jiayi-li23/proxann_data huggingface dataset:
Topic: Health — Drug Industry
Subject: Health
Date: 2009-06-19 00:00:00

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.
Topic: Health — Drug Industry
Subject: Taxation
Date: 2009-07-14 00:00:00

Amends the Internal Revenue Code to exclude from gross income gain from the sale of certain residential leased-fee interests to a holder of the leasehold right if such holder is: (1) an association of apartment owners of a multi-family residential leasehold property; or (2) a cooperative housing corporation for a residential leasehold property. Terminates such exclusion after 2014.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-07-20 00:00:00

Access to Medical Treatment Act - Gives an individual the right to be treated by a health care practitioner with any medical treatment that the individual desires, including a treatment that is not approved, certified, or licensed by the Secretary of Health and Human Services (HHS), if: (1) the practitioner has personally examined the individual and agrees to treat the individual; and (2) the administration of such treatment does not violate licensing laws. Authorizes health care practitioners to provide any method of treatment to such an individual if certain requirements are met, including that: (1) there is no reason to conclude that such treatment will cause danger to the individual; and (2) the patient is informed in writing that such treatment has not been approved, certified, or licensed by the Secretary. Requires a practitioner to report: (1) administering such treatment and discovering it to be a danger to an individual; and (2) the positive effects of an unconventional medical treatment for a life-threatening medical condition. Allows an individual to introduce or deliver into interstate commerce, or to produce, transport, receive, or hold, a food, drug, device, or equipment solely for use in accordance with this Act if there have been no advertising claims made by the manufacturer, distributor, or seller with respect to a medical treatment. States that nothing in this Act shall in any way adversely affect the distribution or sale of dietary supplements.
Topic: Health — Drug Industry
Subject: Taxation
Date: 2009-07-30 00:00:00

Tax Equity for Meal Replacements and Supplements Act of 2009 - Amends the Internal Revenue Code to treat as medical care certain dietary supplements and meal replacement products evaluated by the Food and Drug Administration (FDA) for purposes of the tax exclusion for employer reimbursements of employee medical care expenses.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-07-30 00:00:00

Medicare Prescription Drug Cost Equalization Act - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to require application to specialty tier drugs (very high cost and unique items) of the process for exception from the tiered cost-sharing for drugs included within a formulary. (Under an exception, a nonpreferred drug could be covered under the terms applicable for preferred drugs if the prescribing physician determines that the preferred drug for treatment of the same condition either would not be as effective for the individual, or would have adverse effects for the individual, or both.)
Topic: Health — Drug Industry
Subject: Health
Date: 2009-09-25 00:00:00

Consistency, Accuracy, Responsibility, and Excellence in Medical Imaging and Radiation Therapy Act of 2009 - Amends the Public Health Service Act to require personnel who perform or plan the technical component of either medical imaging examinations or radiation therapy procedures for medical purposes to possess, effective January 1, 2013: (1) certification in each medical imaging or radiation therapy modality and service provided from a certification organization designated by the Secretary of Health and Human Services (HHS); or (2) state licensure or certification where such services and modalities are within the scope of practice as defined by the state for such profession and where the requirements for licensure, certification, or registration meet or exceed the standards established by the Secretary. Exempts physicians, nurse practitioners, and physician assistants. Directs the Secretary to: (1) establish minimum standards for personnel who perform, plan, evaluate, or verify patient dose for medical imaging examinations or radiation therapy procedures; (2) establish a program for designating certification organizations after consideration of specified criteria; (3) provide a method for the recognition of individuals whose training or experience are determined to be equal to, or in excess of, those of a graduate of an accredited educational program in that specialty; and (4) approve and publish a list of accrediting bodies for such certification organizations. Authorizes the Secretary to develop alternative standards for rural or health professional shortage areas as appropriate to assure access to quality medical imaging. Amends the Social Security Act to allow Medicare payment for medical imaging and radiation therapy services furnished on or after January 1, 2013, only if the examination or procedure is planned or performed by an individual who meets this Act's requirements.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-09-29 00:00:00

(This measure has not been amended since it was introduced. The summary of that version is repeated here.) Amends title XVIII (Medicare) of the Social Security Act to postpone until January 1, 2010, the effective date of the requirement that pharmacies, as suppliers of Medicare items and services (including durable medical equipment [DME]), must be accredited by an independent accreditation organization approved by the Secretary of Health and Human Services (HHS). Declares that nothing in this Act shall be construed to affect the application of an accreditation requirement for pharmacies to qualify for bidding in a competitive acquisition area.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-10-08 00:00:00

Drug Price Competition Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to expand the definition of "first applicant" under such Act to allow a generic drug manufacturer that is currently considered an applicant subsequent to a brand-name manufacturer's 180-day exclusivity period to qualify as a first applicant for purposes of filing an abbreviated application for a new drug. Requires such applicant to submit a substantially complete application that contains and lawfully maintains a certification for such drug.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-10-27 00:00:00

Strengthening of FDA Integrity Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to apply debarment provisions currently applicable to abbreviated new drugs to any drug products, including new drugs, animal drugs, exported drugs, biological products, and medical devices. Expands the conditions under which persons (i.e., partnerships, corporations, and associations) are subject to mandatory and permissive debarment preventing such persons from submitting an application for approval of a drug product. Requires the Secretary of Health and Human Services (HHS), in determining the appropriateness and the period of debarment, to consider whether debarment will affect the public health because sufficient quantities of the drug would not be available. Requires the Secretary to annually report to Congress on the implementation of debarment provisions.
Topic: Health — Drug Industry
Subject: Taxation
Date: 2009-11-02 00:00:00

Protecting Americans from Drug Marketing Act - Amends the Internal Revenue Code to deny a business expense tax deduction for expenses relating to advertising or promoting the sale and use of prescription pharmaceuticals.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-12-08 00:00:00

Establishes a six-month grace period following enactment of this Act during which otherwise qualifying durable medical equipment (DME) suppliers that do not yet meet Medicare accreditation and surety bond requirements must meet them. Requires such suppliers to be treated as having met the requirements between the effective date of the requirements and the date on which they first meet them, so long as they actually do meet them within six months after enactment of this Act.
Topic: Health — Drug Industry
Subject: Health
Date: 2010-03-02 00:00:00

Compassionate Access Act of 2010 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to permit an investigational drug, biological product, or device to be made available for expanded access under a treatment investigational new drug application or treatment investigational device exemption if specified Compassionate Investigational Access requirements are met. Gives immunity to the manufacturer, distributor, administrator, sponsor, or physician from suit or liability relating to products approved under this Act. Establishes a procedure for accelerated approval of an investigational drug, biological product, or device that is reasonably likely to predict clinical benefit to a patient suffering from a serious or life-threatening condition. Requires the Secretary to establish: (1) the Accelerated Approval Advisory Committee; (2) a new program to expand access to investigational treatments for individuals with serious or life threatening conditions and diseases; and (3) a demonstration project under the Medicare program to pay for drugs, biological, products, and devices approved under this Act. Requires the Secretary to consider the clinical judgment and risks to the patient from the disease or condition in evaluating the safety and effectiveness of drugs, biological products, and devices that treat serious or life-threatening diseases or conditions, including the evaluation of nonstatistical information.Requires any committee evaluating investigational drugs, devices, or biological product applications to have at least two patient representatives as voting members.
Topic: Health — Drug Industry
Subject: Health
Date: 2010-03-10 00:00:00

Amends the McCarran-Ferguson Act to restore application of the Clayton Act and other antitrust laws to insurers. Prohibits premium variation except by geographic premium rating area and by family enrollment. Requires each health benefits plan issuer that offers health insurance coverage in the individual or group market in a state to accept every employer and individual in the state that applies for such coverage. Places restrictions on federal funding of abortion, except in cases of certain physical conditions, rape, or incest. Limits a health benefits plan to selling health insurance coverage to U.S. citizens and lawful resident aliens. Amends title XVIII (Medicare) and title XIX (Medicaid) of the Social Security Act to revise requirements for: (1) Medicare Advantage, with respect to the blended benchmark amount and elimination of the MA Regional Plan Stabilization Fund; (2) an increase in the physician fee schedule practice expense geographic adjustment; (3) establishment of a Medicare operated prescription drug plan option; and (4) pharmacy reimbursement. Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise requirements for the importation of prescription drugs. Requires the registration of importers and exporters. Prescribes requirements for: (1) the disposition of certain drugs denied admission into the United States; (2) alternative identification of the chain of custody of certain prescription drugs, including through the use of standardized anti-counterfeiting or track-and-trace technologies; and (3) the sale of prescription drugs through an Internet site. Prohibits the introduction of restricted transactions with unregistered foreign pharmacies into a payment system or the completion of such transactions using a payment system. Amends the Internal Revenue Code to disallow a deduction from income for advertising and promotional expenses for prescription pharmaceuticals. Requires a pharmacy benefit manager with a contract with a health benefits plan to comply with fiduciary standards established by the Secretary of Health and Human Services (HHS). Amends SSA title XIX (Medicaid) to require any drug manufacturer with a rebate agreement concerning covered outpatient drugs to report to the HHS Secretary following a rebate period the total number of units used to calculate the monthly average manufacturer price for each covered outpatient drug.
Topic: Health — Drug Industry
Subject: Health
Date: 2010-03-10 00:00:00

Food and Drug Administration Improvement Act of 2010 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require that all fees collected for the review of applications for human drugs, devices, animal drugs, or generic animal drugs be deposited in the general fund of the Treasury. Makes available amounts necessary for the Secretary of Health and Human Services (HHS) to review such applications. Prohibits the Secretary from entering into agreements with persons from whom such fees are collected and terminates any existing agreements. Requires the Secretary to: (1) establish the Center for Postmarket Drug, Device, and Biologic Safety and Effectiveness within the Food and Drug Administration (FDA) to regulate approved drugs; and (2) transfer to the Center all responsibilities for such regulation from the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, or the Center for Devices and Radiological Health Organization. Requires a statement regarding the reporting of negative side effects of prescription drugs in televised direct-to-consumer drug advertisements (currently required in published advertisements). Requires the Commissioner of Food and Drugs to: (1) complete a review of the FDA's regulations and guidance pertaining to the labeling of drugs and biological products; and (2) post on the FDA's website all clinical trial adverse events included in the registry and results data bank of the National Institutes of Health (NIH). Requires payment of a fee to the Secretary for the advertisement of drugs and devices. Requires doctors to inform patients and obtain consent to prescribe an approved drug for a purpose that has not been approved by the FDA.
Topic: Health — Drug Industry
Subject: Health
Date: 2010-03-25 00:00:00

Stop Oxy Abuse Act of 2010 - Directs the Commissioner of Food and Drugs (FDA), within 90 days, to take such actions as may be necessary to modify the approval of, and limit any subsequent approval of, any drug containing controlled-release oxycodone hychloride to use for the relief of severe-only pain instead of moderate-to-severe pain. Applies any such modification to drugs introduced into interstate commerce 180 days after enactment of this Act.
Topic: Health — Drug Industry
Subject: Taxation
Date: 2010-04-21 00:00:00

Protect Medical Innovation Act - Amends the Internal Revenue Code to repeal the excise tax on medical device manufacturers and importers (established by the Patient Protection and Affordable Care Act [PPACA]).
Topic: Health — Drug Industry
Subject: Health
Date: 2010-05-13 00:00:00

Access to Birth Control Act - Amends the Public Health Service Act to require pharmacies to comply with certain rules related to contraceptives, including: (1) providing a customer a contraceptive without delay if it is in stock; (2) immediately informing a customer if the contraceptive is not in stock and either transferring the prescription to a pharmacy that has the contraceptive in stock or expediting the ordering of the contraceptive and notifying the customer when it arrives, based on customer preference, except for pharmacies that do not ordinarily stock contraceptives in the normal course of business; and (3) ensuring that pharmacy employees do not take certain actions relating to a request for contraception, including intimidating, threatening, or harassing customers, interfering with or obstructing the delivery of services, intentionally misrepresenting or deceiving customers about the availability of contraception or its mechanism of action, breaching or threatening to breach medical confidentiality, or refusing to return a valid, lawful prescription. Provides that a pharmacy is not prohibited from refusing to provide a contraceptive to a customer if: (1) it is unlawful to dispense the contraceptive to the customer without a valid, lawful prescription and no such prescription is presented; (2) the customer is unable to pay for the contraceptive; or (3) the employee of the pharmacy refuses to provide the contraceptive on the basis of a professional clinical judgment. Provides that this Act does not preempt state law or any professional obligation of a state board that provides greater protections for customers. Sets forth civil penalties and establishes a a private cause of action for violations of this Act.
Topic: Health — Drug Industry
Subject: Taxation
Date: 2010-06-28 00:00:00

Repeals the excise tax on medical devices enacted by the Health Care and Education Reconciliation Act of 2010. Rescinds the unobligated balance of the discretionary appropriations made available by the American Recovery and Reinvestment Act of 2009.
Topic: Health — Drug Industry
Subject: Health
Date: 2010-07-14 00:00:00

Amends the Federal Food, Drug, and Cosmetic Act to require any registered producer of a drug or device to notify the Secretary of Health and Human Services (HHS), as soon as practicable, of the identity and location of a drug, if such person has reason to believe: (1) that such drug is adulterated or misbranded; and (2) there is a reasonable probability that the use or consumption of, or exposure to, the drug will cause a threat of serious adverse health consequences or death to humans or animals. Authorizes the Secretary to: (1) request that any person who distributes a drug that the Secretary has reason to believe is adulterated, misbranded, or otherwise in violation of the FFDCA voluntarily recall such drug; (2) issue an order requiring any person who distributes a drug that may cause serious adverse health consequences or death to humans or animals to immediately cease distribution of such drug; (3) amend the order to cease distribution to include a recall of the drug after an opportunity for an informal hearing; and (4) issue an order requiring an immediate recall of a drug if the Secretary has credible evidence or information that a drug subject to a cease distribution or recall order presents an imminent threat of serious adverse health consequences or death to humans or animals. Provides for notice to affected persons. Prohibits the failure to comply with the notification requirements of, or orders issued pursuant to, this Act. Requires the Secretary to provide notice of a recall order to consumers to whom the drug was, or may have been, distributed and to appropriate state and local health officials, as necessary.
Topic: Health — Drug Industry
Subject: Health
Date: 2010-07-27 00:00:00

America Rx Act of 2010 - 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.
Topic: Health — Drug Industry
Subject: Health
Date: 2010-07-29 00:00:00

Safe Prescription Drug Disposal and Education Act - Amends the Controlled Substances Act to permit, for purposes of carrying out the grant program established by this Act for drug disposal units: (1) an ultimate user (or an authorized agent of the ultimate user) who has lawfully obtained a controlled substance to deliver such substance, without being registered, to another person for disposal; and (2) such person to receive such substance for disposal, without being registered. Authorizes the Attorney General to make grants to an eligible entity (i.e., a state, local government, local educational agency, Indian tribe, a federal, state, or local governmental agency, corporation, community coalition, or any combination of such entities) to: (1) establish and operate prescription drug disposal units for disposal of unneeded or expired prescription drugs; and (2) design and implement educational programs on the abuse of prescription drugs and on household items that may be used to cause perception, emotion, or behavior similar to that caused by the use of psychotropic drugs. Directs the Director of National Drug Control Policy to carry out a public education and outreach campaign to increase awareness of how ultimate users may lawfully and safely dispose of prescription drugs, including controlled substances, through drug take-back programs.
Topic: Health — Drug Industry
Subject: Health
Date: 2010-08-10 00:00:00

Amends title XVIII (Medicare) of the Social Security Act to exempt qualified hospital-related durable medical equipment (DME) entities from programs for competitive acquisition of items and services. Defines a qualified hospital-related DME entity as a DME supplier that: (1) owns and controls, is owned and controlled by, or is under common ownership and control with one or more hospitals or one or more hospitals and a university; and (2) meets the applicable quality and financial standards. Declares that in the case of certain DME and medical supplies furnished by a qualified hospital-related DME entity in a competitive acquisition area for which a contract is in effect: (1) the competitive acquisition programs shall not apply; and (2) payment shall be made to the entity without regard to whether it submitted a bid or was awarded such a contract, and in the amount payable for such equipment and supplies under the contract for the area and period involved. Limits the application of this Act to items and services furnished by a qualified hospital-related DME entity that: (1) has provided satisfactory assurances that a substantial majority of its patients who are enrolled under Medicare part B (Supplementary Medical Insurance) are patients of a hospital that owns and controls, or is owned and controlled by, the entity or any provider of services affiliated with the hospital; and (2) was either furnishing items and services of such type on or before April 1, 2010, or owns and controls, is owned and controlled by, or is under common ownership and control with, a hospital (or one or more hospitals and a university) that was furnishing such items or services of such type on or before such date.
Topic: Health — Drug Industry
Subject: Health
Date: 2010-09-16 00:00:00

Amends title XVIII (Medicare) of the Social Security Act to treat as a physician, for Medicare purposes, a clinical psychologist acting within the scope of a psychologist's license (or other state law authorization), but only with respect to the furnishing of clinical psychologists services which the psychologist is legally authorized to perform by the state.