The Centers for Medicare & Medicaid Services (CMS) has released an amendment to the Bundled Payments for Care Improvement (BPCI) Advanced Participation Agreement (Amendment). The changes imposed by the 18-page amendment were largely based on input from stakeholders and streamlined aspects of the programme and reduced the burden on participants and non-organisers. If CMS incorporates the change into a modified and adapted participation agreement, participants have until October 1, 2019 (or any other date indicated by CMS) to accept the terms of this agreement and extend the term of the agreement until 2022. As regards the market division action, the Court found that the comparisons which previously allowed competition in Europe in the United States were not in themselves unlawful because they were not manifestly anti-competitive and the type of grant of patents, as recognised by the Supreme Court, supported the conclusion that an agreement to enter a geographical market previously protected by a patent was not a division of the market, otherwise, illegally in itself. In rejecting payment entitlements resulting from the same comparisons, the Court found that, pursuant to FTC v. Actavis, Inc., 570 U.S. 136 (2013), the parties are free to agree on transaction terms that allow for early entry before a patent expires. Thus, the Supreme Court precedent dictated that AbbVie`s comparisons allowed entry into the European market and the United States. Markets prior to abbVie`s patent expiration date were not antitrust-controlled repayment agreements, as the nominal period of non-competition between AbbVie and biosimilar producers was reduced from abbVie`s patent expiration date.

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