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Process to Determine Which Drugs Are Not Usually Self-administered by the Patient

Abbreviations

NUSA	Not usually self-administered by the patient
USA	Usually self administered by the patient
PP	Presumption parameter (illness duration and frequency of administration)
PI	Package insert approved by the FDA
SC	Subcutaneous injection
IV	Intravenous injection
IM	Intramuscular injection
IT	"incident to" a physician's services
MB	Medicare beneficiaries
INI	individual beneficiaries not included because of a physical/mental condition which precludes their "self-administering" any drug

Applicability

This process applies to injectable drugs used in an outpatient setting for Medicare beneficiaries for reasonable and necessary indications, whether or not the site of service for an "IT" (incident to a physician's service) injected drug is reasonable and necessary. Generic or otherwise equivalent drugs with separate J codes may be treated separately or as one drug. The decision is made based on how the Medicare population as a whole uses the drug, not how an individual patient or physician may choose to use a particular drug. This process is defined in the CMS Manual System, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, §50.2, Determining Self-Administration of Drug or Biological.

The term 'administered' refers only to the physical process by which the drug enters the patient's body. 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 and topical medications are considered to be usually self-administered by the patient.

STEP ONE: "Apparent on its face"

These are generally drugs which are virtually always self-administered, ie, it is "apparent on its face" that the drug is usually self-administered, such as Insulin. Often it is the standard of practice for the patient to self-administer these drugs to achieve an immediate effect. They may be infrequently administered "incident to" a physician's services in an office setting, but are not covered in any circumstances. These may be administered by any of a variety of routes.

STEP TWO: Determination of self-administered based on PRESUMPTIVE EVIDENCE

(Follow Step 2 when valid, reliable population based evidence is lacking.) Use the following tables to make a determination until reliable patient use data becomes available to calculate an answer to one or both of the formulae in Step 3. When data becomes available, use Step 3 to reconsider the coverage decision.

Table A: IV or IM Routes of Administration

Route of Administration	Package Insert (PI)	Patient role	Contractor Decision	Contractor's Coverage Status
If the drug is IV	The PI specifies IV administration	None	The drug is NUSA	Covered
If the drug is IM	The PI has no self-administration instructions	None	The drug is NUSA	Covered
If the drug is IM	And the PI explains how to self-administer	May self-administer	The drug may be USA	Follow SC drug process below

Table B: Coverage Decision using Presumption Parameters for making determination

Frequency/Chronicity	Acute condition (Two weeks or less)	Chronic condition (Two weeks or more)
Infrequent Injections (Less than once per week)	NUSA	Carrier discretion
Frequent Injections (Once or more per week)	Carrier discretion	USA

Other factors may be used by Contractors at their discretion to make this determination, such as peer-reviewed medical literature, evidence-based guidelines, practice standards, need for careful monitoring to determine dosage, etc

Multiple Indications

Follow this portion of Step 4 when a drug has multiple indications.

When the drug has been covered (so claims data is available), and has more than one indication, if each SC indication has the same combination of presumption parameters (PPs) (e.g. Acute, Infrequent), the coverage decision is made according to the table above.
If the PP combination varies by indication, but no indication has the PP combination of Chronic/Frequent, the coverage decision is made according to the table above.
If the PP combination varies by indication and one or more indications has the PP combination of Chronic/ Frequent, then proceed as follows:
1. Select beginning and end date for the analysis, and use the same dates for all portions of the analysis. Use either dates of service or dates of claim receipt consistently for all calculations.
2. Count each date of service as one injection, regardless of the amount of drug injected on any particular day.
3. If applicable, calculate the number of IV and IM injections.
4. Calculate the number of SC Injections for each indication, sorted by the ICD-9-CM codes reported.
5. The total injections for all indications must be 100%
6. Add the percentage of injections for all those ICD-9-CM codes that reflect the chronic/frequent uses.
7. If the sum of the SC injections for the Chronic/Frequent combination is more than 50% of the total of all injections, the drug is USA and not covered.
8. If the sum of the SC injections for the Chronic/Frequent combination is equal to or less than 50% of the total of all injections, the drug is NUSA and covered
When the drug has not previously been covered, use other sources of information to estimate the PP for each indication.

Table C: Chronic/Frequent Use Decision Table

Calculation Results	Decision	Status
Sum of SC injections >50%	USA	Not covered
Sum of SC injections < or = 50%	NUSA	Covered

Multiple Routes of Administration and/or Indications Example:

NAME OF DRUG: AMICOVEREDATOL (Fictitious)

Table D: Multiple Routes of Administrations and/or Indications Table:

Route of Administration / Indication	Presumption Parameter(s)	% Of Injections for This Indication	% Of injections for chronic/frequent indications	Contractor's Coverage Status
IV	N/A	10	N/A
IM	N/A	0	N/A
SC: Use #1	Acute, Frequent	68
SC: Use #2	Chronic, Frequent	12	13
SC: Use #3	Acute, Frequent	3
SC: Use #4	Chronic, Frequent	3	3
SC: Use #5	Chronic, Frequent	4	4
TOTAL		100%	20	NUSA/Covered

STEP THREE: COVERAGE DECISION BASED ON EVIDENTIARY CRITERIA

Is sufficient and reliable patient usage data for Medicare beneficiaries available to solve the following formulae? To the extent available, contractors are required to consider evidence of the following types:

Peer-reviewed medical literature
Standards of medical practice
Evidence-based practice guidelines
FDA approved label, and package inserts

Other information submitted by interested individuals or groups may be considered, such as:

reliable patient usage data
Drug Compendia references

X = # of MB who self-administer the drug

(# of MB who have the drug administered "IT" a practitioner) + (# of MB who have the drug administered by others) + (# of MB who self-administer the drug) - (# of INI MB)

- or -

Y = # of times the drug is self-administered

(# of times the drug administered "IT" a practitioner) + (# of times the drug is administered by others + (# of times the MB self-administers the drug) - (# of times the drug is administered to an INI MB)

Where:

X is the percentage of patients who self-administer the drug
Y is the percentage of the time the drug is self-administered (use data with the same time variable for each part of the equation-e.g. month, quarter, year)
MB is a Medicare beneficiary.
Patients "who self-administer the drug" are those who usually self-inject the medication in an outpatient setting. A patient who self-injects is one who self-injects more than 50% of the time the medication is administered by that patient in an outpatient setting.
"Others" are those who are not the patient or not the "IT" practitioner.
INI (individuals not included) are those individual beneficiaries who do not have the capacity to self-administer any drug due to a condition other than the condition for which they are taking the drug in question (e.g. patients with severe dementia).

Table E: Patient Use Data Calculation Results

Table E: Patient Use Data Calculation Results

Calculation Results	Decision	Status
X > 50	USA	Not covered
Y > 50	USA	Not covered
X or Y < or = to 50	NUSA	Covered

Any time there is an addition or deletion to the List of Drugs and Biologicals Excluded as Usually self-administered, the updated list is distributed via ListServs and published in the 'What's New' section of our website. Subsequently, this information appears in the Web Bulletin and the CD ROM Bulletin.