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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, ยง50.2, 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.

  1. 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.
  2. 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.
  3. 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
  4. 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) Number of Injections % 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.

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