COVID-19 Frequently Asked Questions (FAQs) On Medicare

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COVID-19 Frequently Asked Questions (FAQs) onMedicare Fee-for-Service (FFS) BillingThe FAQs in this document supplement the previously released FAQs: 1135 Waiver FAQs,available at ver.pdf.We note that in many instances, the general statements of the FAQs referenced above havebeen superseded by COVID-19-specific legislation, emergency rules, and waivers granted undersection 1135 of the Act specifically to address the COVID-19 public health emergency (PHE). Thepolicies set out in this FAQ are effective for the duration of the PHE unless superseded by futurelegislation.A few answers in this document explain provisions from the Coronavirus Aid, Relief, andEconomic Security (CARES) Act, Public Law No. 116-136 (March 27, 2020). CMS is thoroughlyassessing this new legislation and new and revised FAQs will be released as implementationplans are announced.The interim final rule with comment period (IFC), CMS-1744-IFC, Medicare and MedicaidPrograms; Policy and Regulatory Revisions in Response to the COVID-19 Public HealthEmergency, is available at the following covid-19-publicThe interim final rule with comment period (IFC2), CMS-5531-IFC, Medicare and MedicaidPrograms, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions inResponse to the COVID-19 Public Health Emergency and Delay of Certain Reporting Requirementsfor the Skilled Nursing Facility Quality Reporting Program, is available at the following y-and-regulatoryTable of Contents:A. Payment for Specimen Collection for Purposes of COVID-19 Testing. 4B. Diagnostic Laboratory Services . 6C. Diagnostic Laboratory Services - Serology Testing .11D. High Throughput COVID-19 Testing.12E. Hospital Services .18F. Hospital Inpatient Prospective Payment Systems (IPPS) Payments .27Updated: 1/7/2021pg. 1

G. Hospital Outpatient – Locations off of Hospital Campus.36H. Hospital Outpatient Therapeutic Services Furnished In Temporary Expansion Locations .44I. Partial Hospitalization Program (PHP) Services.46J. Ambulance Services.47K. Ambulance Services- Vehicle and Staffing Requirements for Ambulance Providers and Suppliers .53L. Ambulance: Data Collection and Reporting Requirements for the Medicare Ground Ambulance DataCollection System .55M. Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) .56N. Expansion of Virtual Communication Services for FQHCs/RHCs .60O. Revision of the Home Health Agency Shortage Area Requirement for Visiting Nursing ServicesFurnished by RHCs and FQHCs .64P. Medicare Telehealth.65Q. Physician Services .82R. Scope of Practice.86S. Additional Flexibility under the Teaching Physician Regulations .87T. Home Infusion Services .89U. Medicare Shared Savings Program - Accountable Care Organizations (ACO) .91V. Cost Reporting. 105W. Opioid Treatment Programs (OTPs). 109X. Inpatient Rehabilitation Facility Services . 110Y. Skilled Nursing Facility Services. 113Z. General Billing Requirements . 115AA. Home Health . 116BB. Drugs & Vaccines under Part B . 120CC. National Coverage Determinations (NCD). 134DD. Medicare Payment to Facilities Accepting Government Resources . 143EE. Oxygen. 144FF. Temporary Department of Defense Sites . 144GG. Military Treatment Facilities (MTFs) . 144HH. Hospice . 144II. Ambulatory Surgical Centers (ASC) . 146Updated: 1/7/2021pg. 2

JJ. Diagnosis Coding under International Classification of Diseases, Tenth Revision, Clinical Modification(ICD-10-CM) . 149KK. Chronic Care Management Services . 150LL. Hospital Billing for Remote Services . 151MM. Outpatient Therapy Services . 154NN. Durable Medical Equipment Interim Pricing in the CARES Act. 158OO. Medical Education . 160PP. Applicability Dates of Provisions in Second IFC . 162QQ. Indian Health Service (IHS) Hospitals . 165Updated: 1/7/2021pg. 3

A. Payment for Specimen Collection for Purposes of COVID-19 Testing1. Question: What changes did CMS announce regarding specimen collection fees for COVID19 testing?Answer: As part of the Public Health Emergency (PHE) for the COVID-19 pandemic and in aneffort to be as expansive as possible within the current authorities to have diagnostictesting available to Medicare beneficiaries who need it, in the interim final rule withcomment period, we are changing the Medicare payment rules during the PHE for theCOVID-19 pandemic to provide payment to independent laboratories for specimencollection from beneficiaries who are homebound or inpatients not in a hospital for COVID19 testing under certain circumstances.New: 4/9/202. Question: What has been the Medicare payment policy for specimen collection forlaboratory testing and for transportation and personnel expenses for trained personnel tocollect specimens from homebound patients and inpatients (not in a hospital)?Answer: In general, the Social Security Act (the Act) requires that the Secretary establish anominal fee for specimen collection for laboratory testing and a fee to cover transportationand personnel expenses (generally referred to as a travel allowance) for trained personnelto collect specimens from homebound patients and inpatients (not in a hospital). The travelallowance is paid only when the nominal specimen collection is also payable. Refer to IOM,Pub. 100-04, Chapter 16, Section 60 for more information. For beneficiaries, neither theannual cash deductible nor the 20 percent coinsurance apply to the specimen collectionfees or travel allowance for laboratory tests.New: 4/9/203. Question: How is the IFC changing the Medicare specimen collection and travel allowancepolicy?Answer: This IFC is providing a specimen collection fee and fees for transportation andpersonnel expenses known as a travel allowance for COVID-19 testing under certaincircumstances for the duration of the PHE for the COVID-19 pandemic. The IFC alsodescribes the definition of “homebound” for purposes of our specimen collection policy andallowing for electronic records of mileage for the travel allowance for the duration of thePHE for the COVID-19 pandemic.New: 4/9/204. Question: Who can bill for the Medicare specimen collection fee?Answer: Independent laboratories can bill Medicare through their MAC for the specimencollection fee. The specimen collection fee applies if the specimen is collected by trainedlaboratory personnel from a homebound or non-hospital inpatient and the specimen is atype that would not require only the services of a messenger pick up service. However, thespecimen collection fee is not available for tests where a patient collects his or her ownUpdated: 1/7/2021pg. 4

specimen.New: 4/9/205. Question: What is the nominal fee for specimen collection for COVID-19 testing forhomebound and non-hospital inpatients during the PHE?Answer: The nominal specimen collection fee for COVID-19 testing for homebound andnon-hospital inpatients generally is 23.46 and for individuals in a non-covered stay in a SNFor whose samples are collected by a laboratory on behalf of an HHA is 25.46.Updated: 4/17/206. Question: What are the new level II HCPCS codes for specimen collection for COVID-19testing?Answer: To identify specimen collection for COVID-19 testing, we established two new levelII HCPCS codes effective March 1, 2020. Independent laboratories must use one of theseHCPCS codes when billing Medicare for the nominal specimen collection fee for COVID-19testing for the duration of the PHE for the COVID-19 pandemic. These HCPCS codes are: G2023, specimen collection for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) (Coronavirus disease [COVID-19]), any specimen source G2024, specimen collection for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) (Coronavirus disease [COVID-19]), from an individual in a SNF or bya laboratory on behalf of a HHA, any specimen sourceWe note that G2024 is applicable to patients in a non-covered stay in a SNF and not tothose residents in Medicare-covered stays (whose bundled lab tests would be coveredinstead under Part A’s SNF benefit at §1861(h) of the Act).Updated: 4/17/207. Question: How should a laboratory document the miles traveled to collect a specimen?Answer: An independent laboratory billing Medicare for the travel allowance is required tolog the miles traveled. CMS will not require paper documentation logs that some MACs mayhave otherwise required; electronic logs can be maintained instead. However, laboratorieswill need to be able to produce these electronic logs in a form and manner that can beshared with MACs.New: 4/9/208. Question: What is the definition of homebound for purposes of our specimen collectionpolicy?Answer: Medicare beneficiaries are considered “confined to the home” (that is,“homebound”) if it is medically contraindicated for the patient to leave the home. When itis medically contraindicated for a patient to leave the home, there exists a normal inabilityfor an individual to leave home and leaving home safely would require a considerable andtaxing effort.Updated: 1/7/2021pg. 5

As an example for the PHE for COVID-19 pandemic, this would apply for those patients: (1)where a physician has determined that it is medically contraindicated for a beneficiary toleave the home because he or she has a confirmed or suspected diagnosis of COVID-19; or(2) where a physician has determined that it is medically contraindicated for a beneficiary toleave the home because the patient has a condition that may make the patient moresusceptible to contracting COVID-19.A patient who is exercising “self-quarantine” for his or her own safety during a pandemicoutbreak of an infectious disease, such as COVID-19, would not be considered “confined tothe home” or “homebound” unless it is also medically contraindicated for the patient toleave the home. If a patient does not have a confirmed or suspected diagnosis of aninfectious, pandemic disease such as COVID-19, but the patient’s physician states that it ismedically contraindicated for the patient to leave the home because the patient’s conditionmay make the patient more susceptible to contracting an infectious, pandemic disease, thepatient would be considered “confined to the home” or “homebound” for purposes of ourspecimen collection policy.New: 4/9/20B. Diagnostic Laboratory Services1. Question: What are the general rules around how Medicare pays for clinical diagnosticlaboratory tests?Answer: Medicare Part B, which includes a variety of outpatient services, covers medicallynecessary clinical diagnostic laboratory tests when a doctor or other practitioner orders them.Medically necessary clinical diagnostic laboratory tests are generally not subject to coinsuranceor deductible.Updated: 12/11/202. Question: Are there Healthcare Common Procedure Coding System (HCPCS) and CurrentProcedural Terminology (CPT) codes available for COVID-19 laboratory testing?Answer: Yes, CMS has created two HCPCS codes in response to the urgent need to bill forthese services. The codes are: U0001, CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel and U0002, 2019-nCoV Coronavirus, SARS-CoV-2/2019-nCoV (COVID-19), any technique,multiple types or subtypes (includes all targets), non-CDC.Additionally, the American Medical Association (AMA) Current Procedural Terminology(CPT) Editorial Panel has created CPT code 87635 (Infectious agent detection by nucleic acid(DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirusdisease [COVID-19]), amplified probe technique) Please visit pdated: 1/7/2021pg. 6

testLaboratories can begin billing for the performance of these tests using these codesimmediately via standard Fee-for-service billing practices.Revised: 4/10/203. Question: Are all of these codes available for laboratories to use to bill Medicare?Answer: Yes. The CMS HCPCS codes will be available on the HCPCS and Clinical LaboratoryFee Schedule (CLFS) file beginning April 1, 2020, for dates of service on or after February 4,2020. The AMA CPT code, 87635 will also be available on the HCPCS and CLFS file beginningApril 1, 2020, for dates of service on or after March 13, 2020.Posted: 3/21/204. Question: My laboratory uses the CDC test kit; what code should we use to bill Medicare?Answer: The appropriate code to use would be HCPCS Code U0001 (CDC 2019-nCoV RealTime RT-PCR) Diagnostic Panel).Posted: 3/21/205. Question: My laboratory does not use the CDC test kit; what code should we use to billMedicare?Answer: If your laboratory uses the method specified by CPT 87635, the appropriate codeto use would be CPT 87635. If your laboratory has a test that uses a method not describedby CPT 87635, the appropriate code to use would be HCPCS Code U0002.Posted: 3/21/206. Question: What code should we use to bill Medicare if new types of COVID-19 tests arecreated in the future?Answer: The appropriate code to use would be HCPCS Code U0002 for COVID-19 testmethods that are not specified by either U0001 or 87635. CMS will continue to monitor thetypes of COVID-19 testing methods and adjust coding as necessary depending on themethodology.Posted: 3/21/207. Question: How will Medicare pay for COVID-19 testing on the CLFS?Answer: Local MACs are responsible for developing the payment amount for claims theyreceive for these newly created HCPCS codes and the CPT code in their respectivejurisdictions until Medicare establishes national payment rates on the CLFS. Please -test-pricing.pdf for more informationon current MAC payment rates. If there are questions or concerns about payments,laboratories should contact their MAC with additional information.For more information on CMS’s procedures for public consultation on payment for newclinical diagnostic laboratory tests on the CLFS, please seeUpdated: 1/7/2021pg. 7

icePayment/ClinicalLabFeeSched/Laboratory Public Meetings.Revised 4/1/208. Question: My laboratory does not use the CDC test kit and will have a delay inimplementing the CPT code 87635 in our billing system. May we bill Medicare using U0002?Answer: Yes. For the time being laboratories may continue to use U0002 to bill Medicarefor tests described by the CPT code. We will provide advance notice if this changes.Posted: 3/21/209. Question: How has Medicare changed the requirements for clinical diagnostic laboratorytesting during the PHE for COVID-19?Answer: As part of the Interim Final Rule with Comment (IFC) published in the May 8, 2020Federal Register, CMS removed, for the duration of the PHE for COVID-19, the requirementthat the clinical diagnostic laboratory tests for COVID-19 and certain related viruses must beordered by a treating physician or non-physician practitioner (NPP) who uses the tests inthe management of the patient’s specific medical problem. Medicare also removed certaindocumentation and recordkeeping requirements associated with orders for these COVID-19and related clinical diagnostic laboratory tests, as these requirements would not be relevantin the absence of a treating physician’s or NPP’s order.As part of the IFC published in the September 2, 2020 Federal Register, CMS revised thispolicy by specifying that each beneficiary may receive Medicare coverage for one COVID-19and related test without the order of a physician or other health practitioner, but Medicarewill require such an order to cover further COVID-19 and related tests. We believe thatbroad COVID-19 testing without the order of any healthcare professional—including testingfor the related conditions identified in the May 8th COVID-19 IFC—may result in abeneficiary not receiving the medical attention and oversight required to ensure thatdiagnosis and treatment is applied consistent with CDC guidelines and other medicalstandards. Therefore, this policy change helps ensure that beneficiaries receive appropriatemedical attention, especially if they need multiple tests. It is also designed to stopfraudsters from performing or billing for unnecessary tests. In addition, to help ensure thatbeneficiaries have broad access to testing, CMS will also pay for tests when ordered by apharmacist or other healthcare professional authorized under applicable state law to orderdiagnostic laboratory tests. Medicare makes payment for services of pharmacists andcertain other healthcare professionals only when they have an arrangement with aphysician or other billing practitioner. These changes allow Medicare to continue to pay forthese tests during the PHE when they are ordered by pharmacists and other healthcareprofessionals without such an arrangement.The list of codes for which these ordering requirements apply can be found atUpdated: 1/7/2021pg. 8

-rsv-codes.pdf. This list does notindicate coverage. Practitioners and laboratories should check with their local MedicareAdministrative Contractor regarding specific questions of coverage.Updated: 12/11/2010. Question: Will Medicare keep requiring an order from a treating physician or NPP for flu orother tests?Answer: Because the symptoms for influenza and COVID-19 might present in the same way,during the PHE each beneficiary may receive Medicare coverage for one COVID-19 andrelated test without the order of a physician or other health practitioner when these testsare furnished in conjunction with a COVID-19 clinical diagnostic test as medicallynecessary in the course of establishing or ruling out a COVID-19 diagnosis. Medicare willrequire, for coverage purposes, an order for all further COVID-19 and related tests, inaccordance with the guidance in FAQ B9. The list of codes for which these orderingrequirements apply can be found at rsv-codes.pdf. This list does not indicate coverage. Practitioners and laboratories shouldcheck with their local Medicare Administrative Contractor regarding specific questions ofcoverage.Updated: 12/11/2011. Question: Does the CMS table “COVID-19, Influenza, and RSV Clinical Diagnostic LaboratoryTests for which Medicare Does Not Require a Practitioner Order during the PHE” list clinicaldiagnostic laboratory test codes that Medicare will cover during the PHE?Answer: This table lists codes that, if otherwise covered by Medicare, do not require atreating practitioner’s order as a condition of Medicare payment for the initial test and, forsubsequent tests, can be ordered by a pharmacist or other healthcare professionalauthorized under applicable state law to order diagnostic laboratory tests. The table shouldnot be interpreted as a statement of coverage for the listed codes. There may be somecodes for which there are local coverage determinations that non-cover or limit coverage ofcertain tests. Practitioners and laboratories should check with their local MedicareAdministrative Contractor regarding specific questions of coverage.Updated: 12/11/2012. Question: Please explain the different codes for use in COVID-19 specimen collection?Answer: Medicare established two codes, G2023 and G2024, for specimen collection forCOVID-19 clinical diagnostic laboratory tests. Independent clinical diagnostic laboratoriescan bill for these services as well as a travel allowance (HCPCS codes P9603 and P9604)when they collect specimens from beneficiaries who are homebound or non-hospital (SNF)Part B inpatients, that is, individuals in a Part B SNF stay and individuals whose samples willbe collected by a laboratory on behalf of an HHA. However, these specimen collection feecodes may not be billed for a hospital or SNF inpatient in a Part A stay, as the costs for testsUpdated: 1/7/2021pg. 9

(including sample collection) for those patients are already paid and covered as part of thestay. Please refer to IFC1 and the related ovid-19-faqs-508.pdfMedicare is also paying for specimen collection by hospital outpatient departments andphysician offices at their locations. Hospital outpatient departments can use new HCPCScode C9803 to bill for a clinic visit dedicated to specimen collection. This service isconditionally packaged and only receives separate payment when it is billed withoutanother primary covered hospital outpatient service or with a clinical diagnostic laboratorytest that is assigned status indicator “A” in Addendum B of the OPPS. Physician offices canuse CPT code 99211 when office clinical staff furnish assessment of symptoms andspecimen collection incident to the billing professionals services for both new andestablished patients. When the specimen collection is performed as part of another serviceor procedure, such as a higher-level visit furnished by the billing practitioner, that higherlevel visit code should be billed and the specimen collection would not be separatelypayable. Physicians can bill for services provided by pharmacist’s incident to theirprofessional services consistent with requirements under 42 CFR 410.26 and state scope ofpractice and license requirements. The specimen collection codes (which do not include CPTcode 99211) are only active during the PHE.New 6/19/2013. Question: If a COVID-19 diagnostic laboratory test is performed prior to a procedure in anHOPD, ASC or office, is it included as part of the procedure?Answer: Currently, under the hospital OPPS all available COVID-19 clinical diagnosticlaboratory tests are paid separately, thus, if a COVID-19 clinical diagnostic laboratory test isperformed prior to a procedure and billed separately, it is not bundled into the payment forthe procedure. Specifically, with regard to the hospital setting, if the hospital is billing forspecimen collection for the COVID-19 clinical diagnostic laboratory test along with anotherhospital service, the payment for the specimen collection would be packaged into that ofthe procedure. If the ASC or physician office has obtained a CLIA certificate, the ASC(enrolled as a laboratory) or physician/Non physician-practitioner office can bill for testsunder the clinical laboratory fee schedule (CLFS) that the certificate permits them toperform, separate from billing for the procedure that is being furnished. Practitioners, ASCs,and labs should check with their local Medicare Administrative Contractor regarding specificquestions of coverage.New 6/19/2014. Question: If a physician/non-physician practitioner (NPP) reports CPT code 99211 “Office orother outpatient visit for the evaluation and management of an established patient thatmay not require the presence of a physician”, for assessment and collection of COVID-19diagnostic laboratory test specimen for a new patient as permitted under Medicare duringUpdated: 1/7/2021pg. 10

the COVID-19 PHE, and the physician/Non-physician practitioner (NPP) subsequently, on adifferent day, furnishes an Evaluation and Management (E/M) visit to the patient for otherreasons, can he/she report a new patient E/M visit code for the subsequent visit?Answer: Yes, in this situation, under the unique circumstances of the PHE, the patient is notconsidered an established patient merely due to the reporting of CPT code 99211 forassessment and collection of COVID-19 specimen for a new patient. We note that if a higherlevel E/M visit is furnished to a new patient at the time of COVID-19 specimen collection,the encounter should be reported using the higher level new patient visit code rather thanCPT code 99211, and in this case the patient would be considered an established patient forthe subsequent visit and a new patient E/M visit code should not be reported until 3 yearshave passed, as specified under the usual billing rules.New: 7/28/2015. Question: Can physicians/NPPs apply the Cost Sharing (CS) modifier to claims for presurgery examination services that include COVID-19 testing?Answer: The CS modifier should not be used when pre-surgery examination services are notpaid separately, for example if particular services are considered to be part of services witha global surgical period, End Stage Renal Disease (ESRD) services with a monthly capitationpayment or maternity package services.During the COVID-19 PHE, the modifier can be reported with separately reported visit codesthat result in an order for or administration of a COVID-19 test, when they are related tofurnishing or administering such a test or are for the evaluation of an individual forpurposes of determining the need for such a test.New: 7/28/20C. Diagnostic Laboratory Services - Serology Testing1. Question: Are there new Current Procedural Terminology (CPT) codes for COVID-19 testing?Answer: On April 10, 2020, the American Medical Association (AMA) CPT Committeeannounced two new CPT codes to report when patients receive blood tests that can detectantibodies for COVID-19. These two codes are: 86328: Immunoassay for infectious agent antibody(ies), qualitative or semiquantitative, single step method (e.g., reagent strip); severe acute respiratorysyndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) 86769: Antibody; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)(Coronavirus disease [COVID-19])New: 5/1/202. Question: When will I be able to bill Medicare for these new test codes?Answer: Medicare has updated its billing systems to accept these new test codes.Updated: 1/7/2021pg. 11

New: 5/1/203. Question: My laboratory has a serology test for COVID-19; which CPT code should I use tobill Medicare?Answer: Both new test codes can be used to bill Medicare for COVID-19 serology testingthat can detect antibodies. If your COVID-19 test can be done in a single step, the mostappropriate code to use is 86328. Multi-step antibody testing for COVID-19 can be billedusing 86769.New: 5/1/204. Question: What is the difference between single-step and multi-step antibody test forCOVID-19?Answer: According to the AMA, CPT code 86328 was established for antibody tests using asingle-step method immunoassay. This testing method typically includes a strip with

The specimen collection fee applies if the specimen is collected by trained laboratory personnel from a homebound or non- hospital inpatient and the specimen is a type that would not require only the services o f a messenger pick up service. However, the specimen collection fee is not available for tests where a patient collects his or her own

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