(a) Basis. This part implements section 1847A(i) of the Social Security Act (“the Act”).

(b) Scope. This part sets forth the requirements of the Medicare Part B Drug Inflation Rebate Program, which requires, for each calendar quarter, manufacturers to pay rebates for certain single source drugs and biological products with prices that increase faster than the rate of inflation.

(c) Severability. Were any provision of this part to be held invalid or unenforceable by its terms, or as applied to any person or circumstance, such provisions would be severable from this part and the invalidity or unenforceability would not affect the remainder thereof or any other part of this subchapter or the application of such provision to other persons not similarly situated or to other, dissimilar circumstances.