zli12321/Bills huggingface dataset:
Protecting Patients and Hospitals From Price Gouging Act - Authorizes the President to issue an executive order declaring a market shortage for six months with regard to one or more vital drugs if the total supply of all clinically interchangeable versions of a drug regulated by the Food and Drug Administration (FDA) is inadequate to meet the current or projected demand at the user level. Defines a "vital drug" as any drug or biologic used to prevent or treat a serious or life-threatening disease or medical condition, for which there is no other available source with sufficient supply available. Makes it unlawful, when the President issues such an executive order, for any person to sell vital drugs at a price that: (1) is unreasonably excessive, and (2) indicates that the seller is taking unfair advantage of the circumstances related to a market shortage to increase prices unreasonably during that period. Gives the Attorney General authority to enforce penalties under this Act. Makes any person who sells, or offers to sell, any vital drug during a declared market shortage with the knowledge and intent to charge a price unreasonably excessive under the circumstances guilty of an offense and subject to injunction and penalties. Applies such sanctions, except to a hospital or a physician, in the geographical area where the vital drug market shortage has been declared and to all wholesalers and distributors in the chain of distribution. Sets forth factors for the Attorney General to consider in determining whether an alleged violator's price was unreasonably excessive. Makes a declaration under this Act terminate if: (1) there is enacted a law terminating the market shortage after a national market shortage is declared, or (2) the President issues a proclamation terminating the declaration. Authorizes the President to renew such a market shortage declaration if the severe shortage continues to affect the health and well-being of citizens beyond the initial six-month period.

Date: 2012-09-22
Topic: Health (Drug Coverage and Cost)
Subject: Health
Patients' Access to Treatments Act of 2013 - Amends the Public Health Service Act to establish cost-sharing limits for health plans that cover prescription drugs and use a formulary or other tiered cost-sharing structure. Prohibits such a health plan from imposing cost-sharing requirements, including co-payment and co-insurance, applicable to prescription drugs in a specialty drug tier that exceed the dollar amount of cost-sharing requirements applicable to prescription drugs in a non-preferred brand drug tier. Applies the non-preferred brand drug tier for which beneficiary cost-sharing is lowest, if a formulary used by the health plan contains more than one non-preferred brand drug tier.

Defines: (1) "non-preferred brand drug tier" as a category of prescription drugs within a tier in a formulary for which beneficiary cost-sharing is greater than tiers for generic drugs or preferred brand drugs, and that are not included within a specialty drug tier; and (2) "specialty drug tier" as a category of prescription drugs within a tier in a 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.

Date: 2013-02-04
Topic: Health (Drug Coverage and Cost)
Subject: Health
Medicare Prescription Drug Savings and Choice Act of 2013 - 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: 2013-02-28
Topic: Health (Drug Coverage and Cost)
Subject: Health
Medication Therapy Management Empowerment Act of 2013 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to provide access to services under medication therapy management programs for Medicare part D (Voluntary Prescription Drug Program) eligible individuals with a single chronic disease.

Allows the application of this Act only if the Chief Actuary for the Centers for Medicare & Medicaid Services determines that such application with regard to a particular single chronic disease is not projected to increase overall costs to the Medicare program over the following five year period.

Date: 2013-03-07
Topic: Health (Drug Coverage and Cost)
Subject: Health
Medicare Prescription Drug Price Negotiation Act of 2013 - 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: 2013-03-12
Topic: Health (Drug Coverage and Cost)
Subject: Health
Accessing Medicare Therapies Act of 2013 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act, with respect to cost-sharing under a prescription drug plan, to require incurred costs to include the negotiated price of a covered part D drug if the drug is: (1) classified in the highest copayment tier; (2) furnished to the individual free or at nominal charge under a compassionate treatment program; and (3) covered under the formulary of the plan, if the drug is furnished other than through such a program, or is available through exception or appeal.

Date: 2013-03-18
Topic: Health (Drug Coverage and Cost)
Subject: Health
Improving Cancer Treatment Education Act of 2013 - Amends title XVIII (Medicare) of the Social Security Act to extend Medicare coverage to comprehensive cancer patient treatment education services, including a one-hour patient treatment education session delivered, in advance of treatment, by a registered nurse to an individual diagnosed with cancer (or whose course of treatment has been materially modified).

Amends the Public Health Service Act to require the Director of the National Institutes of Health (NIH) to expand, intensify, and coordinate research programs to: (1) improve the treatment and management of symptoms and side effects associated with cancer and cancer treatment, and (2) evaluate the role of nursing interventions in the amelioration of such symptoms and side effects.

Date: 2013-04-19
Topic: Health (Drug Coverage and Cost)
Subject: Health
Securing Care for Seniors Act of 2013 - Amends part C (Medicare+Choice) of title XVIII (Medicare) of the Social Security Act to terminate after 2013 the permission to disenroll, between January 1 and March 15 of each year, only from a MedicareAdvantage (MA) plan to elect enrollment in the original Medicare fee-for-service program.

Restores the option under previous law to elect to change from an MA plan to the original Medicare fee-for-service plan, or from the original Medicare fee-for-service to an MA plan, once a year during the first three months.

Permits an MA organization to offer individuals enrolled in one of its MA plans one or more incentive programs designed to improve their health care.

Permits an MA plan, through mechanisms such as value based insurance design (VBID) practices, to vary cost sharing for the purpose of encouraging enrollees to use providers that the MA organization has identified as performing well on quality metrics.

Directs the Secretary of Health and Human Services (HHS) to evaluate and, as appropriate, revise for 2017 and periodically thereafter the risk adjustment system so that a risk score, with respect to an individual, takes into account the number of chronic conditions with which the individual has been diagnosed, and, to the extent available, at least two years of diagnostic data including data obtained during the individual's health risk assessments.

Requires the Secretary to take steps necessary to ensure that the MA 5-star rating system: (1) does not disadvantage a plan that enrolls a disproportionately high proportion of enrollees who are full-benefit dual eligible individuals, subsidy eligible individuals, or other individuals with complex health care needs such as individuals with multiple conditions; and (2) allows adjustments to account for differences in socioeconomic and demographic characteristics of enrollees and geographic variation in health outcomes.

Date: 2013-07-19
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 formulary tier of the tiered cost-sharing structure (including a formulary tier used for very high cost or unique items) ineligible for lower-cost sharing through an exception.

Date: 2013-07-25
Topic: Health (Drug Coverage and Cost)
Subject: Health
Access to Hearing Healthcare Act of 2014 - Amends title XVIII (Medicare) of the Social Security Act to revise the definition of Medicare-covered audiology (hearing and balance assessment) services provided by a qualified and legally authorized audiologist to state that such services are covered without regard to any requirement that: (1) the individual receiving them be under the care of (or referred by) a physician or other health care practitioner, or (2) such services are provided under the supervision of a physician or other health practitioner.

Includes audiology services as medical services, as so redefined, under Medicare part B (Supplementary Medical Insurance).

Date: 2014-02-11
Topic: Health (Drug Coverage and Cost)
Subject: Health
Keep the Promise to Seniors Act of 2014 - Prohibits the Secretary of Health and Human Services (HHS) from taking any action (through promulgation of a final or interim final regulation, issuance of regulatory or program guidance, use of federal payment audit procedures, or other enforcement or administrative action, policy, or practice) to implement any provision of the proposed regulation (relating to policy and technical changes to the MedicareAdvantage and part D programs under Medicare) published in the Federal Register on January 10, 2014, insofar as that regulation relates to part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act (SSA), including its application to MedicareAdvantage- Prescription Drug (MA-PD) plans under part C (Medicare+Choice Program).

Date: 2014-03-06
Topic: Health (Drug Coverage and Cost)
Subject: Health
Caring for Military Children with Developmental Disabilities Act of 2014 - Includes in the treatment of military dependents' developmental disabilities under the Department of Defense (DOD) TRICARE program behavioral health treatment, including applied behavior analysis, that is prescribed by a physician or psychologist.

Makes such behavioral health treatment available to retired members of the Coast Guard, the Commissioned Corps of the National Oceanic and Atmospheric Administration (NOAA), the Commissioned Corps of Public Health Service, or their dependents only to the extent that amounts are specifically appropriated to the Defense Health Program Account for their coverage.

Expresses the sense of Congress that amounts should be appropriated for the behavioral health treatment of TRICARE beneficiaries in a manner that ensures that all beneficiaries receive appropriate and equitable access to such treatment.

Date: 2014-05-09
Topic: Health (Drug Coverage and Cost)
Subject: Armed forces and national security
Caring for America's Heroes Act - Eliminates the limit on the number of days each year inpatient mental health services may be provided to military dependents under the Department of Defense (DOD) TRICARE program (a DOD managed care program).

Eliminates the need for TRICARE Standard beneficiaries to obtain: (1) a nonavailability statement or preauthorization to receive mental health services from a civilian provider, or (2) a nonavailability statement to receive mental health services in specialized treatment facilities outside the 200-mile radius of a military medical treatment facility.

Date: 2014-05-13
Topic: Health (Drug Coverage and Cost)
Subject: Armed forces and national security
Prescription Drug and Health Improvement Act of 2013 - 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: 2013-01-23
Topic: Health (Drug Coverage and Cost)
Subject: Health
Medicare Prescription Drug Price Negotiation Act of 2013 - 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: 2013-01-23
Topic: Health (Drug Coverage and Cost)
Subject: Health
Medicare Drug Savings Act of 2013 - 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: 2013-04-16
Topic: Health (Drug Coverage and Cost)
Subject: Health
Medicare Prescription Drug Program Integrity and Transparency Act of 2013 - 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 with respect to a PDP the sponsor offers to prohibit the PDP from entering into a contract with any pharmacy benefits manager (PBM) to manage the prescription drug coverage provided under such plan, or to control the costs of the prescription drug coverage under it, unless the manager satisfies specified PBM audit and disclosure requirements.

Requires a PBM to provide: (1) a particular aggregate average reimbursement rate for generics or a maximum average discount off of an accepted pharmaceutical pricing benchmark for multi-source generics as a whole ("generic effective rate"), and (2) a process for the generic effective rate to be appealed. Revises requirements for contracts with PDP sponsors to require that the PDP sponsor or a subcontractor of the sponsor disclose to a pharmacy, at the time when a contract is offered and at least once every seven days, the methodology and actual per unit reimbursement amount for each covered drug for each contracted pharmacy.

Date: 2013-05-06
Topic: Health (Drug Coverage and Cost)
Subject: Health
Medicare Efficient Drug Dispensing Act of 2013 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to require a prescription drug plan (PDP) sponsor to have in place a payment structure for covered part D drugs that encourages the use of dispensing techniques that foster efficiency and reduce wasteful dispensing of outpatient prescription drugs in long-term care facilities.

Requires a PDP sponsor also to take into account, in establishing fees for dispensing covered Medicare part D drugs to enrollees in a long-term care facility, the utilization of such dispensing techniques to minimize the dispensing of unused drugs, the incremental costs associated with the type of dispensing methodology, and the requirements applicable to long-term care pharmacies.

Date: 2013-09-10
Topic: Health (Drug Coverage and Cost)
Subject: Health
Caring for America's Heroes Act - Eliminates the limit on the number of days each year inpatient mental health services may be provided to military dependents under the Department of Defense (DOD) TRICARE program (a DOD managed care program).

Eliminates the need for TRICARE Standard beneficiaries to obtain: (1) a nonavailability statement or preauthorization to receive mental health services from a civilian provider, or (2) a nonavailability statement to receive mental health services in specialized treatment facilities outside the 200-mile radius of a military medical treatment facility.

Date: 2014-05-01
Topic: Health (Drug Coverage and Cost)
Subject: Armed forces and national security
Recovery Enhancement for Addiction Treatment Act or the TREAT Act - Amends the Controlled Substances Act to increase the number of patients that a qualifying practitioner dispensing narcotic drugs for maintenance or detoxification treatment is initially allowed to treat from 30 to 100 patients per year.

Allows a qualifying physician, after one year, to request approval to treat an unlimited number of patients under specified conditions, including that he or she: (1) agrees to fully participate in the Prescription Drug Monitoring Program of the state in which the practitioner is licensed, (2) practices in a qualified practice setting, and (3) has completed at least 24 hours of training regarding treatment and management of opiate-dependent patients for substance use disorders provided by specified organizations.

Revises the definition of a "qualifying practitioner" to include: (1) a physician who holds a board certification from the American Board of Addiction Medicine; and (2) a nurse practitioner or physicians assistant who is licensed under state law to prescribe schedule III, IV, or V medications for pain, who has specified training or experience that demonstrates specialization in the ability to treat opiate-dependent patients, who practices under the supervision of, or prescribes opioid addiction therapy in collaboration with, a licensed physician who holds an active waiver to prescribe schedule III, IV, or V narcotic medications for opioid addiction therapy, and who practices in a qualified practice setting.

Directs the Comptroller General to initiate an evaluation of the effectiveness of this Act, including an evaluation of: (1) changes in the availability and use of medication-assisted treatment for opioid addiction, (2) the quality of medication-assisted treatment programs, (3) diversion of opioid addiction treatment medication, and (4) changes in state or local policies and legislation relating to opioid addiction treatment.

Date: 2014-07-23
Topic: Health (Drug Coverage and Cost)
Subject: Health
Clay Hunt Suicide Prevention for American Veterans Act or the Clay Hunt SAV Act - Requires the Secretary of Veterans Affairs (VA) and the Secretary of Defense (DOD) to each arrange for an independent third party evaluation of, respectively, the VA and DOD mental health care and suicide prevention programs.

Directs the VA Secretary to publish an Internet website that serves as a centralized source to provide veterans with regularly updated information regarding all of the VA's mental health care services.

Requires the VA Secretary and the DOD Secretary to enter into certain strategic relationships to facilitate:

 the mental health referrals of members of the reserve components who have a service-connected disability and are being discharged or released from the Armed Forces, timely behavioral health services for such members, communication when such members are at risk for behavioral health reasons, and the transfer of documentation for line-of-duty and fitness-for-duty determinations. Requires the VA Secretary to carry out a three-year pilot program to repay the education loans relating to psychiatric medicine that are incurred by individuals who:

 are eligible to practice psychiatric medicine in the Veterans Health Administration (VHA) or are enrolled in the final year of a residency program leading to a specialty qualification in psychiatric medicine, demonstrate a commitment to a long-term career as a psychiatrist in the VHA, and agree to a period of obligated service with the VHA in the field of psychiatric medicine in exchange for the repayment of such loans. Requires the DOD Secretary to submit to Congress a review of the staffing requirements for individual State National Guard Commands with respect to Directors of Psychological Health.

Authorizes the VA Secretary to collaborate with nonprofit mental health organizations to prevent suicide among veterans. Requires the collaborators to exchange training sessions, best practices, and other resources to enhance their suicide prevention efforts. Directs the Secretary to select a Director of Suicide Prevention Coordination within the VA to undertake any collaboration with nonprofit mental health organizations.

Date: 2014-11-17
Topic: Health (Drug Coverage and Cost)
Subject: Armed forces and national security
Classified Veterans Access to Care Act

Requires the Secretary of Veterans Affairs (VA) to:

 establish standards and procedures to ensure that a veteran who participated in a classified mission or served in a sensitive unit while in the Armed Forces may access VA mental health care in a manner that fully accommodates the veteran's obligation to not improperly disclose classified information; disseminate guidance to employees of the Veterans Health Administration, including mental health professionals, on such standards and procedures and on how to best engage such veterans during the course of mental health treatment with respect to classified information; and ensure that an individual may elect to identify as such a veteran on an appropriate form.

Date: 2015-01-20
Topic: Health (Drug Coverage and Cost)
Subject: Armed forces and national security
Patients' Access to Treatments Act of 2015

Amends the Public Health Service Act to establish cost-sharing limits for health plans that cover prescription drugs and use a formulary or other tiered cost-sharing structure. Prohibits such a health plan from imposing higher cost-sharing requirements, including co-payment and co-insurance, for specialty drugs than for other prescription drugs in a non-preferred brand drug tier. Applies the non-preferred brand drug tier for which beneficiary cost-sharing is lowest, if a formulary used by the health plan contains more than one non-preferred brand drug tier.

Date: 2015-03-25
Topic: Health (Drug Coverage and Cost)
Subject: Health
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.

Date: 2015-04-23
Topic: Health (Drug Coverage and Cost)
Subject: Health
Prescription Drug Accountability Act

This bill provides for Department of Veterans Affairs participation in state prescription drug monitoring programs.

Date: 2015-04-28
Topic: Health (Drug Coverage and Cost)
Subject: Armed forces and national security
FEHBP Prescription Drug Oversight 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: 2015-04-30
Topic: Health (Drug Coverage and Cost)
Subject: Government operations and politics
Personal Drug Importation Fairness Act of 2015

This bill allows a drug to be imported by a person other than the drug's manufacturer if the drug: (1) has the same active ingredients, route of administration, and strength as an approved drug; (2) may be lawfully marketed in, and is imported or reimported from, a country included on a list in this Act that the Food and Drug Administration determines has standards for ensuring drug safety and effectiveness that are at least as protective as U.S. standards; (3) is dispensed by a licensed pharmacist; (4) is shipped directly to, or is imported by, the ultimate consumer; (5) is shipped or imported in quantities that do not exceed a 90-day supply; (6) is accompanied by a copy of a valid prescription; and (7) is not a controlled substance.

Date: 2015-06-03
Topic: Health (Drug Coverage and Cost)
Subject: Health
Medicare Prescription Drug Price Negotiation Act of 2015

 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 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 plan.

Date: 2015-07-14
Topic: Health (Drug Coverage and Cost)
Subject: Health
Foster Youth Independence Act of 2015 

This bill amends part E (Foster Care and Adoption Assistance) of title IV of the Social Security Act to allow the chief executive officer of a state to certify that the state will provide assistance and services under the John H. Chafee Foster Care Independence Program to youths who have aged out of foster care and have not attained age 23 if:

 the state has elected to extend the eligibility for foster care to all children up to age 21, or the responsible state agency uses state or other funds not provided under the Program to provide assistance and services comparable to those such youths would receive if the state had made such an election

Date: 2015-07-22
Topic: Health (Drug Coverage and Cost)
Subject: Social welfare
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. Applies these requirements to medication for a domesticated household animal that consumers are not allowed to purchase without a prescription.

Treats a violation of this Act as an unfair or deceptive act or practice under the Federal Trade Commission Act.

Date: 2015-07-23
Topic: Health (Drug Coverage and Cost)
Subject: Commerce
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.

Date: 2015-07-28
Topic: Health (Drug Coverage and Cost)
Subject: Health
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.

Date: 2015-09-16
Topic: Health (Drug Coverage and Cost)
Subject: Health
Health Insurance Rate Review Act

This bill amends the Public Health Service Act to declare that federal requirements that the Department of Health and Human Services (HHS) review unreasonable premium increases in health care coverage do not prohibit a state from imposing additional rate requirements on health insurance issuers that are more protective of consumers. The review is expanded to include all rate increases, not only premium increases.

HHS or the relevant state insurance commissioner or state regulator must ensure that any excessive, unjustified, or unfairly discriminatory rates are corrected before, or as soon as possible after, implementation, including through mechanisms such as denying rates, modifying rates, or requiring rebates to consumers. HHS may apply civil monetary penalties to health insurance issuers that fail to comply with a corrective action taken by HHS and may make the plan involved ineligible for classification as a qualified health plan.

HHS must determine whether HHS or the state insurance commissioner or regulator will undertake such corrective actions based on whether the state can adequately undertake the actions. This Act applies to health plans grandfathered under the Patient Protection and Affordable Care Act.

Date: 2015-10-08
Topic: Health (Drug Coverage and Cost)
Subject: Health
Protecting Seniors Access to Proper Care Act of 2015

This bill amends title XVIII (Medicare) of the Social Security Act to allow an authorized physician or practitioner who is not enrolled as a Medicare provider to, under certain circumstances, prescribe covered drugs under the Medicare prescription drug benefit. Specifically, the physician or practitioner must not be: (1) otherwise disqualified from being enrolled; or (2) a doctor of medicine or osteopathy, unless the doctor's practice prescribes a low-volume of billings for such drugs under Medicare.

Date: 2015-11-18
Topic: Health (Drug Coverage and Cost)
Subject: Health
Medicare Fair Drug Pricing Act of 2015

This bill amends title XVIII (Medicare) of the Social Security Act to require the Centers for Medicare & Medicaid Services (CMS) to negotiate with drug manufacturers in determining the price that may be charged for prescription drugs under the Medicare prescription drug benefit.

Under current law, CMS may not interfere with negotiations between drug manufacturers and prescription drug plan (PDP) sponsors. The bill creates an exception to this prohibition with respect to specified drugs that: (1) are single-source or biological, (2) are not both manufactured by more than two drug manufacturers and manufactured by at least one manufacturer as a generic drug, and (3) meet other specified requirements. CMS must promulgate regulations regarding the identification of such drugs.

With respect to these drugs, CMS shall negotiate the price that may be charged to PDP sponsors and Medicare Advantage (MA) organizations for Medicare and MA enrollees. The bill establishes processes for negotiation and price determination in the initial plan year and subsequent plan years.

A manufacturer must participate in the negotiation process as a condition of coverage under the Medicare prescription drug benefit.

Date: 2015-12-09
Topic: Health (Drug Coverage and Cost)
Subject: Health
This bill prohibits the Department of Health and Human Services from taking any further action on a proposed rule to change how Medicare pays for certain drugs that are typically not self-administered (such as some intravenous medications and chemotherapy drugs).

Date: 2016-04-29
Topic: Health (Drug Coverage and Cost)
Subject: Health
This bill amends title XIX (Medicaid) of the Social Security Act to exclude abuse-deterrent formulations of prescription drugs from the requirement that manufacturers of single-source or innovator drugs pay additional rebates to state Medicaid programs.

Under current law, the Centers for Medicare & Medicaid Services (CMS) must use predictive modeling and other analytic technologies to identify improper Medicaid claims. The bill prohibits a state agency from using or disclosing such technologies except for purposes of administering a state Medicaid program or Children's Health Insurance Program (CHIP). A state agency shall have in effect adequate data security and control policies to ensure that access to such information is restricted to authorized persons for authorized uses.

The bill places $5 million in the Medicaid Improvement Fund to be available beginning in FY2021.

Date: 2016-04-29
Topic: Health (Drug Coverage and Cost)
Subject: Health
Veterans Preventive Health Coverage Fairness Act

This bill exempts veterans from Department of Veteran Affairs medical copayments for medication or hospital care and medical services related to preventive health services.

Date: 2016-09-06
Topic: Health (Drug Coverage and Cost)
Subject: Armed forces and national security
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.)

Date: 2016-09-08
Topic: Health (Drug Coverage and Cost)
Subject: Health
Fair Accountability and Innovative Research Drug Pricing Act of 2016

This bill amends the Public Health Service Act to require manufacturers of certain drugs and biological products to report to the Department of Health and Human Services (HHS) price increases that result in a 10% or more increase in the price of a drug over a 12-month period. Reports are required for prescription drugs and drugs commonly administered in hospitals, except vaccines, drugs for rare conditions, and drugs with annual sales for Medicare and Medicaid enrollees of less than $1.

Manufacturers that do not submit a required report are subject to a civil penalty. The Inspector General of HHS must review drug price information to determine compliance. Collected penalty funds must be used to carry out activities related to this reporting requirement and to improve consumer and provider information about drug value and drug price transparency.

HHS must publish manufacturer reports, a summary of those reports, and supporting analyses.

Date: 2016-09-15
Topic: Health (Drug Coverage and Cost)
Subject: Health
Secondary Payer Advancement, Rationalization, and Clarification Act or the SPARC Act

This bill amends title XVIII (Medicare) of the Social Security Act to specify recovery rules with respect to secondary claims responsibility under the Medicare prescription drug benefit. Under current law, secondary payor provisions apply under the benefit in the same manner as they apply with respect to Medicare Advantage plans.

Date: 2016-09-22
Topic: Health (Drug Coverage and Cost)
Subject: Health
Prescription Drug and Medical Device Price Review Board Act of 2016

This bill establishes the Prescription Drug and Medical Device Price Review Board within the Food and Drug Administration. Each manufacturer of a prescription drug or medical device that is sold in the United States must submit to the board:

 each type of prescription drug and medical device that it sells in the United States, or in a country that is a member of the Organization for Economic Co-operation and Development; the price charged by the manufacturer for the drug or device; and the costs of the manufacturer to produce them. The board must establish a formula for determining whether the average manufacturer price of a prescription drug or medical device over an annual quarter is an excessive price. Manufacturers may not charge excessive prices. Individuals may petition the board to determine whether the price for a prescription drug or medical device is excessive.

The board may subject violators to reduced patent terms, civil penalties, and increased Medicaid rebates. The bill amends the Internal Revenue Code to impose a tax on the sale of prescription drugs or medical devices that have excessive prices.

The board must allow individuals to import from approved counties prescription drugs and devices that are comparable to prescription drugs and devices with excessive prices.

Date: 2016-12-08
Topic: Health (Drug Coverage and Cost)
Subject: Health
Medicare Prescription Drug Price Negotiation Act of 2015

 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 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 plan.

Date: 2015-01-06
Topic: Health (Drug Coverage and Cost)
Subject: Health
Clay Hunt Suicide Prevention for American Veterans Act or the Clay Hunt SAV Act

 Requires the Secretary of Veterans Affairs (VA) to arrange for an independent third party evaluation, to be conducted by September 30, 2018, and each fiscal year thereafter, of the VA's mental health care and suicide prevention programs.

 Directs the Secretary to survey the VA's websites and information resources to publish a website that serves as a centralized source to provide veterans with information regarding the VA's mental health care services.

 Requires the Secretary to carry out a three-year pilot program to repay the education loans relating to psychiatric medicine that are incurred by individuals who:

 are eligible to practice psychiatric medicine in the Veterans Health Administration (VHA) or are enrolled in the final year of a residency program leading to a specialty qualification in psychiatric medicine; demonstrate a commitment to a long-term career as a psychiatrist in the VHA; and agree to a period of two or more years of obligated service with the VHA in the field of psychiatric medicine. Limits the loan repayment to no more than $30,000 for each year an individual performs such obligated service.

 Directs the Secretary to establish a three-year pilot program at not less than five Veterans Integrated Service Networks (VISNs) to assist veterans transitioning from active duty and to improve the access of veterans to mental health services. Requires the pilot program at each VISN to include: (1) a community oriented veteran peer support network carried out in partnership with an entity that has experience in peer support programs, and (2) a community outreach team for each medical center in such VISN.

Authorizes the Secretary to collaborate with nonprofit mental health organizations to prevent suicide among veterans. Requires the Secretary and any such organization to exchange training sessions and best practices.

Directs the Secretary to select a VA Director of Suicide Prevention Coordination to undertake any collaboration with nonprofit mental health organizations.

Extends for one year combat veterans' eligibility for VA hospital care, medical services, and nursing home care for illnesses that have not been medically proven to be attributable to their service, provided they: (1) were discharged or released from active duty between January 1, 2009, and January 1, 2011, and (2) did not enroll to receive such care during the five-year period of eligibility following their discharge or release.

Date: 2015-01-13
Topic: Health (Drug Coverage and Cost)
Subject: Armed forces and national security
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.

Date: 2015-04-23
Topic: Health (Drug Coverage and Cost)
Subject: Health
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.

Date: 2015-04-27
Topic: Health (Drug Coverage and Cost)
Subject: Health
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.

Date: 2015-05-05
Topic: Health (Drug Coverage and Cost)
Subject: Health
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.

Date: 2015-05-06
Topic: Health (Drug Coverage and Cost)
Subject: Commerce