15, 2020 reporting to the NHSN is no longer an option. Instead, hospitals are to submit this data directly to the Federal Government through one of the methods outlined in the COVID-19 Guidance for Hospital Reporting document that was updated on July 10, 2020.

CDC Director Robert Redfield indicated in a prepared remarks that the CDC’s NHSN “is an important surveillance system in our nation’s hospitals, which focuses on fighting antibiotic resistance.

In April, HHS leaders, with input from CDC, created a new system, called HHS Protect, that allows us to combine data through systems like NHSN, as well as other public and private sources. The data reported from hospitals that went into HHS Protect either came through the NHSN, directly to HHS Protect from the states, or through a system called TeleTracking.

What we have now asked is that, going forward, states provide data from hospitals directly through the TeleTracking system or directly to the HHS Protect system.”

July 16, 2020: CDC Webinar: Clinical Management of Multisystem Inflammatory Syndrome in Children (MIS-C) Associated with COVID-19

Previously, the CDC provided a Clinician Outreach and Communication Activity (COCA) MIS-C with COVID-19 call on May 19, 2020. That call focused on providing clinicians information about clinical characteristics of MIS-C, how cases have been diagnosed and treated, and how clinicians have responded to recently reported cases associated with COVID-19. This past Thursday July 17, 2020, a second webinar was held focusing on the clinical management of this patient population. The CDC has provided a recording and slide deck for both webinars.   

July 16, 2020: July 2020 Updated of the Hospital Outpatient Prospective Payment System (OPPS) MLN Article MM11814 Revised

Now in its third iteration, CMS updated MLN Article MM11814 on July 16th. Revisions made reflect the revised Change Request (CR) 11814. Specific revisions include:

• Update to the section on “COVID-19 Laboratory Tests and Services and Other Laboratory Tests Coding Update,”
• Table 1 updated to add 3 new COVID-19 codes: 87426, 0223U, and 0224U,
• HCPCS code Q5112 status indicator was changed from SI=E2 to SI=K, effective April 15, 2020 through September 30, 2020 and section 9 “Drugs, Biologicals, and Radiopharmaceuticals” has been updated by adding new subsections j and k to reflect the change.

July 16, 2020: FDA Closes its COVID-19 Industry Hotline

In the FDA’s Daily Roundup for July 16th they announced that as of 8:00 PM on Friday July 17th they would be closing their COVID-19 Industry Hotline. Moving forward to meet current needs, the FDA will be “providing support for industry and laboratory questions about COVID-19 and medical devices through this directory Contacts for Medical Devices During the COVID-19 Pandemic.”

July 17, 2020: HHS Distributing $10 Billion in Additional Funding to Hospitals in High Impact COVID-19 Areas

The Department of Health and Human Services (HHS) indicated in a July 17th announcement that they are set to begin distributing $10 billion in a second round of high impact COVID-19 area funding to hospitals this week.  In this second round of funding, amounts to be distributed “was based on a formula for hospitals with over 161 COVID-19 admissions between January 1 and June 10, 2020, or one admission per day, or that experienced a disproportionate intensity of COVID admissions (exceeding the average ratio of COVID admissions/bed). Hospitals will be paid $50,000 per eligible admission.” The HHS announcement provides links to a list of hospital recipients of funds as well as a state-by-state breakdown on the funding.

In a related statement by AHA President and CEO Rick Pollack, he thanked HHS for this additional relief but went on to note that “since this distribution of funding for “hot spots” does not take into account the latest spike in cases and hospitalizations in some parts of the country, we look forward to working with the Administration to ensure that additional relief will be distributed to ‘hot spots’ and all hospitals."

July 17, 2020: Medicare Fee-for-Service (FFE) Response to the Public Health Emergency on COVID-19 MLN Article Revised

It seems on an almost weekly basis now MLN SE20011 is being revised. The latest revision updates information on CDC nursing home patients/residents testing and adds clarifying language to the Skilled Nursing Facility (SNF) Benefit Period Waiver – Provider information section.

July 17, 2020: Alabama Medicaid Extends COVID-19 Emergency Expiration Date

Alabama announced in this Alert that “All previously published expiration dates related to the Coronavirus (COVID-19) emergency are once again extended by the Alabama Medicaid Agency (Medicaid). The new expiration date is the earlier of August 31, 2020, the conclusion of the COVID-19 National emergency, or any expiration date noticed by the Alabama Medicaid Agency through a subsequent ALERT.”

July 20, 2020: Office of Civil Rights (OCR) Issues Guidance on Civil Rights Protections Prohibiting Race, Color, and National Origin Discrimination During COVID-19

The OCR announced in a Press Release that they are “issuing guidance to ensure that recipients of federal financial assistance understand that they must comply with applicable federal civil rights laws and regulations that prohibit discrimination on the basis of race, color, and national origin in HHS-funded programs during COVID-19. This Bulletin focuses on recipients' compliance with Title VI of the Civil Rights Act of 1964 (Title VI).”

July 28, 2020 – Save the Date: CDC Webinar: COVID-19 and Diabetes: The Importance of Prevention, Management, and Support

My husband, mother and brother all have adult onset diabetes. This puts each one of them at higher risk for severe illness if they were to contract COVID-19. On Tuesday, July 28, 2020 the CDC is hosting a COCA call where presenters will focus on current information available about this increased risk and the importance of diabetes prevention, management and support. Information for participating in this webinar is available on the CDC website at https://emergency.cdc.gov/coca/calls/2020/callinfo_072820.asp?deliveryName=USCDC_1052-DM32990.

New England Journal of Medicine (NEJM): COVID-19 Rx: Treatment Solutions

Although this free resource was released on May 19th, in keeping with the education offerings from the FDA Hand Sanitizer Quiz and CDC webinars, I wanted to make you aware of this education resource from the NEJM Group. According to the May NEJM Group anouncement, this series of five COVID-19 interactive cases was “designed to teach clinicians on the frontlines of the pandemic, the detailed cases feature clinical information on each of the five fictional patients. In one, the patient is a young woman who arrives to the emergency room with fever and cough. In another, an elderly man with probable Covid-19 and respiratory distress and a history of hypertension and COPD was transferred to the ICU from an outside hospital.”

In a June 30th Press Release, CMS proposed to update National Coverage Determination (NCD) 20.33 noting that currently the NCD covers the transcatheter procedure for patients with symptomatic degenerative mitral regurgitation (MR). Before we take an in depth look at the changes in the Proposed Decision Memo (CAG-00438R), I want to provide relevant background information about the Transcatheter Mitral Valve Repair (TMVR) procedure.

Background

August 2014

The current NCD has been effective since August 7, 2014. Per the related 2014 Decision Memo, the FDA approved the first TMVR device.

Abbott Vascular’s MitraClip® was approved “for the percutaneous reduction of significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.”

Abbott Vascular’s MitraClip® is currently the only FDA-approved TMVR device. The procedure involves clipping together a portion of the mitral valve leaflets as a treatment for reducing MR to improve recovery of the heart from overwork, improve function and potentially halt the progression of heart failure.

August 2019

At the request of the Society of Thoracic Surgeons (STS), the American College of Cardiology (ACC), the American Association for Thoracic Surgery (AATS), and the Society for Cardiovascular Angiography & Interventions (SCAI), CMS opened a National Coverage Analysis (NCA) Tracking Sheet for Transcatheter Mitral Valve Repair (TMVR) (CAG-00438R). The expected release of a Proposed Decision Memo was to have been February 14, 2020.

National Coverage Analysis Issue

 TMVR is used in the treatment of mitral regurgitation (MR). There are two types of MR.

• Primary (degenerative) MR results from structural failure of mitral valve, and
• Secondary (functional) MR results from left ventricular (LV) dysfunction with a largely preserved mitral valve.

Currently, the NCD establishes coverage for the treatment of significant symptomatic Primary MR. The national tracking analysis focused on TMVR for the treatment of significant symptomatic Secondary MR.

June 30, 2020 Proposed Decision Memo for TMVR (CAG-00438R)

TMVR to TEER

CMS opens the Decision Summary by indicating they are replacing the acronym TMVR with TEER (Transcatheter Edge-to-Edge Repair) “to more precisely define the treatment addressed in this proposed NCD, which is applicable to TEER for the treatment of functional mitral regurgitation (MR) and degenerative MR.”

From Coverage for Primary (Degenerative) MR to Coverage for Secondary (Functional) MR

CMS notes that “Cardiac surgery for secondary MR has been shown to improve symptoms but not survival…However, recent evidence reviewed here demonstrates that TEER may improve symptoms, quality of life, and survival of appropriately selected patients with secondary MR.”

CMS has removed Primary (degenerative) MR as an indication for the TEER procedure noting that coverage determinations for on-labeled uses of FDA approved devices for this group of patients will be made by Medicare Administrative Contractors (MACs).

The NCD will now provide coverage indications for the TEER procedure for patients with Secondary (functional) MR.

Coverage with Evidence Development (CED) Requirement Removed from NCD

Currently TMVR is non-covered for the treatment of MR when not furnished under CED. This is no longer a requirement in the Proposed Decision Memo.

Shared-Decision Making

“CMS recognizes the importance of shared decision-making (SDM) in many clinical scenarios and has required SDM in other NCDs (for example, implantable cardiac defibrillators: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=110). 

CMS supports patient SDM in TEER but there is no fully developed tool available at this time.  CMS strongly encourages standardized decision aids or tools [the National Quality Forum (NQF) has published standards for decision aids (www.qualityforum.org/Projects/c-d/Decision_Aids/Final_Report.aspx)] to facilitate the decision making process between a patient and physician and will be monitoring this space closely. 

Tools are in development for other conditions and procedures.  For example, the Patient-Centered Outcomes Research Institute (PCORI) funded research (CER-1306-04350/ NCT02266251), to create and assess a personalized decision assistance tool designed to evaluate important health outcomes between SAVR to TAVR for operable patients with aortic valve disease considering aortic valve replacement.  The work also aims to develop and assess a personalized risk assessment tool designed to evaluate expected health outcomes with TAVR for inoperable patients considering aortic valve replacement.”

Proposed Coverage Requirements for TEER Procedure

1. TEER for mitral valve would be covered as follows:
2. When performed to treat symptomatic moderate-to-severe or severe Functional MR when the patient remains symptomatic despite stable doses of maximally tolerated guideline-directed medical therapy (GDMT).

Guideline Directed Medical Treatment (GDMT)

“The specialty societies publish detailed guidelines for the diagnosis and management of heart failure.  The most recent full guideline was published in 2013, with a focused update in 2016. In addition to lifestyle changes, cornerstones of pharmacologic treatment of systolic heart failure include angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARB), angiotensin receptor-neprilysin inhibitors (ARNI), beta-blockers, mineralocorticoid antagonists (MRA), and diuretics.  For eligible patients, implantable cardiac defibrillators (ICD) can improve survival, while cardiac resynchronization therapy (CRT) can improve symptoms, reduce MR, reduce hospitalizations, and increase survival.”

• Eligible patients must also meet the following criteria:
• Ischemic or non-ischemic cardiomyopathy; and
• Left ventricular ejection fraction of 20 to 50%; and
• New Your Heart Association Functional Class II, III, or Iva (ambulatory); and
• Left ventricular end-systolic dimension ≤ 70mm; and
• Local heart team has determined that mitral valve surgery will not be offered as a treatment option.

FDA Expansion of Approved Indications for MitraClipNote™

 The FDA expanded the approved indications for MitraClip™ on March 14, 2019. The proposed coverage requirements above align with the FDA’s expanded indications.

• Procedure must be furnished according to FDA-approved indication and meet the following conditions:
• All requirements set for in 2a through 2c; and
• The patient is under the care of a heart failure specialist experienced in the care and treatment of mitral valve disease; and
• The heart team also included a heart failure physician specialist experienced in the care and treatment of mitral valve disease; and
• The heart team cardiac surgeon and interventional cardiologist have:
• Independently examined the patient face-to-face, evaluated the patient’s suitability for surgical mitral valve repair, TEER, maximally tolerated GDMT, or palliative therapy; and
• Documented and made available to the other heart team members the rationale for their clinical judgment.

Face-to-Face Examination during COVID-19 Public Health Emergency (PHE)

Per the Proposed Decision Memo, “In the interim final rule with comment period [CMS-1744-IFC], CMS finalized that to the extent an NCD or LCD would otherwise require a face-to-face or in-person encounter for evaluations, assessments, certifications or other implied face-to-face services those requirements would not apply during the public health emergency (PHE) for the COVID-19 pandemic.  This would include the proposed face-to-face examination by the heart team cardiac surgeon and interventional cardiologist.”

2. Requirements in this section apply to TEER for Functional MR as specific in section 1.
3. The patient (pre-op and post-op) is under the care of a heart team that must include:
4. Cardiac surgeon; and
5. Interventional cardiologist; and
6. Interventional echocardiographer; and
7. Providers from other physician groups as well as advanced patient practitioners, nurses, research personal and administrators.
8. The interventional cardiologist or cardiac surgeon must perform the mitral valve TEER. They may jointly participate in the intra-operative technical aspects of TEER as appropriate.
9. Mitral valve TEERs must be performed in hospitals with appropriate infrastructure including but not limited to:
10. On-site heart valve surgery and interventional cardiology programs,
11. Post-procedure intensive care facility with personnel experienced in managing patients who have undergone open-heart valve procedures,
12. Appropriate volume requirements.

Appropriate Volume Requirements

There are two sets of qualifications for appropriate volume requirements (qualifications to begin a mitral valve TEER program and qualifications for mitral valve TEER experience). CMS is proposing “to modify this requirement consistent with the same requirement for the interventional cardiologist as set forth in the June 2019 TAVR NCD Decision Memo. While clinically appropriate, this modification also establishes consistency across valve program areas.”

Proposed Reasons for TEER to Not Be Covered for the treatment of functional MR

1. Coexisting aortic or tricuspid valve disease requiring surgery or transcatheter intervention; or
2. COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use; or
3. ACC/AHA Stage D heart failure; or
4. Estimated pulmonary artery systolic pressure (PASP) > 70 mmHg as assessed by echocardiography or right heart catheterization, unless active vasodilator therapy in the catheterization laboratory is able to reduce the pulmonary vascular resistance (PVR) to < 3 Wood Units or between 3 and 4.5 Wood Units with a v wave less than twice the mean of the pulmonary capillary wedge pressure (PCWP); or
5. Hemodynamic instability requiring inotropic support or mechanical heart assistance; or
6. Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction; or
7. Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.

TEER of the mitral valve for the treatment of functional MR is not covered for patients in whom existing co-morbidities would preclude the expected benefit from correction of the mitral valve.

Optimal Patient Selection for TEER

CMS acknowledges that there are limitations in the trial/study evidence available to assist the heart team in optimal patient selection for TEER. They note in the proposed Decision Memo that they will carefully monitor treated patients for adherence to the criteria and will assess patient outcomes over the next four years through evidence published in the peer reviewed literature. At that time, contingent upon real-world demonstration of outcomes consistent with those achieved in the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (The COAPT Trial), they will consider modifying criteria.

CMS is seeking comments on the proposed national coverage determination. A final decision will be issued no later than 60 days after the conclusion of the 30-day public comment period. I strongly encourage those involved in providing this service to read the proposed decision.

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from July 6th through July 13th.   

Resource Spotlight This Week: National Institute on Aging Provides Government COVID-19 Resources for Older Adults

The National Institutes of Health (NIH) National Institute on Aging has developed a webpage to provide Government COVID-19 Resources for Older Adults. Guidance and Information available on this page includes:

• Federal Resources on Caregiving during COVID-19,
• COVID-19 Financial & Housing Resources for Families,
• Health Information on Coronavirus,
• COVID-19 and Healthcare,
• COVID-19 Safety and Emergency Response,
• COVID-19 Resources for Veterans, and
• Employment Resources for COVID-19

July 6, 2020: EPA Approves First Surface Disinfectant Products Tested on the SARS-CoV-2 Virus

The Environmental Protection Agency (EPA) announced in a News Release that they have approved two products that safely and effectively kill the novel coronavirus, SARS-CoV-2, on surfaces.

• Lysol Disinfectant Spray (EPA Reg. No. 777-99), and
• Lysol Disinfectant Max Cover Mist (EPA Reg. No. 777-127)

July 6, 2020: New and Expanded Flexibilities for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) During the COVID-19 Public Health Emergency MLN Article Revised

MLN SE20016 was initially issued on April 17, 2020. Now in the third iteration, this article was revised on July 6th to include:

• Additional guidance on telehealth services that have cost-sharing waived and additional claims examples, and
• An additional section on the RHC Productivity Standard.

July 7, 2020: HHS Launches ‘Surge’ COVID-19 Testing in Hospital Jurisdictions in Florida, Louisiana and Texas

HHS Announced free COVID-19 testing in Jacksonville, Florida; Baton Rouge, Louisiana; and Edinburg, Texas to “temporarily increase federal support to communities where there has been a recent and intense level of new cases and hospitalizations related to the ongoing outbreak.” HHS, in partnership with eTrueNorth plans to offer 5,000 tests per-city per-day at no charge to people being tested. “The temporary surge testing sites will be live anywhere from five to 12 days.”

July 8, 2020: MLN SE20011 Medicare Fee-for-Services Response to Public Health Emergency on COVID-19 Revised Again

MLN SE20011 article has once again been updated. This most recent revision was to add a row at the end of the Waiver/Flexibility table (page 7) to address services provided by the hospital in the patient’s home as a provider-based outpatient department when the patient is registered as a hospital outpatient.

CMS also added the new section Teaching Physicians and Residents: Expansion of CPT Codes that May Be Billed with the GE Modifier.

July 8, 2020: Department of the Treasury and the Small Business Administration Releases the Paycheck Protection Program (PPP) Loan Data

The PPP was established by the CARES Act and was meant to provide small businesses with funds to pay up to 8 weeks of payroll costs including benefits. On Monday July 8th the Department of Treasury and Small Business Administration released a summary of cumulative PPP data. As of July 8th almost 5 million loans have been approved with the average loan size being $106,542. Downloaded data is available for loans above and below $150,000 by state.

You can also access this date and read more about this program on the U.S. Department of Treasury website at https://home.treasury.gov/policy-issues/cares/assistance-for-small-businesses.

Note, larger companies across the nation applied for and received funding from this program. However, since then, the Department of Treasury has indicated in an FAQ document that “it is unlikely that a public company with substantial market value and access to capital markets will be able to make the required certification in good faith, and such a company should be prepared to demonstrate to SBA, upon request, the basis for its certification.” These companies were given the option to repay the money without penalty and have done just that. COVID Stimulus Watch, a public service of Good Jobs First has made available a list of awards, a list of funds that were later refunded.

July 8, 2020: MLN Article MM11815 Quarterly Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment – REVISED

MLN Article MM11815 was initially released June 12, 2020. This article was updated on July 9, 2020 to reflect a revision to related Change Request (CR) 11815. The revision added information on COVID-19 codes 87426, 0223U and 0224U. The effective date for all three of these new codes was June 25, 2020.

July 9, 2020: Medicare Part A & B Provider Outreach and Education Multi-MAC Collaboration Group Published Modifiers Used During COVID-19 Table

The Provider Outreach and Education A/B MAC Workgroup has developed a table titled Modifiers Used during the COVID-19 Public Health Emergency (PHE). Information included in the table includes the following:

• The Type of Bill (TOB) the modifier would be used on Part A (UB04) or Part B (1500),
• Details about each modifier,
• Links to reference materials for each modifier, and
• When applicable, any exception/special usage for the modifier.

July 9, 2020: HHS Awards More Than $21 Million to Support Health Centers’ COVID-19 Response

HHS indicates in this News Release the awarding of more than $21 million to support health centers’ COVID-19 response efforts noting “the majority of this investment - $17 million – supports 78 Health Center Program look-alikes (LALs) with funding to expand capacity for COVID-19 testing.” Included in this announcement are links to the award recipients as well as links to where you can find more information about the following:

• Health center capacity and the impact of COVID-19 on health center operations, patients, and staff,
• Health Center Program look-alikes, and
• Health Center Controlled Networks.

July 10, 2020: HHS Announces Over $4 Billion in Additional Relief Payments to Healthcare Providers Impacted by the Coronavirus Pandemic

HHS through the Health Resources and Services Administration (HRSA) announced:

• Approximately $3 billion in funding to hospitals serving an large percentage of vulnerable populations on thin margins, and
• Approximately $1 billion to specialty rural hospitals, urban hospitals with certain rural Medicare designations, and hospitals in small metropolitan areas.

HHS is also opening the provider portal to allow dentists to apply for relief. You can read the full announcement on the HHS website at https://www.hhs.gov/about/news/2020/07/10/hhs-announces-over-4-billion-in-additional-relief-payments-to-providers-impacted-by-coronavirus-pandemic.html.

July 10, 2020: HHS Releases May and June COVID-19 State Testing Plans

HHS announced that they have made available May and June COVID-19 Testing plans from all states, territories, and localities. Plans include details on response to surge cases and how to reach vulnerable populations including minorities, immunocompromised individuals and older adults.

Assistant Secretary for Health AMD Brett P. GIroir, M.D. noted in the announcement that “Overall, the plans submitted by the states were very good to excellent; and all will be improved by the ongoing collaboration of states with federal experts. Testing is not just about numbers – it is about targeting testing to the right people at the right time, and incorporation of testing into a comprehensive state plan for COVID-19…We are pleased at what nearly every state has achieved to date, and look forward to continuing to expand SARS-CoV-2 testing capacity in the U.S."

July 10, 2020: Additional Resources Directed to Nursing Homes in COVID-19 Hotspot Areas

In a June 10th Press Release, CMS announced their plan to deploy Quality Improvement Organizations (QIOs) nationwide to provide immediate assistance to nursing homes in hotspot areas as identified by the White House Coronavirus Task Force with an end goal of protecting vulnerable Americans.

CMS issued two Transmittals in June detailing updates being made in the Medicare Program Integrity Manual. This article highlights changes to Chapter 3 – Verifying Potential Error and Taking Corrective Actions. A related article in this week’s newsletter highlights changes to Chapter 6 – Medicare Contractor Medical Review Guidelines for Specific Services.

Transmittal 10197 (Change Request (CR) 11730) was issued on June 26, 2020. The purpose of this CR is to clarify CMS’ authority to request and require documentation, upon request, to determine the appropriateness of claims for payment. Changes are being made in the following two sections of Chapter 3:

• Section 3.2.3.2: Time Frames for Submission, and
• Section 3.2.3.8: No Response or Insufficient Response to Additional Documentation Requests (ADRs).

Transmittal Background

Under the General Information section of this Transmittal CMS notes the following:

• There are times when Medicare Contractors (MACs, Comprehensive Error Rate Testing (CERT), Supplemental Medical Review Contractor (SMRC), Recovery Audit Contractor (RACs), Unified Program Integrity Contractors (UPICs), and other contractors may not be able to make a pre- or post- payment determination based on information available on the claim, its attachments, or the billing history when applicable. When this happens a Contractor may require a provider or supplier to submit medical and related supporting documentation to determine payment amounts due. “CMS and its contractors require that sufficient documentation and information be furnished to support that selected claims meet applicable coverage, coding, and billing requirements for payment.”
• When a Medicare Contractor sends a provider an Additional Documentation Request (ADR), they request information be provided within specified time frames. “In cases where no supporting documentation is received to conduct a medical review, the claim shall be denied.”

Section 3.2.3.2: Time - Frames for Submission

Current Manual Guidance: This section applies to MACs, RACs, CERT, and ZPICs as indicated.

Effective July 27, 2020: This section will apply to MACs, RACs, CERT, SMRC, and UPICs, as indicated.

Current Manual Guidance: There is no additional information prior to subsection A.

Effective July 27, 2020: Contractors will be required, “when authoring correspondence related to ADRs, to cite sections 1815(a), 1833(e), and 1862(a)(1)(A) of the Act exclusively when referring to the authority for requiring submission of documentation.

“Contractors are authorized to collect medical documentation by the Social Security Act (the Act).

Section 1815(a) of the Act states that "...no such payments shall be made to any provider unless it has furnished such information as the Secretary may request in order to determine the amounts due such provider under this part for the period with respect to which the amounts are being paid or any prior period."

Section 1833(e) of the Act states that "[n]o payment shall be made to any provider of services or other person under this part unless there has been furnished such information as may be necessary in order to determine the amounts due such provider or other person under this part for the period with respect to which the amounts are being paid or for any prior period." In addition, Contractors are required to ensure that payment is limited to those items and services that are reasonable and necessary.

Section 1862(a)(1)(A) of the Act states that “[n]ot withstanding any other provision of this title, no payment may be made under part A or part B for any expenses incurred for items or services— which, except for items and services described in a succeeding subparagraph, are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.”

Subsection 3.2.3.2.A: Prepayment Review Time Frames

Current Guidance: MACs and ZPICs

• Shall notify providers that documentation requested is to be submitted within 45 calendar days of the request,
• Should not grant an extension to providers who need more time to comply with the request, and
• Shall deny claims for which the requested documentation was not received by day 46.

Effective July 27, 2020: MACs and UPICs

• Shall notify providers “when they expect documentation to be received,”
• Should not grant extension to providers who need more time to comply with the request, and
• Shall deny claims “when” the requested documentation “to support payment is not received by the expected timeframe.”

Subsection 3.2.3.2.B: Post payment Review Time Frames

Current Guidance: MACs, CERT, and RACs, ZPICs

• MAC, CERT, and RACs shall notify providers that documentation requests is to be submitted within 45 calendar days of the request.
• ZPICs requesting documentation shall be within 30 calendar days of the request.
• Since there are no statutory requirements for when post payment reviews are to be completed, “MACs, CERT, and ZPICs have the discretion to grant extensions to providers who need more time to comply with the request. The number of extensions and the number of days for each extension is solely within the discretion of the MACs, CERT and ZPICs. RACs shall follow the time requirements outlined in their SOW.”

 Effective July 27, 2020: MACs, CERT, SMRC, UPICs and RACs

• “Shall notify providers when they expect documentation to be received.”
• “MACs, CERT, SMRC, UPICs and RACs have the discretion to gran extensions to providers who need more time to comply with the request. The MACs, CERT, SMRC, UPICs and RACs shall deny claims when the requested documentation to support payment is not received by the expected timeframe (including any applicable extensions).”

Subsection 3.2.3.8: No Response or Insufficient Response to Additional Documentation Requests

Current Guidance: This section applies to MACs, RACs, CERT, and ZPICs/UPICs, as indicated.

Effective July 27, 2020: This section will apply to MACs, RACs, CERT, SMRC, and UPICS, as indicated.

Subsection 3.2.3.8.A.: Additional Documentation Requests

Current Guidance: Information is to be provided with 45 calendar days for MACs and RACs or 30 calendar days for ZPICs/UPICs after the date of request (or within a reasonable time following an extension). If not received, the contractors “shall deny the claim, in full or in part, as not reasonable and necessary.”

Effective July 27, 2020:

The following sentence has been added to the beginning of this section:

• “The reviewer authority to request that documentation be submitted, to support claims payment, is outlined in Section 3.2.3.2 of this chapter.”

Also, specific calendar day timeframes have been replaced with the following:

• “If information is requested from both the billing provider or supplier and/or a third party and no response is received within the expected timeframes (or within a reasonable time following and extension), the MACs, RACs, SMRC, and UPICs shall deny the claim, in full or in part, as not reasonable and necessary.”

MACs will be the contractor responsible for counting denials as automated or non-medical record review.

Subsection 3.2.3.8.B: No Response

During Prepayment Review

Current Guidance: A claim shall be denied by MACs and ZPICs/UPICs if no response is received within 45 calendar days after the date of the ADR.

Effective July 27, 2020: Claims shall be denied by the MACs and UPICs if no response is received within “the expected timeframes.”

During Post-payment Review

Current Guidance:

• For MACs claims will be denied as not reasonable and necessary and count as non-medical record reviews if no response is received within 45 calendar days after the date or the ADR (or extension).
• ZPICs/UPICs shall deny the claim if not response is received within 30 calendar days.
• RACs shall count these as complex or non-complex reviews.

Effective July 27, 2020

• MACs, RACs, UPICs and SMRC shall deny claims as not reasonable and necessary if no response is received within the expected timeframes (or extension).
• “These contractors shall cite sections 1815(a), 1833(e), and 1862(a)(1)(A) of the Act exclusively when referring to the authority for requiring submission of documentation, when denying claims for no response within the expected timeframes.”
• The MACs shall count these denials as non-medical record reviews.

Subsection 3.2.3.8.C.: Insufficient Response

The only change made to this section is that the SMRC has been added to the list of applicable contractors.

Moving forward, closely monitor ADR requests to ensure you provide documentation with “expected timeframes.”

In June, CMS issued Transmittal 10184 (Change Request (CR) 11812), providing information about updates being made to the Medicare Program Integrity Manual. Specifically, the Unified Program Integrity Contractors (UPICs) were inserted in several placed in this document. Transmittal specifics will be reviewed later in this article. However, as the UPICs are a recent addition to the acronym soup of Medicare Contractors (i.e., MAC, RAC, CERT, SMRC), I first want to provide you with background information about the UPIC Contractors.

What are the UPICs?

UPICs perform fraud, waste, and abuse detection, deterrence and prevention activities for Medicare and Medicaid claims processed in the United States. Specifically, the UPIC’s perform integrity related activities associated with the following:

• Medicare Part A,
• Medicare Part B,
• Durable Medical Equipment (DME),
• Home Health and Hospice (HH+H), Medicaid, and
• The Medicare-Medicaid data match program (Medi-Medi).

The UPIC contracts operate in five (5) separate geographical jurisdictions in the United States and combine and integrate functions previously performed by the Zone Program Integrity Contractor (ZPIC), Program Safeguard Contractor (PSC) and Medicaid Integrity Contractor (MIC) contracts.

Who Are The UPIC Contractors?

Western Jurisdiction
UPIC Contractor: Qlarant

• Western States: Alaska, Arizona, California, Hawaii, Idaho, Montana, Nevada, North Dakota, Oregon, South Dakota, Utah, Washington and Wyoming
• Link to website: https://www.qlarant.com

Southwestern Jurisdiction
UPIC Contractor: Qlarant

• Southwestern States: Colorado, New Mexico, Oklahoma, Texas, Arkansas, Louisiana, and Mississippi
• Link to website: https://www.qlarant.com

Mid-Western Jurisdiction
UPIC Contractor: CoventBridge Group

• Midwestern States: Iowa, Illinois, Indiana, Kansas, Kentucky, Michigan, Minnesota, Missouri, Nebraska, Ohio and Wisconsin
• Link to website: https://coventbridge.com/midwest-upic/

Northeastern Jurisdiction
UPIC Contractor: SafeGuard Services LLC (SGS)

• Northeastern States: Maine, Vermont, New Hampshire, Massachusetts, Rhode Island, Connecticut, New Your, Pennsylvania, New Jersey, Delaware, Maryland, and District of Columbia
• Link to website: http://www.safeguard-servicesllc.com

South-Eastern Jurisdiction
UPIC Contractor: SafeGuard Services LLC (SGS)

• South-Eastern States: West Virginia, Virginia, North Carolina, South Carolina, Tennessee, Alabama, Georgia, and Florida
• Link to website: http://www.safeguard-servicesllc.com

UPICs in Action

A June 25, 2019 CMS Blog titled Medicaid Program Integrity: A Shared and Urgent Responsibility highlighted the growth of the Medicaid program from $456 billion in 2013 to an estimated $576 billion in 2016 and with this “growth comes a commensurate and urgent responsibility by CMS on behalf of the American taxpayers to ensure sound stewardship and oversight of our program resources.”

The UPICs were cited in this blog for engaging in the following activity related to Education, Technical Assistance and Collaboration:

• CMS conducts State Program Integrity Reviews to assess the effectiveness of the state's program integrity efforts, including its compliance with federal statutory and regulatory requirements. The reviews also assist in identifying effective state program integrity activities and sharing best practices with other states. As a result of the opioid desk reviews, several states have acknowledged the need to increase their opioid-related audit activity and have engaged with the Unified Program Integrity Contractors (UPICs) to develop projects to address this weakness.

Another example of UPICs in Action is the CMS Victimized Provider Project. This program attempts to validate and remediate a provider’s claims as an identity theft victim. CMS advised providers to do the following if they think their identity has been stolen:

• Contact your UPIC who is the CMS fraud contractor that handles investigations on behalf of Medicare.
• Respond to any inquiry from your UPIC as part of a UPICs investigation is to interview the provider.
• Report any suspected ID theft to the police.

UPIC Actions Shared in the Unified Case Management System

CMS Transmittal 871 was released on March 29, 2019. The purpose of this Change Request (CR 11159) was to add Section 4.12 to Chapter 4 in the Medicare Program Integrity Manual. This new section provides instructions related to the UPIC workload entry and update requirements in the Unified Case Management System (UCM).

The purpose for me sharing this older transmittal with you is to make you aware of how many other Medicare Contractors can and probably are following the efforts of the UPICs. This is important because here at MMP we have found that review target efforts are often duplicated by more than one type of Medicare Contractor (i.e. MACs may select a review target based on SMRC findings).

Section 4.12 indicates that “the Unified Case Management (UCM) System is a national database that the UPICs use to enter and update Medicare and Medicaid fraud, waste, and abuse data analysis projects, leads, and investigations initiated by the UPIC. Additionally, the UCM allows the UPICs to enter and track various administrative actions (i.e., pre or post-payment reviews, payment suspensions, revocations, etc.), requests for assistance (RFAs), and requests for information (RFIs) that are fulfilled by UPICs at the request of law enforcement, CMS, or other stakeholders….The following agencies/organizations currently have access to the UCM:

• UPICs
• National Benefit Integrity Medicare Drug Integrity Contractor (NBI MEDIC)
• Railroad Retirement Board (RRB)
• CMS contractors (FPS, PIMAS, Acumen, IBM)
• MAC Medical Review Units associated with MPIP
• CMS
• FBI
• DOJ
• HHS/OIG
• Other federal and state partners seeking to address program integrity concerns in judicial or state health care programs

All workload received and/or initiated by the UPIC shall be saved in the UCM and shall contain identifying information on the potential subject(s) of a project, lead, investigation, etc., as well as general information on activities performed by the UPIC to substantiate the allegation of potential fraud, waste, or abuse. Investigative workload initiated by the UPIC shall contain a summary of the pertinent information related to any activities and/or resolution, and all fields in the UCM shall be updated with the applicable information as it is received by the UPIC.”

CMS Transmittal 10184: Medicare Program Integrity Manual (PIM) Chapter 6 Updates

Now, back to the CMS Transmittal 10184 issued on June 19, 2020. The purpose of this Change Request (CR 11812) is to update various sections within Chapter 4, 6, and 8 in the Medicare Program Integrity Manual. Today I want to call your attention to the updates in Chapter 6 – Medicare Contractor Medical Review Guidelines for Specific Services.

Prior to this CR, the following sections in chapter 6:

• 2 - Medical Review of Home Health Services,
• 5.2 - Conducting Patient Status Reviews of Claims for Medicare Part A Payment for Inpatient Hospital Admissions,
• 7 - Medical Review of Inpatient Rehabilitation Facility (IRF) Services, and
• 7.1 - Reviewing for Intensive Level of Rehabilitation Therapy Services Requirements)

Applied to the following CMS Contractors:

• Medicare Administrative Contractors (MACs),
• Supplemental Medical Review Contractor (SMRC),
• Recovery Audit Contractors (RACs), and the
• Comprehensive Error Rate Testing (CERT) Contractor.

Effective July 21, 2020, UPICs have been added to the applicable Contractors in each of these sections.

Additionally, the Zone Program Integrity Contractor (ZPIC) has been removed from sections 6.5.6 (Length of Stay Reviews), 6.5.9 (Circumvention of PPS), and 6.6 (Referrals to the Quality Improvement Organization (QIO)) and replaced by the UPIC as to the Contractor a referral would be made to.

UPICs and RACs

The following note can be found on the CMS Approved RAC Topics webpage:

“CMS often receives referrals of potential improper payments from the MACs, UPICs, and Federal investigative agencies (e.g., OIG, DOJ). At CMS discretion, CMS may require the RAC to review claims, based on these referrals. These CMS-Required RAC reviews are conducted outside of the established ADR limits.”

UPICs and the OIG

The OIG added the Item Results of UPICs’ Benefit Integrity Activities to their Work Plan in June 2020 indicating that “the Unified Program Integrity Contractors (UPICs) are the only benefit integrity contractors that safeguard both the Medicare and Medicaid programs from fraud, waste, and abuse. The Medicare and Medicaid programs provide health coverage to more than 100 million Americans. UPICs must effectively detect and deter fraud, waste, and abuse. This study will continue OIG's work examining the results from benefit integrity contractors' identification and investigation of fraud, waste, and abuse. It also will identify any barriers and challenges UPICs have experienced while conducting unified benefit integrity activities across Medicare and Medicaid.”

It remains to be seen how involved in medical review of inpatient hospital claims for Part A payment the UPICs may become. For now, it’s important to simply be aware of the UPICs in case they do send your hospital a medical record request.

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from June 30th through July 6th.   

Resource Spotlight This Week: CMS Guidance Regarding Nursing Home and Hospital Visitation

CMS recently posted visitation guidance for hospitals and nursing homes on the CMS Current Emergencies webpage.

Nursing Home Visitation

First, on June 24th CMS posted the FAQ document discussing steps and recommendations for visitation in nursing homes. “Because nursing home residents are especially vulnerable, CMS does not recommend reopening facilities to visitors (except for compassionate care situations) until phase three when:

• There have been no new, nursing home onset COVID-19 cases in the nursing home for 28 days (through phases one and two)
• The nursing home is not experiencing staff shortages
• The nursing home has adequate supplies of personal protective equipment and essential cleaning and disinfection supplies to care for residents
• The nursing home has adequate access to testing for COVID-19
• Referral hospital(s) have bed capacity on wards and intensive care units” 

Hospital Visitation

Two days later on June 26, 2020 CMS released a document regarding hospital visitation during Phase II. CMS notes in the opening paragraph that “Because hospital patients are vulnerable to potential COVID-19 infection, CMS does not recommend completely reopening facilities to visitors until Phase III. However, CMS also recognizes the significant toll of separation of patients from family and other loved ones.

In collaboration with State and local public health authorities, hospitals should develop plans for visitors that both consider patient and public health safety, as well as the emotional and care needs of patients and their families who are facing illness or life-events in separation. As facilities enter Phase II, facilities may consider additional flexibilities so that patients and their families can visit.”

The remainder of this document is in the form of questions and answers related to moving forward with hospital visitation prior to Phase III.

June 25, 2020: AMA Announced New CPT code for COVID-19 Antigen Tests

According to AMA President Susan R. Bailey, M.D. in this AMA announcement, “The new CPT code for antigen testing to detect the coronavirus is the latest in a series of CPT codes developed in rapid response to the pandemic...Moving quickly during this crisis to meet the medical coding needs of the health care industry has enhanced 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.”

New Category I CPT code:

• 87426: Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; severe acute respiratory syndrome coronavirus (eg, SARS-CoV, SARS-CoV-2 [COVID-19])

You can read the entire Press Release on the AMA website.

June 30, 2020: CDC Updates Training for Healthcare Professionals Webpage

Examples of topics available to Healthcare Professionals on this CDC webpage related to COVID-19 includes:

• Clinical Outreach and Communication Activity (COCA) Calls where you can learn the latest clinical information and guidance about COVID-19. Recent calls address infection control in nursing homes and dental settings, multisystem inflammatory syndrome in children (MIS-C0), and clinical perspective from across the nation’s healthcare systems.
• COVID-19 Prevention in Long-term Care Facilities
• COVID-10 Prevention in Hemodialysis Facilities
• Donning and Doffing PPE
• Optimization Strategies for Healthcare PPE
• COVID-19 in Animals

July 1, 2020: MLN SE20011 Medicare Response to Public Health Emergency on the COVID-19 Revised Again!

MLN article SE2011 is now in its’ ninth iteration. In this latest revision CMS revised the billing instructions for SNF. Changes include instructions to readmit the beneficiary on day 101 to start the Skilled Nursing Facility (SNF) benefit period waiver. All other information remains the same, for now.

July 1, 2020: New Point of Origin Code for Transfer from a Designated Disaster Alternate Care Site

MLN article MM11836 initially released on June 12, 2020 and was updated on July 1, 2020 to reflect an updated Change Request (CR) that changes the implementation date to August 3, 2020. The CR announced a new Point of Origin (PoO) Code “G” to indicate a “Transfer from a Designated Disaster Alternative Care Site (ACS),” due to changes relative to the COVID-19 Public Health Emergency (PHE).

July 2, 2020: New OIG Work Plan Item – Use of Medicare Telehealth Services during COVID-19 Pandemic

Following is the detail regarding the new Use of Telehealth Services during COVID-19 Pandemic Work Plan Item:

• “In response to the coronavirus disease 2019 (COVID-19) pandemic, CMS made a number of changes that allowed Medicare beneficiaries to access a wider range of telehealth services without having to travel to a health care facility. Although these changes are currently temporary, CMS is exploring whether telehealth flexibilities should be extended. These two concurrent reviews will be based on Medicare Parts B and C data and will examine the use of telehealth services in Medicare during the COVID-19 pandemic. The first review will examine the extent to which telehealth services are being used by Medicare beneficiaries, how the use of these services compares to the use of the same services delivered face-to-face, and the different types of providers and beneficiaries using telehealth services. The second review will identify program integrity risks with Medicare telehealth services to ensure their appropriate use and reimbursement during the COVID-19 pandemic.”

There were also several Items related to COVID-19 added to the OIG Work Plan in June:

• A Review of Medicare Data to Understand Hospital Utilization During COVID-19,
• Trend Analysis of Medicare Laboratory Billing for Potential Fraud and Abuse with COVID-19 Add-on Testing,
• Medicaid Telehealth Expansion During COVID-19 Emergency,
• Audit of Foster Care Services During Coronavirus Disease 2019 (COVID-19),
• Meeting the Challenges Presented by COVID-19: Nursing Homes,
• Opioid Treatment Program Challenges During the COVID-19 Pandemic,
• Audit of Nursing Home’ Reporting of COVID-19 Information Under CMS’s New Requirements

July 2, 2020: FDA Warns Consumers about Dangerous Alcohol-Based Hand Sanitizers Containing Methanol

The FDA notes in this Press Announcement that they have seen an increase in hand sanitizer products labeled to contain ethanol (also known as ethyl alcohol) that have tested positive for methanol contamination. “State officials have also reported recent adverse events from adults and children ingesting hand sanitizer products contaminated with methanol, including blindness, hospitalizations and death. The agency continues to warn the public not to use specific products listed here and is communicating with manufacturers and distributors of these dangerous products about recalling them.”

July 5, 2020: CDC Health Advisory: Serious Adverse Health Events Associated with Methanol-based Hand Sanitizers

In the wake of the FDA’s warning to the public, the CDC posted an Official Health Advisory on Sunday July 5th highlighting the FDA’s June 19th warning to not use any hand sanitizer manufactured by “Eskbiochem SA de CV” in Mexico, due to the potential presence of methanol, a “toxic alcohol….which can cause blinding and/or death when absorbed through the skin or when swallowed.” This alert goes on to provide recommendations for Clinical and Public Health Officials as well as the general public.

July 6, 2020: Open Letter to the American Public Urging Simple Steps to Stop the Spread of COVID-19

The American Hospital Association (AHA), American Medical Association (AMA), and the American Nurses Association (ANA) posted an Open Letter to the American Public. This letter opens by noting that “Since the beginning of the COVID-19 pandemic, we have urged the American people to protect themselves, their neighbors and their loved ones amidst the worst global health crisis in generations.”

They drive home the fact that as the country has begun to “reopen” there has been “a dramatic uptick in COVID-19 cases” that is negating hard-won gains during the months of staying at home. According to the CDC as of July 6, 2020 the U.S. has had 2,886,267 total cases and 129,811 deaths. More significantly, from July 5th to July 6th there were 44,361 new cases and 235 deaths reported.

A key message in the letter is the urging for everyone to help stop the spread of the virus following three simple steps known to help:

• Wearing a face mask,
• Maintaining physical distancing, and
• Washing your hands.
  

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from June 18th – 29th.  

Resource Spotlight This Week: CDC Social Media Toolkit

The CDC Social Media Toolkit was created to help localize efforts in responding to the virus that causes COVID-19. The following messages and graphics are available to help in this effort:

• Ensure current, correct messaging from a trusted source,
• Create collateral materials, and
• Share resources.

“All graphics and suggested messages are available for use on social media profiles and web pages.

Within this guide you will find information and suggested messages from our COVID-19 response. For more images and CDC content you can visit our Communication Resources page. All social media content is public domain and free to use by anyone for any purpose without restriction under copyright law. Please remember to use the #COVID19 hashtag when tweeting out any COVID-19 related content.”

June 18, 2020: JAMA Network Article: Disparities in Coronavirus 2019 Reported Incidence, Knowledge, and Behavior Among US Adults

The authors of this JAMA Network article undertook this endeavor “to determine the association of sociodemographic characteristics with reported incidence, knowledge, and behavior regarding COVID-19 among US adults.”

US National Survey Parameters:

• Survey was conducted electronically from March 29 to April 13, 2020,
• Survey “oversampled COVID-19 hotspot areas,” and
• Participant criterion included age ≥ 18 years old and residence in the US.

Researchers found that African American participants, men, and people younger than 55 years showed less COVID-19-related knowledge than other groups. Survey results detailed in this article also provides insight into the probability of having COVID-19 or knowing someone who does, knowledge about the spread of and symptoms of COVID-19, and factors associated with hand washing and leaving the house.

June 19, 2020: MLN MM11742 Long Term Hospital (LTCH) Prospective Payment System (PPS) Fiscal Year (FY) 2020 Pricer Revised

MLN article MM11742 was revised to reflect a revised Change Request (CR) 11742 also issued on June 19th. CMS made the following revisions to CR 11742:

• Revise the COVID-19 blanket waiver for the LTCH ALOS policy,
• To include revising the effective date and policy section, and
• Revise the CR release date, transmittal number, and web address of the CR.

June 19, 2020: American Hospital Association (AHA) urges HHS to extend Public Health Emergency (PHE)

In a letter to the Secretary of Health and Human Services (HHS), AHA President and Chief Executive Officer, Richard J. Pollack urged “to extend the public health emergency beyond its current July 25, 2020 expiration date so health care providers can continue to offer the most efficient and effective care possible during the continuing COVID-19 pandemic.” Mr. Pollack urged for the continuance of the PHE until four criteria outlined in the letter are met.

June 22, 2020: CMS Press Release: Call to Action Based on New Data Detailing COVID-19 Impacts on Medicare Beneficiaries

In a June 22nd Press Release, CMS is calling for a renewed commitment to value-based care based on Medicare claims data providing an early look at the impact of COVID-19 on the Medicare population. The initial data reflects claims with a COVID-19 diagnosis (B97.29 from 1/1/2020 – 3/31/2020) and U07.1 (starting 4/1/2020) billed in any of the 25 diagnosis code fields on the claim or encounter record with a date of service from January 1st through May 16, 2020. Data is broken down by Medicare beneficiaries’ state, race/ethnicity, age, gender, dual eligibility for Medicare and Medicaid, and urban/rural locations. Moving forward, CMS indicates that this data will be updated monthly.

“The data shows that older Americans and those with chronic health conditions are at the highest risk for COVID-19 and confirms long-understood disparities in health outcomes for racial and ethnic minority groups and among low-income populations.” This Press Release includes a link to more information on the Medicare COVID-19 data, an FAQ document related to the data release, and a blog by CMS Administrator Seema Verma.

June 25, 2020: Changes to Staffing Information and Quality Measures Posted on the Nursing Home Compare Website and Five Star Quality Rating System Due to the COVID-19 PHE

CMS announced the following changes in a Memorandum Summary:

• “Staffing Measures and Ratings Domain: On July 29, 2020, Staffing measures and star ratings will be held constant, and based on data submitted for Calendar Quarter 4 2019.
• Also, CMS is ending the waiver of the requirement for nursing homes to submit staffing data through the Payroll-Based Journal System. Nursing homes must submit data for Calendar Quarter 2 by August 14, 2020.
• Quality Measures: On July 29, 2020, quality measures based on a data collection period ending December 31, 2019 will be held constant.”

June 25, 2020: CDC Revises Who is at Risk for Severe Illness from COVID-19

On June 25th, the CDC made revisions to the list of people at increased risk of severe illness from COVID-19. They noted that revisions were made to reflect data available as of May 29, 2020, and as new information becomes available, they will again update the information.

With this update comes several changes to the list of conditions. Prior to this update the CDC had indicated that “older adults and people of any age who have serious underlying medical conditions might be at higher risk for severe illness from COVID-19:

• People aged 65 years and older,
• People living in a nursing home or long-term care facility,
• Other high-risk conditions include:
• People with chronic lung disease or moderate to severe asthma,
• People who have serious heart conditions,
• People who are immunocompromised including cancer treatment,
• People of any age with severe obesity (Body Mass Index [BMI] >40) or certain underlying medical conditions, particularly if not well controlled, such as those with diabetes, renal failure, or liver disease might also be at risk,
• People who are pregnant should be monitored since they are known to be at risk with severe viral illness, however, to date data on COVID-19 has not shown increased risk,
• Many conditions can cause a person to be immunocompromised, including cancer treatment, bone marrow or organ transplantation, immune deficiencies, poorly controlled HIV or AIDs, and prolonged use of corticosteroids and other immune weakening medications.

The June 25th revisions indicate that people of any age with the following conditions are at increased risk of severe illness from COVID-19:

• Chronic Kidney Disease,
• Chronic Obstructive Pulmonary Disease,
• Immunocompromised state (weakened immune system) from solid organ transplant,
• Obesity (body mass index {BMI} of 30 or higher),
• Serious heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies,
• Sickle cell disease,
• Type 2 Diabetes, and
• Children who are medically complex, who have neurologic, genetic, metabolic conditions, or who have congenital heart disease are at higher risk for severe illness from COVID-19 than other children.

June 26, 2020: Medicare Fee-for-Service (FFS) Response to the Public Health Emergency on COVID-19 MLN Article Revised Again

MLN Article SE20011 initially released on March 16, 2020 has been updated twice in the past week and is now in its eight iteration. First, on June 19th, a revision added the section, “Medicare Coverage of COVID-19 Testing for Nursing Home Residents and Patients.” Following is an excerpt from the information added to this MLN article:

“Starting on July 6, 2020, and for the duration of the public health emergency, consistent with sections listed below of CDC guidelines titled, “Interim SARS-CoV-2 Testing Guidelines for Nursing Home Residents and Healthcare Personnel,” Original Medicare and Medicare Advantage plans will cover diagnostic COVID-19 lab tests and non-cover tests not considered diagnostic.

• Viral Testing of Residents for SARS-CoV-2
• Initial Viral Testing in Response to an Outbreak
• Recommended testing to determine resolution of infection with SARS-CoV-2
• Public health surveillance for SARS-CoV-2

Tests that are considered non-diagnostic are not covered.”

This article was again updated on June 26th to add a section titled Skilled Nursing Facility (SNF) Benefit Period Waiver – Provider Information and Billing Instruction. In this update CMS provides examples of when to document on the claims that a patient meets the requirement SNF requirement waiver.

June 28, 2020: CDC Updates Considerations for Wearing Cloth Face Coverings

On June 28th the CDC updated this webpage and is recommending people wear cloth face coverings in public settings and when around people outside of their household, especially when other social distancing measures are difficult to maintain. You will find information about the following on this webpage:

• Evidence for effectiveness of cloth face coverings,
• Who should wear a cloth face covering,
• Who should not wear a cloth face covering,
• Feasibility and Adaptations,
• Face shields,
• Surgical Masks, and
• Links to recent studies.

June 29, 2020: New Supplies of Remdesivir for the United States

The Department of Health and Human Services (HHS) announced an agreement to secure more than 500, 000 treatment courses of Remdesivir for the US from Gilead Sciences through September. Per the announcement “hospitals will receive the product shipped by AmerisourceBergen and will pay no more than Gilead’s Wholesale Acquisition Price (WAC), which amounts to approximately $3,200 per treatment course.”

Daniel O’Day, Chairman and CEO of Gilead Sciences indicated in a related Open Letter that normal pricing of a medicine is according to the value provided and cites an approximately $12,000 hospital savings per patient. He went on to indicate that “We have decided to price remdesivir well below this value. To ensure broad and equitable access at a time of urgent global need, we have set a price for governments of developed countries of $390 per vial. Based on current treatment patterns, the vast majority of patients are expected to receive a 5-day treatment course using 6 vials of remdesivir, which equates to $2,340 per patient.”