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Draft Guide On Rx-Price Reports Rekindles Debate Over Non-Interference

Pharmacies support CMS' draft guidance on how Part D sponsors should report prices concessions negotiated with pharmacies, but critics such as the Pharmaceutical Care Management Association say it violates the "non-interference clause" of the Social Security Act and will drive up drug costs for beneficiaries.

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Amgen has sued Sandoz, the first domestic biosimilar applicant that seeks to copy an Amgen product, charging the biosimilar applicant violated the law's patent exchange process by not sharing its manufacturing information -- a move closely watched by stakeholders because the outcome may drive key patent policies as FDA begins implementing the health law's new biosimilar pathway.

The outcome of six close gubernatorial races on Tuesday (Nov. 4) -- in Alaska, Florida, Georgia, Kansas, Maine and Wisconsin, which currently have Republican governors -- could determine whether those states look to expand Medicaid under the Affordable Care Act in 2015.

CMS is looking to launch a pilot to provide integrated care similar to the Program of All-Inclusive Care for the Elderly to a younger population, according to one CMS official.

Sens. Amy Klobuchar (D-MN) and Chuck Grassley (R-IA) Wednesday (Oct. 29) asked the Federal Trade Commission for updated data on patent settlement agreements, saying the data would help inform their legislative strategy in light of a recent Supreme Court decision.

HHS officials, including those from CMS and the Office of Medicare Hearings and Appeals, laid out a number of steps the agency has taken to work through the backlog of claims at the third level of appeals and said more changes are on the way, including potential adjustments to some of OMHA's pilot programs and allowing those appealing claims to discuss their situations with those deciding the cases at lower levels of appeals.

The Occupational Safety and Health Administration in a tentative regulatory step toward fighting infectious disease transmission in health care settings floats the idea of written, highly specific control plans, which sources say is outside the traditional OSHA approach and akin to injury and illness prevention programs.

CMS next year will likely propose the first revisions to the Medicaid managed care regulations in 12 years, a CMS official said Tuesday (Oct. 28) at a Medicaid Health Plans of America conference.

The HHS Office of Inspector General is expected to publish within the next month a report on Medicaid managed care plans that likely will highlight inaccurate provider directories, CMS Director of the Division of Managed Care Plans James Golden said.