Department of Health and Human Services 
Office of Inspector General 
Congressional Mandate:  
Part B Payment Amounts for 
Two Drugs Included 
Noncovered 
Self-Administered Versions in 
2022 
 
Ann Maxwell  
Deputy Inspector General 
   for Evaluation and Inspections 
November 2023, OEI-BL-22-00380  Department of Health and Human Services 
O  ffice of Inspector General 
 
Issue Brief 
 
N  ovember 2023, OEI-BL-22-00380 
 
Congressional Mandate: Part B Payment Amounts for Two Drugs 
Included Noncovered Self-Administered Versions in 2022 
With certain exceptions, self-administered drugs are not covered 
Key Results 
under Medicare Part B.1  However, the billing codes used in setting 
The Centers for Medicare &  payments for Part B drugs often include multiple versions of the 
Medicaid Services (CMS) correctly  same drug and, in a small number of cases, some of those versions 
removed noncovered self- may be self-administered.  Specifically, CMS interprets a relevant 
administered versions of Orencia 
statute to require the inclusion of prices for noncovered self-
and Cimzia when calculating 
administered versions when the agency calculates the payment 
2022 payment amounts, as 
amount for a billing code in limited circumstancesi.e., if both the 
required by law.  
covered and noncovered versions of a product are approved by the 
Payment amounts for both  U.S. Food & Drug Administration (FDA) under the same application 
Fasenra and Xolair included  number.2, 3 
noncovered self-administered 
versions in 2022.  However,  In two earlier reports, the Office of Inspector General (OIG) evaluated 
including the self-administered  the financial impact of including the prices of noncovered self-
versions did not substantially 
administered versions when setting the Part B payment amounts for 
affect per-injection payment 
the provider-administered versions of these drugs.  OIG found that 
amounts.   
the inclusion of the noncovered versions of two drugsOrencia and 
Required Action  Cimziacaused Medicare and its enrollees to pay an extra 
$863 million from 2014 through 2018.4  
In accordance with regulations, 
CMS is required to remove self-
Although Congress did not change the way CMS sets Part B payment 
administered versions of Fasenra 
amounts for all drugs with noncovered versions, the OIG reports 
and Xolair from payment amount 
contributed to Congress enacting provisions requiring CMS to 
calculations in subsequent 
remove noncovered self-administered versions of Cimzia and 
quarters if the exclusion would 
Orencia from payment amount calculations for their billing codes 
result in lower payment amounts. 
beginning in July 2021 if the exclusions would result in lower 
payment amounts.5  In that same legislation, Congress required OIG to conduct periodic studies to 
identify additional billing codes for which both noncovered self-administered versions and covered 
provider-administered versions of a drug are used to set Part B payment amounts, and to subsequently 
determine whether those self-administered versions should be excluded.6  In general, for the drugs that 
OIG identifies, CMS is required to remove noncovered self-administered versions 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.7 
This review fulfills OIGs statutory responsibility to periodically identify additional billing codes for which 
both noncovered self-administered versions and covered provider-administered versions are used to 
set Part B payment amounts.  In addition, we assessed whether CMS had correctly removed higher-cost, 
self-administered versions of Orencia and Cimzia when calculating 2022 payment amounts for those 
two drugs, as required by law. 
  FINDINGS 
CMS correctly removed noncovered self-administered versions of 
Orencia and Cimzia when calculating 2022 payment amounts  
In accordance with statute, CMS correctly removed higher-cost, self-administered versions of 
Orencia and Cimzia from payment determinations, resulting in substantially lower payment 
amounts for both drugs in 2022.  For example, the fourth-quarter payment amount for a typical 
750 mg injection of Orencia was reduced from $4,337 to $3,243 (25 percent).8  The payment 
amount that quarter for a typical 400 mg injection of Cimzia was reduced from $3,138 to $2,164 
(31 percent).9  As a result, Medicare Part B and its enrollees saved a total of $480 million in 2022 
for the two drugs. 
OIG identified two drugsFasenra and Xolairfor which Part B 
payment amounts included noncovered self-administered versions in 
2022   
As previously mentioned, the noncovered versions provisions enacted by Congress did not 
prospectively alter the way CMS sets payment amounts for all Part B drugs; rather, the 
provisions require OIG to identify any additional billing codes (i.e., other than those representing 
Orencia and Cimzia) for which both noncovered self-administered versions and covered 
provider-administered versions are used to set Part B payment amounts, and to determine 
whether the self-administered versions should be excluded from payment amount calculations.  
Among Part B drugs paid for in 2022, we identified twoFasenra and Xolairfor which CMS 
included noncovered self-administered versions in setting the payment amounts.  Both drugs 
are administered via an injection under the skin (i.e., subcutaneous administration) every few 
weeks.   
Fasenra and Xolair each have a version that is approved and marketed for self-administration 
and another version that is intended to be administered by a provider in an office or outpatient 
setting.  For each drug, the self-administered version was approved by FDA under the same 
application number as was the provider-administered version, meaning that CMS was following 
policy when setting 2022 payment amounts.      
 
 
 
 
Part B Payment Amounts for Two Drugs Included Noncovered Self-Administered Versions in 2022 
OEI-BL-22-00380  Findings | 2   
CMS included self-administered versions in payment amounts for two high-expenditure 
drugs in 2022. 
HCPCS  Drug  2022 Part B  Administration  Product  Administration 
Indication(s) 
Code  Name  Expenditures  Frequency  Formulation  Method 
Prefilled  Provider-
Every 4 weeks for 
Severe  syringe  administered 
the first 3 doses, 
J0517  Fasenra  $227 million  eosinophilic 
followed by every 
asthma  Autoinjector 
8 weeks  Self-administered 
pen 
 
Provider-
Allergic asthma;  Vial 
administered 
chronic hives; 
and chronic 
J2357  Xolair  $442 million  Every 2 or 4 weeks  Prefilled 
rhinosinusitis 
syringe 
with nasal  Self-administered 
(2 dosage 
polyps 
sizes) 
Source: OIG analysis of CMS average sales price (ASP) files, drug product data, and Part B expenditure data. 
Note: The manufacturer of Xolair began marketing a single-dose prefilled autoinjector version (3 dosage sizes) in August 2023i.e., after the 
time period covered by this report.  The autoinjector version can be self-administered.   
Fasenra is a brand-name drug indicated for the add-on maintenance treatment of patients with 
severe eosinophilic asthma.10  It is administered as a subcutaneous injection once every 4 weeks 
for the first three doses, followed by once every 8 weeks.  Fasenra is available as (1) a single-
dose prefilled syringe intended for provider-administration, and (2) a single-dose autoinjector 
pen marketed for self-administration.  In total, Medicare Part B and its enrollees paid 
$227 million for Fasenra in 2022. 
Xolair is a brand-name drug indicated for allergic asthma, chronic hives, and chronic 
rhinosinusitis with nasal polyps.11  It is administered as a subcutaneous injection every 2 or 4 
weeks.  At the time of our review, Xolair was available only as (1) a single-dose prefilled syringe 
that can be self-administered, and (2) a single-dose vial containing powder for reconstitution 
that is intended only for provider administration.  Two dosage sizes were available for the self-
administered version.  In total, Medicare Part B and its enrollees paid $442 million for Xolair in 
2022.  In August 2023, the manufacturer of Xolair released an additional formulation of the drug 
(a single-dose prefilled autoinjector) that also can be self-administered.12  In subsequent 
quarters, the prefilled autoinjector version should also be excluded from calculations if doing so 
would result in lower payment amounts.13 
Including the self-administered versions did not substantially affect 
quarterly per-injection payment amounts for Fasenra and Xolair    
CMS calculated 2022 payment amounts for Fasenra and Xolair in accordance with statute and 
policy.  As previously mentioned, when OIG (1) identifies Part B drug billing codes for which 
both noncovered self-administered versions and covered provider-administered versions were 
Part B Payment Amounts for Two Drugs Included Noncovered Self-Administered Versions in 2022 
OEI-BL-22-00380  Findings | 3  used to set payment amounts and (2) determines that the self-administered versions should be 
excluded, CMS is generally required to remove these versions from calculations in subsequent 
quarters only if the exclusions would result in lower payment amounts.14  To demonstrate 
potential savings, we recalculated quarterly 2022 payment amounts with the self-administered 
versions of Fasenra and Xolair removed.   
In the first and second quarters of 2022, removing the self-administered version of Fasenra 
would not have reduced payments.  In the third and fourth quarters, excluding the self-
administered version of Fasenra would have decreased Medicare payment amounts by $5.22 
and $25.11 per dose, respectively (.1 percent and .5 percent).15  For example, the payment 
amount for a typical 30 mg injection in the fourth quarter of 2022 would have decreased from 
$5,084 to $5,059.       
For Xolair, excluding the self-administered versions from payment amount calculations would 
have reduced payment amounts in each quarter, with decreases ranging from $0.84 to $7.41 per 
dose (.1 percent to .6 percent, respectively).16  For example, the payment amount per 150 mg 
injection in the fourth quarter of 2022 would have decreased from $1,160 to $1,152.17      
Two additional codes may warrant further review from CMS 
OIG identified two additional drugsheparin injection and Granixfor which versions that can 
be self-administered and versions that are administered by providers were included in payment 
amounts.  However, we could not determine whether the versions that can be self-administered 
would meet CMSs definition of usually self-administered set forth by the Medicare Benefit 
Policy Manual and applied by CMSs contractors.18  Specifically, CMS states in its guidance to 
contractors that, in general, drugs used for acute conditions are less likely to be self-
administered by patients.19  CMS defines an acute condition as one that begins over a short time 
period; is likely to be of short duration; and/or requires a course of treatment lasting less than 2 
weeks regardless of frequency or route of administration.  Determining whether heparin 
injection and Granix are used for acute or chronic conditions would require information beyond 
the scope of our study. 
Heparin Injection 
Heparin is a blood thinner (i.e., anticoagulant) used to prevent blood clots from forming in 
patients.20  Most indications for heparin injection are for the treatment of acute conditions, such 
as blood clots associated with surgery and other procedures.  For each quarter under review, 
manufacturers reported pricing data for around 70 national drug codes (NDCs) representing 
heparin.  Product information for only one NDC, representing a prefilled syringe, explicitly 
mentions that patients can self-administer the product.21  It may be unlikely that providers 
would prescribe injectable heparin for self-administration long-term, because oral formulations 
of blood thinners are widely available and tend to be used for chronic conditions.   
Part B Payment Amounts for Two Drugs Included Noncovered Self-Administered Versions in 2022 
OEI-BL-22-00380  Findings | 4  Granix  
Granix is used during chemotherapy to support the production of white blood cells.22  In 
general, it is intended to be used daily during the duration of chemotherapy until the patients 
white blood cell count returns to normal levels.  Marketing and product information indicate 
that some prefilled syringe formulations of Granix are appropriate for self-administration.23  
However, because a course of treatment may vary considerably among patients, it is unclear 
whether Granix meets the definition of usually self-administered set forth by the Medicare 
Benefit Policy Manual and applied by CMSs contractors.24   
 
 
 
Part B Payment Amounts for Two Drugs Included Noncovered Self-Administered Versions in 2022 
OEI-BL-22-00380  Findings | 5  CONCLUSION 
Congress requires OIG to conduct periodic studies to identify billing codes for which both 
noncovered self-administered versions and covered provider-administered versions of drugs are 
used to set Part B payment amounts, and to determine whether the self-administered versions 
should be excluded from Part B payment amount calculations.25, 26  OIG found that CMS 
included noncovered self-administered versions of Fasenra and Xolair when calculating 2022 
Part B payment amounts (in accordance with payment policies).  However, including the self-
administered versions did not substantially affect payment amounts that year.      
REQUIRED ACTION 
In accordance with regulations, CMS must remove self-administered versions of Fasenra and Xolair 
from payment amount calculations in subsequent quarters if the exclusion would result in lower 
payment amounts. 
OIG identified two additional drugs that have one or more versions that may be considered 
noncovered self-administered drugs; however, we do not have sufficient data to make a 
definitive determination as to whether these are usually self-administered and therefore not 
covered by Part B.  CMS and its contractors may wish to further examine the characteristics of 
these drugs to determine whether certain versions of heparin injection and Granix meet agency 
criteria for being considered usually self-administered.  
OIG will periodically conduct similar studies identifying additional drug billing codes for which 
self-administered versions and provider-administered versions are used in Part B payment 
amount calculations, and that subsequently should be considered for exclusion from payment 
amount calculations.  If and when we identify such self-administered versions, we will notify 
CMS of our findings. 
Part B Payment Amounts for Two Drugs Included Noncovered Self-Administered Versions in 2022 
OEI-BL-22-00380  Conclusion | 6  METHODOLOGY 
Medicare sets payment amounts for Part B drugs using HCPCS codes.  Because more than one 
NDC may meet the definition of a HCPCS code, CMS must first crosswalk manufacturers NDCs 
to their corresponding HCPCS codes.  We used CMSs ASP files to identify all NDCs used to set 
Part B 2022 ASP-based payment amounts.   
Using drug compendia data; prescription drug packaging and labeling information from FDA; 
and manufacturer resources, we determined whether each NDC represents a product that is 
typically self-administered.  We based our definition of self-administered on CMSs guidance.27   
We then identified the HCPCS codes to which each self-administered NDC is crosswalked.  We 
removed HCPCS codes that were not also crosswalked to a provider-administered product, and 
we removed HCPCS codes for which self-administration is allowed under Part B coverage criteria 
(e.g., HCPCS codes representing blood clotting factors).   
For the remaining HCPCS codes, we recalculated Part B payment amounts using CMSs volume-
weighted ASP formula in each quarter of 2022 with the self-administered NDCs removed.28  We 
calculated the difference between the actual and alternate payment amounts in each quarter.  
We also calculated total 2022 expenditures. 
Limitations 
There may be limited circumstances in which providers could administer typically self-
administered versions of drugs, such as when a patient is not able or willing to self-inject.  Our 
analysis did not take into account these circumstances. 
Standards 
We conducted this study in accordance with the Quality Standards for Inspection and Evaluation 
issued by the Council of the Inspectors General on Integrity and Efficiency.  
APPENDIX A 
Part B Payment Amounts for Two Drugs Included Noncovered Self-Administered Versions in 2022 
OEI-BL-22-00380  Methodology | 7  ACKNOWLEDGMENTS AND CONTACT 
Acknowledgments 
Bahar Adili served as the team leader for this study.  Others in the Office of Evaluation and 
Inspections Baltimore Regional Office who conducted the study include Sydney Johnson and 
Kasey Memphis.  Office of Evaluation and Inspections headquarters staff who provided support 
include Robert Gibbons, Michael Novello, and Sarah Swisher.  
This report was prepared under the direction of Dave Tawes, Regional Inspector General for 
Evaluation and Inspections in the Baltimore Regional Office; Heather Barton, Deputy Regional 
Inspector General; and Louise Schoggen, Assistant Regional Inspector General. 
 
Contact 
To obtain additional information concerning this report, contact the Office of Public Affairs at 
Public.Affairs@oig.hhs.gov.  OIG reports and other information can be found on the OIG website 
at oig.hhs.gov. 
Office of Inspector General 
U.S. Department of Health and Human Services 
330 Independence Avenue, SW 
Washington, DC 20201 
Part B Payment Amounts for Two Drugs Included Noncovered Self-Administered Versions in 2022 
OEI-BL-22-00380  Acknowledgments and Contact | 8  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 OIG, Excluding Noncovered Versions When Setting Payment for Two Part B Drugs Would Have Resulted in Lower Drug Costs for 
Medicare and Its Beneficiaries, OEI-12-17-00260, November 2017.  OIG, Loophole in Drug Payment Rule Continues To Cost 
Medicare and Beneficiaries Hundreds of Millions of Dollars, OEI-BL-20-00100, July 2020.  CMS did not concur with our 
recommendation to seek legislative change that would provide the agency with flexibility to determine when noncovered 
versions should be included in the calculation of the Part B payment amount. 
5 Section 1847A(g)(3) of the Act as amended by Section 405 of Division CC, Title IV, of the Consolidated Appropriations Act, 
2021 (Section 405 of CAA 2021).  Under Section 1847A(g)(3), Part B payment for Cimzia and Orencia must be the lesser of (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. 
6 Section 1847A(g)(1) of the Act as amended by Section 405 of CAA 2021. 
7 If and when OIG identifies a noncovered self-administered NDC, OIG shall inform the Secretary of the U.S. Department of 
Health and Human Services (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). 
8 A typical dose of Orencia is determined on the basis of the condition for which Orencia is being administered and, in some 
cases, the patients body weight.  Prior OIG work found that most Part B claims for Orencia were for 750 mg.  To maintain 
 
Part B Payment Amounts for Two Drugs Included Noncovered Self-Administered Versions in 2022 
OEI-BL-22-00380  Endnotes | 9    
consistency with prior OIG work, we calculated the actual payment amount and potential payment amount based on a dose of 
750 mg. 
9 A typical dose of Cimzia is determined on the basis of the condition and the patient.  Prior OIG work found that most Part B 
claims for Cimzia were for 400 mg.  To maintain consistency with prior OIG work, we calculated the actual payment amount 
and potential payment amount based on a dose of 400 mg. 
10 Fasenra package insert, http://www.azpicentral.com/pi.html?product=fasenra, accessed on July 20, 2023. 
11 Xolair package insert, https://www.gene.com/download/pdf/xolair_prescribing.pdf, accessed on July 20, 2023. 
12 FDA, National Drug Code Directory, https://www.accessdata.fda.gov/scripts/cder/ndc/index.cfm, accessed on October 4, 
2023.  Three dosage sizes are available for the single-dose prefilled autoinjector version.  Because the autoinjector was 
released after CY 2022, ASP data for the autoinjector were not included in 2022 payment amount calculations.  
13 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). 
14 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). 
15 A typical dose of Fasenra is a single 30 mg/mL subcutaneous injection.   
16 A typical dose of Xolair is determined on the basis of the condition for which Xolair is being administered and, in some 
cases, the patients body weight as well as blood antibody levels.  A single dose of Xolair ranges from 75 mg to 600 mg.  We 
calculated the actual payment amount and potential payment amount based on a dose of 150 mg (i.e., one provider-
administered vial or one 150 mg size prefilled syringe). 
17 For Xolair, excluding the self-administered versions from payment amount calculations would have decreased fourth-quarter 
payment amounts per injection by $7.41 from $1,159.56 to $1,152.15.  
18 CMS provides its contractors with instructions for determining whether drugs are usually self-administered by the patients. 
See Medicare Benefit Policy Manual, ch. 15  50.2.  Each contractor makes its own individual determination for each drug.  CMS 
recently issued a request for information regarding drugs and biologicals which are not usually self-administered by the 
patient.  See 88 Fed. Reg. 52387 (August 7, 2023). 
19 Medicare Benefit Policy Manual, ch. 15  50.2. 
20 MedlinePlus, Heparin Injection, https://medlineplus.gov/druginfo/meds/a682826.html, accessed on July 20, 2023. 
21 NDC 00264-5705-10 represents a self-administered version of heparin sodium injection.  
 
Part B Payment Amounts for Two Drugs Included Noncovered Self-Administered Versions in 2022 
OEI-BL-22-00380  Endnotes | 10    
22 Granix package insert, https://www.granixhcp.com/globalassets/granix-hcp/prescribing-information.pdf, accessed on 
July 20, 2023. 
23 For example, see https://www.granixrx.com/about-granix, accessed on July 31, 2023; Granix package insert, 
https://www.granixhcp.com/globalassets/granix-hcp/prescribing-information.pdf, accessed on July 20, 2023.  The following 
NDCs represent self-administered versions of Granix: 63459-0910-17, 63459-0910-36, 63459-0912-17, and 63459-0912-36.  
24 CMS provides its contractors with instructions for determining whether drugs are usually self-administered by the patient. 
See Medicare Benefit Policy Manual, ch. 15  50.2.  Each contractor makes its own individual determination for each drug.   
25 Section 1847A(g)(1) of the Act as amended by Section 405 of CAA 2021. 
26 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). 
27 For example, Medicare Benefit Policy Manual, ch. 15  50.2.  
28 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). 
Part B Payment Amounts for Two Drugs Included Noncovered Self-Administered Versions in 2022 
OEI-BL-22-00380  Endnotes | 11