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Daily News

December 15, 2017

Sen. Bob Corker (R-TN) said Friday (Dec. 15) that he flipped his vote on the GOP tax bill to a yes, likely guaranteeing the bill’s passage in the Senate.

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The Federal Circuit dealt what appears to be the final death blow against Amgen's arguments in the suite of cases between the company and Sandoz over interpretation of the so-called biosimilar patent dance.

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CMS on Friday (Dec. 15) confirmed that due to high consumer enrollment demand this year, like in previous years, anyone who leaves their name with the call center prior to the open enrollment deadline will be contacted by a call center employee and can still enroll for coverage starting Jan. 1, 2018.

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While House Republican leaders say they will tackle entitlement reform in 2018 -- which could include Medicare and Medicaid cuts -- lobbyists and analysts say it would be difficult for such cuts to get through the Senate, especially in light of Senator-elect Doug Jones' (D) recent win in Alabama.

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Congressional Medicaid advisers on Thursday (Dec. 14) debated the merits of policies on the calculation and oversight of drug rebates, including giving CMS more power over classifying drugs as brands for determining rebate amounts.

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Despite bipartisan interest in the House and Senate to provide additional funding to combat the opioid epidemic, neither chamber has any concrete plans to add money to a year-end budget deal as Congress runs up on the final weeks of the year.

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December 14, 2017

Beneficiary advocates Thursday continued to call on CMS to extend the open enrollment period or at the very least employ a special enrollment period that would allow consumers who started the application process but were unable to finish by the Dec. 15 deadline to enroll in a plan.

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FDA is planning a number of deregulatory moves in 2018, including expanding access to some drugs currently requiring prescriptions without the intervention of a health care provider, so long as they are coupled with safe guards to aid in self-selection and safe use, the agency announced in the White House Office of Management and Budget's Fall 2017 Unified Agenda released Thursday (Dec. 14).

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House Speaker Paul Ryan (R-WI) said Thursday (Dec. 14) that the GOP will revisit problems with the Affordable Care Act in 2018, but did not specify in what way, and also said Republicans plan to pass entitlement reform through the reconciliation process next year, specifically pointing to welfare while not mentioning Medicare, Medicaid or Social Security.

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Sen. Susan Collins’(R-ME) vote for the final GOP tax bill may be in jeopardy, as funding for cost-sharing reductions and reinsurance was not included in the Dec. 22 Continuing Resolution and the House Freedom Caucus says the two policies likely will now reach the House floor in January, as a part of an omnibus.

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Lobbies representing agents and brokers say their industry continues to play a key role in enrolling individuals in qualified health plans and are pleased with CMS' work to improve their exchange experience, but stress that because so many exchange plans have lowered or axed commissions it may be difficult to maintain that role in future years.

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FDA Commissioner Scott Gottlieb on Monday (Dec. 4) announced the agency will establish a regulatory framework for how it regulates nontraditional manufacturers of 3D-printed medical devices.

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December 13, 2017

House Republicans on Wednesday (Dec. 13) added the CHIP bill they already passed, including partisan offsets, to a must-pass bill to fund the government until Jan. 19.

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Representatives of the drug-distribution sectors argued over the causes of drug prices at a House Energy & Commerce health subcommittee hearing Wednesday (Dec. 13), but lawmakers were left with unanswered questions and committee Chair Greg Walden (R-OR) said the subcommittee will likely hold another hearing on drug prices early next year.

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The preliminary tax deal hammered out by House and Senate GOP leaders includes the Senate provision to repeal the ACA's individual mandate, and is expected to lower the medical expense deduction threshold to 7.5 percent of income as proposed by the Senate, whereas the House would have scrapped the deduction.

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More than 1 million Americans selected plans from Dec. 3 through Dec. 9, the sixth week of open enrollment that ends on Friday (Dec. 15), and nearly 4.7 million have signed up for coverage since Nov. 1, CMS announced Wednesday (Dec. 13).

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Next year the administration will continue to divvy up set-aside funds for states to fight the opioid epidemic based on a state's population, rather than need, Assistant Secretary for Mental Health and Substance Use Elinore McCance-Katz told senators Wednesday (Dec. 13).

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Brand drug companies and industry-supported patient advocacy groups are attempting to use FDA’s reexamination of the Hatch-Waxman drug patent framework to push for greater exclusivity protections, which would further delay potential generic competition.

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The Association for Accessible Medicines wants FDA to exert greater pressure on brands thought to be manipulating Risk Evaluation and Mitigation Strategies (REMS) to block generic competition.

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Neither the brand nor the generic drug lobby appear keen on FDA Commissioner Scott Gottlieb’s idea to publish the letters it sends to brand companies explaining that a potential generic competitor has adequate safety protections in place to be sold brand drug samples for the bioequivalence testing required as a prerequisite of generic approval.

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