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Daily News

December 03, 2018

Commercial entities that could serve as vendors between manufacturers and providers are a key part of the Trump administration’s proposed Medicare Part B demo, but it is still unclear which, if any, will decide to participate in CMS’ competitive selection process.

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Sen. Bill Cassidy (R-LA) told Inside Health Policy that he is in the early stages of developing a bill that would address payment models for high-cost prescription drugs such as gene therapies.

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CMS on Friday (Nov. 30) gave a green light to New Hampshire to move forward with a stringent program of Medicaid work requirements, as well as a transition of the state’s expansion population from the exchanges to Medicaid managed care and the elimination of retroactive coverage for beneficiaries in the expansion population.

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November 30, 2018

The parent company of Blue Cross Blue Shield of Florida and its subsidiaries recently filed suit in the U.S. Court of Federal Claims seeking reimbursement for cost-sharing reduction payments due in benefit years 2015 through 2017, when the administration shut off the payments.

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CMS, worried about potential nursing home staff inadequacies after looking at payroll-based staffing data, will send state survey agencies a list of nursing homes with reduced staffing so surveyors can follow up.

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Although Capitol Hill leaders have expressed little interest in doing anything health care-related during the remaining two weeks of the lame-duck session, a bipartisan group of senators is calling for a Senate vote on legislation to delay the health insurance tax.

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A case that could define the extent of CMS’ authority to issue legal interpretations without conducting notice-and-comment rulemaking will be argued before the Supreme Court on Jan. 15.

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Top HHS officials on Thursday (Nov. 29) said they weren’t afraid of using a firm regulatory hand to drive interoperability shortly after CMS Administrator Seema Verma said it would be easier for the agency to use Medicare requirements to compel hospitals and doctors, which received incentive payments for electronic health record use under the previously-called meaningful use program, to share health records with patients than to do so for post-acute care providers that were not part of meaningful use.

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In advance of World AIDS Day on Dec. 1, FDA announced a pilot program with the World Health Organization (WHO) that would provide WHO with FDA reviews of new HIV drug applications, thereby allowing WHO to make regulatory decisions about the new drugs faster and to share their decisions with regulators in developing countries with HIV-affected patient populations, FDA writes.

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Consumer advocacy group Families USA Thursday (Nov. 30) launched a new National Center for Coverage Innovation (NCCI) with a “two-track” strategy of developing and supporting near-term, pragmatic health insurance reforms, while also laying the groundwork for larger-scale federal changes.

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After six months and over 250 applications, FDA finally announced the eight winners of an innovation challenge in which medical device developers submitted to the agency their best ideas for preventing and treating opioid addiction.

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AbbVie announced Friday (Nov. 30) that it has reached an agreement to delay the launch of Pfizer’s biosimilar referencing the blockbuster arthritis drug Humira.

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November 29, 2018

The Trump administration released four policy concepts that states could pursue under the controversial new Section 1332 guidance out last month, including an accounts-based system that lets state direct public funds into a consumer account for the purchase of coverage and other health expenses.

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The incoming Democratic chairman of the House health care committees allege the Trump administration stepped outside the law by issuing guidance that gives states broad flexibility to use the law’s 1332 waivers to get around longstanding Obamacare guardrails, and they ask the agency to produce background information justifying its actions.

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Incoming Senate Finance Chair Chuck Grassley outlined his agenda for lowering drug prices in a floor speech Thursday (Nov. 29) that included praise for actions taken by the Trump administration but made no mention of HHS’ controversial proposal to base Medicare Part B reimbursement on drug prices set by foreign governments.

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A device industry lawyer alleges that FDA’s proposals to reform its 510(k) process violates the agency’s statutory authority, threatens to monkey around with the device market, and would increase the cost of device innovation and health care more generally.

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A medical device expert and former FDA staffer says that the Medical Device Enforcement and Quality Report released by FDA on Nov. 21 appears intended to dispel criticism that the agency does not take sufficient enforcement action when appropriate while also appealing to Congress for help with funding for device-related postmarket activities.

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FDA Commissioner Scott Gottlieb on Wednesday (Nov. 28) took to Twitter to condemn a Chinese researcher who made headlines after announcing he had edited the genes of a set of twin girls born this month using the CRISPR-Cas 9 gene editing tool.

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FDA once again issued a warning letter to an e-cigarette company for selling e-cigarette e-liquids with labeling or advertising that resembles kid-friendly food products and for illegally selling to a minor.

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The Health Resources and Services Administration quickly finalized a regulation to push up implementation of the 340B ceiling price and penalties rule to Jan. 1, saying the action will not interfere with HHS’ overall drug-pricing strategy and HRSA can continue with additional 340B rulemaking after the ceiling price and penalties regulation has been implemented.

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