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Daily News

December 12, 2018

FDA Commissioner Scott Gottlieb announced his agency will be discussing how to crack down on bad actors within the dietary supplement industry, including forming a working group to analyze how FDA could improve its oversight, reexamining the agency’s operating procedures, and potentially asking Congress for new authority in the space.

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Another web-based health insurance broker has been approved by CMS to utilize the new enhanced direct enrollment that allows consumers to enroll in coverage without having to first visit healthcare.gov.

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Consumers across the country are now able to use the enhanced direct enrollment pathway to sign up for qualified health plans, except for those in one state: Texas.

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December 11, 2018

HHS Secretary Alex Azar invited safety net hospitals on Tuesday (Dec. 11) to give him feedback on how the 340B drug discount program could be improved, but said HHS is concerned about the rapid expansion of 340B and will focus future reforms on “targeting the program to the populations it was intended to serve.”

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House Ways & Means Republicans put a spotlight on a package of bills Tuesday (Dec. 11) as part of their Medicare Red Tape Relief Project, including legislation to give providers an annual vehicle to tell CMS how to reduce administrative burden, codify CMS’ quality measure removal factors, permanently get rid of physician supervision requirements for critical access hospitals, repeal the 96-hour rule for critical access hospitals, and require prior authorization notification and a study on simplification.

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National Coordinator for Health IT Don Rucker told lawmakers on Tuesday (Dec. 11) he is optimistic that his office’s upcoming rule implementing the 21st Century Cures Act will be helpful in pushing providers to share data.

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FDA announced Tuesday (Dec. 11) in new guidance documents that when insulin is reclassified from a drug to a biologic in 2020, it will not qualify for the 12-year exclusivity that new biologics receive.

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FDA on Tuesday (Dec. 11) issued a proposed rule and a batch of guidance documents aimed at spurring biologics competition by bringing more biosimilars to market.

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Senate health committee Chairman Lamar Alexander (R-TN) called on think tank leaders to help craft legislation to lower health care costs, saying the federal government will not be able to cut health insurance costs until it can lower the overarching costs of healthcare.

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Senate health committee Chairman Lamar Alexander (R-TN) called on think tank leaders to help craft legislation to lower health care costs, saying the federal government will not be able to cut health insurance costs until it can lower the overarching costs of healthcare.

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The White House Office of Management and Budget on Friday (Dec. 7) began reviewing two parts of the advanced notice of Medicare Advantage and Part D changes for 2020, including the call letter and 2020 capitation rates.

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The Republican and Democratic senators who recently introduced a Medicaid-rebate bill support the House Medicare/Medicaid legislative package that their bill is being used to help pay for.

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Oklahoma is seeking CMS’ permission to add work requirements to its traditional Medicaid program -- a request expected to be closely watched because CMS Administrator Seema Verma has said the agency will be cautious about approving work requirements in non-expansion states.

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The PBM lobby said that the vendor role in the Trump administration’s Medicare Part B demo should be filled by entities such as pharmacy benefit managers or specialty pharmacies, but not by manufacturers in comments submitted to HHS and CMS on Thursday (Dec. 6).

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Pennsylvania Auditor General Eugene DePasquale recommends state lawmakers let Pennsylvania directly manage its prescription drug benefit and no longer rely on pharmacy benefit managers, which DePasquale says are raking in huge profits at the expense of taxpayers.

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December 10, 2018

The Supreme Court declined Monday (Dec. 10) to hear a pair of cases about whether states can block Medicaid money from going to clinics that provide abortions. The court’s decision not to take the cases leaves in place two lower-court rulings that said states violate federal law if they try to exclude Planned Parenthood from their Medicaid programs.

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CMS posted the estimated pass-through funding amounts that four additional state-based reinsurance programs can expect for the 2019 plan year, leaving Wisconsin and New Jersey as the only states for which figures are not yet publicly available.

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Outgoing House Ways & Means Committee Chairman Rep. Kevin Brady (R-TX) introduced a year-end tax package on Monday (Dec. 10) that delays the Affordable Care Act’s medical device tax, health insurance tax and “Cadillac tax,” and he told reporters he hopes the bill will pass with bipartisan support before Christmas.

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Insurers, beneficiary advocates, retailers and employers floated guiding principles they hope will drive an expected bipartisan effort by the incoming Congress to tackle “surprise medical billing,” and urged lawmakers to end surprise medical billing and standardize payments to out-of-network physicians.

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FDA released new draft guidance on Monday (Dec. 10) that agency head Scott Gottlieb and Deputy Commissioner Anna Abram say will make it more feasible for compounding pharmacies to become outsourcing facilities and ensure those facilities maintain current good manufacturing practices (CGMP).

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