[Code of Federal Regulations]
[Title 12, Volume 1]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR447.331]

[Page 315]
 
                         TITLE 42--PUBLIC HEALTH
 
  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 
                 HEALTH AND HUMAN SERVICES--(Continued)
 
PART 447--PAYMENTS FOR SERVICES--Table of Contents
 
Subpart F--Payment Methods for Other Institutional and Noninstitutional 
                                Services
 
Sec. 447.331  Drugs: Aggregate upper limits of payment.

    (a) Multiple source drugs. Except for brand name drugs that are 
certified in accordance with paragraph (c) of this section, the agency 
payment for multiple source drugs must not exceed, the amount that would 
result from the application of the specific limits established in 
accordance with Sec. 447.332. If a specific limit has not been 
established under Sec. 447.332, then the rule for ``other drugs'' set 
forth in paragraph (b) applies.
    (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 
under Sec. 447.332 must not exceed in the aggregate, payment levels that 
the agency has determined by applying the lower of the--
    (1) Estimated acquisition costs 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 under Sec. 447.332 does not apply if a physician certifies 
in his or her own handwriting that a specific brand is medically 
necessary for a particular recipient.
    (2) The agency must decide what certification form and procedure are 
used.
    (3) A checkoff 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.

[52 FR 28657, July 31, 1987]