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Daily News

August 13, 2019

A federal appeals court on Tuesday (Aug. 13) reversed a lower court’s ruling and sided with CMS in a move that prevents hospitals from receiving Medicaid DSH payments to cover costs for which they have already been compensated by private insurers or Medicare.

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FDA warned domestic and foreign drug makers that beginning Sept. 12 it will inactivate drug listings in the National Drug Code (NDC) directory that haven’t been recently updated or certified or that include an establishment with an expired registration.

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The insurance industry on Monday (Aug. 12) joined the chorus of voices urging the Trump administration to reverse course on a proposed regulation that rolls back protections for transgender individuals or those who have ended a pregnancy, but it also wants the agency to maintain proposed changes to the Obama-era rule’s requirements on communications with consumers with limited English proficiency (LEP).

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Democratic presidential candidate and South Bend, Indiana Mayor Pete Buttigieg unveiled a rural health plan that closely mirrors that of other Democratic presidential candidates, including Sen. Elizabeth Warren’s proposals on reimbursement, telehealth and workforce disparities, and Sen. Michael Bennet’s call for CMS to adopt new payment policies to tackle social determinants of health.

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Analysts at McDermott Will & Emery say that some health care watchers believe prior authorization-like programs will become increasingly common in fee-for-service Medicare after CMS proposed adding prior authorization to certain hospital procedures in the proposed outpatient hospital rule for 2020, though stakeholders note those requirements are for a fairly small and specific set of circumstances.

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Democratic presidential candidate Sen. Kirsten Gillibrand (NY) released a rural health plan Wednesday (Aug. 7) that calls for expanding long-term services and supports (LTSS), but otherwise echoes the calls of other Democratic presidential candidates for more Medicare and Medicaid reimbursement and telehealth services as candidates increasingly focus on rural health in their presidential bids.

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August 12, 2019

The Trump administration on Monday (Aug. 12) finalized a controversial rule that will make it more difficult for legal immigrants who receive Medicaid to become permanent U.S. residents, drawing outcry from stakeholders across the health care industry who say the policy will drive up the number of uninsured patients and increase the costs of uncompensated care.

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John O’Brien, HHS’ top drug-pricing official, is stepping down after nine months and will be replaced by John Brooks, the principal deputy director of the Center for Medicare and formerly a White House Domestic Policy Council official, HHS announced Monday (Aug. 12). The departure comes after several of President Donald Trump’s marquee drug-pricing policies were blocked or pulled in recent months.

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FDA will hold a public meeting on Nov. 7 to solicit ideas on ways to improve the drug development process, including through new trial designs such as master protocols that could cross multiple therapeutic areas and be implemented in the near term, the agency announced Friday (Aug. 9).

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CMS cancelled the Medicare Advantage Qualifying Payment Arrangement Incentive Demonstration due to low participation rates, and some physicians may have opted not to participate partly because there was no ability to access bonuses from the Merit-based Incentive Payment System or the alternative pay models, according to the American Medical Group Association (AMGA).

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The controversial inflationary rebate policy in the Senate Finance Committee’s drug-pricing package could incentivize drug makers to raise prices before the bill would take effect in 2022, sources say.

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Brand drug makers’ return to price hikes this year helped CVS Health’s pharmacy benefit manager make a lot more money from rebates in the second quarter of this year than Wall Street expected, according to the company’s second quarter earnings report.

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August 09, 2019

Democratic presidential candidate Elizabeth Warren’s rural health plan would boost the authority of the Federal Trade Commission to oversee the health care industry after an FTC official in May said the commission lacks authority to adequately oversee mergers and anti-competitive behavior by hospitals.

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CMS put out a fact sheet to help providers make sure they are correctly billing for nursing home services -- and abiding by the so-called three-day stay requirement -- after the HHS Office of the Inspector General found CMS has not corrected problems that contributed to noncompliance.

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The House Energy & Commerce Committee wants CMS Administrator Seema Verma to testify this fall as part of the committee’s oversight of Medicare and Medicaid, a committee source told Inside Health Policy.

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A group of five senators, including 2020 presidential hopefuls Elizabeth Warren (D-MA) and Bernie Sanders (I-VT), pilloried drug-maker AveXis on Friday (Aug. 9) for not telling FDA it had manipulated testing data for its new gene therapy drug, Zolgensma, until after the drug’s approval.

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The White House Office of Management and Budget on Friday (Aug. 9) completed its review of a proposed rule by the Substance Abuse and Mental Health Services Administration to change the privacy scheme 42 CFR Part 2.

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CMS encouraged state Medicaid agencies on Thursday (Aug. 8) to alter state operational policies or state plans as needed to participate in a new model and allow emergency medical services (EMS) providers to administer on-scene treatment or transport a Medicaid beneficiary to a location other than a hospital and still receive Medicaid reimbursement.

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The White House budget office has wrapped up its review of FDA’s proposed rule to require color graphics depicting the negative health consequences of smoking be added to cigarette packages and in cigarette advertisements.

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FDA sent warning letters to four e-cigarette and hookah companies Thursday (Aug. 8) telling them to remove 44 flavored e-cigarette and hookah tobacco products from the market, as none of the products have received marketing authorization.

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