Bindinglaw

US · guidance

CMS Pub. 100-04, ch. 17, § 10

Payment Rules for Drugs and Biologicals

activein force · 2026-08-25 – presentas-observed

Drugs for inpatient hospital and inpatient skilled nursing facility (SNF) beneficiaries are included in the

respective prospective payment system (PPS) rates, except for hemophilia clotting factors for hospital

inpatients under Part A.

All hospital outpatient drugs are excluded from SDP because the payment allowance for such drugs is

determined by a different methodology. Non pass-through drugs with estimated per day costs less than

or equal to the applicable drug packaging threshold that are furnished to hospital outpatients are

packaged under the outpatient prospective payment system (OPPS). Their costs are recognized and

included but paid as part of the ambulatory payment classification (APC) group payment for the service

with which they are billed. Non pass-through drugs with estimated per day costs greater than the

applicable drug packaging threshold are paid separately.

Drugs that are granted “pass through” payment status are required by law to be paid at either the

amount paid under the physician fee schedule, or, if the drug is included in the Part B drug competitive

acquisition program (CAP), at the Part B drug CAP rate. Drugs that have pass-through status may have

coinsurance amounts that are less than 20 percent of the OPPS payment amount. This is because pass-through payment amounts, by law, are not subject to coinsurance. CMS considers the amount of the

pass-through drug payment rate that exceeds the otherwise applicable OPPS payment rate to be the

pass-through payment amount. Thus, in situations where the pass-through payment rate exceeds the

otherwise applicable OPPS payment rate, the coinsurance is based on a portion of the total drug

payment rate, not the full payment rate.

Hospitals must report all appropriate HCPCS codes and charges for separately payable drugs, in

addition to reporting the applicable drug administration codes. Hospitals should also report the HCPCS

codes and charges for drugs that are packaged into payments for the corresponding drug administration

or other separately payable services. Historical hospital cost data may assist with future payment

packaging decisions for such drugs. Drugs are billed in multiples of the dosage specified in the HCPCS

code long descriptor. If the drug dose used in the care of a patient is not a multiple of the HCPCS code

dosage descriptor, the provider rounds to the next highest unit based on the HCPCS long descriptor for

the code in order to report the dose provided.

If the full dosage provided is less than the dosage for the HCPCS code descriptor specifying the

minimum dosage for the drug, the provider reports one unit of the HCPCS code for the minimum

dosage amount.

OPPS Pricer includes a table of drugs and prices and provides the contractor with the appropriate

prices.

Section 90 relates specifically to billing for hospital outpatients. The remainder of this chapter relates

to procedures for pricing and paying DME recipients, and to beneficiaries who receive drugs under

special benefits such as pneumococcal, flu and hepatitis vaccines; clotting factors, immunosuppressive

therapy, self administered cancer and anti emetic drugs, and drugs incident to physicians‟ services.

The Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 defines a

Specified Covered Outpatient Drug (SCOD) as a covered outpatient drug for which a separate APC has

been established and that is either a radiopharmaceutical agent, or a drug or biological for which

payment was made on a pass-through basis on or before December 31, 2002. Payment for SCODs is

set, by law, at the average acquisition cost. Under the OPPS, a single payment is made for SCODs that

represents payment for both the acquisition cost of the drug and any associated pharmacy overhead or

nuclear medicine handling costs.

Drugs or biologicals must meet the coverage requirements in Chapter 15 of the Medicare Benefit Policy

Manual. Additionally, for end stage renal disease (ESRD) patients, see the Medicare Benefit Policy

Manual, Chapter 11. For ESRD patient billing for drugs and claims processing, see Chapter 8 of this

manual.

The following chart describes the general payment provisions for drugs.

Table - Drug Payment Methodology

Key to the following Table:

NOTES:

DME MACs do not process claims for blood clotting factors.

Unless noted otherwise, claims for these drugs are submitted to the A/B MAC (B)

† - Drugs & biologicals outside the composite rate and/or ESRD PPS are paid as described in 2 below. Those inside the

composite rate and/or ESRD PPS are paid as described in 1. (ESRD PPS effective January 1, 2011)

1 - Included in PPS rate, or other provider-type all inclusive encounter rate

2 – Price taken from CMS drug/biological pricing file effective on the specific date of service.

3 - Based on reasonable cost (101% reasonable cost in CAH)

4 - Lower of cost or 95% AWP paid for drug in addition to PPS rate, or in addition to reasonable cost if excluded from PPS

5 - OPPS-APC, whether pass-thru drug or not

6 - Cannot furnish as that “provider” type

7 - May not bill DME-MAC or MAC for drugs furnished incident-to a physicians’ service

8 - Payment made at the time of cost settlement

A - Bills are submitted to the DME MAC

++ Except in the State of Washington, where CMS permits the ESRD Facility to bill for immunosuppressive drugs due to

the unique State assistance to the beneficiary provided only via the ESRD Facility.

Provider/Drug Hepatitis

Vaccine

Pneumoco

ccal &

Flu

Vaccines

Hemophi

lia

Clotting

Factors

Immuno

-

Suppress

ive

Erythrop

oiesis

Stimulati

ng

Agents

ESA’s)

Self Admin

Anti-Cancer

Anti-Emetic

for cancer

treatment

Other

Drugs

Hospital Inpatient (IP)

A -Prospective Payment

System (IPPS)

3 3 2 1 1 1 1

Hospital IP A - not

IPPS

3 3 3 3 3 3 3

Hospital IP B -

Outpatient Prospective

3 3 5 5 5 5 5

Payment System

(OPPS)

Hospital IP B - not

OPPS hospital

3 3 3 3 3 3 3

Hospital Outpatient

(OP) - OPPS hospital

3 3 5 5

(8 - for

30-day

supply)

5 5 5

Hospital OP - not OPPS

hospital

3 3 3 3

(8 - for

30-day

supply)

3 3 5

Skilled Nursing Facility

(SNF) IP

3 3 1 1 1 1 1

SNF OP or IP B 3 3 3 3 6 6 6

End Stage Renal

Disease (ESRD)

Facility

2 2 6 6++ 1 or 2† 6 1 or 2†

Comprehensive

Outpatient

Rehabilitation Facility

(CORF)/ Outpatient

Rehabilitation Facility

(ORF)

2 2 6 6 6 6 6

Community Mental

Health Clinic (CMHC)

6 6 6 6 6 6 6

Rural Health Clinical

(RHC)/Federally

Qualified Health Clinic

(FQHC) -hospital based

1 8 5 5 5 5 5

RHC/FQHC-

independent

1 8 6 6 6 6 6

Home Health Agencies

3 3 6 6 6 6 6

Hospice 6 6 6 6 1 1 1

Physicians 2 2 2 2 2 2 2

Pharmacy 2 2 2, 7 2, A 2 2, A 2, 7

Durable Medical

Equipment, Prosthetics,

Orthotics, and Supplies

(DMEPOS) Supplier

2 2 2 2 2 2 2

Critical Access Hospital

(CAH) IP A or B

3 3 3 3 3 3 3

CAH OP-Method I or II 3 3 3 3

(8 - for

30-day

supply)

3 3 3

NOTES:

Independent and provider-based RHCs and FQHCs generally do not bill for pneumococcal/influenza

vaccines, except when the only service involved is the administration of the vaccine. Instead,

RHCs/FQHCs are generally paid for pneumococcal/influenza vaccines at cost settlement via the

Medicare cost report. Hepatitis B vaccine payment is bundled into the encounter rate for both

Independent and provider-based RHCs and FQHCs.

Influenza, pneumococcal, and Hepatitis B vaccines are paid on a reasonable cost basis in a hospital

outpatient department. Neither deductible nor coinsurance apply.

HHAs cannot bill for vaccines, except on TOB 34X, since vaccines are not part of the HH benefit and

cannot be paid under HH PPS.

Influenza, PPV, and Hepatitis B vaccines are paid once for the vaccine and once for the administration

of the vaccine. The provider or supplier (including physician) must enter each of the HCPCS on

separate lines of the claim.

A Part B blood clotting factor claim from a Part B supplier is processed by the A/B MAC (B).

A Part A blood clotting factor claim from a Part A provider, including a hospital-based hemophilia

center, is processed by the hospital’s Medicare contractor.

History

(Rev.11764, Issued: 12-22-2022; Effective:01-01-23; Implementation:01-03-23 )

Provenance

Source
cms.gov
Retrieved
2026-08-25
Edition
iom-2026-08-25
Content hash
1edb0cc4fc5d3afb267cbec05a29d21af05b2a2670fa1010fec7e6d25daa938a
View the official source →

The link goes to the issuing authority’s own document — the one we read to produce this record. Where a source publishes whole titles rather than sections, your browser may need a moment to jump to the provision.

Unofficial copy of government-published law, reproduced from official sources with full provenance. Not an official publication; verify against official sources before relying on it in a filing. Records in the 'guidance' corpus, and only that corpus, are sub-regulatory (interpretive guidelines, survey procedures) and are not binding law. Validity bounds follow each jurisdiction's declared temporalBasis.

Coverage · API docs

Bindinglaw

Point-in-time US law with the receipt attached. Source URL, retrieval time, content hash, and validity dates on every answer.

curl api.binding.law/v1/law/coverage

© 2026 binding.law · a Jubal, Inc. productAttorneys and firms never pay. Ever.