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340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties (US Department of Health and Human Services Regulation) (HHS) (2018 Edition) The Law Library presents the complete text of the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties (US Department of Health and Human Services Regulation) (HHS) (2018 Edition). Updated as of May 29, 2018 The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), referred to as the "340B Drug Pricing Program" or the "340B Program." This final rule will apply to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. This final rule sets forth the calculation of the 340B ceiling price and application of civil monetary penalties (CMPs). This book contains: - The complete text of the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties (US Department of Health and Human Services Regulation) (HHS) (2018 Edition) - A table of contents with the page number of each section
340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties (US Health Resources and Services Administration Regulation) (HRSA) (2018 Edition) The Law Library presents the complete text of the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties (US Health Resources and Services Administration Regulation) (HRSA) (2018 Edition). Updated as of May 29, 2018 The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), referred to as the "340B Drug Pricing Program" or the "340B Program." This final rule will apply to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. This final rule sets forth the calculation of the 340B ceiling price and application of civil monetary penalties (CMPs). This book contains: - The complete text of the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties (US Health Resources and Services Administration Regulation) (HRSA) (2018 Edition) - A table of contents with the page number of each section
Civil Monetary Penalties (US Centers for Medicare and Medicaid Services Regulation) (CMS) (2018 Edition) The Law Library presents the complete text of the Civil Monetary Penalties (US Centers for Medicare and Medicaid Services Regulation) (CMS) (2018 Edition). Updated as of May 29, 2018 The Department of Health and Human Services (HHS) is issuing a new regulation to adjust for inflation the maximum civil monetary penalty amounts for the various civil monetary penalty authorities for all agencies within HHS. We are taking this action to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990 (the Inflation Adjustment Act), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. In addition, this interim final rule includes updates to certain agency-specific regulations to identify their updated information, and note the location of HHS-wide regulations. This book contains: - The complete text of the Civil Monetary Penalties (US Centers for Medicare and Medicaid Services Regulation) (CMS) (2018 Edition) - A table of contents with the page number of each section
"Health Resources and ServicesAdministration (HRSA), within in theDepartment of Health and HumanServices (HHS), oversees the 340BDrug Pricing Program, through whichparticipating drug manufacturers givecertain entities within the health caresafety net-known as coveredentities-access to discounted priceson outpatient drugs. Covered entitiesinclude specified federal grantees andhospitals. The number of coveredentity sites has nearly doubled in thepast 10 years to over 16,500.The Patient Protection and AffordableCare Act (PPACA) mandated that GAOaddress questions related to the 340Bprogram. GAO examined: (1) theextent to which covered entitiesgenerate 340B revenue, factors thataffect revenue generation, and howthey use the program; (2) howmanufacturers' distribution of drugs at340B prices affects covered entities' ornon-340B providers' access to drugs;and (3) HRSA's oversight of the 340Bprogram. GAO reviewed key laws andguidance, analyzed relevant data, andconducted interviews with 61 340Bprogram stakeholders selected torepresent a range of perspectives,including HRSA, 29 covered entities,10 manufacturers and representatives,and 21 others. Selection ofstakeholders was judgmental and thus,responses are not generalizable. "
The 340B Drug Pricing Program (340B Program) and the Medicaid Drug Rebate Program require manufacturers to provide discounts on outpatient drugs in order to have their drugs covered by Medicaid. These discounts take the form of reduced sales prices for covered entities participating in the 340B Program--eligible hospitals and federal grantees--and rebates on drugs dispensed to Medicaid beneficiaries, shared by states and the federal government. This book looks at important issues pertaining to the 340B Drug Pricing Program.
The Medical-Legal Aspects of Acute Care Medicine: A Resource for Clinicians, Administrators, and Risk Managers is a comprehensive resource intended to provide a state-of-the-art overview of complex ethical, regulatory, and legal issues of importance to clinical healthcare professionals in the area of acute care medicine; including, for example, physicians, advanced practice providers, nurses, pharmacists, social workers, and care managers. In addition, this book also covers key legal and regulatory issues relevant to non-clinicians, such as hospital and practice administrators; department heads, educators, and risk managers. This text reviews traditional and emerging areas of ethical and legal controversies in healthcare such as resuscitation; mass-casualty event response and triage; patient autonomy and shared decision-making; medical research and teaching; ethical and legal issues in the care of the mental health patient; and, medical record documentation and confidentiality. Furthermore, this volume includes chapters dedicated to critically important topics, such as team leadership, the team model of clinical care, drug and device regulation, professional negligence, clinical education, the law of corporations, tele-medicine and e-health, medical errors and the culture of safety, regulatory compliance, the regulation of clinical laboratories, the law of insurance, and a practical overview of claims management and billing. Authored by experts in the field, The Medical-Legal Aspects of Acute Care Medicine: A Resource for Clinicians, Administrators, and Risk Managers is a valuable resource for all clinical and non-clinical healthcare professionals.
Stepped-up efforts to ferret out health care fraud have put every provider on the alert. The HHS, DOJ, state Medicaid Fraud Control Units, even the FBI is on the case -- and providers are in the hot seat! in this timely volume, you'll learn about the types of provider activities that fall under federal fraud and abuse prohibitions as defined in the Medicaid statute and Stark legislation. And you'll discover what goes into an effective corporate compliance program. With a growing number of restrictions, it's critical to know how you can and cannot conduct business and structure your relationships -- and what the consequences will be if you don't comply.