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MMP’s November 11, 2020 COVID-19 Updates article included the November 9th FDA announcement where they had issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy Bamlanivimab. How should our hospital code and bill for providing this drug?
As a reminder from the November 11th article, Bamlanivimab is not authorized for patients already hospitalized due to COVID-19. Instead, it is to be given in an outpatient setting and “is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions.”
November 10, 2020: CMS Posts Medicare Monoclonal Antibody COVID-19 Infusion Program Instruction
CMS posted the document Medicare Monoclonal Antibody COVID-19 Infusion Program Instruction on the CMS Current Emergencies Coronavirus Disease 2019 webpage in the Billing & Coding section. CMS notes that during the public health emergency (PHE), Medicare will cover and pay for these infusions the same way it covers and pays for COVID-19 vaccines (when furnished consistent with the EUA). The following Coding and Billing Guidance is excerpted from the CMS Infusion Program Instruction.
Coding for Monoclonal Antibody COVID-19 Infusion
CMS identified specific code(s) for the monoclonal antibody product and specific administration code(s) for Medicare payment:
Eli Lilly and Company's Antibody Bamlanivimab (LY-CoV555), EUA effective November 9, 2020
- Long descriptor: Injection, bamlanivimab-xxxx, 700 mg
- Short descriptor: bamlanivimab-xxxx
- Long Descriptor: intravenous infusion, bamlanivimab-xxxx, includes infusion and post administration monitoring
- Short Descriptor: bamlanivimab-xxxx infusion
Billing for Monoclonal Antibody COVID-19 Infusion Administration
Health care providers can bill for the administration of the monoclonal antibody infusion on a single claim for COVID-19 monoclonal antibody administration or submit claims on a roster bill, in accordance with the FDA EUA.
- The EUA for COVID-19 monoclonal antibody treatment bamlanivimab contains specific requirements for administration that are considerably more complex than for other services that are billed using roster billing. CMS expects that health care providers will maintain appropriate medical documentation that supports the medical necessity of the service. This includes documentation that supports that the terms of the EUA are met, including that it is being used for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) for a patient that is at high risk for progressing to severe COVID-19 and/or hospitalization. The documentation should also include the name of the practitioner who ordered or made the decision to administer the infusion, even in cases where claims for these services are submitted on roster bills.
- When COVID-19 monoclonal antibody doses are provided by the government without charge, providers should only bill for the administration. Health care providers should not include the monoclonal antibody codes on the claim when the product is provided for free.
Health care providers who participate in a Medicare Advantage Plan should submit claims for bamlanivimab administration to Original Medicare for all patients enrolled in Medicare Advantage in 2020 and 2021.
I have been told conflicting information about documenting a positive COVID-19 test. Is physician documentation that a patient has COVID-19 sufficient for the hospital to receive additional payment?
The short answer is no. However, reminiscent of the late Paul Harvey, here is the rest of the story.
COVID-19: Timeline to a New Code
The CDC announced the release of a new code specifically for reporting COVID-19 during the March 18th ICD-10-CM Coordination and Maintenance Committee Meeting. This code became effective on April 1st, 2020. Following is a timeline of events prompting the speed with which this code was made available for use:
- January 31, 2020: An emergency meeting was convened by the World Health Organization (WHO) Family of International Classifications (WHOFIC) Network Classification and Statistics Advisory Committee (CSAC) and a new ICD-10 emergency code was established.
- U07.1, 2019-nCoV acute respiratory disease
- February 20, 2020: The CDC published supplemental guidance for coding encounters related to COVID-19. At that time hospitals were instructed to used ICD-10-CM code B97.29 (Other coronavirus as the cause of diseases classified elsewhere) when coding a confirmed COVID-19 infection. Note, ICD-10-CM code B97.29 was to be used by hospitals for discharges occurring on or after January 1, 2020, and on or before March 31, 2020.
- March 18, 2020: The Coordination and Maintenance Committee Meeting met virtually. It was announced that the COVID-19 code (U07.1) effective date was changed from October 1, 2020 to April 1, 2020 due to the national health emergency.
- March 31, 2020: The CDC released the document ICD-10-CM Official Coding and Reporting Guidelines for coding COVID-19 April 1, 2020 – September 30, 2020. The guidelines indicated that you are to “Code only a confirmed diagnosis of the 2019 novel coronavirus disease (COVID-19) as documented by the provider, documentation of a positive COVID-19 test result, or a presumptive 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 the type of test performed; the provider’s documentation that the individual has COVID-19 is sufficient.”
- April 1, 2020: The CDC published an ICD-10-CM Tabular Lists of Diseases and Injuries Addenda which established a new chapter (Chapter 22: Codes for special purposes [U00-U85https://www.cdc.gov/nchs/icd/icd10cm.htm">CDC ICD-10-CM webpage as well as the CMS ICD-10-CM webpage. The updated guidelines includes a new section in Chapter 1 (Certain Infectious and Parasitic Diseases) related to coding COVID-19.
Hospital Inpatient Setting: Timeline to Additional Payment for Treating COVID-19 Patients
- March 27, 2020: The Coronavirus Aid, Relief, and Economic Security (CARES) Act was signed into law. Within this law was the following guidance regarding additional payment for treatment of patients diagnosed with COVID-19:
- Sec. 3710 Medicare Hospital Inpatient Prospective Payment System Add-On Payment for COVID-19 Patients During Emergency Period: “For discharges occurring during the emergency period, in the case of a discharge of an individual diagnosed with COVID-19, the Secretary shall increase the weighting factor that would otherwise apply to the diagnosis-related group to which the discharge is assigned by 20 percent. The Secretary shall identify a discharge of such an individual through the use of diagnosis codes, condition codes, or other such means as may be necessary.”
- April 24, 2020: MLN Matters Article MM11764 details guidance in Change Request 11764 regarding coding COVID-19 and the implementation of the temporary payment adjustment as mandated by section 3710 of the CARES Act.
- August 14, 2020: Transmittal 10300 (Update to the Implementation of the Increased Payments for COVID-19 Discharges Under the Inpatient Prospective Payment System (IPPS) Under Section 3710 of the CARES Act) was released to prospectively update “the implementation of section 3710 of the CARES Act to require that a positive laboratory test be documented in the patient’s medical record for the increased payment for COVID-19 discharges under the Inpatient Prospective Payment System (IPPS).”
- Note, Transmittal 10300 has since been rescinded and replaced with Transmittal 10361 (Change Request 11925).
- August 17, 2020: MLN Matters Article SE20015 initially released on April 15, 2020 was revised on August 17, 2020 to add the following language:
- “To address potential Medicare program integrity risks, effective with admissions occurring on or after September 1, 2020, claims eligible for the 20 percent increase in the MS-DRG weighting factor will also be required to have a positive COVID-19 laboratory test documented in the patient’s medical record. Positive tests must be demonstrated using only the results of viral testing (i.e., molecular or antigen), consistent with CDC guidelines. The test may be performed either during the hospital admission or prior to the hospital admission.
For this purpose, a viral test performed within 14 days of the hospital admission, including a test performed by an entity other than the hospital, can be manually entered into the patient’s medical record to satisfy this documentation requirement. For example, a copy of a positive COVID-19 test result that was obtained a week before the admission from a local government-run testing center can be added to the patient’s medical record. In the rare circumstance where a viral test was performed more than 14 days prior to the hospital admission, CMS will consider whether there are complex medical factors in addition to that test result for purposes of this documentation requirement.”
Coding vs. Billing for COVID-19
As indicated earlier in this article, the ICD-10-CM guidelines indicate that you code only confirmed cases of COVID-19 as documented by the provider, documentation of a positive COVID-19 test result, or a presumptive positive COVID-19 test result.
However, CR 11925, for admissions occurring on or after September 1, 2020 hospitals are “required to have a positive COVID-19 laboratory test documented in the patient’s medical record. Positive tests must be demonstrated using only the results of viral testing (i.e., molecular or antigen), consistent with CDC guidelines. The test may be performed either during the hospital admission or prior to the hospital admission.”
What do you do when a physician documents that a patient has a confirmed case of COVID-19 but there is no positive test result in the record?
“A hospital that diagnoses a patient with COVID-19 consistent with the ICD-10-CM Official Coding and Reporting Guidelines but does not have evidence of a positive test result can decline, at the time of claim submission, the additional payment resulting from the application at the time of claim payment of the 20 percent increase in the MS-DRG relative weight to avoid the repayment. To do so, the hospital will inform its MAC and the MAC will notate the claim with MAC internal claim processing coding for processing. The Pricer software will not apply the 20 percent increase to the claim when that MAC internal claim processing coding is present on a claim with the ICD-10-CM diagnosis code U07.1 (COVID-19). The updated Pricer software package reflecting this change will be released in October 2020.
To notify your MAC when there is no evidence of a positive laboratory test documented in the patient’s medical record, enter a Billing Note NTE02 “No Pos Test” on the electronic claim 837I or a remark “No Pos Test” on a paper claim.”
Hospital IPPS Payments under Section 3710 the CARES Act
CMS has made available the document COVID-19 Frequently Asked Questions (FAQs) on Medicare Fee-for-Service (FFS) Billing. Section F of this document, titled Hospital IPPS Payments under the CARES Act, answers questions about section 3710 of the CARES Act and provides examples illustrating the increase in IPPS operating MS-DRG payments. Note, during the COVID-19 Public Health Emergency (PHE), this document has been updated on a fairly regular basis and as of the October 28, 2020, the update is 152 pages in length. I encourage you to check for updates on a regular basis.
How would you code a foreign body that is intentionally left in the body during an operation since the ICD-10-CM codes are for situations where the foreign body was unintentionally left behind?
The answer to this question comes from Coding Clinic, First Quarter 2014, page 21. We are not to assign a complication code for something left intentionally during surgery. Coding Clinic made this change to reflect The National Quality Forum revised information on Serious Reportable Events in Healthcare.
Coding Clinic, First Quarter 2014, page 21
Given the ongoing COVID-19 Pandemic, has CMS delayed the start date for the Hospital Price Transparency requirement?
There has been no delay in this requirement. CMS actually reaffirmed the January 1, 2020 effective date by including the following information in their Thursday October 1, 2020 MLNConnects newsletter:
Hospital Price Transparency: Requirements Effective January 1
Starting January 1, 2021, each hospital operating in the United States is required to provide clear, accessible pricing information online about the items and services they provide in two ways:
- Comprehensive machine-readable file with all items and services
- Display of shoppable services in a consumer-friendly format
Is your organization prepared to be compliant? Visit the new Hospital Price Transparency website for resources to help you prepare:
What COVID-19 testing-related services are eligible for waiving cost-sharing and how are they identified in Medicare claims?
CMS provided the following information in the Thursday, August 27, 2020 edition of MLNConnects:
The Families First Coronavirus Response Act waives cost-sharing under Medicare Part B (coinsurance and deductible amounts) for COVID-19 testing-related services through the end of the public health emergency. In April, CMS provided evaluation and management categories for applicable medical visits. We are now specifying HCPCS procedure codes for this cost-sharing waiver for:
- Physicians/Non-Physician Practitioners (ZIP)
- Hospital Outpatient Departments paid under the Outpatient Prospective Payment System (PDF)
- Rural Health Clinics and Federally Qualified Health Centers (ZIP)
- Critical Access Hospitals (CAHs) use the Outpatient list; Method II CAHs use the Outpatient and Physicians/Non-Physician Practitioners lists as applicable
Use the Cost Sharing (CS) modifier on applicable claim lines to identify the service as subject to this cost-sharing wavier. If you use the CS modifier with HCPCS codes that are not on the list, we will return the claim.
For more information, see MLN Matters Special Edition Article SE20011 Medicare Fee-For-Service (FFS) Response to the Public Health Emergency on the Coronavirus (COVID-19) (PDF).
Thursday, August 27, 2020 edition MLNConnects:
Situational Depression is coded to F43.21, Adjustment Disorder with Depressed Mood per the Alphabetic Index. Would it be appropriate to assign Adjustment Disorder with Anxiety, F43.22, for Situational Anxiety?
No, assign F41.8, Other Specified Anxiety Disorder, when Situational Anxiety is documented with no further specification. Adjustment Disorder with Anxiety, F43.22 would not be used since an adjustment disorder was not documented.
August 24, 2020, Coding Clinic Correspondence
Have Medicare Contractors started performing Medical Reviews again?
In last week’s newsletter we answered this question by reviewing recent CMS Guidance regarding Medicare Administrative Contractors (MACs), Supplemental Medical Review Contractor (SMRC) and Recovery Audit Contractor (RAC) resuming medical reviews.
Since then, the Comprehensive Error Rate Testing (CERT) has posted the following notice on the CMS CERT webpage:
“Effective August 11, 2020, the Centers for Medicare & Medicaid Services (CMS) is resuming Comprehensive Error Rate Testing (CERT) program activities that were temporarily suspended in response to the public health emergency (PHE) for the 2019-Novel Coronavirus (COVID-19) pandemic. Specifically, the CERT program will resume sending documentation request letters to and conducting phone calls with providers or suppliers to request medical documentation for claims in Reporting Year (RY) 2021 (claims submitted 7/1/2019 through 6/30/2020) and RY 2022 (claims submitted 7/1/2020 through 6/30/2021).
Due to the cyclical nature of the CERT program improper payment measurement and the statutory timeline required for improper payment reporting under the Payment Integrity Information Act of 2019 (PIIA) (i.e., reporting annually), improper payment measurements cannot pause for an extended period without missing the statutorily required due dates.
The CERT program will not resume sending documentation request letters to, or conducting phone calls with, providers or suppliers to request medical documentation for claims in RY 2020 (claims submitted 7/1/2018 through 6/30/2019). The CERT program will report the 2020 Medicare Fee-for-Service (FFS) program improper payment rate in the November 2020 Department of Health and Human Service (HHS) Agency Financial Report (AFR) based on the data that CMS currently has or that providers or suppliers voluntarily submit.
CMS has altered CERT program activities in the short term (i.e., ceasing provider contact for RY 2020 claims) and adjusted data collection in the longer term (i.e., sample size reduction for RY 2021 and RY 2022 claims) to account for the challenges incurred by providers and suppliers during the PHE, while continuing to maintain appropriate accountability measures and meet statutory obligations.”
Given the ongoing COVID-19 Public Health Emergency, has CMS extended the Testing Period for the Appropriate Use Criteria Program set to begin in Calendar Year 2020?
Yes, CMS updated their Appropriate Use Criteria Program webpage on August 10, 2020 with the following Notice:
“The EDUCATIONAL AND OPERATIONS TESTING PERIOD for the AUC Program has been extended through CY 2021. There are no payment consequences associated with the AUC program during CY 2020 and CY 2021. We encourage stakeholders to use this period to learn, test and prepare for the AUC program.”
Have Medicare Contractors started performing Medical Reviews again?
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.
American Hospital Association Letter to CMS
The American Hospital Association (AHA) expressed concern about CMS’s decision to resume medical review audits on August 3, 2020 in a July 29, 2020 letter to CMS Administrator Seema Verma. The letter ends with the AHA stating that “to be clear, we urge the agency to refrain from differentiation between medical review audits and the other flexibilities you have created, and instead ensure all of the relevant waivers remain active during the pandemic.”
Medicare Administrative Contractors (MACs) Guidance
On August 4, 2020, Palmetto GBA posted an article to their website providing additional detail about the resumption of medical reviews. Specifically,
- Beginning August 17th, the MACs are resuming post-payment reviews of items/services provided prior to March 1, 2020,
- The Targeted Probe and Educate (TPE) program will restart later, and
- MACs will continue to offer detailed review decisions and education as appropriate.
CMS included this same guidance in their August 6, 2020 MLNConnects e-newsletter.
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