S 3 ISRSCommentsClose CommentsPermalink

To amend part D of title XVIII of the Social Security Act to provide for fair prescription drug prices for Medicare beneficiaries.CommentsClose CommentsPermalink

January 4, 2007

Mr. REID (for himself, Mr. BAUCUS, Mr. LEAHY, Ms. MIKULSKI, Mr. SCHUMER, Mrs. CLINTON, Ms. CANTWELL, Mr. KOHL, Ms. STABENOW, Mr. WEBB, and Mrs. BOXER, Mr. BROWN, Ms. KLOBUCHAR, Mr. CASEY, and Mr. LEVIN) introduced the following bill; which was read twice and referred to the Committee on FinanceCommentsClose CommentsPermalink

To amend part D of title XVIII of the Social Security Act to provide for fair prescription drug prices for Medicare beneficiaries.CommentsClose CommentsPermalink

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

SECTION 1. SHORT TITLE; SENSE OF THE CONGRESS.

SEC. 2. REPEAL OF PROHIBITION.

(a) Short Title- This Repeal of Prohibition- CommentsClose CommentsPermalink





(1) IN GENERAL- Section 1860D-11(i) of the Social Security Act (42 U.S.C. 1395w-111(i)) is amended by striking `the Secretary--' and all that follows through `may not require' and inserting `the Secretary may not require'. CommentsClose CommentsPermalink





(2) RULE OF CONSTRUCTION- Nothing in the amendment made by paragraph (1) shall be cited as theonstrued as doing any of the following: CommentsClose CommentsPermalink





(A) Preventing the sponsor of a prescription drug plan or an MA organization offering an MA-PD plan under part D of title XVIII of the Social Security Act from obtaining a discount or reduction of the price for a covered part D drug. CommentsClose CommentsPermalink





(B) Affecting the authority of the Secretary of Health and Human Services to ensure appropriate and adequate access to covered part D drugs under prescription drug plans and under MA-PD plans under such part, including compliance of such plans with formulary requirements under section 1860D-4(b)(3) of the Social Security Act (42 U.S.C. 1395w-104(b)(3)). CommentsClose CommentsPermalink





(C) Limiting access by individuals enrolled in such prescription drug plans and MA-PD plans to community pharmacies. CommentsClose CommentsPermalink





(3) CONDUCT OF NEGOTIATIONS- Section 1860D-11 of the Social Security Act (42 U.S.C. 1395w-111) is amended by adding at the end the following new subsection: CommentsClose CommentsPermalink





`(k) Efforts to Promote and Ensure Access to Fair Prices- CommentsClose CommentsPermalink





`(1) USE OF AGENCY RESOURCES- To the extent that the Secretary promotes and ensures access to fair prices by engaging in any direct negotiations with a drug manufacturer with respect to prices for covered part D drugs, the Secretary-- CommentsClose CommentsPermalink





`(A) may only do so utilizing the resources of the Department of Health and Human Services; and CommentsClose CommentsPermalink





`(B) may not enter into a contract with any public or private entity or enter into an Interdepartmental Agreement for the purpose of conducting such negotiations.'. CommentsClose CommentsPermalink





(b) Accountability- Section 1860D-11(k) of the Social Security Act, as added by subsection (a)(3), is amended by adding at the end the following new paragraph: CommentsClose CommentsPermalink





`(2) ANNUAL REPORT ON EFFORTS TO PROMOTE AND ENSURE ACCESS TO FAIR PRICES- The Secretary shall submit to Congress an annual report on the efforts of the Secretary to promote and ensure access to fair prices for prescription drugs under this part.'. CommentsClose CommentsPermalink





(c) Effective Date- The amendments made by this section shall take effect on the date of enactment of this Act. CommentsClose CommentsPermalink

(a) Access of Congressional Support Agencies to Data on Prescription Drug Plans and Medicare Advantage Plans- Section 1860D-42 of the Social Security Act (42 U.S.C. 1395w-152) is amended by adding at the end the following new subsection: CommentsClose CommentsPermalink





`(c) Providing Part D Data to Congressional Support Agencies- CommentsClose CommentsPermalink





`(1) IN GENERAL- Notwithstanding any provision under this part that limits the use of prescription drug data collected under this part and subject to the restriction under paragraph (6), upon the request of a congressional support agency, the Secretary shall provide such agency with the following data collected from, or related to, prescription drug plans and MA-PD plans: CommentsClose CommentsPermalink





`(A) AGGREGATE NEGOTIATED PRICE CONCESSIONS- Aggregate negotiated price concessions described in section 1860D-2(d)(2) (as determined necessary and appropriate by the congressional support agency to carry out the legislatively mandated duties of the agency). CommentsClose CommentsPermalink





`(B) NEGOTIATED PRICE CONCESSIONS- The negotiated rebates, discounts, and other price concessions (as currently reported pursuant to section 1860D-2(d)(2)). CommentsClose CommentsPermalink





`(C) DRUG CLAIMS DATA- Data or a representative sample of data regarding drug claims submitted under section 1860D-15(c)(1)(C) (as determined necessary and appropriate by the congressional support agency to carry out the legislatively mandated duties of the agency). CommentsClose CommentsPermalink





`(D) REINSURANCE PAYMENTS- The amount of reinsurance payments paid under section 1860D-15(a)(2), provided at the plan level. CommentsClose CommentsPermalink





`(E) RISK-CORRIDOR PAYMENTS- The amount of any adjustments of payments made under subparagraph (B) or (C) of section 1860D-15(e)(2), provided at the plan level. CommentsClose CommentsPermalink





`(2) PROHIBITION ON DISCLOSURE OF DATA BY CONGRESSIONAL SUPPORT AGENCIES- CommentsClose CommentsPermalink





`(A) Data provided to a congressional support agency under this subsection shall not-- CommentsClose CommentsPermalink





`(i) be disclosed by such agency in the performance of the agency's duties in cases where such disclosure by the Secretary would be prohibited under applicable Federal law, or where such disclosure would result in the disclosure of trade secrets; and CommentsClose CommentsPermalink





`(ii) be disclosed, reported, or released by such agency in identifiable form. CommentsClose CommentsPermalink





`(B) IDENTIFIABLE FORM- For purposes of subparagraph (A)(ii), the term `identifiable form' means any representation of information described in subparagraphs (A) through (E) of paragraph (1) that permits identification of a specific prescription drug plan, MA-PD plan, pharmacy benefit manager, drug manufacturer, drug wholesaler, drug, or individual enrolled in a prescription drug plan or an MA-PD plan under this part. CommentsClose CommentsPermalink





`(3) SAFEGUARDING DATA- Each congressional support agency shall adopt and maintain reasonable safeguards to protect against the unauthorized disclosure of data provided under this subsection. Such safeguards shall only permit the congressional support agency to disclose the data to another agency or entity if the agency or entity is-- CommentsClose CommentsPermalink





`(A) under a subcontract with the congressional support agency to support any analysis conducted by the congressional support agency with respect to such data; and CommentsClose CommentsPermalink





`(B) is subject to the same data disclosure provisions and safeguards as the congressional support agency is subject to under this paragraph and paragraph (2). CommentsClose CommentsPermalink





`(4) DISCLOSURE EXEMPTION- Data provided under this subsection shall be exempt from disclosure undersection 552 of title 5, United States Code. CommentsClose CommentsPermalink





`(5) CONGRESSIONAL SUPPORT AGENCY DEFINED- In this subsection, the term `congressional support agency' means-- CommentsClose CommentsPermalink





`(A) the Medicare Payment Advisory Commission; CommentsClose CommentsPermalink





`(B) the Congressional Research Service; CommentsClose CommentsPermalink





`(C) the Congressional Budget Office; and CommentsClose CommentsPermalink





`(D) the Government Accountability Office. CommentsClose CommentsPermalink





`(6) RESTRICTION ON DISCLOSURE OF PRICE CONCESSIONS- The Secretary may only release data on the negotiated price concessions described in paragraph (1)(B) to the congressional support agency described in paragraph (5)(C). CommentsClose CommentsPermalink





`(7) RULE OF CONSTRUCTION- Nothing in this subsection shall be construed to limit the ability of a congressional support agency to obtain information not described in paragraph (1).'. CommentsClose CommentsPermalink





(b) Study on Market Competition and Reports on Limitations of Data Elements for Studying the Prescription Drug Program- CommentsClose CommentsPermalink





(1) STUDY AND REPORT ON MARKET COMPETITION BY THE CONGRESSIONAL BUDGET OFFICE- CommentsClose CommentsPermalink





(A) IN GENERAL- The Director of the Congressional Budget Office shall conduct a study on the effect of market competition on prices for drugs under part D of title XVIII of the Social Security Act (42 U.S.C. 1395w-101 et seq.) that includes a review of-- CommentsClose CommentsPermalink





(i) the number and extent of discounts and other price concessions received by prescription drug plans and MA-PD plans for covered part D drugs under such part; CommentsClose CommentsPermalink





(ii) the relationship between such discounts and price concessions and drug utilization; CommentsClose CommentsPermalink





(iii) the relationship between such discounts and price concessions and the manufacturer's best price (as defined in section 1927(c)(2)(B) of the Social Security Act (42 U.S.C. 1396r-8(c)(2)(B)) for covered outpatient drugs; and CommentsClose CommentsPermalink





(iv) the extent to which the efforts of the Secretary of Health and Human Services (as reported by the Secretary under section 1860D-11(k) of the Social Security Act, as added by section 2(b)) to promote and ensure access to fair prices for prescription drugs under such part have an effect upon payers in non-Medicare markets. CommentsClose CommentsPermalink





(B) REPORT- Not later than 1 year after the date of enactment of this Act, the Director of the Congressional Budget Office shall submit a report containing the results of the study conducted under subparagraph (A). CommentsClose CommentsPermalink





(2) REPORTS ON LIMITATIONS OF DATA ELEMENTS FOR STUDYING THE PRESCRIPTION DRUG PROGRAM- Not later than 180 days after the date of enactment of this Act, the Medicare Payment Advisory Commission and the Government Accountability Office shall each submit a report to Congress commenting on the limitations on the usefulness of the data described in subparagraphs (A) through (E) of section 1860D-42(c)(1), as added by subsection (a), to inform Congress on negotiated prices for covered part D drugs (as defined in section 1860D-2(e) of such Act (42 U.S.C. 1395w-102(e)) under the Medicare prescription drug program. CommentsClose CommentsPermalink





(c) Disclosure of Drug Claims Data to the State Agency Responsible for Administering the State Plan Under the Medicaid Program- Section 1860D-42 of the Social Security Act (42 U.S.C. 1395w-152), as amended by subsection (a), is amended by adding at the end the following new subsection: CommentsClose CommentsPermalink





`(d) Disclosure of Drug Claims Data to the State Agency Responsible for Administering the State Plan Under the Medicaid Program- Notwithstanding any provision under this part that limits the use of prescription drug data collected under this part, upon the request of a State agency with responsibility for administering the State plan under title XIX, the Secretary shall provide such State agency with the data described in paragraph (1)(C) of subsection (c) with respect to full-benefit dual eligible individuals (as defined in section 1935(c)(6)) who are enrolled in the State plan. The provisions of paragraphs (2) and (3) of subsection (c) shall apply to a State agency with respect to data provided under this subsection in the same manner as such provisions apply to a congressional support agency with respect to data provided under subsection (c).'. CommentsClose CommentsPermalink





(d) Public Disclosure of Data by the Secretary of Health and Human Services- Section 1860D-42 of the Social Security Act (42 U.S.C. 1395w-152), as amended by subsections (a) and (c), is amended by adding at the end the following new subsection: CommentsClose CommentsPermalink





`(e) Disclosure of Drug Prices Charged to Enrollees- CommentsClose CommentsPermalink





`(1) IN GENERAL- The Secretary shall make available to the public, upon request and in an electronic form determined appropriate by the Secretary, data on the prices charged for each covered part D drug under each prescription drug plan and MA-PD plan to individuals enrolled in the plan. Such data shall reflect actual prices posted on the Internet website of the Centers for Medicare & Medicaid Services and shall be made available in a manner that permits linkage of the data to data contained in other public prescription drug plan and MA-PD plan data files. CommentsClose CommentsPermalink





`(2) NOMINAL FEE FOR DATA PROVIDED- The Secretary may charge a nominal fee for data provided under paragraph (1) based on the cost of preparing and providing such data.'. CommentsClose CommentsPermalink





(e) Dissemination of Retail Drug Prices- Section 1860D-4(k) of the Social Security Act (42 U.S.C. 1395w-104(k)) is amended-- CommentsClose CommentsPermalink





(1) in the heading, by striking `Pharmaceutical Prices for Equivalent Drugs' and inserting `Prescription Drug Price Negotiation Act of 2007'Information at Point of Sale'; CommentsClose CommentsPermalink





(2) by striking `in general- A PDP sponsor' and inserting `pharmaceutical prices for equivalent drugs- CommentsClose CommentsPermalink





`(A) IN GENERAL- A PDP sponsor'; CommentsClose CommentsPermalink





(3) by redesignating paragraph (2) as subparagraph (B) and indenting appropriately; CommentsClose CommentsPermalink





(4) by redesignating subparagraphs (A) and (B) as clauses (i) and (ii), respectively, and indenting appropriately; CommentsClose CommentsPermalink





(5) in clause (i), as redesignated under paragraph (4)-- CommentsClose CommentsPermalink





(A) by striking `subparagraph (B)' and inserting `clause (ii)'; and CommentsClose CommentsPermalink





(B) by striking `paragraph (1)' and inserting `subparagraph (A)'; and CommentsClose CommentsPermalink





(6) by adding at the end the following new paragraph: CommentsClose CommentsPermalink





`(2) DRUG PRICES CHARGED TO ENROLLEES- CommentsClose CommentsPermalink





`(A) IN GENERAL- A PDP sponsor offering a prescription drug plan shall provide that each pharmacy that dispenses a covered part D drug shall inform an enrollee of the price charged for such drug under the prescription drug plan. CommentsClose CommentsPermalink





`(B) TIMING OF NOTICE- The information under subparagraph (A) shall be provided at the time of purchase of the drug involved, including for purchases of covered part D drugs by mail order.'. CommentsClose CommentsPermalink

(a) Findings- The Senate makes the following findings: CommentsClose CommentsPermalink





(1) Currently, beneficiaries enrolled in the Medicare part D prescription drug program must satisfy a resource standard in order to be eligible for the low-income subsidy. CommentsClose CommentsPermalink





(2) The resource standard used to determine eligibility for the low-income subsidy has resulted in many Medicare beneficiaries who are in financial need being disqualified from receiving additional assistance. CommentsClose CommentsPermalink





(3) Under S. 1 from the 108th Congress, as passed by the Senate, beneficiaries were not subjected to a resource standard to qualify for additional assistance. CommentsClose CommentsPermalink





(b) Sense of the Senate- It is the Sense of the Senate that Congress should revisit the resource standard used to determine the eligibility of individuals for premium and cost-sharing subsidies under section 1860D-14 of the Social Security Act (42 U.S.C. 1395w-114). CommentsClose CommentsPermalink

(a) Findings- CommentsClose CommentsPermalink





(1) Pharmacists play a critical role in delivering prescription drugs to Medicare beneficiaries enrolled in prescription drug plans and MA-PD plans under the Medicare part D prescription drug program. CommentsClose CommentsPermalink





(2) Pharmacists have encountered difficulties in providing services under their contracts with PDP sponsors offering prescription drug plans and MA organizations offering MA-PD plans under part D. CommentsClose CommentsPermalink





(b) Sense of the Senate- It is the sense of the Senate that Congress that the Congress should enact, and the President should sign, legislation taddress issues related to pharmacies under the Medicare part D prescription drug program. CommentsClose CommentsPermalink

To amend part D of title XVIII of the Social Security Act to provide for fair prescription drug prices for Medicare beneficiaries.CommentsClose CommentsPermalink