II 109th CONGRESS 1st Session S. 778 IN THE SENATE OF THE UNITED STATES April 13, 2005 Mrs. Boxer (for herself and Mr. Lautenberg) introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To amend titles XVIII and XIX of the Social Security Act to require a pharmacy that receives payments or has contracts under the medicare and medicaid programs to ensure that all valid prescriptions are filled without unnecessary delay or interference.

1.

Short title

This Act may be cited as the Pharmacy Consumer Protection Act of 2005 .

2.

Medicare pharmacy requirements

(a)

In general

Title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) is amended by adding at the end the following new section:

1898.

Pharmacy requirements

(a)

Requirements

No payment (as defined in subsection (b)(1)) may be made to a pharmacy unless the pharmacy complies with the following requirements: (1)

Valid prescriptions filled

The pharmacy ensures that each valid prescription is filled without unnecessary delay or other interference, consistent with the normal timeframe for filling prescriptions. (2)

Prescribed item not in stock

The pharmacy ensures that, if the prescribed item is not in the pharmacy's stock, the pharmacy will order such item without unnecessary delay or, if the patient prefers, the pharmacy will transfer the prescription to a local pharmacy of the patient's choice or return the prescription to the patient, at the patient's request. (b)

Definitions

For purposes of this section: (1)

Payment

For purposes of this section the term payment means either of the following: (A) Direct payment to a pharmacy. (B) Payment to a pharmacy through a contract with a PDP sponsor offering a prescription drug plan, an MA organization offering an MA–PD plan, or a fallback prescription drug plan. (2)

Prescribed item

The term prescribed item means a drug or device approved by the Food and Drug Administration under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), or a biological product licensed under section 351 of the Public Health Services Act (42 U.S.C. 238 et seq.). (3)

Valid prescription

The term valid prescription means a prescription issued by a licensed health care provider for a prescribed item (as defined in paragraph (2)). (c)

Rule of construction

Nothing in this section shall prohibit a pharmacy from refusing to dispense a prescribed item, in accordance with standard pharmacy practice, if there is a valid medical concern that such prescribed item will cause problems due to therapeutic duplications, drug-disease contraindications, drug interactions (including serious interactions with prescription or over-the-counter medications), incorrect dosage or duration of drug treatment, drug-allergy interactions, or drug abuse or misuse. Any refusal to dispense a prescribed item must be based on generally accepted practice among health care providers.

. (b)

Conforming amendment

Section 1860D–4(b)(1)(A) of the Social Security Act (42 U.S.C. 1395w–104(b)(1)(A)) is amended by adding , such terms and conditions shall require that the pharmacy complies with the requirements of section 1898 before the period at the end.

3.

Medicaid pharmacy requirements

Section 1902(a)(23) of the Social Security Act (42 U.S.C. 1396a(a)(23)) is amended— (1) by striking and (B) and inserting (B); and (2) by inserting the following before the semicolon at the end: , and (C) any pharmacy that provides services to any individual eligible for medical assistance shall comply with the requirements of section 1898.

4.

Effective Date

The amendments made by this act shall apply to prescriptions issued or filled on or after January 1, 2006.