jiayi-li23/proxann_data huggingface dataset:
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2015-04-23 00:00:00

Medicare Drug Savings Act of 2015

Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act (SSAct) to require drug manufacturers to pay the Secretary of Health and Human Services 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, 2015, 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 sponsor or MedicareAdvantage organization for such period.

Specifies a formula for determination of Medicaid rebate amounts for such drugs or biologicals.

Amends SSAct 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: 2015-04-27 00:00:00

Medical Electronic Data Technology Enhancement for Consumers’ Health Act or the MEDTECH Act

(Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to exempt certain software from requirements for medical devices. The exemption applies to:

 administrative software used in health care facilities; software for maintaining or encouraging a healthy lifestyle unrelated to medical care; electronic patient records that are part of certified health information technology; software for transferring, storing, converting, or displaying medical information; and software that provides medical recommendations and the basis for those recommendations to health care professionals. Software remains subject to regulation as a medical device if: (1) the software acquires, processes, analyzes, or interprets medical information; or (2) the Food and Drug Administration (FDA) identifies use of the software as reasonably likely to have serious adverse health consequences.

When assessing a medical device that includes a software function exempted from medical device requirements, the FDA may assess the impact of the software on the functioning of the device.

The Department of Health and Human Services must report on the health risks and benefits associated with exempted software.

The FDA must classify a medical device accessory based on its intended function, not based on the classification of the medical device with which it is used.
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2015-05-05 00:00:00

Ensuring Seniors Access to Local Pharmacies Act of 2015 

Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to direct any prescription drug plan that has in its network one or more pharmacies located in a health professional shortage area, in a medically underserved area, or among a medically underserved population, and that provides a reduction in coinsurance or copayments for covered part D drugs, to extend to any pharmacy located in that area, or among that population, the option to be an in-network pharmacy under terms and conditions comparable to those the plan has agreed upon with other in-network pharmacies located in the area or among that population.
Topic: Health — Drug Coverage and Cost
Subject: Commerce
Date: 2015-05-06 00:00:00

Fairness to Pet Owners Act of 2015

Directs the Federal Trade Commission to require prescribers of animal drugs to verify prescriptions and provide copies of prescriptions to pet owners, pet owner designees, and pharmacies, without the prescriber demanding payment or establishing other conditions.

Treats a violation of this Act as an unfair or deceptive act or practice under the Federal Trade Commission Act.
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2015-05-18 00:00:00

Medicaid Generic Drug Price Fairness Act of 2015

This bill amends title XIX (Medicaid) of the Social Security Act to increase the amount of rebate with respect to each generic drug in the manner that the rebate for a dosage form and strength of a single source drug or an innovator multiple source drug is increased, except as provided in special application rules, including a special rule for certain noninnovator multiple source drugs.
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2015-05-20 00:00:00

Value Based Insurance Design Seniors Copayment Reduction Act of 2015

Directs the Department of Health and Human Services (HHS) to establish a demonstration program to test Value-Based Insurance Design methodologies in Medicare Advantage plans under part C (Medicare+Choice) of title XVIII (Medicare) of the Social Security Act for beneficiaries with chronic clinical conditions.

Defines "value-based insurance design methodology" as one for identifying specific prescription medications and clinical services for which copayments or coinsurance should be reduced or eliminated due to the high-value and effectiveness of such medications and services for specific clinical conditions.

Directs HHS to expand the demonstration program, except in certain circumstances, by issuing regulations to implement, on a permanent basis, those components that are beneficial to Medicare beneficiaries and the Medicare program.
Topic: Health — Drug Coverage and Cost
Subject: Armed forces and national security
Date: 2015-07-08 00:00:00

Joint Formularies for Veterans Act of 2015

This bill directs the Department of Defense (DOD) and the Department of Veterans Affairs (VA) to jointly establish: (1) a uniform formulary with respect to systemic pain and psychotropic drugs that are critical for the transition of an individual from receiving health care services furnished by DOD to health care services furnished by VA, and (2) a uniform formulary for DOD and VA that includes all appropriate systemic pain and psychotropic drugs.

Nothing in this Act shall be construed to prohibit DOD and VA from each maintaining its own formularies.
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2015-07-16 00:00:00

Safe and Affordable Prescription Drugs Act of 2015

Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require the Department of Health and Human Services (HHS) to promulgate regulations within 180 days permitting individuals to import a prescription drug purchased from an approved foreign pharmacy that:

 is dispensed by a pharmacist licensed in that country; is purchased for personal use in quantities not greater than a 90-day supply; is filled using a valid prescription issued by a physician licensed to practice in the United States; and has the same active ingredient or ingredients, route of administration, dosage form, and strength as a prescription drug approved under the FFDCA. Sets forth exceptions, including for controlled substances and biological products.

 Establishes a certification process for approving pharmacies in certain foreign countries. Requires HHS to publish a list of approved foreign pharmacies.
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2015-07-29 00:00:00

Medicare Prescription Drug Savings and Choice Act of 2015

This bill amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to require the Centers for Medicare & Medicaid Services (CMS) to offer one or more Medicare-operated prescription drug plan options.  In doing so, CMS must: (1) negotiate prices with drug manufacturers; (2) establish an appeals process for denials of plan benefits, including the option for external review and determination by an independent entity; and (3) establish and apply a formulary and formulary incentives. In general, a Medicare-operated drug plan must meet the same requirements as apply to any other prescription drug plan.
Topic: Health — Drug Coverage and Cost
Subject: Commerce
Date: 2015-09-09 00:00:00

Preserve Access to Affordable Generics Act

This bill amends the Federal Trade Commission Act to authorize the Federal Trade Commission (FTC) to initiate a proceeding against parties to any agreement resolving or settling a patent infringement claim in connection with the sale of a drug. Such an agreement, with specified exceptions, is presumed to have anticompetitive effects and is a violation of this Act if the filer of an abbreviated new drug (generic) application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug.

An agreement is exempted if the only consideration granted to the generic manufacturer is: (1) the right to market the generic drug prior to the expiration of any statutory exclusivity, (2) a payment for reasonable litigation expenses, and (3) a covenant not to sue on any claim that the generic drug infringes a patent.

An entity subject to an FTC enforcement order may petition for the order be reviewed in federal court. Civil penalties are imposed for violations of this Act.

This bill amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to require a brand name manufacturer and generic manufacturer to submit to the FTC any other agreements the parties enter into within 30 days of entering into an agreement related to the manufacturing, marketing, sale, or exclusivity period of a drug.

This bill amends the Federal Food, Drug, and Cosmetic Act to forfeit the 180-day exclusivity period for a generic drug if the FTC or a court decides that an agreement violated this Act.

The FTC is granted exclusive authority to litigate matters relating to anticompetitive practices in connection with the sale of generic drugs. The FTC may not commence enforcement actions (other than cease and desist requests) more than six years after the FTC is notified of an agreement.
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2015-09-10 00:00:00

Prescription Drug Affordability Act of 2015

This bill amends titles XVIII (Medicare) and XIX (Medicaid) of the Social Security Act to modify provisions related to the affordability of prescription drugs under the Medicare and Medicaid programs. Specifically, the bill:

 requires the Centers for Medicare & Medicaid to negotiate lower prices on behalf of beneficiaries for drugs covered under Medicare Part D; accelerates closure of the Medicare Part D coverage gap known as the "donut hole," under which beneficiaries who have reached a certain level of yearly drug costs become fully responsible for any additional drug costs up to a certain limit; requires drug manufacturers to issue rebates for prescription drugs dispensed to eligible low-income individuals under Medicare or Medicaid; and expands the application of certain prescription drug rebate requirements under Medicaid to include rebates for generic drugs. The bill also amends the Federal Food, Drug, and Cosmetic Act to: (1) allow the importation by individuals of prescription drugs from Canada and, potentially, other countries; and (2) establish certain conditions on the award of market exclusivity with respect to drugs. Specifically, a drug manufacturer's market exclusivity shall be terminated if the manufacturer commits, or fails to report, a drug-related violation such as misbranding, illegal marketing, or fraud.

In addition, the bill amends the Federal Trade Commission Act to: (1) establish restrictions on certain anticompetitive patent settlements known as "pay-for-delay" agreements, which effectively block generic drug competition; and (2) allow the Federal Trade Commission to initiate proceedings to enforce these restrictions against any parties to such a settlement.The bill also requires drug manufacturers to produce and share annual reports containing specified information related to domestic and foreign sales.
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2015-10-28 00:00:00

Cody Miller Patient Medication Information Act

This bill amends the Federal Food, Drug, and Cosmetic Act to direct the Food and Drug Administration (FDA) to regulate the authorship, content, format, and dissemination of patient medication information for prescription drugs. (Patient medication information includes the instructional brochures provided to patients when a prescription is filled.)

FDA regulations must require drug patient medication information to be scientifically accurate, to be based on the approved professional labeling, and to include plain language that is not promotional in tone or content and that provides specified information including drug uses and side effects.

The regulations must include standards for: (1) timely reviews and updates of patient medication information, (2) updates to help communicate information that is shared by similar drugs, and (3) assessing the effectiveness of patient medication information in promoting patient understanding and safe and effective use of medications. The FDA must develop a public electronic repository for all patient medication information.

When a prescription drug is sold or dispensed, patient medication information must be provided.
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2015-12-10 00:00:00

Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to establish a reciprocal marketing approval process that allows for the sale of a drug, biological product, or medical device that has not been approved by the Food and Drug Administration (FDA) if the product is approved for sale in another country.

For a product to be granted reciprocal marketing approval, the product's sponsor must submit a request to the FDA that demonstrates: (1) the product may be sold in at least one country from a specified list of countries, (2) the FDA and listed countries have not withdrawn approval of the product because of safety or effectiveness concerns, and (3) there is a public health or unmet medical need for the product.

The FDA may: (1) require postmarket studies of a product granted reciprocal marketing approval, or (2) decline to approve a product that is not safe and effective.

The FDA must grant or decline reciprocal marketing approval not later than 30 days after receiving a request. During that period, the FDA and product sponsor must negotiate and finalize product labeling and, for a medical device, classify the device.

Congress may pass a joint resolution to grant reciprocal marketing approval to a product that the FDA declines to approve through this process.

User fees apply to requests for reciprocal marketing approval.

The FDA must encourage the sponsors of potentially eligible products to request reciprocal marketing approval.
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2016-02-02 00:00:00

Expanding Access to Prescription Drug Monitoring Programs Act

This bill amends the Public Health Service Act and revises the Harold Rogers Prescription Drug Monitoring Program to require a state receiving grant funds for a prescription drug monitoring program to make relevant prescription information available to all individuals authorized by the state to prescribe controlled substances, including nurse practitioners and physician assistants.
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2016-02-23 00:00:00

Preventing Overprescribing for Pain Act of 2016

This bill requires the Centers for Disease Control and Prevention to issue guidelines for the safe prescribing of opioids for the treatment of acute pain. (Opioids are drugs with effects similar to opium, such as certain pain medications.)
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2016-03-01 00:00:00

Increasing Competition in Pharmaceuticals Act

This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding review and approval of generic drug applications or supplements to generic drug applications for drugs: (1) for which there is a shortage, or (2) that have not been recently introduced to the market by more than one manufacturer and for which tentative approval has not been granted to more than two applications.

The Food and Drug Administration (FDA) must prioritize the review of such submissions and act on them within 150 days. User fees are waived for such an application unless the drug is under patent. The FDA may expedite the inspection of a facility proposed to manufacture such a drug.

The FDA must award a transferrable generic drug priority review voucher to the sponsor of such an application upon approval. A voucher may be used to have the FDA review and take action upon a generic drug application within 150 days of submission. The FDA may revoke a voucher awarded for a drug that is not marketed within one year of approval. This voucher program is terminated at the end of FY2022.

The FDA must periodically report on generic drug applications filed before FY2016 that are still pending.

For a new drug application to be eligible for a priority review voucher as a tropical disease product application, the application must include new, essential clinical investigations.

The Government Accountability Office must study the FDA's program for drug risk evaluation and mitigation strategies.
Topic: Health — Drug Coverage and Cost
Subject: Taxation
Date: 2016-03-03 00:00:00

Protecting Americans from Drug Marketing Act

This bill amends the Internal Revenue Code to deny a tax deduction for the cost of direct-to-consumer advertising of prescription drugs. The bill defines "direct-to-consumer advertising" as any dissemination by or on behalf of a sponsor of a prescription drug product of a prescription drug advertisement that is primarily targeted to the general public through: (1) publication in journals, magazines, other periodicals, and newspapers; (2) broadcasting through media such as radio, television, and telephone communication systems; and (3) dissemination on the Internet (including social media).
Topic: Health — Drug Coverage and Cost
Subject: Armed forces and national security
Date: 2016-04-11 00:00:00

This bill exempts from the requirement that veterans pay a Department of Veterans Affairs copayment for:

 any opioid antagonists furnished to a veteran at high risk for overdose of a specific medication or substance in order to reverse the effect of such an overdose, and education on their use.
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2016-04-27 00:00:00

Reducing Existing Costs Associated with Pharmaceuticals for Seniors Act of 2016 or the RxCAP Act of 2016

This bill amends title XVIII (Medicare) of the Social Security Act to eliminate beneficiary cost-sharing above the Medicare prescription benefit's annual out-of-pocket threshold beginning in plan year 2018. Under current law, the Medicare prescription drug benefit provides coverage above that threshold only with cost-sharing in the form of either copayment or coinsurance.
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2016-09-12 00:00:00

Improving Transparency and Accuracy in Medicare Part D Spending Act

This bill amends title XVIII (Medicare) of the Social Security Act to prohibit Medicare Prescription Drug Plan sponsors from retroactively reducing payment on clean claims submitted by pharmacies. (A "clean claim" is a Medicare claim that is free of defects such as incomplete documentation.)
Topic: Health — Drug Coverage and Cost
Subject: Health
Date: 2016-11-30 00:00:00

Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2016

This bill amends titles II (Old Age, Survivors, and Disability Insurance) and XVIII (Medicare) of the Social Security Act to indefinitely extend Medicare coverage of immunosuppressive drugs for kidney transplant recipients. Under current law, such coverage is limited to 36 months following a transplant.
Topic: Education — Higher
Subject: Education
Date: 2007-01-12 00:00:00

College Student Relief Act of 2007 - Amends the Higher Education Act of 1965 to phase-in cuts in the interest rate charged undergraduate student borrowers under the Federal Family Education Loan (FFEL) and Direct Loan (DL) programs, thereby reducing such rate from 6.8% in July 2006 to 3.4% in July 2011. Limits FFEL lender insurance to 95% of the unpaid balance of such loans. (Currently, 97% of a FFEL issued after June 2006 is federally-insured.) Provides for graduated reductions in the percentage of defaulted FFEL loan collections a guaranty agency is allowed to retain until, beginning in October 2010, it is equal to the average rate paid to collection agencies that have contracts with the Secretary of Education. Eliminates exceptional performer status for lenders, servicers, and guaranty agencies, which rewards such entities for high due diligence in FFEL collection. Reduces special allowance payments made to FFEL lenders to compensate them for the difference between FFEL interest rates and market rates. Exempts small lenders from such reduction. Increases the loan fee charged FFEL lenders from .5% to 1% of the principal amount of loans disbursed after June 2007. Prohibits its collection from borrowers. Increases, after June 2007, the rebate fee charged a holder of FFEL consolidated loans, provided that at least 90% of the total principal and accrued unpaid interest outstanding on loans held by such holder are such loans.
Topic: Education — Higher
Subject: Taxation
Date: 2007-01-04 00:00:00

401Kids Family Savings Act of 2007 - Amends the Economic Growth and Tax Relief Reconciliation Act of 2001 to extend through 2015 provisions allowing increased annual contributions to Coverdell education savings accounts. Amends the Internal Revenue Code to: (1) allow tax-free distributions from a Coverdell education savings account for first-time homebuyer expenses; (2) permit rollovers from Coverdell education savings accounts to Roth individual retirement accounts (Roth IRAs); and (3) rename Coverdell education savings accounts as 401Kids Savings Accounts.
Topic: Education — Higher
Subject: Education
Date: 2007-01-04 00:00:00

Veterans' Equity in Education Act of 2007 - Amends the Higher Education Act of 1965 with respect to calculation of financial assistance for which a student receiving veterans' education benefits may be eligible. Reduces, for the first year a student receives such benefits, the factor in the eligibility formula representing estimated educational financial assistance already received by the student by the amount of military pay deductions for such benefits made by or on behalf of the student while on active duty in the U.S. armed forces or in the Selective Reserve.
Topic: Education — Higher
Subject: Education
Date: 2007-01-04 00:00:00

Higher Education Science and Technology Competitiveness Act - Amends the Higher Education Act of 1965 to direct the Secretary of Education to award grants to public institutions of higher education to establish and implement statewide articulation agreements that provide a seamless transition for the transfer of students from two-year institutions to four-year institutions through a common core curricula in math, science, engineering, and technology that reflects the workforce needs of private industry.
Topic: Education — Higher
Subject: Armed forces and national security
Date: 2007-01-04 00:00:00

G.I. Advanced Education in Science and Technology Act - Directs the Secretary of Veterans Affairs to pay a monthly stipend to each individual who is entitled to veterans' basic educational assistance and is pursuing full-time a doctoral degree in the sciences of engineering, mathematics, or other technology disciplines. Allows such payment in addition to any other authorized Montgomery GI Bill educational assistance. Makes such payment $1,200 a month (adjusted for inflation for fiscal years after 2005) for up to 60 months.