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Daily News

October 01, 2019

FDA notified device manufacturers, providers and patients on Tuesday (Oct. 1) that connected medical devices and health care networks that use certain communication software are vulnerable to potential cybersecurity attacks.

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More than 800,000 new beneficiaries would enroll in Medicaid within five years if Florida adopted Medicaid expansion, and the state’s costs would largely be offset by projected savings, according to a new report from Leavitt Partners.

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As CMS weighs policy options for setting 340B drug pay rates, it is being tugged in different directions by 340B hospitals, for-profit hospitals that don’t participate in the drug discount program, physicians and drug makers.

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September 30, 2019

The Trump administration is inviting states to participate in health-contingent wellness demonstrations for their individual markets that would lower premiums by up to 30% for people who meet certain health requirements.

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The proposed 2021 Notice of Benefit and Payment Parameters, which will lay out exchange-related policies and is expected to include revised guidance on drug co-pay coupons that was delayed for 2020, is now under review by the White House Office of Management and Budget.

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HHS reduced the backlog of Medicare appeals by about 25% as of June 30, according to a status report submitted to the federal D.C. district court, and the American Hospital Association said that reduction was the result of its lawsuit.

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The Department of Justice is now appealing U.S. District Judge Reed O’Connor’s ruling in a class action case -- DeOtte v. Azar - that bars HHS from enforcing the Affordable Care Act’s contraceptive mandate on essentially any individual or employer that objects to the requirement.

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The White House budget office has begun its review of a final CMS rule that aims to loosen various requirements in the landmark Medicaid managed care regulations adopted by the Obama administration in 2016.

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The White House budget office has begun its review of a final CMS rule that aims to loosen various requirements in the landmark Medicaid managed care regulations adopted by the Obama administration in 2016.

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A medical software industry lawyer called out what he sees as “absolutely horrible” and “legally wrong” language in the revised version of FDA’s clinical decision support software (CDS) draft guidance, which clarifies which CDS tools under the provisions of the 21st Century Cures Act are no longer classified as medical devices and thus are not regulated by FDA.

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A food industry alliance group founded and led by four of the largest food companies will meet with the White House Oct. 11 to discuss a draft FDA proposed rule that lays out nutrient content claims and defines the term “healthy,” which is currently under review by the White House Office of Management and Budget.

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FDA on Monday (Sept. 30) issued a draft guidance detailing the methods and best research practices stakeholders, especially drug makers, can use to find out what’s important to patients, including identifying the burdens of living with and treating a disease, as well as the benefits and risks in managing a disease.

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CMS continues to urge companies to take advantage of a new rule finalized in July that lets them fund tax-free health reimbursement arrangements for workers to purchase individual coverage on- or-off the health insurance exchanges and released a new tool that can help businesses with the decision-making process.

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September 27, 2019

CMS is signaling a continued effort to lower reimbursement for 340B drugs, even as a court suit over the agency’s earlier cuts continues, by collecting hospital data to back up future reimbursement rates.

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The White House Office of Management and Budget is reviewing a proposed regulation on transparency in cost-sharing for Affordable Care Act plans that likely stems from the president’s June Executive Order.

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President Donald Trump on Thursday (Oct. 3) is expected to sign an executive order on protecting and improving Medicare during a trip to The Villages, FL, according to the White House.

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Accountable Care Organizations on Friday (Sept. 27) again pushed against a new beneficiary notification requirement that is part of CMS’ ACO overhaul, but CMS says it won’t budge on the requirement just yet.

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House lawmakers on both sides of the aisle are concerned the chamber’s impeachment investigation could delay surprise billing legislation, but lawmakers from both parties say they still hope to pass a surprise billing fix by the end of the year.

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Consumer organizations say the federal government should create privacy regulations for health data in third-party apps that are not covered under the Health Insurance Portability and Accountability Act (HIPAA) amid efforts by California and consumer groups to regulate the privacy of that data.

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FDA is creating new Sentinel Coordination Centers via a five-year contract as part of its bid to grow the agency’s flagship Sentinel System into a vigorous national scientific resource, the agency announced Friday (Sept. 27).

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