Page 56 - Medicare Benefit Policy Manual

I. 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 (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 §1879 of the Act). Therefore, physicians or providers may charge the beneficiary
for an excluded drug.

J. Provider and Physician Appeals

A physician accepting assignment may appeal a denial under the provisions found in Pub.
100-04, Medicare Claims Processing Manual, chapter 29.

K. Reasonable and Necessary

A/B MACs (A) and (B) will make the determination of reasonable and necessary with
respect to the medical appropriateness of a drug to treat the patient’s condition. MACs
will continue to make the determination of whether the intravenous or injection form of a
drug is appropriate as opposed to the oral form. MACs will also continue to make the
determination as to whether a physician’s office visit was reasonable and necessary.
However, MACs should not make a determination of whether it was reasonable and
necessary for the patient to choose to have his or her drug administered in the physician’s
office or outpatient hospital setting. That is, while a physician’s office visit may not be
reasonable and necessary in a specific situation, in such a case an injection service would
be payable.

L. Reporting Requirements

Each A/B MAC (A), (B), or (HHH), or DME MACs must report to CMS its complete list
of injectable drugs that the A/B MACs (A), (B), or (HHH), or DME MACs has
determined are excluded when furnished incident to a physician’s service on the basis
that the drug is usually self-administered. The CMS expects that A/B MACs (A), (B),
and (HHH), and DME MACs will review injectable drugs on a rolling basis and update
their list of excluded drugs as it is developed and no less frequently than annually. For
example, A/B MACs (A), (B), and (HHH), and DME MACs should not wait to publish this
list until every drug has been reviewed. A/B MACs (A), (B), and (HHH), and DME MACs
must enter their self-administered drug exclusion list to the Medicare Coverage Database
(MCD). This database can be accessed at www.cms.hhs.gov/mcd. See Pub.100-08, Medicare
Program Integrity Manual, Chapter 3, Section 3.3, “Policies and Guidelines Applied During
Review”, for instructions on submitting these lists to the MCD.

M. Drugs Treated as Hospital Outpatient Supplies