zli12321/Bills huggingface dataset:
Steps Toward Access and Reform Act of 2009 or the STAR Act of 2009 - Sets conditions for lawsuits arising from health care liability claims regarding health care goods or services or any medical product affecting interstate commerce. Sets a statute of limitations of three years after the date of manifestation of injury or one year after the claimant discovers the injury, with certain exceptions. Provides that nothing in this Act limits recovery of the full amount of available economic damages. Limits noneconomic damages to $250,000. Makes each party liable only for the amount of damages directly proportional to such party's percentage of responsibility. Allows the court to restrict the payment of attorney contingency fees. Limits the fees to a decreasing percentage based on the increasing value of the amount awarded. Allows the introduction of collateral source benefits and the amount paid to secure such benefits as evidence. Prohibits a provider of such benefits from recovering any amount from an award in a health care lawsuit involving injury or wrongful death. Authorizes the award of punitive damages only where: (1) it is proven by clear and convincing evidence that a person acted with malicious intent to injure the claimant or deliberately failed to avoid unnecessary injury the claimant was substantially certain to suffer; and (2) compensatory damages are awarded. Limits punitive damages to the greater of two times the amount of economic damages or $250,000. Denies punitive damages in the case of products approved, cleared, or licensed by the Food and Drug Administration (FDA) or otherwise considered in compliance with FDA standards. Provides for periodic payments of future damages. Directs the Secretary of Health and Human Services (HHS) to carry out a program of loan forgiveness for primary health care providers who agree to provide medical services in medically underserved communities for a period of not less than four years. Amends the Internal Revenue Code to allow: (1) providers of medical care a bad debt tax deduction for up to 75% of their cost in providing uncompensated medical care to low-income individuals; and (2) a refund of excise tax on fuel used in mobile mammography vehicles; and (3) a tax deduction for the travel expenses of veterans and a family member to a medical center of the Department of Veterans Affairs. Amends the Bipartisan Trade Promotion Authority Act of 2002 to include among the overall trade negotiating objectives of the United States avoiding negotiating trade agreements that could restrict, or be interpreted to restrict, the access of consumers in the United States to certain pharmaceutical imports. Amends title XVIII (Medicare) of the Social Security Act to authorize payment after January 1, 2010, for chest radiology services that use computer-aided detection technology for the early detection of lung cancer.

Date: 2009-07-31
Topic: Health (Drug Coverage and Cost)
Subject: Health
Patient Health and Real Medication Access Cost Savings Act of 2009 or the PHARMACY Bill - Declares that a consumer shall have the right to choose to purchase prescription drugs from any domestic pharmacy that meets all applicable federal and state license and permit requirements. Directs the Secretary of Health and Human Services (HHS) to issue regulations that: (1) prohibit a pharmacy benefit manager (PBM) from providing incentives to, encouraging, or requiring pharmacy benefit plan enrollees to use certain pharmacies or from excluding an eligible pharmacy from a plan's pharmacy network; (2) require a PBM to ensure that pharmacy benefit plan enrollees pay a specified copayment for brand name drugs; (3) require a PBM to reimburse a pharmacy in the network of a pharmacy benefit plan that is federally funded, at specified rates, for brand-name drugs, generic drugs, and additional professional services; (4) require a PBM to be reimbursed by a pharmacy benefit plan sponsor for adjudicating and processing claims; (5) limit the amount that a PBM charges a pharmacy benefit plan sponsor for a drug that is dispensed to enrollees to the amount the PBM paid the pharmacy for such drug; (6) require a manufacturer of prescription drugs to pay all rebates directly to the pharmacy benefit plan sponsor and not to a PBM; and (7) require a pharmacy benefit plan sponsor to provide a list of the wholesale acquisition costs of the top 500 most frequently prescribed drugs to physicians in a plan any insurance-related charge of which is underwritten by a federal, state, or local government. Amends title XVIII (Medicare) of the Social Security Act to include pharmacist services as "medical and other health services" under Medicare. Directs the Secretary, by January 1, 2011, to establish a pharmaceutical access program to provide affordable prescription drugs to individuals who receive drug benefits under federal programs (except Medicaid). Requires: (1) a pharmacy that dispenses prescription drugs in the United States to remit to the Secretary 50 cents for each brand name prescription and $1.00 for generic drug prescription dispensed; and (2) the sponsor of a pharmacy benefit plan that is not federally funded to increase the professional dispensing fee paid to pharmacies by the same amounts. Requires the use of funds generated from such fees to provide affordable access to prescription drugs to low-income individuals who have enrolled in the program.

Date: 2009-12-03
Topic: Health (Drug Coverage and Cost)
Subject: Health
Medicare Prescription Drug Price Negotiation Act of 2010 - 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.

Date: 2010-03-03
Topic: Health (Drug Coverage and Cost)
Subject: Health
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.

Date: 2010-07-14
Topic: Health (Drug Coverage and Cost)
Subject: Health
Amends the Public Health Service Act to consider certain drugs designated for a rare disease or condition as covered outpatient drugs for children's hospitals under the 340B drug discount program (a program limiting the cost of covered outpatient drugs to certain federal grantees).

Date: 2010-09-28
Topic: Health (Drug Coverage and Cost)
Subject: Health
Medicare Prescription Drug Gap Reduction Act of 2009 - Amends title XVIII (Medicare) of the Social Security Act (SSA) to reduce the coverage gap in prescription drug coverage under SSA part D (Voluntary Prescription Drug Benefit Program), based on savings to the Medicare program resulting from the negotiation of prescription drug prices. Grants the Secretary of Health and Human Services authority similar to that of other federal entities that purchase prescription drugs in bulk to negotiate contracts with manufacturers of covered part D drugs. States that the Secretary shall be required to: (1) negotiate contracts with manufacturers of covered part D drugs for each fallback prescription drug plan; and (2) participate in negotiation of contracts of any covered part D drug upon request of an approved prescription drug plan or Medicare Advantage Prescription Drug Plan. Prohibits the Secretary from requiring a particular formulary or instituting a price structure for the reimbursement of covered part D drugs in order to carry out, and promote competition, under part D.

Date: 2009-01-15
Topic: Health (Drug Coverage and Cost)
Subject: Health
Medicare Prescription Drug Savings and Choice Act of 2009 - 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.

Date: 2009-01-27
Topic: Health (Drug Coverage and Cost)
Subject: Health
Access to Durable Medical Equipment Act - Amends part B (Supplementary Medical Insurance) of title XVIII (Medicare) of the Social Security Act, as amended by the Medicare Improvements for Patients and Providers Act of 2008, with respect to Medicare quality standards for suppliers of items and services which shall be applied by recognized independent accreditation organizations. Applies to pharmacies and pharmacists the eligible professional exemption from such accreditation requirements, unless such standards are designed specifically for application to pharmacies and pharmacists. Authorizes the Secretary of Health and Human Services to exempt pharmacies and pharmacists from such standards if licensing, accreditation, or other mandatory quality requirements apply to them with respect to the furnishing of items and services.

Date: 2009-03-03
Topic: Health (Drug Coverage and Cost)
Subject: Health
Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 - Amends SSA title II (Old Age, Survivors and Disability Insurance) (OASDI) to: (1) continue entitlement to prescription drugs used in immunosuppressive therapy furnished to an individual who receives a kidney transplant for which payment is made under Medicare; and (2) extend Medicare secondary payer requirements for end stage renal disease (ESRD) beneficiaries. Amends title XVIII (Medicare ) of SSA to apply special rules to kidney transplant recipients receiving additional coverage for immunosuppressive drugs. Deems such individual to be enrolled under Medicare part B and makes the individual responsible for the full amount of the applicable premiums. Applies deductible and coinsurance requirements to the provision of such drugs. Amends the Public Health Service Act, the Employee Retirement Income Security Act of 1974 (ERISA), and the Internal Revenue Code to set forth requirements for group health plans to provide coverage of immunosuppressive drugs for kidney transplant patients.

Date: 2009-03-10
Topic: Health (Drug Coverage and Cost)
Subject: Health
Reforming an Entitlement through Premium Adjustments based on Income Resources (REPAIR) Act of 2009 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to require an income-related reduction in the part D premium subsidy. Declares that, in the case of an individual whose modified adjusted gross income exceeds a certain applicable threshold amount for a month after December 2009, the monthly amount of the part D premium subsidy shall be reduced (and the monthly beneficiary premium shall be increased) by the monthly adjustment amount determined according to a specified formula.

Date: 2009-03-24
Topic: Health (Drug Coverage and Cost)
Subject: Health
Amends title XVIII (Medicare) of the Social Security Act with respect to the use of average sales price methodology for calculating payments for drugs and biologicals under Medicare part B (Supplementary Medical Insurance). Excludes from the manufacturer's average sales price when calculating such payments any customary prompt pay discounts extended to wholesalers.

Date: 2009-06-09
Topic: Health (Drug Coverage and Cost)
Subject: Health
340B Program Improvement and Integrity Act of 2009 - Amends the Public Health Service Act to expand the drug discount program to allow participation as a covered entity by certain: (1) children's hospitals; (2) critical access hospitals; and (3) rural referral centers. Expands the program to include drugs used in connection with an inpatient or outpatient service by enrolled hospitals (currently, only outpatient drugs are covered under the program). Prohibits enrolled hospitals from obtaining covered outpatient drugs through a group purchasing arrangement. Requires the Secretary of Health and Human Services (HHS) to establish reasonable exceptions to such prohibition, including for drugs unavailable through the program and to facilitate generic substitution when a generic covered drug is available at a lower price. Requires a hospital enrolled in the 340B drug discount program to issue a credit to a state Medicaid program for inpatient drugs provided to Medicaid recipients. Requires the Secretary to: (1) provide for improvements in compliance by manufacturers and covered entities with the requirements of the drug discount program; and (2) establish and implement an administrative process for resolving claims by covered entities and manufacturers of violations of such requirements. Requires manufacturers to offer each covered entity covered drugs for purchase at or below the applicable ceiling price if such a drug is made available to any other purchaser at any price.

Date: 2009-06-11
Topic: Health (Drug Coverage and Cost)
Subject: Health
Medicare Safe Needle Disposal Coverage Act of 2009 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to cover as a part D drug any devices approved for home use by the Food and Drug Administration (FDA) for the safe and effective containment, removal, decontamination, and disposal of home-generated needles, syringes, and other sharps through a sharps container, decontamination/destructive device, or sharps-by-mail program or similar program.

Date: 2009-06-19
Topic: Health (Drug Coverage and Cost)
Subject: Health
Addressing Cost Containment Measures To Ensure the Sustainability and Success of ADAP Act or the ACCESS ADAP Act - Transfers funds from discretionary amounts appropriated under the American Recovery and Reinvestment Act that remain unobligated to the Secretary of Health and Human Services (HHS) to be used in FY2010 to provide assistance in reducing AIDS Drug Assistance Program waiting lists and to address other cost containment measures that state AIDS Drug Assistance Programs implement after January 1, 2009. Requires amounts transferred under this Act to be used by states in a manner consistent with their state programs. Requires the Secretary, in allocating such funds, to: (1) give special consideration to the total scope and the basis of a state's needs, including the total number of patients on a waiting list, eligibility requirements, and other cost containment measures; and (2) ensure that funds be used only to provide treatments to individuals who were eligible to participate in the state program on the date of enactment of this Act.

Date: 2010-05-24
Topic: Health (Drug Coverage and Cost)
Subject: Health
Medicare Prescription Drug Price Negotiation Act of 2010 - 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.

Date: 2010-05-25
Topic: Health (Drug Coverage and Cost)
Subject: Health
Addressing Cost Containment Measures To Ensure the Sustainability and Success of ADAP Act or the ACCESS ADAP Act - Requires specified funds to be transferred to the Secretary of Health and Human Services (HHS) from discretionary amounts appropriated under the American Recovery and Reinvestment Act that remain unobligated, to be obligated during the FY2010 grant period under the AIDS Drug Assistance Program to provide assistance in reducing waiting lists and to address other cost containment measures that state AIDS Drug Assistance Programs implement after January 1, 2009. Requires amounts transferred under this Act to be used by states in a manner consistent with their state programs. Requires the Secretary, in allocating such funds, to: (1) give special consideration to the total scope and the basis of a state's needs, including the total number of patients on a waiting list, eligibility requirements, and other cost containment measures; and (2) ensure that funds be used only to provide treatments to individuals who were eligible to participate in the state program on the date of enactment of this Act or who would have been eligible to participate in the state program  but were not so eligible because of the implementation of cost-containment measures after January 1, 2009.

Date: 2010-12-03
Topic: Health (Drug Coverage and Cost)
Subject: Health
Medicare Enhancements for Needed Drugs Act of 2010 - Directs the Comptroller General to review and report to Congress on the retail cost of prescription drugs in the United States during 2004 through 2010, with an emphasis on the prescription drugs most utilized for individuals age 65 or older. Requires the Comptroller General to conduct an ongoing study that compares the average retail cost in the United States for each of the 20 most utilized prescription drugs for individuals age 65 or older with: (1) the average prices at which private health plans, the Department of Defense (DOD) under the Defense Health Program, and the Department of Veterans Affairs (VA) acquire each such drug; and (2) the average negotiated price for each such drug that eligible beneficiaries have access to under a Medicare prescription drug plan providing only basic prescription drug coverage. Amends title XVIII (Medicare) of the Social Security Act (SSA) to include in the comparative plan information for beneficiaries under Medicare part D (Voluntary Prescription Drug Benefit Program) a comparison of average aggregate prescription drug plan beneficiary costs and savings with such costs for a beneficiary with no prescription drug plan. Repeals the prohibition against interference by the Secretary of Health and Human Services (HHS) with the negotiations between drug manufacturers and pharmacies and prescription drug plan sponsors. Authorizes the Secretary instead, like other federal entities that purchase prescription drugs in bulk, to negotiate contracts with manufacturers of covered part D drugs. Requires the use of the resulting savings to the Medicare Prescription Drug Account to strengthen the part D program and to reduce the federal deficit. Requires the Secretary to ensure that each part D eligible individual has: (1) a choice of enrollment in a comprehensive prescription drug plan in the area in which the individual resides; or (2) in any case in which such a plan is not available, the opportunity to enroll in a comprehensive fallback prescription drug plan.

Date: 2010-12-10
Topic: Health (Drug Coverage and Cost)
Subject: Health
Health Care Tax Deduction Act of 2011 - Amends the Internal Revenue Code to allow individuals a tax deduction from gross income for health insurance premiums and unreimbursed prescription drug expenses paid for the benefit of the taxpayer and the taxpayer's spouse and dependents.

Date: 2011-01-05
Topic: Health (Drug Coverage and Cost)
Subject: Taxation
Restoring Consumer-driven Health Care Act of 2011 - Repeals provisions of the Internal Revenue Code, as added by the Patient Protection and Affordable Care Act, that: (1) limit payments from health and medical savings accounts and health flexible spending arrangements solely to medications that are prescribed drugs or insulin, and (2) increase taxes on distributions from health and medical savings accounts that are not used for qualified medical expenses.

Date: 2011-02-08
Topic: Health (Drug Coverage and Cost)
Subject: Taxation
Stop Asian Carp Act - Directs the Secretary of the Army, acting through the Chief of Engineers, to study the watersheds of the Illinois, Chicago, and Calumet Rivers, including their tributaries, that drain directly into Lake Michigan to determine the feasibility and best means of implementing the hydrologic separation of the Great Lakes and the Mississippi River Basins to prevent the introduction or establishment of populations of aquatic nuisance species between the Great Lakes and Mississippi River Basins through the Chicago Area Water System (CAWS) and other aquatic pathways.Requires the study to: (1) include options to address flooding, Chicago wastewater and stormwater infrastructure, waterway safety operations, and barge and recreational vessel traffic alternatives; and (2) contain a detailed analysis of the environmental benefits and costs of each option.Directs: (1) the Secretary to carry out this Act at full federal cost; and (2) the President, or the Council on Environmental Quality as a designee to the President, to oversee the study to ensure its thoroughness and timely completion.Requires the Director of the United States Geological Survey (USGS), in cooperation with the Director of the United States Fish and Wildlife Service, to: (1) monitor and survey all waters that connect to the Great Lakes Basin or could connect to it due to flooding, underground hydrological connection, or human-made diversion to identify additional threats that could allow Asian Carp to enter the Basin; and (2) prioritize each threat and help identify means to impede the passage of Asian Carp to the Basin.

Date: 2011-03-03
Topic: Health (Drug Coverage and Cost)
Subject: Water resources development
Positive Reduction of Incarceration by Maximizing Education Act or PRIME Act - Directs the Attorney General, through the Director of the Office of Juvenile Justice and Delinquency Prevention, to establish national, regional, and local public awareness campaigns focused on promoting the advantages of continued education among youth.

Date: 2011-03-03
Topic: Health (Drug Coverage and Cost)
Subject: Education
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.

Date: 2011-03-09
Topic: Health (Drug Coverage and Cost)
Subject: Government operations and politics
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.

Date: 2011-03-09
Topic: Health (Drug Coverage and Cost)
Subject: Health
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.

Date: 2011-03-10
Topic: Health (Drug Coverage and Cost)
Subject: Health
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.

Date: 2011-03-11
Topic: Health (Drug Coverage and Cost)
Subject: Health
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.

Date: 2011-04-06
Topic: Health (Drug Coverage and Cost)
Subject: Commerce
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.

Date: 2011-06-15
Topic: Health (Drug Coverage and Cost)
Subject: Health
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.

Date: 2011-06-21
Topic: Health (Drug Coverage and Cost)
Subject: Health
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.

Date: 2011-06-22
Topic: Health (Drug Coverage and Cost)
Subject: Health
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.

Date: 2011-07-27
Topic: Health (Drug Coverage and Cost)
Subject: Health
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.

Date: 2011-09-20
Topic: Health (Drug Coverage and Cost)
Subject: Health
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.

Date: 2011-12-08
Topic: Health (Drug Coverage and Cost)
Subject: Health
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.

Date: 2012-03-19
Topic: Health (Drug Coverage and Cost)
Subject: Health
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.

Date: 2012-03-20
Topic: Health (Drug Coverage and Cost)
Subject: Health
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.

Date: 2012-09-13
Topic: Health (Drug Coverage and Cost)
Subject: Health
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.

Date: 2012-09-19
Topic: Health (Drug Coverage and Cost)
Subject: Health
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.

Date: 2011-01-25
Topic: Health (Drug Coverage and Cost)
Subject: Health
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.

Date: 2011-01-25
Topic: Health (Drug Coverage and Cost)
Subject: Health
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.

Date: 2011-04-05
Topic: Health (Drug Coverage and Cost)
Subject: Health
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.

Date: 2011-05-04
Topic: Health (Drug Coverage and Cost)
Subject: Health
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.

Date: 2011-05-26
Topic: Health (Drug Coverage and Cost)
Subject: Health
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.

Date: 2011-07-13
Topic: Health (Drug Coverage and Cost)
Subject: Health
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).

Date: 2011-07-14
Topic: Health (Drug Coverage and Cost)
Subject: Taxation
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.

Date: 2011-07-29
Topic: Health (Drug Coverage and Cost)
Subject: Health
Prescription Drug Cost Reduction Act - Amends title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services (HHS) to establish a program requiring a manufacturer to provide a rebate to the Secretary for drugs or biologicals furnished under Medicare part B (Supplementary Medical Insurance). Requires the Secretary to negotiate a contract with a manufacturer to establish the amount of payment under Medicare part B for any drug or biological for which the Medicare part B program is the majority purchaser. Requires that payment for both a drug or biological functionally equivalent to another drug or biological and that other drug or biological to be the same as for the least costly of them. Directs the Secretary of HHS to study physician reimbursement for drugs and biologicals furnished under Medicare part B. Imposes on a pharmacy benefit manager (PBM) specified fiduciary duties to the head of each federal agency with which the PBM contracts. Requires the Secretary to develop a form for use by physicians and practitioners to certify that any off-label use (not approved by the Food and Drug Administration [FDA]) for which an applicable drug is prescribed under Medicare is for a medically accepted indication. Amends the Public Health Service Act to: (1) include among "340B" program-covered entities (permitted to buy outpatient drugs at significant discounts) the Program of All-Inclusive Care for the Elderly (PACE); and (2) direct the Secretary to establish a mechanism to ensure that a manufacturer does not pay a duplicate discount with respect to a drug subject to a 340B program agreement if the PACE program receives any rebate (including any negotiated price concessions) for the drug under Medicare part D (Voluntary Prescription Drug Benefit Program). Makes an organization offering prescription drug coverage eligible to receive from the Secretary 10% of the estimated annual savings to the federal government as a result of the organization's participation in the drug discount program under the Public Health Service Act.

Date: 2011-10-12
Topic: Health (Drug Coverage and Cost)
Subject: Health
Coordination of Pro Bono Medically Recommended Dental Care Act - Amends the Public Health Service Act to direct the Secretary of Health and Human Services (HHS) to award competitive grants to, or enter into contracts with, eligible entities to fund the employment costs of professionals who will use grant or contract funds to: (1) coordinate the provision of medically recommended dental care to eligible low-income individuals by volunteer dentists in a manner consistent with state licensing laws; and (2) verify the medical, dental, and financial needs of individuals who may be eligible for free dental services. Requires an eligible: (1) entity to be tax exempt and provide for the participation of eligible individuals in a free dental services program on a national basis; and (2) individual to be entitled to benefits or be enrolled under Medicare, Medicaid, or a state plan or waiver under the State Children's Health Insurance Program (CHIP, formerly known as SCHIP).

Date: 2011-11-16
Topic: Health (Drug Coverage and Cost)
Subject: Health