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Daily News

September 27, 2019

FDA on Thursday (Sept. 26) finalized software policy guidance that clarifies which clinical decision support (CDS) tools won’t be considered devices and thus can get around agency enforcement oversight.

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September 26, 2019

FDA’s plan to streamline its reviews of new drugs through a major reorganization effort has been approved by Congress, agency drug center director Janet Woodcock announced Thursday (Sept. 26).

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Families USA, along with 13 other organizations, launched a philanthropy-backed, half-million-dollar ad campaign encouraging lawmakers to pass legislation by the end of the year that ends surprise medical bills.

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A continuing resolution to fund the government and a number of so-called health extenders through Nov. 21 passed the Senate on Thursday (Sept. 26) and the president is expected to sign the legislation.

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Consumer advocates are urging CMS to extend for at least another year a policy that provides penalty relief for Medicare beneficiaries who did not enroll in part B due to misinformation about Affordable Care Act plans.

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Health care policy experts say FDA and CMS need new staff, training and resources from Congress in order to collaborate on real-world evidence that could be used simultaneously for regulatory evaluation and new payment models.

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FDA will issue its regulation on flavored e-cigarettes, which is expected to ban all flavored vaping products from the market, in the next few weeks, Acting FDA Commissioner Ned Sharpless told lawmakers at a House Energy & Commerce subcommittee hearing Wednesday (Sept. 25), during which lawmakers pressed the acting chief for an explanation as to why FDA decided two years ago to delay premarket application compliance deadlines for electronic nicotine delivery systems (ENDS) products, including e-cigarettes.

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September 25, 2019

Senate Finance Chair Chuck Grassley said he hopes to rally support from the president and more lawmakers for the drug pricing package he sponsored with Finance ranking Democrat Ron Wyden (OR) after the full bill text’s expected release Wednesday (Sept. 25) evening.

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CMS significantly revised its proposals for discharge planning requirements for hospitals, critical access hospitals and home health agencies in a final rule released Wednesday (Sept. 25) after providers had raised concerns about what they viewed as the overly prescriptive nature of some aspects of the planning and the burdens of others.

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CMS finalized a rule Wednesday (Sept. 25) that revamps the Conditions of Participation and Conditions of Coverage for hospitals, home health providers, transplant centers, ambulatory surgical centers and other providers and facilities by removing regulations that CMS deemed burdensome or unnecessary.

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The Democratic governor of Michigan on Monday (Sept. 23) signed legislation meant to soften the state’s planned Medicaid work requirements and, at the same time, called on the Republican-led legislature to do more to avoid coverage losses when the requirements take effect next year.

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Sen. Mark Warner (D-VA) filed paperwork forcing the Senate to vote on a resolution under the Congressional Review Act that would undo the Trump administration's policy that allows states to use Affordable Care Act 1332 waivers to navigate around the law's coverage requirements.

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Acting FDA Commissioner Ned Sharpless on Wednesday (Sept. 25) told lawmakers that implementing a user fee program for e-cigarette makers could help the agency with its electronic nicotine delivery system (ENDS) product enforcement activities.

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FDA on Tuesday (Sept. 24) announced the first FDA-approved vaccine for both monkeypox and smallpox, a disease that FDA biologics director Peter Marks said many Americans have no immunity to and that could pose a national security threat if it were released intentionally.

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BURBANK -- Representatives from California’s Attorney General Office and Department of HHS expressed confidence the Affordable Care Act would survive the latest legal challenge and stressed, if the law were to be overturned, California would try to protect consumers but it would be impossible to fully mitigate the loss of federal funds.

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September 24, 2019

The House Democrats’ impeachment inquiry all but kills the chances of House Speaker Nancy Pelosi (D-CA) striking a deal on drug pricing with President Donald Trump, lobbyists and analysts say, though they had always said there was little prospect in government drug price negotiation becoming law.

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CMS Administrator Seema Verma called on insurance plans to work with CMS to drive value-based arrangements, warning that, while premiums are going down for Medicare Advantage plans, private insurers could become obsolete if Medicare for All were to move forward.

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Lawmakers are searching for a way to penalize private equity-backed physician staffing firms that rely on surprise billing as part of their business model, but experts say that it is nearly impossible to target these “bad actors” without handicapping the entire system.

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California Assemblyman Richard Bloom (D) last week succeeded in his long-term effort to get the legislature to pass a bill requiring that all issuers in the state cover hearing aids for children, but he pulled the measure before it was officially sent to Gov. Gavin Newsom due to concerns raised by the governor’s office, including whether the bill runs afoul of Affordable Care Act age discrimination requirements by focusing on children, a Bloom aide says.

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CMS Administrator Seema Verma said a recent court ruling that found CMS didn’t have the authority to implement site-neutral pay cuts for certain clinic visits was a setback to agency efforts to correct market distortions, and she pushed back on what she called “[e]ndless litigation from entrenched special interests.”

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