Medicare Prescription Drug Internet Access and Safe Importation Act of 2000

Summary: Amends the Federal Food, Drug, and Cosmetic Act to provide for the promulgation of criteria for Internet pharmacies eligible to participate with a Medicare carrier in accordance with this Act.

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.