jiayi-li23/proxann_data huggingface dataset:
Topic: Health — Drug Coverage and Cost
Subject: Government operations and politics
Date: 2011-03-09 00:00:00

FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act - Prohibits the Office of Personnel Management (OPM) from entering a contract or approving a health benefits plan with a carrier that is a party to a pharmacy benefit manager (PBM) carrier arrangement to provide or administer prescription drug coverage under the Federal Employees Health Benefits Program (FEHBP) unless the PBM and the carrier comply with the requirements for PBM carrier arrangements set forth by this Act. Directs OPM to terminate a contract or discontinue a plan that fails to comply with such requirements. Prohibits: (1) a PBM under a carrier arrangement from being under common corporate control with a prescription drug manufacturer or a retail pharmacy, and (2) OPM from permitting a carrier under common corporate control with a PBM to earn a profit from such control. Sets forth terms and requirements for PBM carrier arrangements under the FEHBP, including: (1) drug substitution restrictions, (2) PBM reimbursement of carriers, (3) sale by a PBM of utilization and claims data, (4) drug pricing and the basis for reimbursement, (5) PBM provision to plan enrollees of an explanation of benefits statement regarding prescription drugs, (6) nondiscriminatory contracts regarding required participation, (7) OPM access to PBM contract information, and (8) civil monetary penalties for making false statements or claims to the government.
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2011-03-09 00:00:00

Voluntary State Discount Prescription Drug Plan Act of 2011 - Amends title XIX (Medicaid) of the Social Security Act to require drug manufacturers to pay rebates to state prescription drug discount programs as a condition of participating in a Medicaid rebate agreement for outpatient prescription drugs, but only if the state has elected to establish an optional state prescription drug discount program.
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2011-03-10 00:00:00

Medicare Prescription Drug Savings and Choice Act of 2011 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to provide for: (1) establishment of one or more Medicare operated prescription drug plan options; and (2) an appeals process for denials of benefits under a Medicare operated prescription drug plan.
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2011-03-11 00:00:00

Part D Off-Label Prescription Parity Act - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to permit a prescription drug plan (PDP) sponsor offering a PDP or a MedicareAdvantage (MA) organization offering an MA-PD plan to offer coverage of covered part D drugs for uses that are determined to be for medically accepted indications based upon: (1) guidance provided by the Secretary of Health and Human Services (HHS) for determining accepted uses of covered part D drugs; and (2) supportive clinical evidence in peer reviewed medical literature.
Topic: Health — Drug Coverage and Cost
Subject: Commerce
Date: 2011-04-06 00:00:00

Fairness to Pet Owners Act of 2011 - Requires the Federal Trade Commission (FTC) to promulgate rules relating to veterinary prescriptions, including rules requiring the prescriber of an animal drug to: (1)  provide the pet owner a copy of the veterinary prescription and a written disclosure that the pet owner may fill the prescription through the prescriber (if available) or through another pharmacy determined by the pet owner; and (2) provide or verify the prescription by electronic or other means consistent with applicable state law, if requested by any person designated to act on behalf of the pet owner. Prohibits the prescriber of an animal drug from setting conditions on providing a copy of the prescription or verifying such prescription by: (1) requiring the purchase of the drug from the prescriber or from another person; (2) requiring payment in addition to, or as part of, the fee for an examination and evaluation; or (3) requiring the pet owner to sign a waiver or disclaim liability of the prescriber for the accuracy of the veterinary prescription, or delivering to the pet owner a notice waiving or disclaiming such liability.   Permits the prescriber to require payment of fees for an examination and evaluation before providing a veterinary prescription, but only if the prescriber requires immediate payment in the case of an examination that reveals no requirement for an animal drug.
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2011-06-15 00:00:00

Medicare Drug Savings Act of 2011 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act (SSA) to require drug manufacturers to pay the Secretary of Health and Human Services (HHS) drug rebates for rebate eligible (low-income) individuals. Excludes from Medicare coverage as a part D drug any drug or biological manufactured by a manufacturer that has not entered into and have in effect a rebate agreement with the Secretary. Requires a rebate agreement to require a drug or biological manufacturer to provide to the Secretary a rebate, determined according to a specified formula, for each rebate period ending after December 31, 2011, for any covered Medicare part D drug dispensed after that date to any rebate eligible individual for which payment was made by a prescription drug plan (PDP) sponsor or MedicareAdvantage (MA) organization for such period. Specifies a formula for determination of Medicaid rebate amounts for such drugs or biologicals. Amends SSA title XIX (Medicaid) to exclude any amounts paid under a rebate agreement from the determination of best price and average manufacturer price under the Medicaid program.
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2011-06-21 00:00:00

Medicare Prescription Drug Price Negotiation Act of 2011 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services (HHS) to negotiate with pharmaceutical manufacturers the prices that may be charged to Medicare part D prescription drug plan (PDP) sponsors and MedicareAdvantage (MA) organizations for covered part D drugs for part D eligible individuals who are enrolled under a PDP or under an MA-Prescription Drug (MA-PD) plan.
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2011-06-22 00:00:00

America Rx Act of 2011 - Requires the Secretary of Health and Human Services (HHS) to establish the America Rx program to provide qualified residents with access to discounted prices for outpatient prescription drugs through rebate agreements that the Secretary negotiates with prescription drug manufacturers. Makes eligible only those residents that are not covered under any public or private program that provides substantial benefits towards the purchase of outpatient prescription drugs. Requires rebates to be payable to the Secretary at least quarterly and to be paid, directly or through states, to participating pharmacies that provide discounts to qualified residents. Denies manufacturers who do not participate in the rebate program a tax deduction for advertising and marketing expenses of drugs. Authorizes the Secretary to suspend or terminate the America Rx program if the Secretary determines that American Health Benefit Exchanges (health insurance exchanges) are operational, and the America Rx program is no longer needed to ensure that qualified residents have access to outpatient prescription drugs at affordable prices.
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2011-07-27 00:00:00

340B Program Improvement Act - Amends the Public Health Service Act to make revisions to the 340B drug discount program (a program limiting the cost of covered outpatient drugs to certain federal grantees). Includes drugs used in connection with an inpatient or outpatient service by enrolled hospitals as covered drugs under the program (currently, only outpatient drugs are covered under the program). Requires hospitals enrolled in the 340B program to provide to each state a credit on the estimated annual purchases by such hospitals of covered drugs provided to Medicaid recipients for inpatient use. Sets forth a formula for calculating the credit. Allows a hospital to avoid paying such credits under certain circumstances. Eliminates the requirement that hospitals enrolled in the 340B program report the National Drug Code numbers for drugs administered by a physician if the state is precluded from seeking a rebate on such drugs because they were purchased at a discount under the 340B program. Removes the exclusion that prohibited covered entities added to the 340B program under the Patient Protection and Affordable Care Act from purchasing drugs for a rare disease or condition as covered outpatient drugs. Treats a facility or organization that is eligible for the 340B program as satisfying any geographic location requirements in relation to a hospital or a critical access hospital for purposes of determining provider-based status under Medicare.
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2011-09-20 00:00:00

Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2011 - Amends title II (Old Age, Survivors and Disability Benefits) (OASDI) of the Social Security Act (SSA) to extend the months of coverage of immunosuppressive drugs for kidney transplant patients. Amends SSA title XVIII (Medicare) to make eligible for enrollment in Medicare part B (Supplementary Medical Insurance), solely for the purpose of such drug coverage, every individual whose insurance benefits under Medicare part A (Hospital Insurance) have ended by reason of a kidney transplant or the end of any requirement for a regular course of dialysis. Directs the Secretary of Health and Human Services (HHS) to determine a monthly premium rate for such individuals equal to 35% of the monthly actuarial rate for enrollees age 65 and over. Prescribes a formula for detemination of a government contribution to such a premium.
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2011-12-08 00:00:00

Part D Beneficiary Appeals Fairness Act - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act, with respect to a prescription drug plan (PDP) that provides for any tiered cost-sharing within a formulary (including a structure that provides for different co-payment or coinsurance amounts for drugs in different tiers included within the formulary), to authorize a Medicare part D eligible individual enrolled in the plan to request an exception to the tiered cost-sharing structure. States that in no case may the Secretary of Health and Human Services (HHS) allow a PDP sponsor to make any element of the tiered cost-sharing structure (including a tier used for very high cost or unique items) ineligible for lower-cost sharing through an exception.
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2012-03-19 00:00:00

Patients' Access to Treatments Act of 2012 - Amends the Public Health Service Act to prohibit a health plan offering group or individual health insurance that provides coverage for prescription drugs and uses a formulary or other tiered cost-sharing structure from imposing co-payment, coinsurance, or other cost-sharing requirements applicable to prescription drugs in a specialty drug tier that exceed the dollar amount of such requirements applicable to prescription drugs in a non-preferred brand drug tier. Provides that if a formulary used by such a health plan contains more than one non-preferred brand drug tier, such prohibition shall be applied with respect to the non-preferred brand drug tier for which beneficiary cost-sharing is lowest. Defines: (1) "non-preferred brand drug tier" as a category of drugs within a tier in such formulary for which beneficiary cost-sharing is greater than tiers for generic drugs or preferred brand drugs in the plan's formulary, that are prescription drugs, and that are not included within a specialty drug tier; and (2) "specialty drug tier" as a category of drugs within a tier in such formulary for which beneficiary cost-sharing is greater than tiers for generic drugs, preferred brand drugs, or non-preferred drugs in the plan's formulary and that are prescription drugs.
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2012-03-20 00:00:00

Medicare Pharmacy Transparency and Fair Auditing Act - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to require each contract entered into with a prescription drug plan (PDP) sponsor for the offering of a prescription drug plan to prohibit the PDP sponsor from contracting with any pharmacy benefits manager (PBM) to manage the prescription drug coverage under such plan, or to control the costs of such coverage, unless the manager satisfies specified PBM audit and disclosure requirements.
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2012-09-13 00:00:00

Negotiating for Seniors Act - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to repeal the prohibition against: (1) interference by the Secretary of Health and Human Services (HHS) with the negotiations between drug manufacturers and pharmacies and prescription drug plan sponsors, and (2) the Secretary's requiring a particular formulary or instituting a price structure for the reimbursement of covered Medicare part D drugs.
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2012-09-19 00:00:00

FDA User Fee Corrections Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food and Drug Administration Safety and Innovation Act (P.L. 112-144), to: (1) make clerical corrections to provisions of such Act; and (2) eliminate the restriction that appropriated funds shall be available only for payment of increases in the cost of reviewing medical device applications, including related personnel costs. Specifies due dates in FY2013 under FFDCA for the drug master file fee, the abbreviated new drug application and prior approval supplement filing fees, and the generic drug facility and active pharmaceutical ingredient facility fees.
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2011-01-25 00:00:00

Prescription Drug and Health Improvement Act of 2011 - Amends title XVIII (Medicare) of the Social Security Act (SSA) with respect to prescription drug plans to repeal the prohibition against: (1) interference by the Secretary of Health and Human Services (HHS) with negotiations between drug manufacturers and pharmacies and prescription drug plan sponsors, and (2) requiring a particular formulary or instituting a price structure for the reimbursement of covered part D (Voluntary Prescription Drug Benefit Program) drugs. Grants the Secretary authority similar to that of other federal entities that purchase prescription drugs in bulk to negotiate contracts with manufacturers of covered part D drugs.
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2011-01-25 00:00:00

Medicare Prescription Drug Price Negotiation Act of 2011 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services (HHS) to negotiate with pharmaceutical manufacturers the prices that may be charged to Medicare part D prescription drug plan (PDP) sponsors and MedicareAdvantage (MA) organizations for covered part D drugs for part D eligible individuals who are enrolled under a PDP or under an MA-Prescription Drug (MA-PD) plan.
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2011-04-05 00:00:00

Amends part B (Supplementary Medical Insurance) of title XVIII (Medicare) of the Social Security Act to exclude from the average sales price in calculating Medicare payments for drugs and biologicals any customary prompt pay discounts from manufacturers to wholesalers.
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2011-05-04 00:00:00

Stop Trafficking of Pills Act or STOP Act - Amends title XIX (Medicaid) of the Social Security Act (SSA) to require state Medicaid plans to: (1) identify prescription drugs that present a high-risk of misuse or overutilization, (2) establish a dosage level for each such drug that would be deemed excessive in the absence of evidence of medical necessity, (3) identify Medicaid-eligible individuals who are either receiving a prescription drug at excessive dosage levels or who have been convicted of a drug-related offense, and (4) ensure that they are assigned to a state-established restricted recipient program. Requires a state to establish a Medicaid Lock-in Program to ensure that a high-risk prescription drug user is assigned to: (1) a single and exclusive physician for purposes of receiving any medical assistance related to a prescription drug, and (2) a single and exclusive pharmacy to receive any physician-prescribed drug. Requires a state to establish a Medicaid prescription drug restriction program to ensure that the state claims processing system does not permit a prescription drug to be dispensed to a high-risk prescription drug user more than once every 20 days. Amends part D (Miscellaneous) of SSA title XXVIII (Medicare) to direct the Secretary of Health and Human Services (HHS) to establish a similar restricted recipient program for high-risk prescription drug users under the Medicare program.
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2011-05-26 00:00:00

Prize Fund for HIV/AIDS Act - Prohibits any person from having the right to exclusively manufacture, distribute, sell, or use in interstate commerce a qualifying treatment for HIV/AIDS or a manufacturing process for such a treatment, including the exclusive right to rely on health registration data or the 30-month stay-of-effectiveness period for Orange Book patents, notwithstanding provisions of U.S. patent law and other relevant statutes. Establishes remuneration in lieu of such market exclusivity. Makes the elimination of exclusive rights for a product that is a qualifying treatment for HIV/AIDS and that has a significant use for other diseases (dual use products) applicable only with respect to the marketing, distribution, sale, or use of a qualifying treatment for HIV/AIDS or a manufacturing process for such treatment that occurs on or after October 1, 2012. Establishes the Prize Fund for HIV/AIDS. Requires the Secretary of Health and Human Services (HHS) to designate a Prize Fund Director to administer the Fund. Directs the Prize Fund Director to award prize payments for medical innovation relating to a qualifying treatment for HIV/AIDS or a new manufacturing process for such a treatment to: (1) the first person to receive market clearance with respect to the drug or biological product; (2) the holder of the patent with respect to a manufacturing process; or (3) in the case of open source contributions, the persons or communities that openly shared knowledge, data, materials, and technology on a royalty-free and nondiscriminatory basis. Allows the Prize Fund Director to authorize multiple nonprofit intermediaries to manage Fund payments to reward projects for: (1) interim research and development of new qualifying treatments for HIV/AIDS, or (2) open source dividend prizes Sets forth transitional rules. Establishes an annual fee for health insurers to fund this Act. Establishes the Donor Innovation Prize Fund to enable the Secretary to reward owners and developers of products that permit open competition for products in developing countries.
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2011-07-13 00:00:00

Affordable Medicines Utilization Act of 2011 - Amends title XIX (Medicaid) of the Social Security Act, with respect to FY2012-FY2014, to require an increase in the quarterly Medicaid payment to a state by 50% of the generic drug utilization savings amount if the state's generic substitution rate for the most recent preceding fiscal year for which data is available is greater than its rate for the most recent second preceding fiscal year for which data is available. Directs the Secretary of Health and Human Services (HHS) to determine the state's generic substitution rate for such fiscal years. Defines "generic substitution rate" as the share of all drug units for which Medicaid payment is made to a state for the 20 most widely prescribed multiple source drugs under the state program that have a specific National Drug Code.
Topic: Health — Drug Coverage and Cost
Subject: Taxation
Date: 2011-07-14 00:00:00

Restoring Access to Medication Act - Repeals provisions of the Patient Protection and Affordable Care Act that limited payments for medications from health savings accounts, medical savings accounts, and health flexible spending arrangements to only prescription drugs or insulin. Rescinds appropriated but unobligated discretionary funds determined by the Director of the Office of Management and Budget (OMB) to be equal to the reduction in tax revenues resulting from the repeal in this Act. Requires the Director to report to the Secretary of the Treasury and Congress the accounts and amounts identified for rescission. Exempts unobligated funds of the Department of Veterans Affairs (VA) or the Social Security Administration (SSA).
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2011-07-29 00:00:00

Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2011 - Amends title II (Old Age, Survivors and Disability Benefits) (OASDI) of the Social Security Act (SSA) to extend the months of coverage of immunosuppressive drugs for kidney transplant patients. Amends SSA title XVIII (Medicare) to make eligible for enrollment in Medicare part B (Supplementary Medical Insurance), solely for the purpose of such drug coverage, every individual whose insurance benefits under Medicare part A (Hospital Insurance) have ended by reason of a kidney transplant or the end of any requirement for a regular course of dialysis. Directs the Secretary of Health and Human Services (HHS) to determine a monthly premium rate for such individuals equal to 35% of the monthly actuarial rate for enrollees age 65 and over. Prescribes a formula for detemination of a government contribution to such a premium.