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Daily News

October 11, 2019

A New York federal judge on Friday (Oct. 11) temporarily blocked the Trump administration’s so-called public charge rule to make it difficult for immigrants to become permanent U.S. residents if they briefly use Medicaid or other forms of public assistance.

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Federal appellate judges grilled a lawyer for the Trump administration on Friday (Oct. 11) over the administration’s policy allowing states to add work requirements to their Medicaid programs, with all the members of a three-judge panel -- two Democratic appointees and one Republican appointee -- expressing skepticism that work requirements can promote the goals of Medicaid.

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The Congressional Budget Office estimates that House Democrats’ bill to negotiating drug prices would save taxpayers $345 billion in six years, but that savings would come at the cost of 8 to 15 fewer drugs being invented over a decade -- FDA approves about 30 new drugs annually.

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FDA is examining the authorities it has under tobacco and drug regulations that it could bring to bear on suppliers and distributors that tamper with vaping products linked to the outbreak of lung illnesses that have now been identified in 49 states, the District of Columbia and the U.S. Virgin Islands, officials from FDA and the Centers for Disease Control and Prevention told reporters Friday (Oct. 11).

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Conservative advocacy group Americans for Tax Reform says the White House’s executive orders that aim to rein in agency regulations could provide a “strong basis” for federal lawsuits against FDA and HHS should the agencies move forward with a ban on flavored vaping products, which is expected to be implemented through guidance within weeks.

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CMS will begin to automatically enroll consumers into 2020 marketplace plans on Oct 15, ahead of the Nov. 1 start of open enrollment, according to a recent webinar.

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October 10, 2019

CMS is not conducting adequate oversight of hundreds of millions of dollars in administrative expenses tied to states’ implementation of Medicaid work requirements, the Government Accountability Office said Thursday (Oct. 10), and CMS rejected GAO’s recommendation to consider the administrative costs of such programs when looking at whether 1115 waivers are budget neutral.

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Medicare Advantage plans are offering transportation benefits, companionship programs, and pest control as part of their 2020 benefit packages, but beneficiary advocates and Oregon’s senators say the new Medicare Plan Finder tool doesn’t give enough information to beneficiaries on these benefits.

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Planned Parenthood Action Fund unveiled 89 endorsements for key House and Senate races as part of a $45 million campaign to combat the Trump administration’s changes to the Title X program and other reproductive health policies in the 2020 election.

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HHS is on the hook to pay potentially $24 million or so it allegedly netted from debts owed by Colorado’s failed ACA co-op since the department has no authority to override the state’s law governing liquidation priorities, the Federal Court of Claims ruled last week.

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Humira tops the list of seven drugs with the biggest unsupported price increases that collectively added $5.1 billion in U.S. drug spending, according to the Institute for Clinical and Economic Review, which published the inaugural annual list Tuesday (Oct. 8).

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California Gov. Gavin Newsom (D) on Monday (Oct. 7) signed the nation’s first state law discouraging settlements between drug makers that delay generic competition, sparking strong opposition from the generic drug lobby, which alleges the law is unconstitutional.

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President Donald Trump on Wednesday (Oct. 9) signed a pair of executive orders that, according to the White House, aim to create a transparent process for regulation and reduce regulatory burdens on small businesses. However, consumer advocacy organization Public Citizen says the orders could actually stall the expected FDA guidance that would impose a ban on flavored vaping products and chill future agency guidance.

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October 09, 2019

The Tenth Circuit Court of Appeals could soon deliver a ruling in the ongoing case on whether HHS wrongly assumed that the Affordable Care Act's risk adjustment program had to be budget neutral, and whether state-wide adoption of that policy means that average premiums in the risk adjustment methodology should stand.

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New proposals on the anti-kickback statute released Wednesday (Oct. 9) do not include any safe harbors for drug value-based pay arrangements, but HHS Secretary Alex Azar said the agency is still working on opportunities for such arrangements that he hopes to move on as soon as possible.

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Colorado’s proposed public option will be administered by private issuers, not the state, and similarly to Washington state’s version would lower premiums by up to 18% by capping provider payments to a percentage of Medicare.

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Lobbyists and stakeholders – including providers paid less by Medicare Advantage than fee-for-service Medicare -- are watching closely to see how the Trump administration intends to base Medicare fee-for-service rates on Medicare Advantage-negotiated rates and many say the recent executive order raises lots of unanswered questions, including whether the order would apply when MA pay rates are higher than fee-for-service rates.

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In line with House Republicans, Blue Dog Democrats on Tuesday (Oct. 8) urged House Speaker Nancy Pelosi to hold votes on several bipartisan drug pricing bills, instead of wrapping them into government price negotiation legislation that Republicans oppose.

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HHS on Wednesday (Oct. 9) released long-awaited proposals to change the physician-self referral and anti-kickback statute regulations aimed at easing providers’ participation in value-based pay models, including new, permanent exceptions to the Stark Law for value-based pay arrangements within and outside Medicare and a new safe harbor under the anti-kickback statute for certain incentives beneficiaries can access through CMS demonstrations.

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October 08, 2019

Days after CMS unveiled a tool to help employers who are thinking about funding a health reimbursement account that workers can use to buy individual coverage (ICHRA), a private company launched a similar, interactive affordability calculator and administrative platform that can facilitate the new coverage option finalized in July.

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