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Changes in Noridian's List of Drugs that are Usually Self Administered R1

Recent changes in the list of drugs that Noridian considers as "usually self-administered, and therefore never covered have been confusing. Below are some questions and answers meant to clarify these changes.

Q1. What are the effective dates of the recent changes in Noridian's list of drugs that are usually self administered?

A1. See below.

*Indicates does not need to be billed to the Medicare program since is excluded as a benefit because of being usually self-administered, but that if billed, such as for a denial, this is the appropriate code, indicating statutorily non-covered, and if billed to Medicare after 12/01/2013, this code with modifier is required.

Examples of modifier use:

1. Simponi® -Aria™ and physician administration of this IV drug are both "reasonable and necessary": J3590-KX, 96365-KX.
2. Same administration as (1), but with some reason that "reasonable and necessary are not met: both codes to be submitted with either GA (if ABN obtained) or GZ (if failed to obtain ABN).
3. Patient could self-administer Simponi®, but requests physician administration of this SQ drug: J3590-GY, 96372-GA or GZ (if billed to Medicare, such as for a denial, but does not need to be billed to Medicare).
4. Orencia® IV and physician admin of this IV drug is "reasonable and necessary: J0129-KX, 96365-KX.
5. Same administration as (4), but with some reason that "reasonable and necessary" are not met: both codes to be submitted with either GA (if ABN obtained) or GZ (if failed to obtain ABN).
6. Patient could self-administer Orencia®SQ, but instead obtains physician administration of Orencia® IV: J0129-GA, 963XX-GA (if ABN obtained), or J0129-GZ, 963XX-GZ (if did not obtain an ABN); for 963XX select the appropriate administration code from the 96365-96376 series.
7. Patient could self-administer Orencia® SQ, but requests physician administration of this SQ drug: J3590-GY, 96372-GA or GZ (if billed to Medicare, such as for a denial, but does not need to be billed to Medicare).
8. Cimzia® (lyophilized) and physician administration is reasonable and necessary: J0718-KX, 96372-KX.
9. Same administration as (8), but with some reason that "reasonable and necessary are not met: both codes to be submitted with either GA (if ABN obtained) or GZ (if failed to obtain ABN).
10. Patient could self administer Cimzia® (non-lyophilized), but requests physician administration of this SQ drug: J3590-GY, 96372-GA or GZ (if billed to Medicare, such as for a denial, but does not need to be billed to Medicare).
11. Patient self administers any of these drugs: No claim to be submitted to AB MAC for either drug or administration.

Q2. When is physician administration "medically reasonable and necessary"?

A2. Depending on Part D Plan selection, each of these three drugs is usually covered under both Part B and Part D. Evidence-based guidance describing the medical necessity of various modes of administration is not available, but Noridian can point out that the following factors are ones that Medicare considers to be unrelated to medical decision making.

1. Patient convenience.
2. Patient co-pays and financial liability. The fact that a patient may experience a greater financial liability under one payment arrangement versus another is not a consideration that Medicare may consider in determining the medical reasonableness or necessity of the service.

Medicare rules expect that if a patient is clinically able to self-administer a drug and there is no clear medical justification to do otherwise, then the patient must either self-administer that drug or self-pay for the alternative.

Q3. We have been using the chemotherapy administration codes for administration of these drugs. May we continue using those codes?

A3. No. The preamble to the chemotherapy administration section of the CPT Manual is very specific about the circumstances that permit use of these codes (96401-96417). The administration of these three drugs do not meet the criteria specified in this section, instead, an appropriate code from the 96365-96376 section should be selected to represent administration of one of these three drugs.

Noridian is publishing an article about the use of the chemotherapy administration codes that will appear on the website about the time this appears.

Q4. Will Noridian be performing mass adjustments for any claims for these drugs that have been denied incorrectly?

A5. No. Noridian will not be performing mass adjustments for several reasons. First, we estimate that the number of incorrectly denied services is small. And second, because of overlap in coding between covered and non-covered services, it would be difficult to identify incorrectly denied services without a review of medical records.

If a provider has experienced claims that are believed to have been denied incorrectly, please submit the appropriate records for a redetermination.

• JE Part A Redeterminations

Q6. Do the instructions regarding medical necessity of administration apply to claims related to those patients who were started on one of the drugs before October 2013 that CMS has determined to not usually be self-administered (IV Orencia, lyophilized Cimzia or IV Simponi)?

A6. Medicare requires that both the drug and the method of drug administration must be "reasonable and necessary" (see Internet Only Manual 100-02, Chapter 15, Section 50.4.3.(2)). Documentation supporting the medical necessity should be maintained in the medical record and made available to Medicare upon request.

Q7. Will Medicare clarify the use of these codes?

A7. For services rendered on or after January 1, 2014, CMS is issuing new codes for the intravenous form of golimumab (J1602, Injection, golimumab, 1 mg, for intravenous use) and for certolizumab pegol when administered under the care of a physician (J0717 Injection, certolizumab pegol, 1 mg (code may be used for Medicare when drug administered under the direct supervision of a physician, not for use when drug is self administered)). The current code for certolizumab pegol (J0718) will be discontinued after 12/31/2013 since its use is ambiguous. The code for the intravenous form of abatacept (J0129) remains unchanged with the current descriptor (Injection, abatacept, 10 mg (code may be used for Medicare when drug administered under the direct supervision of a physician, not for use when drug is self administered)).