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Daily News

April 23, 2019

FDA again is extending the period of time during which it will not enforce certain combination product postmarketing safety reporting requirements, the agency announced via an updated guidance on Tuesday (April 23).

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A month after reporting it received tens of thousands of adverse events associated with surgical staplers and staples, FDA is stepping up its regulation of the devices by: issuing a proposed order to upclassify the Class I devices as Class II; issuing draft guidance on labeling recommendations to ensure adequate use; and scheduling a public meeting on May 30 to gather input on the first two efforts.

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Ohio Attorney General Dave Yost (R) on Monday (April 22) called for the Ohio legislature to enact four policies targeting spread pricing practices by pharmacy benefit managers that would route all state drug purchases through a single PBM contract, give the state auditor unrestricted authority to review all PBM drug contracts, make PBMs fiduciaries and ban nondisclosure agreements regarding drug pricing with the state.

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FDA and Duke University’s Robert J. Margolis, MD, Center for Health Policy will host a meeting May 16 to gather input on how to apply the agency’s benefit-risk framework throughout the human drug lifecycle and how to communicate information relating to benefit-risk assessments.

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April 22, 2019

HHS on Monday (April 22) announced new models for primary care -- Primary Care First and Direct Contracting -- that are designed to encourage primary care providers to take on more financial risk for the outcomes of their patients and are projected to encompass a quarter of all fee-for-service Medicare beneficiaries.

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Total Medicare costs are expected to grow from about 3.7% of gross domestic product to 5.9% of GDP between 2018 and 2038, with the Hospital Insurance Trust Fund only expected to pay fully for Medicare Part A until 2026 -- a projection that is unchanged from last year -- according to the Medicare trustee’s report released Monday (April 22).

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Lawmakers in two Western states are only a few steps away from approving legislation that could result in government-sponsored health plans competing for the first time in the Affordable Care Act’s health insurance exchanges.

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Medicare Trustees lowered their estimated spending projections for retail drugs in large part because rebates are bigger than they expected, and the health insurance lobby says that finding bolsters their case against HHS’ plan to eliminate rebates.

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A federal appeals court has agreed to expedite its consideration of the two cases challenging the legality of Medicaid work requirements after CMS asked that the cases be accelerated.

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A measure that would allow Florida to import prescription drugs from Canada is likely to pass the state legislature before it adjourns on May 3, the senate president’s office said Friday (April 19).

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Senate Finance Committee Chair Chuck Grassley (R-IA) on Monday (April 22) again detailed plans to find “workable solutions” to improve nursing home oversight after Government Accountability Office and HHS Office of Inspector General reports are out this summer.

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In the wake of a 35-day partial government shutdown that furloughed 41 percent of the agency’s staff earlier this year, a group of FDA policy experts sent a letter to the agency asking for more details on how much funding FDA had and from what sources; exactly how many personnel were exempted, excepted and furloughed throughout the shutdown; and how FDA is preparing for future shutdowns.

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April 19, 2019

CMS is moving forward with its plan to launch a new Medicare pay model for nursing homes beginning in fiscal 2020, and the agency is proposing a 2.5% pay bump for nursing homes in a proposed rule released Friday (April 19).

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CMS on Friday (April 19) proposed to increase Medicare payments to hospices by 2.7% in fiscal 2020 as well as to modify the content of hospice election statements to better inform beneficiaries of exactly what services are provided, and which ones aren’t tied to their terminal illnesses.

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The Montana legislature gave final approval to a six-year extension of the state’s Medicaid expansion Thursday (April 18), along with a request for CMS to approve work requirements, and Gov. Steve Bullock (D) indicated he would sign it into law.

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The Congressional Budget Office estimates that 1.4 million more people went uninsured in 2018 compared to 2016 and most of the drop came from unsubsidized individuals in the individual market.

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According to new information by the HHS Office of Civil Rights (OCR) released Friday (April 19), smartphone apps created by third-party developers and not by providers or business associates covered under the Health Insurance Portability and Accountability Act (HIPAA) are not subject to HIPAA rules, even if a breach occurs.

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CMS reversed course and, along with the Office of the National Coordinator for Health IT, will give stakeholders an additional 30 days to comment on proposed interoperability rules the agencies released in February, pushing the comment deadline back to June 3.

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FDA on Friday (April 19) approved the first generic naloxone nasal spray, commonly known as Narcan, for use in a community setting by people who do not have medical training.

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House Democrats are asking why Trump administration did not distribute Title X grants to several Planned Parenthood branches that had previously received funds, and instead allocated funding to programs that do not provide birth control.

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