HR 5142 IH

To amend title XVIII of the Social Secuirty Act to provide under contract with a Medicare carrier for an official website through which Medicare beneficiaries and others can obtain Internet access to safe and competitively priced domestic and international prescription drugs, and for other purposes.

September 7, 2000

Mr. STARK introduced the following bill; which was referred to the Committee on 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

To amend title XVIII of the Social Security Act to provide under contract with a Medicare carrier for an official website through which Medicare beneficiaries and others can obtain Internet access to safe and competitively priced domestic and international prescription drugs, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the `Medicare Prescription Drug Internet Access and Safe Importation Act of 2000'.

SEC. 2. PROMOTING ACCESS OF MEDICARE BENEFICIARIES TO SAFE AND COMPETITIVELY PRICED PRESCRIPTION DRUGS THROUGH THE INTERNET.

Section 1842 of the Social Security Act (42 U.S.C. 1395u) is amended by adding at the end the following new subsection:

`(u) CONTRACT TO PROVIDE OFFICIAL WEBSITE TO PROVIDE ACCESS TO SAFE AND COMPETITIVELY PRICED DOMESTIC AND INTERNATIONAL PRESCRIPTION DRUGS TO MEDICARE BENEFICIARIES THROUGH THE INTERNET-

`(1) CONTRACT-

`(A) IN GENERAL- The Secretary shall enter into a contract arrangement with a qualified carrier under which the carrier will provide for the operation of an Internet site through which medicare beneficiaries, physicians, and pharmacies serving medicare beneficiaries can identify one or more Internet pharmacies (which are qualified under paragraph (2)) through which such individuals and pharmacies may directly purchase safe and effective domestic and international prescription drugs.

`(B) QUALIFICATIONS FOR CARRIER OPERATING OFFICIAL WEBSITE- For purposes of paragraph (1), a qualified carrier is a carrier that demonstrates to the satisfaction of the Secretary the ability to operate the Internet site and to provide for appropriate screening and oversight of the qualified Internet pharmacies so as to ensure the delivery of safe products.

`(C) CONTRACT WITH ONLY 1 CARRIER- The Secretary shall enter into such a contract with only 1 carrier.

`(D) SEEKING MOST COMPETITIVE PRICE- In entering into a contract with a carrier under this subsection, the Secretary shall seek to obtain the greatest accessibility at the most competitive price available for prescription drugs for medicare beneficiaries, physicians, and pharmacies serving medicare beneficiaries. For this purpose, the carrier may limit the number of Internet pharmacies which are linked through the carrier's website under this subsection.

`(E) POSTING OF PRICES FOR COVERED DRUGS- The contractor shall agree to post in a clear and visible manner on the homepage for its Internet site, or on a page directly linked to the homepage (by a clear and visible link on the homepage), the five lowest prices for a particular prescription drug, including its therapeutic brand and generic equivalents, requested by the medicare beneficiary.

`(F) RECOVERY OF ADMINISTRATIVE COSTS- The carrier shall seek to recover the administrative costs of the contract under this subsection by assessing a reasonable fee (which may be based on such criteria as the contractor determines most efficient) on Internet pharmacies which use the carrier's website to post pharmaceutical products for sale of medicare beneficiaries, physicians, and pharmacies serving medicare beneficiaries. Such fees shall be adjusted from year to year as necessary to recover administrative costs over a multi-year period.

`(G) PRIVACY STANDARDS- The carrier shall not disclose any personal or medical information regarding a medicare beneficiary if the information is not utilized solely for the processing of claims, delivery of covered drugs, or is not vital to the immediate health or welfare of the medicare beneficiary.

`(2) QUALIFICATIONS FOR INTERNET PHARMACIES- For purposes of this subsection, the Secretary shall establish standards for qualification of Internet pharmacies which may participate in the carrier's website. In establishing such standards, the Secretary shall consider the recommendations of the National Association of Boards of Pharmacy and shall assure that each qualified Internet pharmacy--

`(A) is licensed in each State as a pharmacy;

`(B) is in compliance with applicable requirements of Federal and State law governing the practice of pharmacy;

`(C) agrees not to dispense a drug except upon a prescription of a practitioner licensed by law to administer the drug;

`(D) agrees to post in a clear and visible manner on the homepage for its Internet site, or on a page directly linked to the homepage (by a clear and visible link on the homepage), such information regarding the identity of the pharmacy and restrictions applicable to its dispensing of prescription drugs as the Secretary shall specify; and

`(E) meets such other requirements as the Secretary shall establish.'.

SEC. 3. INTERNET PHARMACIES FOR MEDICARE BENEFICIARIES.

(a) IN GENERAL- Chapter VIII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.) is amended--

(1) in section 801(d)(1), by striking `Except as provide in paragraph (2),' and inserting `Except as provided in paragraph (2) or section 801A,'; and

(2) by inserting after section 801 the following section:

`SEC. 801A. (a) PROMULGATION OF CRITERIA FOR INTERNET PHARMACIES ELIGIBLE TO PARTICIPATE WITH A MEDICARE CARRIER UNDER 1842(u) OF THE SOCIAL SECURITY ACT- The Secretary shall by regulation promulgate uniform criteria for the operation of Internet pharmacies pursuant to subsection (d)(1), including requirements regarding the manner in which such pharmacies serve medicare beneficiaries and physicians or pharmacies serving medicare beneficiaries. In establishing such criteria, the Secretary shall with respect to Internet pharmacies consider the recommendations of the National Association of Boards of Pharmacy. Such criteria shall provide that a waiver under subsection (c) will be provided to a medicare Internet pharmacy only if the following conditions are met:

`(1) The Internet pharmacy is licensed under a uniform name as a pharmacy among the States in each State.

`(2) The Internet pharmacy is in compliance with applicable requirements of Federal and State law governing the practice of pharmacy.

`(3) The Internet pharmacy agrees that it will dispense a drug as written for an individual only upon a prescription of a practitioner licensed by law to administer the drug.

`(4) The Internet site of the Internet pharmacy posts in a clear and visible manner on the homepage for the site, or on a page directly linked to

the homepage (by a clear and visible link on the homepage), the following information:

`(A) A statement that the Internet pharmacy will dispense prescription drugs only upon a valid prescription by a licensed practitioner.

`(B) The street address for the principal place of business for the Internet pharmacy.

`(C) The name of the chief pharmacist for the Internet pharmacy, the professional degree held by such pharmacist, and an identification of the pharmacy licenses held by the pharmacist.

`(D) A telephone number at which pharmacists of the Internet pharmacy may be reached.

`(5) The Internet pharmacy contracts that it will make available through the Internet site to physicians or pharmacies serving medicare beneficiaries the same covered drugs as are available to medicare beneficiaries through the site.

`(6) The Internet pharmacy shall not disclose any personal or medical information regarding a medicare beneficiary if the information is not utilized solely for the processing of claims, delivery of covered drugs, or is not vital to the immediate health or welfare of the medicare beneficiary.

`(7) Such other conditions as the Secretary may establish by regulation.

`(b) ENFORCEMENT-

`(1) SUSPENSION OR REVOCATION OF WAIVER- After notice and opportunity for a hearing, the Secretary may suspend or revoke the waiver of an Internet pharmacy under subsection (c) on any of the following grounds:

`(A) The Internet pharmacy ceases to comply with any condition described in subsection (a).

`(B) The Internet pharmacy has violated any provision of section 301.

`(C) The Internet pharmacy has violated a provision of the Controlled Substances Act, or has violated any State law regarding controlled substances.

`(D) The Internet pharmacy has violated a State law regarding the unauthorized operation of a pharmacy or the unauthorized practice of medicine.

`(E) The Internet pharmacy has engaged in such other conduct as, with respect to financial misconduct as well as the safety or effectiveness of drugs, justifies the suspension or revocation in the interest of protecting medicare beneficiaries from the Internet pharmacy.

`(2) CRIMINAL PENALTY FOR SUBSEQUENT IMPORTATIONS- If the waiver of an Internet pharmacy under subsection (c) is suspended or revoked by the Secretary under paragraph (1), any importation by the Internet pharmacy of a covered drug into the United States after the suspension or revocation takes effect shall be considered to be a violation of the provisions of section 301(t) that relate to section 801(d).

`(3) FEE TO FUND THE SECRETARY'S ENFORCEMENT OF THIS ACT- The Secretary shall collect a reasonable fee necessary to carry out the enforcement of this act.

`(c) WAIVER OF RESTRICTION ON REENTRY OF EXPORTED DRUGS-

`(1) IN GENERAL- If the Secretary determines that an Internet pharmacy meets the requirements described in paragraphs (1) and (2) of subsection (d), the Secretary shall establish a waiver providing that, notwithstanding section 801(b)(1), the Internet pharmacy may import into the United States any covered drug.

`(2) COVERED DRUGS- For purposes of this section, the term `covered drug' means a drug that--

`(A) is a drug for which an application has been approved pursuant to section 505 or pursuant to section 351 of the Public Health Service Act; and

`(B)(i) is a prescription drug; or

`(ii) is a drug composed wholly or partly of insulin.

`(3) RULE OF CONSTRUCTION REGARDING SAFETY AND EFFECTIVENESS, ADULTERATION AND MISBRANDING, AND OTHER REQUIREMENTS- A waiver of section 801(d)(1) under paragraph (1) may not be construed as waiving any other provision of Federal law regarding the drugs involved.

`(d) Requirements for Waiver-

`(1) INTERNET PHARMACY QUALIFIED UNDER 1842(u) OF THE SOCIAL SECURITY ACT- For purposes of subsection (c)(1), the requirement described in this paragraph is that the Internet pharmacy involved operate, in accordance with criteria under subsection (a), an Internet site through which medicare beneficiaries, physicians, and pharmacies serving medicare beneficiaries can purchase covered drugs.

`(2) INFORMATION REGARDING IMPORTATION--For purposes of subsection (c)(1), the requirement described in this paragraph is that the Internet pharmacy involved provide to the Secretary such information as the Secretary may require for purposes of determining whether the requirements of this Act have been met with respect to the covered drug being imported.

`(e) DEFINITIONS- For purposes of this section:

`(1) The term `covered drug' has the meaning given such term in subsection (c)(2).

`(2) The term `generic drug' means a drug approved under section 505(j) of the Federal Food, Drug, and Cosmetic Act.

`(3) The term `Internet' means collectively the myriad of computer and telecommunications facilities, including equipment and operating software, which comprise the interconnected world-wide network of networks that employ the Transmission Control Protocol/Internet Protocol, or any predecessor or successor protocols to such protocol, to communicate information of all kinds by wire or radio.

`(4) The term `Internet pharmacy' means an Internet site through which a medicare beneficiary or a physician or pharmacy serving medicare beneficiaries can purchase a drug, whether the purchase is a sale for resale or sale at retail.

`(5) The term `Internet site' means a site on the telecommunications medium known as the World Wide Web of the Internet.

`(6) The term `Medicare beneficiary' means an individual entitled to benefits under part A of title XVIII of the Social Security Act, or enrolled under part B of such title, or both.

`(7) The term `prescription drug' means a drug that is subject to section 503(b).'.

(b) EFFECTIVE DATE- This act shall take effect six months after the date of enactment.

END