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Daily News

June 18, 2019

Senate health committee Chairman Lamar Alexander (R-TN) told his colleagues that he favors the network-matching proposal to end surprise medical bills, despite pushback from physicians, providers and other stakeholder groups.

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CMS has determined that the 1332 waiver applications recently submitted by Colorado and North Dakota are complete and has opened the federal public comment period through July 5.

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Senators and stakeholders on Tuesday (June 18) said parts of the Senate health committee’s bipartisan package to lower health costs would particularly help rural areas, including provisions on maternal health and telemedicine, but some said more could be done.

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FDA has expanded its patent certification list to include additional data that can help subsequent generic drug applicants determine when their products can be approved and marketed, the agency announced Tuesday (June 18).

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American Hospital Association Executive Vice President Tom Nickels said the group plans to make information from 1,100 hospitals on how they use the 340B drug discount program public and to share information from AHA’s voluntary transparency initiative with the Health Resources and Services Administration.

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Senate health committee Chair Lamar Alexander (R-TN) told Sen. Robert Casey (D-PA) and the rest of the health committee he is committed to finding a path forward for over-the-counter drug monograph reform legislation that has stalled in the Senate.

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Some biologics experts are perplexed by the Trump administration’s argument that subjecting biologics products to United States Pharmacopeia (USP) monographs would hamper innovation.

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Americans for Safe Access and data company Aurelius Data Inc. have partnered to develop a research platform that will compile use, perception and biometric data on consumers who are using cannabis products to help their medical conditions, and will make those insights available in a subscription-based database that allows users to see what regimens patients are using.

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Senate health committee Chair Lamar Alexander (R-TN) said Tuesday (June 18) that his committee will mark up its bipartisan legislation to lower health costs next week.

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June 17, 2019

CMS on Monday (June 17) offered Inpatient Rehabilitation Facilities the option to settle certain Part A appeals for partial payment -- and in certain instances full payment -- as the agency seeks to cut down the backlog of Medicare appeals.

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CMS proposed a new rule on Monday (June 17) that would streamline the electronic prior authorization process for Medicare Part D by sidestepping certain Health Insurance Portability and Accountability Act (HIPAA) requirements and requiring Part D plans implement transaction standards developed by the National Council for Prescription Drug Plans (NCPDP).

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The Energy & Commerce health subcommittee's hearing on solutions to end surprise billing, held last Wednesday (June 12), underscored that while policymakers and stakeholders agree patients should be shielded from unexpected medical bills, there are still wide gaps in opinion regarding who should be responsible for the costs.

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The Pharmaceutical Research and Manufacturers of America is running attack ads that say AARP cares more about insurers than seniors, but AARP says the poll that PhRMA is relying on for that message is so misleading that the seniors’ group filed a complaint with the organization that guards against push polling.

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Former FDA Commissioner Scott Gottlieb named payer tactics as one of the biggest obstacles facing the gene therapy space, as novel drugs seeking coverage after receiving FDA approval are often viewed by payers as not having enough data on which to base a coverage decision.

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The House on Thursday (June 13) voted to add an amendment to its fiscal 2020 HHS funding bill that would increase funding for Graduate Medical Education by $5 million and pay for that by cutting Department of Education funding.

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FDA made a sizeable notch in its enforcement belt on Friday (June 14), announcing that it requested U.S. Marshals seize $3.5 million worth of dietary supplements.

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After a patient died and another developed an invasive infection from fecal microbiota transplantation (FMT) treatment, which is not approved by FDA, the agency issued a safety alert urging health care providers to communicate the risks of the treatment to their patients, and to test stool donors and stool samples for multi-drug resistant organisms (MDROs) before use.

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June 14, 2019

Amgen, Merck and Eli Lilly on Friday (June 14) filed a lawsuit to block the Trump administration from forcing drug makers to disclose drug prices in advertisements.

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CMS Administrator Seema Verma cautioned the Trump administration against finalizing proposed policies that could undermine the Affordable Care Act, including banning silver-loading, cutting ACA subsidies and ending auto reenrollment, according to an internal agency memo.

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CMS and the HHS Office of Inspector General are at loggerheads on how best to detect abuse and neglect of beneficiaries, with the OIG touting a close look at claims data as a solution and CMS preferring to rely on work by state survey agencies.

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