Prior authorization request form Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM

EFFECTIVE DATE: 03|06|2020 POLICY LAST UPDATED: 05|03|2023

OVERVIEW This policy is effective for dates of service between 3/06/20 to5/11/2023. This policy addresses testing for COVID-19. For dates of service after on or after 5/12/2023, please refer to COVID-19 Diagnostic Testing After Public Health Emergency.

This policy applies to all Blue Cross & Blue Shield of Rhode Island (BCBSRI) in-network/participating providers, including, but not limited to the Rhode Island Department of Health Laboratory as well as out-of- network/non-participating providers with BCBSRI. However, please note that BCBSRI participating providers should continue to refer to an in-network laboratory when possible.

BCBSRI reserves the right to implement and revoke this policy and/or make a change to the waiver of member cost share without the contractual sixty-day (60) notification for a change in policy that is normally required under BCBSRI contracts with its providers. This would apply both for the effective date, due to the urgent and emergent nature of a pandemic, as well as for the withdrawal of the policy.

Notice of the implementation and withdrawal of this policy will only be communicated to BCBSRI providers via a notice on BCBSRI’s provider website/portal under Alerts and Updates.

MEDICAL CRITERIA Not applicable

PRIOR AUTHORIZATION
Not applicable

POLICY STATEMENT Commercial Products Testing is covered when medically appropriate for the individual, as determined by the individual’s attending health care provider. Clinical decisions about testing are made by the individual’s attending health care provider and may include testing of individuals with signs or symptoms compatible with COVID-19, as well as asymptomatic individuals with known or suspected recent exposure to SARS-CoV-2, that is determined to be medically appropriate by the individual’s health care provider, consulting CDC and Rhode Island Department of Health (DOH) guidelines as appropriate. See DOH guidelines at https://health.ri.gov/covid/testing/; Centers for Disease Control and Prevention, Overview of Testing for SARS-CoV-2, available at https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html.

In adherence with the Rhode Island Office of the Health Insurance Commissioner & Medicaid Program Instructions During the COVID-19 State of Emergency issued on March 13, 2020, Health Insurance Bulletin 2020-05, and federal requirements under the Families First Coronavirus Response Act (FFCRA) and the Coronavirus Aid, Relief and Economic Security Act (CARES Act), BCBSRI will TEMPORARILY waive cost-share (e.g. co-pays and/or deductibles) for diagnostic laboratory testing and the collection of specimens related to COVID-19. This policy applies to laboratory tests that have been approved by the FDA or which have followed the emergency use authorization process outlined by the FDA and are listed on the FDA website.

Payment Policy | TEMPORARY COVID-19 Diagnostic Testing

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 2 (401) 274-4848 WWW.BCBSRI.COM

BCBSRI requires a physician or advanced practice provider order for all laboratory testing to diagnose or treat conditions. Therefore, an order is required for testing described in this policy, with the exception of home tests.

Medicare Advantage Plans Coverage follows Medicare guidelines for COVID-19 and related diagnostics testing as set forth in Interim Final Rule CMS-3401. As subsequent guidance is issued, BCBSRI will revise this policy as necessary.

In adherence with federal requirements under the FFCRA and the CARES Act, as well as CMS guidance, BCBSRI will TEMPORARILY waive cost-share (e.g., co-pays and/or deductibles) for diagnostic laboratory testing and the collection of specimens related to COVID-19. This policy applies to laboratory tests that have been approved by the FDA or which have followed the emergency use authorization process outlined by the FDA and are listed on the FDA website. In accordance with CMS guidance, this coverage without cost share applies to one COVID diagnostic test and one of each related test (flu, pneumonia, etc.) without an order from a physician or other practitioner. All future tests require an order.

Home Testing COVID-19 diagnostic tests that can be self-administered at the member’s home or otherwise outside of a lab or healthcare setting (“home tests”) are covered. Home tests are available over-the-counter (OTC) (without either a prescription or individualized clinical assessment by a health care provider), through pharmacies, retail stores, and online retailers.

Note: For home tests, BCBSRI will reimburse the cost of the test itself only. No reimbursement shall be made for shipping, handling or other administrative fees. Individuals who purchase OTC COVID-19 tests during the public health emergency will be able to seek reimbursement from both Commercial and Medicare Advantage Plans. More information regarding home tests can be found here: COVID-19 Home Test Kits - For members | Blue Cross Blue Shield of Rhode Island (bcbsri.com)

COVERAGE Benefits may vary between groups and contracts. Please refer to the appropriate Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for applicable laboratory services benefits and excluded services/coverage. Please note that BCBSRI’s plans generally exclude coverage for services required for or related to employment, education, marriage, adoption, insurance purposes, court order, or similar third parties when not medically necessary.

Testing conducted solely to screen for general workplace health and safety (such as employee “return to work” testing), for public health surveillance for SARS-CoV-2, or for any other purpose not primarily intended for individualized diagnosis or treatment of COVID-19 or another health condition such as travel related testing is not covered.

BCBSRI Cost Share Waiver
BCBSRI will waive all member cost share for BCBSRI subscribers (this waiver of the cost share should also apply to BlueCard HOST members/those members of other Blue Cross Blue Shield Plans nationally, due to requirements of the FFCRA and CARES Act) for laboratory testing and specimen collection related to COVID-19 as outlined in this policy, during the time period this policy is in effect. Providers should NOT collect cost share from a member in accordance with this policy.

BACKGROUND Effective for dates of service on or after February 4, 2020, Centers for Medicare and Medicaid Services (CMS) has developed Healthcare Common Procedure Coding System (HCPCS) billing codes, U0001 and U0002 to bill for tests and track new cases of the virus. Code U0001 may be used for CDC testing laboratories. Code U0002 may be used for tests established by laboratories that develop their own validated COVID-19 diagnostics when submitting claims to Medicare or health insurers.

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 3 (401) 274-4848 WWW.BCBSRI.COM

Effective for dates of service on or after March 1, 2020, the Centers for Medicare and Medicaid Services (CMS) has also established Healthcare Common Procedure Coding System (HCPCS) billing codes, G2023 and G2024 to identify and reimburse specimen collection for COVID-19 testing. These codes are billable and separately reimbursed when rendered by clinical diagnostic laboratories.

Effective for dates of service on or after March 13, 2020, the American Medical Association (AMA) created a new CPT (Current Procedural Terminology) code, 87635, that will streamline coronavirus testing offered by hospitals, health systems and laboratories in the United States. It is intended as industry standard for reporting of novel coronavirus tests across the nation’s health care system.

Effective for dates of services on or after April 10, 2020, the American Medical Association (AMA) created new CPT (Current Procedural Terminology) codes, 86328 and 86769, for serologic laboratory testing to address the urgent clinical need to report antibody testing related to COVID-19.

Effective for dates of service on or after April 14, 2020, the Centers for Medicare and Medicaid Services (CMS) has also established Healthcare Common Procedure Coding System (HCPCS) billing codes, U0003 and U0004 to represent clinical diagnostic laboratory tests that make use of high-throughput technologies. This technology involves high sophisticated equipment that requires more intensive technician training and more time intensive processes to ensure quality. High throughput technology uses a platform that employs automated processing that allows for increased test capacity (i.e. more than two hundred specimens a day) and allows for more rapid diagnosis.

Effective for dates of service on or after May 20, 2020, the American Medical Association (AMA) created new CPT (Current Procedural Terminology) codes, 0202U for testing related to COVID-19.

Effective for dates of service on or after June 25, 2020, the American Medical Association (AMA) created new CPT (Current Procedural Terminology) codes, 87426, 0223U and 0224U for testing related to COVID-

19. Effective for dates of service on or after August 10, 2020, the American Medical Association (AMA) created new CPT (Current Procedural Terminology) codes 86408, 86409, 0225U and 0226U for testing related to COVID-19.

    Effective for dates of service on or after September 8, 2020, the American Medical Association (AMA) created new CPT (Current Procedural Terminology) code 86413 for testing related to COVID-19.

    Effective for dates of service on or after October 6, 2020, the American Medical Association (AMA) created new CPT (Current Procedural Terminology) codes 87636, 87637, 87811, 0240U and 0241U for testing related to COVID-19. As the COVID-19 pandemic continues to progress, and the season for influenza and respiratory syncytial virus (RSV) approaches, clinicians need to be able to rapidly distinguish influenza A, influenza B and RSV infections from infections caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

    Effective for dates of service on or after November 10, 2020, the American Medical Association (AMA) created new CPT (Current Procedural Terminology) code 87428 for testing related to COVID-19.

    Effective for dates of service on or after January 1, 2021, Centers for Medicare and Medicaid Services (CMS) has developed Healthcare Common Procedure Coding System (HCPCS) billing code, U0005 to represent testing by nucleic acid (DNR or RNA) using amplified probe technique and making use of high throughput technologies that is completed within two calendar days from the date of specimen collection. Code U0005 is reported in addition to code U0003 or U0004 when appropriate.

    Effective for dates of service on or after February 21, 2022, the American Medical Association (AMA) created new CPT (Current Procedural Terminology) code 87913 for testing related to COVID-19.

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 4 (401) 274-4848 WWW.BCBSRI.COM

Effective for dates of service on or after April 4, 2022, Centers for Medicare and Medicaid Services (CMS) announced coverage for over-the-counter COVID tests including all OTC, FDA-approved, authorized, or cleared COVID-19 tests (that are self-administered with a specimen that’s self-collected) at no cost to people with Medicare Part B, including those with Medicare Advantage. The coverage cap is 8 tests per month per member.

CODING
Medicare Advantage Plans and Commercial Products
The following codes for diagnostic laboratory testing are to be billed by the laboratory processing the test and are covered with no cost share effective for the dates of service identified above:

86328 Immunoassay for infectious agent antibodies, qualitative or semiquantitative, single step method (eg, reagent strip); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID- 19]) 86408 Neutralizing antibody, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]); screen 86409 Neutralizing antibody, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]); titer 86413 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) antibody, quantitative 86769 Antibody; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) 87426 Infectious agent antigen detection by immunoassay technique (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]), qualitative or semiquantitative; severe acute respiratory syndrome coronavirus (eg, SARS-CoV, SARS-CoV-2 [COVID-19]) (Revised text 1/01/2022) 87428 Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; severe acute respiratory syndrome coronavirus (eg, SARS-CoV, SARS-CoV-2 [COVID-19]) and influenza virus types A and B 87635 Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique
87636 Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) and influenza virus types A and B, multiplex amplified probe technique 87637 Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), influenza virus types A and B, and respiratory syncytial virus, multiplex amplified probe technique 87811 Infectious agent antigen detection by immunoassay with direct optical (ie, visual) observation; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) 87913 Infectious agent genotype analysis by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]), mutation identification in targeted region(s) 0202U Infectious disease (bacterial or viral respiratory tract infection), pathogen-specific nucleic acid (DNA or RNA), 22 targets including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), qualitative RT- PCR, nasopharyngeal swab, each pathogen reported as detected or not detected
0223U Infectious disease (bacterial or viral respiratory tract infection), pathogen-specific nucleic acid (DNA or RNA), 22 targets including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), qualitative RT- PCR, nasopharyngeal swab, each pathogen reported as detected or not detected
0224U Antibody, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), includes titer(s), when performed 0225U Infectious disease (bacterial or viral respiratory tract infection) pathogen-specific DNA and RNA, 21 targets, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), amplified probe technique, including multiplex reverse transcription for RNA targets, each analyte reported as detected or not detected

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 5 (401) 274-4848 WWW.BCBSRI.COM

0226U Surrogate viral neutralization test (sVNT), severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) (Coronavirus disease [COVID-19]), ELISA, plasma, serum 0240U Infectious disease (viral respiratory tract infection), pathogen-specific RNA, 3 targets (severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2], influenza A, influenza B), upper respiratory specimen, each pathogen reported as detected or not detected 0241U Infectious disease (viral respiratory tract infection), pathogen-specific RNA, 4 targets (severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2], influenza A, influenza B, respiratory syncytial virus [RSV]), upper respiratory specimen, each pathogen reported as detected or not detected U0001 CDC 2019 novel coronavirus (2019-ncov) real-time rt-pcr diagnostic panel
U0002 2019-ncov coronavirus, sars-cov-2/2019-ncov (covid-19), any technique, multiple types or subtypes (includes all targets), non-cdc U0003 Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique, making use of high throughput technologies as described by CMS-2020-01-R U0004 2019-nCoV Coronavirus, SARS-CoV-2/2019-nCoV (COVID-19), any technique, multiple
types or subtypes (includes all targets), non-CDC, making use of high throughput technologies as described by CMS-2020-01-R U0005 Infectious agent detection by nucleic acid (DNA or RNA); Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique, CDC or non- CDC, making use of high throughput technologies, completed within 2 calendar days from date of specimen collection (list separately in addition to either HCPCS code U0003 or U0004) as described by CMS-2020-01- R2

Note: U0003 should identify tests that would otherwise be identified by CPT code 87635, but are being performed with the high throughput technologies.
U0004 should identify tests that would otherwise be identified by HCPCS code U0002, but are being performed with the high throughput technologies.
Neither U0003 nor U0004 should be used for tests that detect COVID-19 antibodies (CPT codes 86328 and 86769).

The following HCPCS codes for specimen collection are covered and separately reimbursed with no cost share effective for the dates of service identified above for hospital outpatient services and by clinical diagnostic laboratories for nursing home or home health patients:

C9803 Hospital outpatient clinic visit specimen collection for severe acute respiratory syndrome coronavirus 2 (sars-cov-2) (coronavirus disease [covid-19]), any specimen source 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 skilled nursing facility or by a laboratory on behalf of a home health agency, any specimen source.

Please note: Use of Modifier QW is required for any test that is CLIA (Clinical Laboratory Improvement Amendments) waived:

QW CLIA waived test

Over-the-counter (OTC) Covid testing kits FDA approved for self-administered test with a specimen that’s self-collected; will be reimbursed to the patient at no cost to the patients with Medicare Part B, including those with Medicare Advantage. The coverage cap is 8 tests per month per member.
HCPCS Code K1034 Provision of COVID-19 test, nonprescription self-administered and self-collected use, FDA approved, authorized, or cleared, one test count.

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 6 (401) 274-4848 WWW.BCBSRI.COM

Please note: Use of this HCPCS Code by Providers will not be reimbursed.

REIMBURSEMENT
BCBSRI reserves the right to audit medical and/or any administrative records related to adherence to all the requirements of this policy.

RELATED POLICIES TEMPORARY Cost Share Waiver for Treatment of Confirmed Cases of COVID-19 During the COVID- 19 Crisis TEMPORARY Encounter for Determination of Need for COVID-19 Diagnostic Testing TEMPORARY Telemedicine/Telehealth and Telephone Preventive Medicine Evaluation and Management Visits and Annual Wellness Visits During the COVID-19 Crisis TEMPORARY Telemedicine Telehealth and Telephone Services During the COVID-19 Crisis – Effective 3/5/20 – 3/17/20 TEMPORARY Telemedicine/Telehealth and Telephone Services During the COVID-19 Crisis – Effective 3/18/20 TEMPORARY Timely Filing Limit Extension Policy – Additional 180 Days During the COVID-19 Crisis

PUBLISHED BCBSRI’s website under Medical and Payment Policies
Provider Communication sent May 3, 2023 Provider Update, July 2023 Provider Update, October 2022 Provider Update, September 2022 Provider Update, June 2022

REFERENCES

1. Families First Coronavirus Response Act, Public Law No: 116-127
   https://www.congress.gov/bill/116th-congress/house-bill/6201/text/pl
2. The Coronavirus Aid, Relief and Economic Security Act (CARES Act), Public Law No. 116–136 https://www.congress.gov/bill/116th-congress/house-bill/748/text
3. Centers for Disease Control and Prevention, Overview of Testing for SARS-CoV-2, available at https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html.
4. CMS-3401-IFC https://s3.amazonaws.com/public-inspection.federalregister.gov/2020-19150.pdf
5. DOL FAQs Part 42 and 43 https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part- 42.pdf
   https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part- 43.pdf
6. DOH guidelines, https://health.ri.gov/covid/testing/
7. OHIC Bulletin 2020-05, http://www.ohic.ri.gov/documents/2020/July/OHIC%20Bulletin%202020- 05%20Coverage%20for%20COVID-19%20Testing%20.pdf
8. CMS COVID-19 Over-the-Counter Tests, http://www.cms.gov/COVIDOTCtestsProvider
9. DOL FAQs Part 51 https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource- center/faqs/aca-part-51.pdf

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 7 (401) 274-4848 WWW.BCBSRI.COM

This medical policy is made available to you for informational purposes only. It is not a guarantee of payment or a substitute for your medical judgment in the treatment of your patients. Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement, and those documents will supersede the provisions of this medical policy. For information on member-specific benefits, call the provider call center. If you provide services to a member which are determined to not be medically necessary (or in some cases medically necessary services which are non-covered benefits), you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense. Please refer to your participation agreement(s) for the applicable provisions. This policy is current at the time of publication; however, medical practices, technology, and knowledge are constantly changing. BCBSRI reserves the right to review and revise this policy for any reason and at any time, with or without notice. Blue Cross & Blue Shield of Rhode Island is an independent licensee of the Blue Cross and Blue Shield Association.

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500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 8 (401) 274-4848 WWW.BCBSRI.COM