[Code of Federal Regulations]

[Title 42, Volume 4]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR447.331]



[Page 329]

 

                         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]