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Daily News

February 12, 2019

Utah will ask CMS for permission to partially expand its Medicaid program after Gov. Gary Herbert (R) signed a bill Monday (Feb. 11) that significantly scales back the state’s voter-approved Medicaid expansion plan.

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As the American Hospital Association pushes back against a CMS proposal that hospitals be required to send electronic notifications to community providers when a patient is admitted, discharged or transferred, the agency signals that more Medicare data sharing requirements may be on the way.

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Prominent House Republicans are discussing legislation to obviate the ongoing legal threat to the Affordable Care Act by fully repealing the individual coverage requirement, but Democrats are unwilling to tamper with the Obamacare statute and don’t want to make any moves that could threaten the health law or tamper with the ongoing appeals process.

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This week is the deadline for CMS to say how Medicare will pay hospitals for expensive CAR-T cancer treatments, and that first-of-its-kind national coverage decision will set a precedent that likely spills over into the commercial market.

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February 11, 2019

FDA Commissioner Scott Gottlieb on Monday (Feb. 11) said he hopes to start a “public conversation” about reforming 1994 dietary supplement law to expand the agency’s authority, including in the exclusivity space, coming as FDA also takes steps to beef up its current oversight of the industry.

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The Trump administration’s focus on price transparency has not omitted the health insurance space: CMS is exploring ways to increase price transparency in exchange plans and is seeking feedback from stakeholders on ways to help consumers understand their cost-sharing responsibilities.

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The Office of the National Coordinator for Health IT on Monday (Feb. 11) unveiled a long-awaited proposed rule implementing the 21st Century Cures Act’s call to prevent information blocking and laying out seven exceptions to what Congress defined as blocking the sharing of electronic information. ONC also asks for information on what pricing information could be included as part of electronic health information to help the public see what they are paying for health care.

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CMS on Monday (Feb. 11) unveiled proposals to impose new interoperability requirements on providers, including new conditions of Medicare participation for hospitals as well as new stipulations for Medicare Advantage, Medicaid and exchange plans.

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Two FDA advisory panels on Tuesday (Feb. 12) will discuss the safety and efficacy of a novel esketamine drug-device combination intended to treat treatment-resistant depression (TRD), with the proposed treatment marking the first antidepressant product for which a randomized withdrawal trial was used to help show efficacy.

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More than 300 House lawmakers touted supplemental benefits for the chronically ill in Medicare Advantage as part of an annual letter praising the program, and they also urged CMS to do as much as possible to build on the broader category of supplemental benefits the agency authorized last year.

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February 10, 2019

The Department of Justice on Friday (Feb. 8) asked the Fifth Circuit Court of Appeals to reject a request by the Democratic-led House to intervene in Texas v. Azar to defend the Affordable Care Act.

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February 08, 2019

The White House is pushing back on Democrats’ claims of Obamacare “sabotage” with a new report saying that the Trump administration's regulatory changes to the Affordable Care Act will create $453 billion in benefits for consumers and taxpayers over the next 10 years.

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Capping out-of-pocket Part D costs is a priority for the administration, but HHS Secretary Alex Azar told patient advocates that lowering drug list prices comes first, according to sources familiar with the conversations.

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Hospitals are pleased that a bipartisan group of senators on Wednesday (Feb. 6) reintroduced the Resident Physician Shortage Reduction Act, which would add 15,000 additional Medicare-funded residency slots over five years, shortly after Sen. John Barrasso (R-WY) expressed concerns that graduate medical education funding needs to be reworked to better help rural areas.

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Sen. Sherrod Brown (D-OH) and House Democrats are pushing sister bills to curb rising drug prices: one would direct Medicare to negotiate drug prices and let the government force generic competition before patents and exclusivities expire when negotiations fail; the other would penalize companies that price gouge.

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Five Democratic senators, including a presidential candidate and another potential candidate, introduced a bill to let the government condition drug exclusivity on companies keeping price increases in the single digits.

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FDA on Friday (Feb. 8) updated its public list of brand drugs for which generic drug makers complain they can’t get a hold of the samples needed for generic development.

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Device industry lawyers believe FDA’s move toward allowing use of objective performance criteria to evaluate certain new medical devices, rather than relying on predicate devices, could improve the agency’s 510(k) process by creating a more streamlined pathway for well-understood devices.

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February 07, 2019

The House Energy & Commerce Committee officially identified three pieces of legislation it will push to reverse the Trump administration’s actions to unravel the Affordable Care Act.

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NEW ORLEANS -- Senate Finance Committee Chairman Sen. Chuck Grassley (R-IA) and Sen. Patrick Leahy (D-VT) introduced a bill Tuesday (Feb. 5) that they say would lower drug prices by blocking tactics brand-drug makers use to delay generic drug development by withholding drug samples.

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