Department of Health and Human Services 
Office of Inspector General 
Early Alert: Part B Payment 
Amount for Tezspire 
Included a Noncovered 
Self-Administered Version in 
2023 
 
Ann Maxwell  
Deputy Inspector General 
   for Evaluation and Inspections 
November 2023, OEI-BL-24-00030  Department of Health and Human Services 
O  ffice of Inspector General 
 
Early Alert Brief 
 
N  ovember 2023, OEI-BL-24-00030 
 
Early Alert: Part B Payment Amount for Tezspire Included a 
Noncovered Self-Administered Version in 2023 
With certain exceptions, self-administered drugs are not covered 
Key Results 
under Medicare Part B.1  However, the billing codes used in setting 
The payment amount for Tezspire  payments for Part B drugs often include multiple versions of the 
in the third and fourth quarters of  same drug and, in a small number of cases, some of those versions 
2023 included a noncovered self-
may be self-administered.  Specifically, CMS interprets a relevant 
administered version of the drug.   
statute to require the inclusion of prices for noncovered self-
Including the self-administered  administered versions when the agency calculates the payment 
version led to a small increase in 
amount for a billing code if both the covered and noncovered 
the per-injection payment amount 
versions of a product are approved by the U.S. Food & Drug 
for those quarters.  
Administration (FDA) under the same application number.2, 3   
Required Action 
The Office of Inspector General (OIG) is required to conduct periodic 
In accordance with regulations, the 
studies to identify billing codes for which both noncovered self-
Centers for Medicare & Medicaid 
administered versions and covered provider-administered versions 
Services (CMS) is required to 
of a drug are used to set Part B payment amounts, and to 
remove the self-administered 
version of Tezspire from payment  subsequently determine whether those self-administered versions 
amount calculations in subsequent  should be excluded.4  In general, for the drugs that OIG identifies, 
quarters if the exclusion would  CMS is required to remove noncovered self-administered versions 
result in lower payment amounts. 
from payment amount calculations in subsequent quarters if the 
exclusions would result in lower payment amounts; however, the 
statute provides CMS with some discretion in addressing the requirement.5  In a recent report, OIG 
identified two drugsFasenra and Xolairfor which Part B payment amounts included both 
noncovered self-administered versions and covered provider-administered versions in 2022.   
In conducting other work, OIG determined that the Part B payment amount for the drug Tezspire 
included a noncovered self-administered version and a covered provider-administered version 
beginning in July 2023.  OIG is issuing this early alert brief so that CMS can remove the self-
administered version of Tezspire from payment amount calculations in subsequent quarters if the 
exclusion would result in lower payment amounts.  OIG will follow this early alert brief with a full 
assessment of billing codes in 2023 to determine if there are any additional codes for which self-
administered versions and provider-administered versions were used to set payment amounts that year.  
The payment amount for Tezspire in the third and fourth quarters of 
2023 included a noncovered self-administered version of the drug 
OIG found that CMS had included a higher-cost, self-administered version of Tezspire in its payment 
amount calculations for both the third and fourth quarters of 2023.  The self-administered version of 
Part B Payment Amount for Tezspire Included a Noncovered Self-Administered Version in 2023 
OEI-BL-24-00030  1   Tezspire was approved by FDA under the same application number as was the provider-administered 
version, meaning that CMS was following policy when setting the payment amounts. 
Tezspire is a brand-name drug indicated for the add-on maintenance treatment of patients with severe 
asthma.6  It is administered as an injection under the skin (i.e., subcutaneous administration) once every 
4 weeks.  Tezspire is available as (1) a single-dose prefilled syringe intended for provider administration 
and (2) a single-dose prefilled pen intended for self-administration.7, 8 
Including the self-administered version led to a small increase in the 
per-injection payment amount  
When calculating payment amounts in the initial quarters after the billing code (i.e., Healthcare 
Common Procedure Coding System (HCPCS) code) representing Tezspire was established, CMS 
included sales data for only the prefilled syringe version intended for provider administration as it was 
the sole version available for sale.9  However, in early 2023, the manufacturer of Tezspire began selling 
the newly approved self-administered version and subsequently reported sales data to CMS.  In 
accordance with statute and policy, beginning in the third quarter of 2023, CMS used sales data for 
both versions when calculating payment amounts for Tezspire.   
In the third and fourth quarters of 2023, excluding the self-administered version of Tezspire would have 
decreased Medicare payment amounts by $12 and $71 per dose, respectively (.3 percent and 
1.8 percent).10  For example, the payment amount in the fourth quarter of 2023 would have decreased 
from $3,901.80 to $3,830.40 per injection. 
Sales data for both the provider-administered and self-administered versions of Tezspire 
were used to set payment amounts beginning in third-quarter 2023. 
 
Source: OIG analysis of CMS average sales price (ASP) files and HCPCS Application Summary documents.    
REQUIRED ACTION 
In accordance with regulations, CMS must remove the self-administered version of Tezspire from payment 
amount calculations in subsequent quarters if the exclusion would result in lower payment amounts. 
Part B Payment Amount for Tezspire Included a Noncovered Self-Administered Version in 2023 
OEI-BL-24-00030  2    
Endnotes
 
1 Medicare Part B does cover a small number of self-administered drugs, including certain oral anti-cancer drugs; blood clotting 
factors; and inhalation and infusion drugs used with durable medical equipment.  See Section 1861(s)(2) of the Social Security 
Act (the Act) regarding coverage of drugs and biologicals that are not usually self-administered.  Also, see 42 CFR  
414.900(b) and the Medicare Benefit Policy Manual, ch. 15  50.  At Section 50.2 of the same manual, CMS describes how 
contractors can determine whether a drug is usually self-administered. 
2 Medicare sets payment amounts for Part B drugs using Healthcare Common Procedure Coding System (HCPCS) codes.  
Because more than one national drug code (NDC) may meet the definition of a HCPCS code, CMS must first crosswalk 
manufacturers NDCs to their corresponding HCPCS codes.  In interpreting the Act, CMS staff determined that (1) all versions 
of a product listed under the same U.S. Food & Drug Administration (FDA) application number must be considered the same 
drug or biological, for payments made under Part B, and (2) for a product marketed under the same application number, 
labeling that indicates that a version may be used primarily when the drug is not covered under Part B (e.g., the version is for 
self-administration only) cannot be used as a basis to exclude that version from a payment amount calculation.  See Sections 
1847A(b)(4)(A) and 1847A(b)(5) of the Act.  Also, see CMS, Update to Information Regarding Medicare Payment and Coding for 
Drugs and Biologics, May 18, 2007,  
https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/Downloads/051807_coding_annoucement.pdf, accessed on 
July 27, 2023. 
3 CMSs interpretation is supported by Allergan, Inc. v. Sylvia Mathews Burwell, Case No. 13-00264, 2016 U.S. Dist. LEXIS 43550 
(D.D.C. March 30, 2016).  The U.S. District Court for the District of Columbia considered whether the manufacturer of a 
biological marketed as BOTOX for therapeutic use (i.e., the covered version) and as BOTOX Cosmetic (i.e., the noncovered 
version) was required to report ASP data for the noncovered version to CMS. 
4 Section 1847A(g)(1) of the Act as amended by Section 405 of CAA 2021. 
5 If and when OIG identifies a noncovered self-administered NDC, OIG shall inform the Secretary and the Secretary shall, to the 
extent the Secretary deems appropriate, apply a lesser of payment amount for the HCPCS code, as follows: (A) the amount of 
payment that would result if the self-administered drug were excluded from the determination of the payment amount, or (B) 
the amount of payment determined without that exclusion.  CMS is required to exclude the NDC from payment amount 
calculations if the exclusion would result in a lower payment amount.  CMS regulations require that the agency exclude such an 
NDC from payment amount calculations beginning on the first day of the second quarter following the publication of the 
corresponding OIG report.  Regulations provide an exception to not lower payment amounts if the drug is in short supply, as 
identified by FDA, for that quarter.  See Section 1847A(g)(2) of the Act and 42 CFR  414.904(d)(4)(i)(ii) & (iv). 
6 Tezspire package insert, https://www.azpicentral.com/pi.html?product=tezspire, accessed on August 24, 2023.  
7 FDA approved an additional version (single-dose vial) of Tezspire.  However, the manufacturer does not include this version 
on its website, and no sales were reported to CMS for the product. 
8 In total, Medicare Part B and its enrollees paid $59 million for Tezspire in the first six months of 2023.  At the time of our 
analysis, Part B expenditure data for third-quarter 2023 were not available.  
9 To calculate HCPCS code payment amounts, CMS averages pricing data by sales volume for all NDCs crosswalked to a HCPCS 
code.  Medicare pays for most Part B drugs at 106 percent of the volume-weighted average sales prices.  42 U.S.C. 1395w-
3a(b)(1). 
10 A typical dose of Tezspire is a single 210 mg/1.91 mL injection. 
Part B Payment Amount for Tezspire Included a Noncovered Self-Administered Version in 2023 
OEI-BL-24-00030  3