Just in time for new COVID-19 vaccine, administration, and treatment codes.
The government is working at warp speed to make a COVID-19 vaccine available in the United States. To that end, the Centers for Medicare & Medicaid Services (CMS) recently published an interim final rule with comment period (IFC) to implement Section 3713 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which established Medicare Part B coverage and payment for COVID-19 vaccine and administration.
The IFC allows CMS to skip the rulemaking process and make the vaccines available as soon as they are ready, using the same billing process that is in place for influenza and pneumococcal vaccinations. For the duration of the public health emergency (PHE) for COVID-19, at least, Medicare Part B will pay 100 percent of the Medicare payment amount for the vaccine(s), which is not subject to patient deductible.
The PHE for COVID-19 went into effect Jan. 31, 2020, and the Health and Human Services (HHS) secretary has renewed it three times this year (every 90 days). The next expiration date is Jan. 21, 2021.
Breaking News: AMA Issues New CPT Vaccine and Admin Codes
Two COVID-19 vaccines – Pfizer and Moderna – have been assigned to new CPT codes (91300 and 91301) and four new codes are added (0001A, 0002A, 0011A, 0012A) for the administration of these vaccines.
Remember: Medicare Administrative Contractors will not accept these new codes until they have received official instruction from CMS. Always check payer policies for coding and billing guidance on new codes, especially early release codes.
New Price Transparency Requirements for Providers Effective Immediately
The IFC also adds new requirements for providers that pertain to COVID-19 testing price transparency, effective Nov. 2, 2020, until the end of the PHE for COVID-19:
- Price Transparency: Providers of COVID-19 diagnostic tests are required to make public their cash prices for those tests. The CARES Act established this requirement and CMS implements the provision in this IFC. CMS also adds definitions for:
- “provider of a diagnostic test for COVID-19” (holds CLIA certificate or has submitted CLIA application);
- “COVID-19 diagnostic test” (e.g., those reported with CPT® codes 86408, 86409, 87635, 87426, 86328, and 86769 and U0001 – U0004); and
- “cash price” (price the patient is charged).
These cash prices must be posted on the provider’s website or through signage (if the provider doesn’t have a website); providers must make public the cash price for each COVID-19 diagnostic test that they offer in plain language. The notice must include:
The Medicare allowed amount for the COVID-19 vaccine will be 95 percent of the average wholesale price, or reasonable cost under the OPPS. Expect a unique admin code for each COVID-19 vaccine product.
- a description of each COVID-19 diagnostic test they provide,
- the corresponding cash price,
- the billing codes for each test, and
- any other information necessary such as price variations based on site of service.
- Penalty for Noncompliance: CMS discusses in the IFC ways in which it plans to enforce these requirements:
- Strike 1: Written warning
- Strike 2: Request provider submit and comply with a corrective action plan
- Strike 3: Civil monetary penalty (up to $300 for every day the violation is ongoing)
COVID-19 Treatment Coding Guidance
On Nov. 9, the U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) for the investigational monoclonal antibody therapy, bamlanivimab, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients who have tested positive for COVID-19 and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
- Add-On Payments: The IFC establishes an add-on payment for cases involving the use of new COVID-19 treatments (e.g. bamlanivimab) under the Medicare Inpatient Prospective Payment System (IPPS). Effective for dates of service on or after Nov. 2, 2020, until the end of the PHE for COVID-19, Medicare Part A will pay hospitals the lesser of (1) 65 percent of the operating outlier threshold for the claim or (2) 65 percent of the amount by which the costs of the case exceed the standard diagnosis-related group (DRG) payment, including the adjustment to the relative weight for certain cases that include the use of a drug or biological product authorized or approved for treating COVID-19, but not the operating outlier payments.
- Separate Payments: The IFC establishes separate payment for new COVID-19 treatments under the Outpatient Prospective Payment System (OPPS) for the remainder of the PHE for COVID-19 when these treatments are provided at the same time as a Comprehensive Ambulatory Payment Classification (C-APC) service.
BREAKING NEWS: CMS has identified a specific code for the monoclonal antibody product and a specific administration code for Medicare payment, effective Nov. 9, 2020:
Q0239 Inject bamlanivimab-xxxx, 700 mg
M0239 Intravenous infusion, bamlanivimab-xxxx, includes infusion and post administration monitoring
See the special announcement for billing instructions.
Payment Model Extension
The IFC also modifies policies of the Comprehensive Care for Joint Replacement model to extend performance year (PY) 5 by six months; creating an episode-based extreme and uncontrollable circumstances COVID-19 policy; providing two reconciliation periods for PY 5, and adding DRGs 521 and 522 for hip and knee procedures.
Instructions to Payers for Preventive Health Services
The IFC also amends regulations regarding coverage of preventive health services to implement Section 3203 of the CARES Act, which shortens the time frame within which non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage must begin to cover, without cost sharing, qualifying coronavirus preventive services, including recommended COVID-19 immunizations.
Plans and issuers subject to Section 2713 of the Public Health Services (PHS) Act must cover, without cost sharing, recommended immunizations, as well as the administration of such immunizations, regardless of how the administration is billed, and regardless if the provider is in- or out-of-network.
This coverage is required to be provided within 15 business days after the date of the U.S. Preventive Services Task Force or Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention (CDC) makes an applicable recommendation for such. This applies even if the immunization is not listed for routine use on the CDC’s immunization schedules.
Comment on the IFC
See CMS-9912-IFC, published in Federal Register Nov. 6, for complete details and commenting instructions. Public comments must be received by CMS no later than 5 p.m. EST on Jan. 4, 2021.