I 113th CONGRESS 2d Session H. R. 5808 IN THE HOUSE OF REPRESENTATIVES December 8, 2014 Ms. DeGette (for herself and Mr. Reed ) introduced the following bill; which was referred to the Committee on Energy and Commerce , and in addition to the Committee on Ways and Means , for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To amend title XVIII of the Social Security Act in order to strengthen rules applied in case of competition for diabetic testing strips, and for other purposes.

1. Short title This Act may be cited as the Protecting Access to Diabetes Supplies of 2014 . 2. Strengthening rules applied in case of competition for diabetic testing strips (a) Special rule applied in case of competition for diabetic testing strips (1) In general Paragraph (10) of section 1847(b) of the Social Security Act ( 42 U.S.C. 1395w–3(b) ) is amended— (A) in subparagraph (A), by striking the second sentence and inserting the following new sentence: The volume for such types of products shall be determined through the use of multiple sources of data that measure consumption and utilization of diabetic testing strips among individuals in the United States. ; and (B) by adding at the end the following new subparagraphs: (C) Demonstration of ability to furnish types of diabetic testing strips With respect to the program described in subparagraph (A), the Secretary shall reject a bid submitted by an entity if the entity does not, as part of the demonstration to the Secretary described in such subparagraph submitted by the entity, demonstrate that the entity has an ability to furnish the types of diabetic testing strips included in its bid, including an ability to obtain and maintain an inventory of such strips by volume in a manner consistent with its bid. (D) Use of unlisted types in calculation of percentage In determining under subparagraph (A) whether a bid submitted by an entity under such subparagraph covers 50 percent (or such higher percentage as the Secretary may specify) of all types of diabetic testing strip products, the Secretary may not attribute a percentage to types of diabetic testing strips that the Secretary does not provide the entity with the option to identify by type and market share volume. (E) Contract requirement Any contract entered into with an entity for diabetic testing strips under the competition conducted pursuant to paragraph (1) shall include a requirement that the entity offers, makes available to, and maintains in inventory of (or otherwise has ready access to, such as through purchasing contracts) each of the types of diabetic testing strip products that is included in the bid submitted by the entity. In the case that an entity enters into such a contract with the Secretary and fails to fulfill the requirement described in the preceding sentence, the Secretary shall terminate such contract. (F) Monitoring adherence to demonstration The Secretary shall establish a process to monitor, on an ongoing basis, the extent to which an entity that enters into a contract with the Secretary for diabetic testing strips under the competition conducted pursuant to paragraph (1) adheres to the demonstration that the entity provided to the Secretary under subparagraph (A). . (2) Conforming amendment Section 1847(b)(3)(A) of the Social Security Act ( 42 U.S.C. 1395w–3(b)(3)(A) ) is amended by adding at the end the following new sentence: In the case that such a contract is for diabetic testing strips, such contract shall include the information required under paragraph (10)(E). (b) Codifying and Expanding Anti-Switching Rule Section 1847(b) of the Social Security Act ( 42 U.S.C. 1395w–3(b) ), as amended by subsection (a)(1), is further amended— (1) by redesignating paragraph (11) as paragraph (12); and (2) by inserting after paragraph (10) the following new paragraph: (11) Additional special rule in case of competition for diabetic testing strips (A) In general With respect to diabetic testing strips furnished by an entity to an individual under the competitive acquisition program established under this section, the entity shall furnish to the individual the brand of such strips that is compatible with the home blood glucose monitor selected by the individual. (B) Prohibition on influencing and incentivizing An entity described in subparagraph (A) may not attempt to influence or incentivize the individual described in such subparagraph to switch the brand of glucose monitor or testing strips selected by the individual, including by— (i) persuading, pressuring, or advising the individual to switch such brand; or (ii) furnishing information about alternative brands to the individual in the case that the individual has not requested such information. (C) Provision of information An entity described in subparagraph (A) may not communicate directly to an individual described in such subparagraph until the entity has verbally provided the individual with standardized information, to be supplied to the entity by the Secretary, that describes the rights of the individual with respect to the entity. The information described in the preceding sentence shall include information regarding— (i) the requirements established in subparagraphs (A) and (B); (ii) the right of the individual to contact other mail order suppliers of diabetic testing strips or to purchase such strips at a retail pharmacy in the case that the entity is not able to furnish the brand of such strips that is compatible with the home blood glucose monitor selected by the individual; and (iii) the right of the individual described in subparagraph (D) to reject diabetic testing strips furnished to the individual by the entity. (D) Individuals allowed to switch from unwanted products (i) In general The Secretary shall establish a process under which an individual furnished with diabetic testing strips under the competitive acquisition program established under this section may reject the strips by notification, including notification by telephone or electronic mail, to the supplier and to the Secretary. (ii) Consequences of rejection In the case that an individual rejects diabetic testing strips under clause (i)— (I) any payment made to the supplier under this title for a portion of such strips furnished for use during the period beginning with the date on which the individual rejects the strips shall be recovered by the Secretary; and (II) the individual may obtain different diabetic testing strips from a supplier, and the Secretary shall process a claim for such different diabetic testing strips without regard to any benefit or coverage limitations arising from the fact that a claim has already been submitted and payment made for the rejected diabetic testing strips. (iii) Prohibition on future claims In the case that an individual rejects diabetic testing strips under clause (i), the supplier who supplied the rejected diabetic testing strips to the individual may not submit additional claims for payment on behalf of the individual for the type or brand of diabetic testing strips so rejected by the individual, unless the individual makes a separate expression of consent to the supplier to be furnished with such type or brand of diabetic testing strips by the supplier. . (c) Effective date The amendments made by this section shall apply with respect to diabetic testing strips furnished on or after July 1, 2016.