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Focus on Regulation

Tag Archives: healthcare

U.S. Senate passes bill requiring prescription drug ads to include prices (updated)

Update (9/18/2018): Last week, as the U.S. House of Representatives was reconciling its spending bill for the Health and Human Services Department (HHS) with the amendment package passed by the U.S. Senate that is discussed below, House Republicans declined to adopt S.Amdt. 3964, which would have provided HHS with $1 million to issue rules requiring pharmaceutical companies to list prices

Italy approves new provisions on informed consent and advance decision of medical treatments – Why it matters for clinical trials in emergency situations

On December 14th, 2017, the Italian Senate passed a long-awaited bill (DDL no 2801) governing the informed consent to medical treatments, which also allows individuals to express their wishes on medical treatments in the future (so-called advanced decision, sometimes also referred to as living will, and translated as “Biotestamento” in Italian ). Advanced decision of

Draft Fee Regulations – Attempts to Address Incentivising Loopholes

Section 18A of the South African Medicines Act (the “Medicines Act“) prohibits the supply of any medicine, medical device or in-vitro diagnostic device, according to a bonus system, rebate system or any other incentive scheme. Although no definitions in respect of these prohibited activities have been included in the Medicines Act, considerable guidance as to

CMS Proposes Network Adequacy Standards for 2017 as State Regulators Approve Network Access and Adequacy Model Law

On November 22, 2015, the National Association of Insurance Commissioners (NAIC) approved new standards designed to ensure that consumers have adequate access to doctors, hospitals, and other healthcare providers under health benefit plans that use provider networks. Read More: CMS Proposes Network Adequacy Standards for 2017 as State Regulators Approve Network Access and Adequacy Model

OIG Issues Supplemental Special Advisory Bulletin Expanding Guidance on Independent Charity Patient Assistance Programs

Likely in response to recent controversy and public scrutiny, on 21 May 2014, the Office of Inspector General issued a supplemental Special Advisory Bulletin regarding independent charitable organizations that provide cost-sharing assistance for prescription drugs, including to federal healthcare program beneficiaries. Read More: OIG Issues Supplemental Special Advisory Bulletin Expanding Guidance on Independent Charity Patient

FTC issues advisory opinion approving physician hospital organization’s clinical integration model

On February 13, 2013, the FTC staff issued a favorable Advisory Opinion to the Norman Physician Hospital Organization (Norman PHO) allowing it to move forward with its clinical integration plan. The Norman PHO, an affiliation of the Norman Regional Health System and approximately 280 participating physicians, seeks to transition from a messenger model when dealing