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Daily News

April 19, 2019

State regulators, issuers and other experts balk at CMS’ proposal that would let employees buy a short-term plan using a Health Reimbursement Arrangement (HRA) for “excepted benefits,” arguing that healthier workers could rely on the less generous products instead of purchasing comprehensive coverage.

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Senate Majority Leader Mitch McConnell (R-KY) plans to introduce legislation in May that would raise the national minimum age to purchase tobacco products, including vaping devices, from 18 to 21, the senator announced Thursday (April 18).

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As part of a broader effort to reconsider its regulation of implantable medical devices, FDA on Thursday (April 18) announced the release of a draft guidance detailing the types of information manufacturers should include in premarket submissions for devices containing nitinol, an alloy of nickel and titanium.

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April 18, 2019

CMS Thursday (April 18) unveiled the final 2020 Notice of Benefit and Payment parameters, which the agency says aims to minimize significant regulatory changes and offer more stability to the exchange market.

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CMS has eschewed concerns from wide-ranging stakeholders and adopted a proposal to index premium adjustments to individual market estimates rather than the employer-sponsored rates currently used to measure growth.

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The Trump administration’s final exchange rule out Thursday (April 18) made no changes to the silver-loading mechanism used to mitigate the loss of cost-sharing subsidies, and said it would consider comments received on the proposed rule for future policy-making.

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CMS on Thursday (April 18) proposed to increase Medicare payments to inpatient psychiatric facilities by 1.7% in fiscal 2020 while adding a new quality measure intended to assess whether patients with certain diagnoses are filling their prescriptions after being discharged from such facilities.

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CMS announced Thursday (April 18) that it will allow exchange plans to stop allowing copay coupons from drug makers to count toward enrollees’ out-of-pocket maximums when generic equivalents are available.

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House Energy & Commerce Committee Chair Frank Pallone (D-NJ) and Florida Rep. Donna Shalala (D) on Tuesday (April 16) introduced a bill that would allow FDA to collect user fees for e-cigarettes, raise the minimum age to purchase tobacco to 21, prohibit online sales of tobacco products, ban all characterizing tobacco product flavors, require FDA to finalize rulemaking to implement graphic health warnings for cigarette packages, and hold all deemed tobacco products to the same advertising and sales requirements applied to combustible cigarettes.

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The heads of two major dietary supplement lobbies support establishing incentives for the dietary supplement industry, including the possibility of exclusivity, but they are adamant such incentives should not mirror exclusivity as it exists in the prescription drug space.

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CMS on Thursday (April 18) added more power wheelchairs and pressure reducing support surfaces to the list of durable medical equipment that must undergo prior authorization.

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FDA’s food center director Susan Mayne announced the agency will stay the course on its plan to have industry comply with food facility defense regulations beginning in July.

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FDA has ordered surgical mesh for transvaginal repair of pelvic organ prolapse (POP) manufacturers Boston Scientific and Coloplast to stop selling and distributing the products, the agency announced Tuesday (April 16).

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The House Judiciary Committee is planning a markup on the CREATES Act and pay-for-delay legislation, sources say.

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In a loss for the brand-drug industry, the U.S. Supreme Court on Monday (April 15) declined to hear Allergan’s appeal defending its sale of patents to a Mohawk tribe, leaving a lower court ruling against Allergan in place.

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Three bipartisan Senate bills to speed approvals of generics and insulin biosimilars were introduced Thursday, and Republican Sen. Cory Gardner, who faces a tough re-election race in Colorado, jumped on the drug-pricing bandwagon by sponsoring a bill to stop brands from abusing citizen petitions.

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Reps. Jan Schakowsky (D-IL) and Francis Rooney (R-FL) have reintroduced a bill that would require manufacturers to provide HHS with advance notice and justification of price hikes on prescription drugs.

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April 17, 2019

Inpatient rehabilitation facilities would receive a 2.3% pay bump under a proposed fiscal 2020 pay rule released by CMS Wednesday (April 17).

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Drug discount managers, switches, pharmacy services administrative organizations, third-party vendors: Those are new types of companies that could elbow their way into the new system that would be created by drug-rebate reforms.

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Top officials from UnitedHealth Group, the nation’s largest health insurer, blasted Medicare for All and other, similar public option proposals during a quarterly call with investors on Tuesday (April 16).

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