(a) [Reserved]
(b) Other drugs. The agency payments for brand name drugs certified in accordance with paragraph (c) of this section and drugs other than multiple source drugs for which a specific limit has been established must not exceed, in the aggregate, payments levels that the agency has determined by applying the lower of the--.
(1) EAC plus reasonable dispensing fees established by the agency; or
(2) Providers' usual and customary charges to the general public.
(c) Certification of brand name drugs. (1) The upper limit for payment for multiple source drugs for which a specific limit has been established does not apply if a physician certifies in his or her own handwriting (or by an electronic alternative means approved by the Secretary) that a specific brand is medically necessary for a particular beneficiary.
(1) The upper limit for payment for multiple source drugs for which a specific limit has been established does not apply if a physician certifies in his or her own handwriting (or by an electronic alternative means approved by the Secretary) that a specific brand is medically necessary for a particular beneficiary.
(2) The agency must decide what certification form and procedure are used.
(3) A check-off box on a form is not acceptable but a notation like ``brand necessary'' is allowable.
(4) The agency may allow providers to keep the certification forms if the forms will be available for inspection by the agency or HHS. [72 FR 39239, July 17, 2007, as amended at 75 FR 69597, Nov. 15, 2010] Sec. 447.514 [Reserved]