I 111th CONGRESS 2d Session H. R. 5888 IN THE HOUSE OF REPRESENTATIVES July 27, 2010 Mr. Michaud (for himself, Ms. Pingree of Maine, and Mr. Grijalva) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To establish an America Rx program to establish fairer pricing for prescription drugs for individuals without access to prescription drugs at discounted prices.

1.

Short title; purpose

(a)

Short title

This Act may be cited as the America Rx Act of 2010. (b)

Purpose

The purpose of this Act is to establish an America Rx program that utilizes manufacturer rebates and pharmacy discounts to reduce prescription drug prices to those residents who are without access to discounted prices for outpatient prescription drugs.

2.

America Rx program

(a)

Establishment

(1)

In general

Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall establish a program (in this section referred to as the America Rx program) consistent with the provisions of this section to provide qualified residents with access to discounted prices for outpatient prescription drugs through rebate agreements that the Secretary has negotiated with prescription drug manufacturers. (2)

Outreach

The Secretary shall provide for— (A)outreach efforts to build public awareness of the program and maximize enrollment of qualified residents; and (B)simplified eligibility procedures and uniform eligibility standards for qualified residents. (b)

Rebate agreements with manufacturers

(1)

In general

Under the America Rx program the Secretary shall negotiate with manufacturers of outpatient prescription drugs rebate agreements with respect to drugs offered under the program to qualified residents. (2)

Minimum amount of rebates

In negotiating the amount of such a rebate under paragraph (1), the Secretary shall take into consideration the amount of the rebate calculated under the Medicaid program, the average manufacturer price of prescription drugs, and other information on prescription drug prices and price discounts. The Secretary shall negotiate the amount of such rebates in a manner so that the rebates on average are comparable to the average percentage rebate obtained in outpatient prescription drugs provided under section 1927(c) of the Social Security Act (42 U.S.C. 1396r–8(c)). (3)

Discounted prices

The Secretary shall specify the method for computing and applying such discounts, including a method for computing and applying discounts on a uniform, average percentage basis. (4)

Payment

Rebates under such agreements shall be payable to the Secretary according to a schedule (not less often than quarterly) negotiated with manufacturers and shall be paid, directly or through States, to participating pharmacies that provide discounts to qualified residents. (5)

Incentive

In order to induce manufacturers of outpatient prescription drugs to enter into such rebate agreements to carry out the purpose described in section 1(b), the Secretary shall provide, in the case of a manufacturer that has not entered into such an agreement, for a denial of a deduction under chapter 1 of the Internal Revenue Code of 1986 for the amount of expenses of the manufacturer for advertising and marketing of drugs of the manufacturer, other than expenses for free samples of drugs subject to section 503(b)(1) of the Federal Food Drug, and Cosmetic Act intended to be distributed to patients. (6)

Application of rebates

Amounts received by the Secretary as rebates under this subsection shall be placed into an appropriate account in the Treasury and shall be available in advance of appropriations to the Secretary for the payment of discounts and other costs of participating pharmacies in carrying out the America Rx program and for the payment of administrative costs in carrying out the program. Under the America Rx program, participating pharmacies shall be ensured reasonable and timely payment of discounts they provide to qualified residents under the program. (c)

Role of States in administering program

(1)

In general

Under the America Rx program the Secretary may enter into appropriate arrangements with States under which States provide for the administration of the program in return for payment of the reasonable administrative expenses associated with such administration. (2)

Administrative functions

Such administration functions may include— (A)determinations of eligibility of qualified residents; (B)arrangements with participating pharmacies; and (C)such other functions as the Secretary determines appropriate. (3)

Contractual authority

In carrying out responsibilities under this section, the Secretary and States may enter into agreements with pharmacy benefit managers and other third parties. (d)

Program eligibility

(1)

Qualified resident defined

For purposes of this section, the term qualified resident means an individual who— (A)is a citizen or national of the United States or is lawfully present in the United States (as determined in accordance with section 1411 of the Patient Protection and Affordable Care Act); and (B)as determined under regulations of the Secretary, is not covered under any public or private program that provides substantial benefits (which may be discounted prices) towards the purchase of outpatient prescription drugs. (2)

Screening

(A)

For other governmental programs

Individuals who apply for benefits under the America Rx program shall be screened for eligibility under the Medicaid program and other applicable Governmental health care programs and, if found eligible, shall be enrolled in such program or programs. (B)

Screening by Health Insurance Exchanges

In the case of individuals enrolling in a qualified health plan through a Health Insurance Exchange under title I of the Patient Protection and Affordable Care Act, the Exchange shall provide (at the time of enrollment) for a screening of the individual to determine if the individual is a qualified resident for purposes of the America Rx program. (3)

Relation to other coverage

In order not to discourage employers and health insurance issuers from providing comprehensive prescription drug coverage through a group health plan or health insurance coverage, no such employer or issuer may participate in a Health Insurance Exchange if the Secretary determines that the prescription drug benefits under the plan or coverage have been reduced as a result of the America Rx program. (4)

Protection of the low income

Nothing in this section shall be construed as reducing the prescription drug benefits available to low-income individuals, as well as senior citizens and the disabled, under the Medicare or Medicaid programs as a result of the implementation of the America Rx program. (e)

Arrangements with participating pharmacies

(1)

In general

Under the America Rx program arrangements are made with pharmacies for the provision of prescription drugs at discounted prices to qualified residents in a reasonably accessible manner. Such arrangements shall provide that— (A)each participating pharmacy shall— (i)provide discounts on prices for outpatient prescription drugs for qualified residents in return for prompt reimbursement of the amount of such discounts and a reasonable dispensing fee; (ii)not charge qualified residents more (before such discounts) for outpatient prescription drugs than the amount that individuals who are not qualified residents are charged for such drugs; and (iii)report to the Secretary (or the Secretary’s designee) information regarding the discounts provided and fees incurred; and (B)the program shall— (i)ensure the reasonable and timely payment to a participating retail pharmacy on a prompt basis (no less promptly than as provided under the Medicare program) for discounted prices provided to qualified residents under the program and for reasonable dispensing fees; and (ii)not impose any additional fees on such pharmacies in connection with participation in the program. (2)

Discounted prices

The amount of the discount provided to enrolled qualifying residents shall reflect the amount of rebates obtained, reduced by expenses relating to administrative costs of the Federal and State governments and of participating pharmacies. (f)

Definitions

For purposes of this section: (1)The term Health Insurance Exchange means such an Exchange as established and operated under part 3 of subtitle D of title I of the Patient Protection and Affordable Care Act. (2)The term manufacturer has the meaning given such term in section 1927(k)(5) of the Social Security Act (42 U.S.C. 1396r–8(k)(5)). (3)The term Medicaid program means a State program under title XIX of the Social Security Act, including such a program operating under a Statewide waiver under section 1115 of such Act. (4)The term outpatient prescription drug has the meaning given the term covered outpatient drug in section 1927(k)(2) of the Social Security Act (42 U.S.C. 1396r–8(k)(2)). (5)The term Secretary means the Secretary of Health and Human Services. (6)The term State has the meaning given such term for purposes of title XIX of the Social Security Act.