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Physicians Use FDA's Biosimilar Naming Plan To Lobby Against CMS Payment Proposal

A coalition of physicians is using FDA's plan to give biosimilars distinct names to lobby against CMS' payment proposal for such products.

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Key stakeholders praised HHS for proposing a long-awaited rule on the ACA's nondiscrimination provisions but said they are upset the administration didn't offer specific examples of discriminatory benefit design.

The Alliance for Safe Biologic Medicines (ASBM) says FDA should use “meaningful” four letter suffixes in naming biologics and biosimilars, rather than using suffixes “devoid of meaning” that the agency proposed as a naming scheme in a draft guidance and proposed rule released last week.

CMS is offering states an option to use Supplemental Nutrition Assistance Program eligibility or other means-tested program eligibility policies to determine whether certain populations are also eligible for Medicaid, a move the National Association of Medicaid Directors says could be helpful to states.

HHS' proposed revisions to its oversight of research involving human participants aim to strengthen participant protection, ease the regulatory burden on researchers and acknowledge new technological advancements, such as electronic health data.

The brand-name pharmaceutical industry is pleased with certain changes the Health Resources and Services Administration made that some say could restrict the scope of patients eligible to be treated with discounted drugs under the 340B program, but drug makers say HRSA's newly issued guidance doesn't go far enough to resolve their concerns about 340B program integrity.

The Medical Group Management Association is calling on CMS to extend the 2015 meaningful use reporting period so that providers will have enough time to implement changes to the program once the final rule laying out these changes is released.

HHS released for public comment proposed revisions to the regulatory oversight of research involving human participants, with the updates reflecting the significant growth in technology, expansion of scientific research into new areas and increased number of sites at which individual studies are conducted.

The first FDA-approved biosimilar may enter the market as soon as Thursday (Sept. 3) due to a federal appeals court's denial of Amgen’s emergency motion to block Sandoz from marketing its biosimilar Zarxio.