S.Amdt. 3167

SA 3167. Mr. TOOMEY (for himself, Mr. Casey, Mr. Crapo, and Mr. Carper) submitted an amendment intended to be proposed by him to the bill H.R. 3474, to amend the Internal Revenue Code of 1986 to allow employers to exempt employees with health coverage under TRICARE or the Veterans Administration from being taken into account for purposes of the employer mandate under the Patient Protection and Affordable Care Act; which was ordered to lie on the table; as follows:

At the appropriate place, insert the following:

TITLE __--OTHER PROVISIONS

SEC. _01. CLARIFICATION OF ORPHAN DRUG EXCEPTION TO ANNUAL FEE ON BRANDED PRESCRIPTION PHARMACEUTICAL MANUFACTURERS AND EMPLOYERS.

(a) In General.--Paragraph (3) of section 9008(e) of the Patient Protection and Affordable Care Act (Public Law 111-148) is amended to read as follows:

“(3) Exclusion of orphan drug sales.--

“(A) In general.--The term ‘branded prescription drug sales' shall not include sales of any drug or biological product--

“(i) with respect to which a credit was allowed for any taxable year under section 45C of the Internal Revenue Code of 1986; or

“(ii) which is approved or licensed by the Food and Drug Administration for marketing solely for 1 or more rare diseases or conditions.

“(B) Limitation.--Subparagraph (A) shall not apply with respect to any drug or biological product after the date on which the drug or biological product is approved or licensed by the Food and Drug Administration for marketing for any indication other than the treatment of a rare disease or condition.

“(C) Rare disease or condition.--For purposes of this paragraph, the term ‘rare disease or condition' has the meaning given such term under section 45C(d)(1) of the Internal Revenue Code of 1986, except that in the case of any drug or biological product that has not been designated under section 526 of the Federal Food, Drug, and Cosmetic Act for a particular indication, determinations under such section 45C(d)(1) shall be made on the basis of the facts and circumstances as of the date such drug or biological product is approved or licensed by the Food and Drug Administration for marketing for the treatment of such disease or condition.”.

(b) Effective Date.--The amendment made by this section shall apply to branded prescription drug sales after the date of the enactment of this Act.