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Daily News

May 18, 2018

Medicare beneficiary advocates allege CMS' draft “Medicare & You” handbook for 2019 distorts the facts surrounding traditional Medicare and Medicare Advantage by suggesting MA is the cheaper option, describing MA prior authorization as a “right,” and failing to note traditional Medicare's broader provider network.

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Durable medical equipment and oxygen lobbyists say CMS' recent move to raise Medicare reimbursement for DME in the second half of 2018 offers much needed relief for rural areas, but they are upset the interim final rule didn't extend that pay raise to other non-competitive bid areas, aside from Hawaii and Alaska.

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The House, in rejecting the farm bill Friday (May 18), sank a provision that would have created agricultural Association Health Plans. The provision would have authorized $65 million for the secretary of Agriculture to create up to 10 loans and grants to help support the creation of the plans.

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CMS is writing another Part D rule, according to the unified agenda that outlines agency rulemaking plans, and Ross Margulies, an associate at Foley Hoag, expects that many of the president’s proposals to curb drug prices will be included in that rule.

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The House Energy & Commerce Committee approved 32 opioid-related bills on Thursday (May 17), including a bill that would weaken privacy protections for medical records containing information about substance use disorders and a watered-down version of a bill that would allow Medicaid to cover treatment for opioid use disorder in large inpatient treatment centers.

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May 17, 2018

CMS officially put drug plans on notice to stop using so-called gag orders that prohibit pharmacists from telling customers when it is more expensive to use insurance to buy drugs.

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The House will vote next week on the Right to Try bill passed out of the Senate last August, House leadership said Thursday.

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FDA's long-awaited list of brand drugs for which generics have sought the agency's help in obtaining the samples necessary for testing and approval confirms that Risk Evaluation and Mitigation Strategies are not the only tool used by brands to withhold samples.

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CMS' Medicare Evidence Development & Coverage Advisory Committee will meet in August to consider a National Coverage Determination for chimeric antigen receptor (CAR)-T cell therapies after UnitedHealthcare requested such a determination to make sure there is a level playing field across Medicare for coverage of the expensive therapies.

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Insurers in the Affordable Care Act’s individual market made a profit in 2017 as premiums increased on average by 22 percent, leaving many in a profitable position for the first time since the ACA took effect, despite constant uncertainty surrounding Obamacare, according to new analysis by the Kaiser Family Foundation using data from the National Association of Insurance Commissioners.

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Virginia Democratic Sens. Tim Kaine and Mark Warner are asking HHS Secretary Alex Azar to immediately take steps to help stabilize the individual insurance marketplace and protect consumers from premium hikes.

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CMS' chief actuary says the Trump administration’s proposed rule on short-term health plans could have a much larger impact on the Affordable Care Act markets and federal spending than the agency originally estimated, with the actuary now estimating the plans could attract 1.4 million consumers and increase federal spending by $1.2 billion in the first year alone.

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FDA on Wednesday (May 16) approved US WorldMeds LLC’s Lucemyra, the first agency-approved non-opioid treatment for mitigating the symptoms of opioid withdrawal.

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Specialists with a big stake in Part B warn HHS that following through with the administration’s proposal to let Part D plans negotiate Part B drug prices would cause patients to face access restrictions in Part D that they don’t have to deal with in Part B.

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FDA, as it crafts a new framework to regulate artificial intelligence used in medical products, is simultaneously partnering with Harvard to look into how AI also could be used as a regulatory tool.

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The House Ways & Means Committee approved Wednesday (May 16) six relatively uncontroversial and bipartisan bills aimed at reducing opioid abuse in Medicare.

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May 16, 2018

The House Appropriations Committee approved Wednesday (May 16) a fiscal 2019 FDA spending bill, and in the process tacked on a controversial tobacco amendment that several Democrats and one Republican argued would essentially rewrite the Tobacco Control Act and weaken FDA’s ability to regulate tobacco products, especially e-cigarettes and cigars that appeal to youth.

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House appropriators added to their FDA spending bill Wednesday (May 16) a measure calling for FDA to analyze MedWatch data to see whether certain television advertisements -- specifically those from legal firms or marketing firms that warn consumers of dangers associated with specific medicines -- affect medication adherence.

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A federal appeals court on Wednesday (May 16) dismissed the administration's appeal of a lower court ruling on the ACA's cost-sharing reduction payments, effectively ending House Republicans' participation in the matter.

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A federal court in Texas has agreed to let 17 Democratic attorneys general intervene in a lawsuit to defend the Affordable Care Act against 20 GOP-states that say the law is unconstitutional and should be tossed now that Congress has repealed the individual mandate.

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