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Daily News

December 15, 2018

The White House cheered the Texas federal district court's decision late Friday to toss out the entire Affordable Care Act along with the individual mandate as Democrats and key healthcare stakeholders blasted the ruling, but all parties noted the law will remain in effect pending appeal. California Attorney General Xavier Becerra immediately announced he would appeal Judge Reed O'Conner's sweeping ruling.

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December 14, 2018

The Trump administration knew that its move to nearly eliminate the Affordable Care Act’s marketing and outreach budget would significantly affect enrollment, according to a series of e-mails obtained by the watchdog group Democracy Forward.

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The Medicaid and CHIP Payment and Access Commission is considering draft recommendations to alter two key areas of hospital payment policy in Medicaid: disproportionate share hospital payments and the upper payment limit for hospitals.

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CBO on Thursday (Dec. 13) added two options to reduce Medicare Advantage plan payments to its suggestions on ways to reduce the deficit -- change payments to plans for beneficiary health risks and reduce quality bonus payments to MA plans.

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The Medicaid and CHIP Payment and Access Commission discussed recommending that Congress or CMS create “safe harbors” for the Medicaid best price rule to allow states to experiment with new payment models for high-cost prescription drugs.

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Reducing the federal Medicaid match is one of the options laid out by the Congressional Budget Office in its latest report on ways to reduce the deficit, released Thursday (Dec. 13).

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CMS on Friday (Dec. 14) approved New Mexico’s request to add premiums and copayments and waive retroactive coverage for some beneficiaries in its Medicaid program, including drug copayments in some situations.

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Janssen Pharmaceuticals, which is a subsidiary of Johnson & Johnson, announced Thursday (Dec. 13) that it entered into an outcome-based contract with Oklahoma’s Medicaid program for a long-acting injectable drug used to treat schizophrenia.

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December 13, 2018

The Congressional Budget Office once again included dozens of health-related policies in its list of deficit reduction concepts that could be used for offsets over the 10-year budget period, and one of the largest revenue raisers would be to repeal the forthcoming 40 percent tax on high-cost employer plans -- or the “Cadillac” tax -- and instead limit the open ended tax exclusion for employer-sponsored insurance (ESI).

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FDA on Thursday (Dec. 13) scrapped a controversial generic drug labeling proposal that would have allowed generic drug makers to update their drug labels with new information independent of labeling changes to the brand reference product.

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CMS says it is committed to providing Americans in need of insurance coverage with a seamless experience through healthcare.gov even as consumer advocates express deep concerns that the administration has upended the process by cutting funds and, most recently, overhauling the page on the website that describes ways to apply for coverage.

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A medical device industry lawyer says a newly unveiled FDA final rule on medical device classification and reclassification improves on the 2014 proposed rule, and it could indicate the agency intends to reclassify more devices as it moves to update its 510(k) process.

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Doctors, hospitals, insurers and others across the health care industry are urging the Department of Homeland Security to withdraw its proposed rule that would make it more difficult for legal immigrants who receive Medicaid and other public benefits to become permanent residents.

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The Congressional Budget Office’s Dec. 7 publication of its cost estimate for the Senate’s over-the-counter monograph reform bill bolstered stakeholders’ hopes that the bill might pass the upper chamber before the end of the lame-duck session.

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December 12, 2018

CMS tells Inside Health Policy that the agency is still having conversations with officials in New Jersey and Wisconsin over federal reinsurance funding, which is why the agency has not yet posted either state’s estimated federal pass-through funding amounts for their 2019 plan year programs.

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The HHS Office of Civil Rights is asking for feedback on how to change the Health Insurance Portability and Accountability Act to remove obstacles to efficient care coordination while also protecting patients’ health information, as well as how to encourage providers to share information for treatment and care coordination, making it easier to share information with parents and caregivers and dealing with the opioid crisis.

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HHS Secretary Alex Azar said Wednesday (Dec. 12) he does not know why Obamacare enrollment numbers continue to drop, arguing that the administration has taken several steps to stabilize the marketplace.

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The top regulatory officer at HHS said Wednesday (Dec. 12) that rebates are an “obvious problem” driving up list prices for prescription drugs, and noted that Pfizer recently raised list prices to make up for rebates it pays to pharmacy benefit managers.

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Heading into 2019, FDA plans to step up pharmaceutical enforcement and improve its inspection assessments using digital tools, FDA Commissioner Scott Gottlieb said Wednesday (Dec. 12).

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FDA issued final guidance intended to clarify the role data integrity plays in current good manufacturing practices (CGMP) for drugs and to promote partnerships between FDA and its international regulatory counterparts on best practices on data security to help manufacturers advance their own compliance policies, FDA Commissioner Scott Gottlieb said Wednesday (Dec. 12).

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