This process applies only to medications described in the program instructions of the Internet Only Manual (IOM) Medicare Benefit Policy Manual, Chapter 15, Section 50.2 at
http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf.
Introduction
This process applies only to injectable drugs used in an outpatient setting for Medicare beneficiaries for reasonable and necessary indications. Generic or otherwise equivalent drugs with separate “J” codes may be treated separately or as one drug.
CMS Instructions to Each Contractor
“Contractors must describe the process they will use to determine whether a drug is usually self-administered by the patient and as such cannot be covered as “incident to” a physician’s service. Contractors must continue to assure that not only is the drug medically reasonable and necessary for any individual claim, but also that the route of administration is medically reasonable and necessary.”
The words “by the patient” mean for Medicare beneficiaries as a collective whole. If the drug is not covered, it is not covered for all patients and for all routes of administration. For example, if a drug is usually self-administered based on the frequency of its subcutaneous injections, and therefore is not covered, the less-frequent intravenous form of the drug also will not be covered, even when administered by a physician (e.g. insulin, even if for an “emergency” indication). Even if a specific patient could never self-administer any injectable drug (because of cognitive impairment, blindness, paralysis, other mental or physical disability, etc.) if a particular drug is usually self-administered by most of the Medicare population, the drug would not be covered for this individual. If a drug has multiple uses and the drug is self-administered more than 50% of the time for the total of all uses, then the drug would not be covered even for uses that require physician administration.
When a drug is usually self-administered, and therefore not covered, no payment may be made even when the drug is given incident to a physician’s service for reasons such as:
• Teaching self-administration,
• Adjusting or titrating the dose,
• Monitoring for immediate side effects, and
• Emergency use.
If a drug has multiple uses, and the drug is administered "incident to" a physician’s service for its most frequent uses, and therefore covered, then the drug is covered even for uses that can be self-administered. However, when a drug is thereby covered, payment still requires that the drug is actually administered incident to a physician’s service and is reasonable and necessary for the condition treated.
No payment may be made for an otherwise-covered drug that is self-administered.
Noridian will use the following process to determine coverage:
Step 1
Determination of Self-Administration: “Apparent on its face”
For certain injectable drugs, the nature of the condition(s) for which it is administered will be sufficient to determine that the drug is or is not usually self-administered.
When the predominant use is for a condition that is recurrent, identifiable by the patient, given for an immediate effect and provided with self-administration instructions in the drug’s package insert approved by the United States Food and Drug Administration (FDA), the drug is usually self-administered. Examples include sumatriptan to treat migraine headaches, insulin to treat diabetes and alprostadil to treat erectile dysfunction.
On the other hand, a drug that a reasonably prudent patient would not be expected to self-administer is not usually self-administered, and is therefore covered. Examples include a drug usually requiring clinical expertise to administer (e.g. a drug given intravenously or for use in an implanted intravenous or intrathecal pump), a drug usually administered during a procedure (e.g. a local anesthetic or an injected releasing hormone to measure a hormonal response) and a drug usually requiring a physician to titrate the next dose (e.g. erythropoietin alfa for chemotherapy support).
Further, a drug generally used only for an acute condition such that the course of scheduled injections lasts less than two weeks, is not usually self-administered.
If, and only if, you are unable to make a determination from step 1, go to step 2.
Step 2
If there are not multiple indications for a drug or there is no reliable usable data, skip directly to step 3.
Using Presumptive Evidence to Combine Information When a Drug Has Multiple Indications and there is Reliable Usable Data:
1. Select beginning and end dates for the analysis. For consistency try to use the same dates for all calculations.
2. Calculate the total injections during this period, including any intravenous or intramuscular injections. This total will be 100%.
3. Drug indications will be sorted by diagnoses and where similar will be combined to facilitate analysis.
4. Calculate the number of subcutaneous injections, but do not include those for courses of treatment consisting of scheduled injections lasting less than two weeks. (Any indication with scheduled injections lasting less than two weeks is weighted as not usually self-administered, even if administered subcutaneously.)
5. Add to this number (from # 4) those injections for courses of treatment lasting two weeks or longer and with injections at least weekly (i.e. those that are both “chronic” and “frequent”)
6. If this sum is equal to or less than 50% of the total injections during the period, the drug is not usually self administered and is covered.
7. If this sum is more than 50% of the total injections during the period, proceed to Step 3.
Step 3
Determination of Self-Administration using Evidentiary Criteria:
When available, evidence of the following types must be considered:
• Peer-reviewed medical literature
• Standards of medical practice
• Evidence-based practice guidelines
• FDA approved indications
• FDA approved package insert (which is not to be used by itself
as the only determining factor)
Further, evidence of the following types may be considered:
• Drug compendia references
• Reliable patient use data
• The need for physician monitoring to determine each dose
• Other relevant parameters according to contractor discretion
The above data will be used for each indication to supplement available utilization data on the percentage of self-administered injections. Where it appears more reliably available, utilization data on the percent of beneficiaries receiving a drug by self-administration may be used as an alternative to percent of injections.
Provider Notice of Non-Covered Drugs
After making determinations by the above three-step process, Noridian will provide notice on our web site, http://www.noridianmedicare.com, 45 days prior to the date that any drug will change from current covered status to being not covered. During the 45-day period, the Noridian existing medical review and payment procedures will remain in effect. After the 45-day period, we may deny payment for the drug(s) subject to the notice.
Beneficiary Appeals
If a beneficiary’s claim for a particular drug is denied because the drug is subject to the “self-administered drug” exclusion, the beneficiary may appeal the denial. Because it is a “benefit category” denial and not a denial based on medical necessity, an Advance Beneficiary Notice of Noncoverage (ABN) is not required. A “benefit category” denial (i.e., a denial based on the fact that there is no benefit category under which the drug may be covered) does not trigger the financial liability protection provisions of Limitation On Liability [under Section 1879 of the Act]. Therefore, physicians or providers may charge the beneficiary for such an excluded drug.
Provider and Physician Appeals
A physician accepting assignment and the hospital may appeal a denial under the provisions found in the IOM Medicare Claims Processing Manual, Publication 100-04, Chapter 29, Appeals of Claims Decisions at http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c29.pdf
Reasonable and Necessary
Noridian will make the determination of reasonable and necessary with respect to the medical appropriateness of a drug to treat the patient’s condition, and will continue to make the determination of whether the intravenous or injection form of a drug is appropriate as opposed to the oral form. We will also continue to make the determination as to whether a physician’s office visit was reasonable and necessary. However, while a physician’s office visit may not be reasonable and necessary in a specific situation, the medical necessity of the injection will still be determined on its own merits based on this process for determining which drugs are usually self administered.
Sources: IOM Medicare Benefit Policy Manual, Publication 100-02, Chapter 15, Covered Medical and Other Health Services, Section 50.2, Determining Self-Administration of Drug or Biological; IOM Medicare Claims Processing Manual, Publication 100-04, Chapter 29, Appeals of Claims Decisions.
