Article

Process for Determining Self-Administered Drug Exclusions – Medical Policy Article

A53020

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Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
National Government Services, Inc.	MAC - Part A	06101 - MAC A	J - 06	Illinois
National Government Services, Inc.	MAC - Part B	06102 - MAC B	J - 06	Illinois
National Government Services, Inc.	MAC - Part A	06201 - MAC A	J - 06	Minnesota
National Government Services, Inc.	MAC - Part B	06202 - MAC B	J - 06	Minnesota
National Government Services, Inc.	MAC - Part A	06301 - MAC A	J - 06	Wisconsin
National Government Services, Inc.	MAC - Part B	06302 - MAC B	J - 06	Wisconsin
National Government Services, Inc.	A and B and HHH MAC	13101 - MAC A	J - K	Connecticut
National Government Services, Inc.	A and B and HHH MAC	13102 - MAC B	J - K	Connecticut
National Government Services, Inc.	A and B and HHH MAC	13201 - MAC A	J - K	New York - Entire State
National Government Services, Inc.	A and B and HHH MAC	13202 - MAC B	J - K	New York - Downstate
National Government Services, Inc.	A and B and HHH MAC	13282 - MAC B	J - K	New York - Upstate
National Government Services, Inc.	A and B and HHH MAC	13292 - MAC B	J - K	New York - Queens
National Government Services, Inc.	A and B and HHH MAC	14111 - MAC A	J - K	Maine
National Government Services, Inc.	A and B and HHH MAC	14112 - MAC B	J - K	Maine
National Government Services, Inc.	A and B and HHH MAC	14211 - MAC A	J - K	Massachusetts
National Government Services, Inc.	A and B and HHH MAC	14212 - MAC B	J - K	Massachusetts
National Government Services, Inc.	A and B and HHH MAC	14311 - MAC A	J - K	New Hampshire
National Government Services, Inc.	A and B and HHH MAC	14312 - MAC B	J - K	New Hampshire
National Government Services, Inc.	A and B and HHH MAC	14411 - MAC A	J - K	Rhode Island
National Government Services, Inc.	A and B and HHH MAC	14412 - MAC B	J - K	Rhode Island
National Government Services, Inc.	A and B and HHH MAC	14511 - MAC A	J - K	Vermont
National Government Services, Inc.	A and B and HHH MAC	14512 - MAC B	J - K	Vermont

Article Information

General Information

Article ID
A53020

Original ICD-9 Article ID
A47521

Article Title
Process for Determining Self-Administered Drug Exclusions – Medical Policy Article

Article Type
Article

Original Effective Date
10/01/2015

Revision Effective Date
N/A

Revision Ending Date
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Retirement Date
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Article Guidance

Article Text
The Centers for Medicare and Medicaid Services (CMS) published guidelines instructing contractors to develop a process to determine whether a drug or biological is usually self-administered and excluded from payment. (See CMS Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50.2). These instructions include the following:

The Medicare program provides limited benefits for outpatient prescription drugs. The program covers drugs that are furnished "incident to" a physician's service provided that the drugs are not usually self-administered by the patients who take them. Section 112 of the Benefits, Improvements & Protection Act of 2000 ( BIPA) amended sections 1861 (s)(2)(A) and 1861 (s)(2)(B) of the [Social Security] Act to redefine this exclusion. The prior statutory language referred to those drugs "which cannot be self administered." Implementation of the BIPA provision requires interpretation of the phrase "not usually self-administered by the patient."

The term "administered" refers only to the physical process by which the drug enters the patient's body. It does not refer to whether the process is supervised by a medical professional (for example, to observe proper technique or side-effects of the drug). Injectable drugs, including intravenously administered drugs, are typically eligible for inclusion under the "incident to" benefit. With limited exceptions, other routes of administration including, but not limited to, oral drugs, suppositories, topical medications are considered to be usually self-administered by the patient. For the purpose of applying this exclusion, the term "usually" means more than 50 percent of the time for all Medicare beneficiaries who use the drug.

Contractors are further instructed to make this determination on a drug-by-drug basis, not on a beneficiary-by-beneficiary basis.

"Apparent on its face"

For certain injectable drugs, it will be apparent due to the nature of the condition(s) for which they are administered or the usual course of treatment for those conditions, they are, or are not, usually self-administered. On the other hand, an injectable drug, administered at the same time as chemotherapy, used to treat anemia secondary to chemotherapy is not usually self-administered.

Evidence Criteria for applying the Medicare Self-Administered Drug Exclusion:

Peer reviewed medical literature
Standards of medical practice
Evidence-based practice guidelines
FDA approved label
Package insert
Drug compendia references
Self-administration utilization statistics

Acute: For the purpose of determining whether a drug is usually self-administered, an acute condition means a condition that begins over a short time period, is likely to be of short duration and/or the expected course of treatment is for a short, finite interval. A course of treatment consisting of scheduled injections lasting less than two weeks, regardless of frequency or route of administration, is considered acute.

Usually: For the purposes of applying this exclusion, the term "usually" means more than 50 percent of the time for all Medicare beneficiaries who use the drug. Therefore, if a drug is self-administered by more than 50 percent of Medicare beneficiaries, the drug is excluded from coverage and you may not make any Medicare payment for it.

Drugs NOT Usually Self-administered:

Drugs delivered intravenously may usually be presumed not usually self-administered
Drugs delivered intramuscularly may usually be presumed not usually self-administered

Drug Usually Self-administered:

Drugs delivered subcutaneously may be usually presumed self-administered
Drugs delivered by other routes of administration such as oral, suppositories, and topical medications are all considered to be usually self-administered

Notice of Non-Covered Drugs

Contractors must provide notice 45 days prior to the date that these drugs will not be covered. During the 45-day time period, contractors will maintain existing medical review and payment procedures. After the 45-day notice, contractors may deny payment for the drugs subject to the notice.

CMS further provided that Part A MACs may opt to adopt the determinations of the Part B MACs within their jurisdiction(s). In the interest of providing consistent coverage for all providers within each state, the National Government Services Part A MACs will adopt the coverage decisions for injectable drugs subject to the self-administered drug exclusion as determined by the Part B MAC in each respective state. HCPCS codes for the same drugs that apply only to providers that bill the Part A MAC (e.g., HCPCS codes used for drugs billable under the Outpatient Prospective Payment System [OPPS]) are included when applicable. The list of drugs excluded from Medicare coverage as self-administered drugs can be accessed on our contractor Web site at www.NGSMedicare.com. It can also be found on the Medicare Coverage Database at www.cms.gov/mcd.

Response To Comments

Number	Comment	Response
1

Coding Information

Bill Type Codes

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

Code	Description
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N/A

Revenue Codes

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the article, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes.

Code	Description
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Not applicable
N/A

CPT/HCPCS Codes

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ICD-10-CM Codes that are Covered

N/A

ICD-10-CM Codes that are Not Covered

N/A

Bill Type Codes

Code	Description
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Revenue Codes

Code	Description
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Coding Table Information

Excluded CPT/HCPCS Codes - Table Format

Code	Descriptor Generic Name	Descriptor Brand Name	Exclusion Effective Date	Exclusion End Date	Reason for Exclusion
			N/A	N/A

Non-Excluded CPT/HCPCS Ended Codes - Table Format

Code	Descriptor Generic Name	Descriptor Brand Name	Exclusion Effective Date	Exclusion End Date	Reason for Exclusion

Revision History Information

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Associated Documents

Updated On	Effective Dates	Status
04/02/2014	10/01/2015 - N/A	Currently in Effect	You are here

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Process for Determining Self-Administered Drug Exclusions – Medical Policy Article

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