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Daily News

September 21, 2018

Maryland officials announced that the state's final Affordable Care Act individual market premiums for 2019 will decrease on average 13 percent, bringing the rates significantly lower than the original requests due to the state's new reinsurance program.

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The Trump administration will again allot $10 million for marketing and outreach during the upcoming Affordable Care Act open enrollment period, which is 90 percent less than spent by the Obama administration in 2017.

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Former CMS officials, a Democrat and a Republican, discussed the intense political pressure CMS staff would be subject to if Medicare were to negotiate drug prices, and they said the current system is preferable.

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The Advanced Medical Technology Association (AdvaMed) President and CEO Scott Whitaker is upset the Senate tucked into its recently passed opioid bill a provision expanding the sunshine law to require that drug and medical device makers also publicly disclose payments made to nurse practitioners, physician assistants and midwives – not just doctors and hospitals – for promotional talks, consulting and other interactions.

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Rep. Suzan DelBene (D-WA) is drumming up support for a letter that will ask CMS to adjust the low-volume threshold in order to include more providers in the Merit-based Incentive Payment System as part of the final 2019 physician fee schedule – an agency move that would be supported by some stakeholders like Premier and the American Medical Group Association even though the American Medical Association and others want CMS to finalize the exemption as proposed.

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Sen. Chuck Grassley (R-IA) is pressing FDA to provide more information about its recent spate of warning letters and civil monetary penalties to more than 1,300 e-cigarette companies.

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The Advanced Medical Technology Association (AdvaMed), the American Hospital Association and American College of Cardiology are concerned that aspects of FDA's Medical Device Safety Action Plan – including a voluntary 510(k) program for moderate-risk devices and a required software bill of materials (SBOM) – could create more medical device safety issues than it would solve, according to comments the groups recently submitted to FDA's docket.

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September 20, 2018

CMS on Thursday (Sept. 20) told assisters working to help people get coverage through healthcare.gov that certain victims of Hurricane Florence may qualify for an exceptional circumstance special enrollment (SEP) period that allows them additional time to enroll, and they may be eligible for other SEPs due to relocating outside of their region or other reasons.

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HHS Secretary Alex Azar said that the agency is not directing or encouraging states to include opioid-abuse treatment, substance-abuse treatment, or mental health benefits in short-term plans and is leaving regulation of the plans up to individual states.

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Two top Democrats on the House Committee on Oversight and Government Reform want the committee’s chairman, Rep. Trey Gowdy (R-SC), to subpoena HHS and CMS for documents about the Trump administration’s support of Medicaid work requirements.

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HHS’ Biomedical Advanced Research and Development Authority (BARDA) has entered into a contract with Opiant Pharmaceuticals, a company that develops nasal sprays for substance use and eating disorders, to develop a fast-acting, long-lasting intranasal form of nalmefene to reverse overdose, HHS announced Thursday (Sept. 20).

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Brand drug makers have inched closer to getting Congress to lower their share of seniors’ drug costs by adding to opioid legislation an unrelated package that combines the brand-backed Part D measure with watered-down pro-generic legislation and a provision that averts steep drug cost increases for seniors in 2020.

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A White House budget official said HHS is being extremely deliberative about potential changes to to the Stark, or physician self-referral, and anti-kickback statutes because making changes the wrong way could increase fraud and abuse and hurt Medicare’s budget.

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A White House budget official said that the administration is doing “a lot of work right now on medical device stuff that nobody knows about,” and that he hopes to see some of those ideas start coming from CMS in the next six months.

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Senate Judiciary Chair Chuck Grassley (R-IA) remains concerned that CMS isn't doing enough to oversee nursing home quality, and in a Sept. 19 letter asks when the agency plans to evaluate its new electronic survey of nursing home deficiencies and what steps the agency is taking to improve the collection of data needed to track nursing home quality.

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FDA awarded nearly $3 million worth of grants to five universities to study and recommend improvements in the use of continuous manufacturing of biologics, an emerging manufacturing technique the agency says will reduce manufacturing costs and drive down drug prices.

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FDA is wholeheartedly embracing continuous manufacturing as a move that will lower drug costs and reduce product shortages, but the Association for Accessible Medicines recently told Inside Health Policy it is concerned the move could have unintended negative consequences for generic drug makers.

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September 19, 2018

FDA issued three guidances -- two final and a new draft guide -- intended to help drug manufacturers and repackagers prepare to comply with the upcoming deadline for including product identifiers on product packages or cases, and to help them understand when product packages are exempted from the requirements, known as a grandfathering exemption.

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Several congressional Medicaid advisers said Thursday (Sept. 13) they’re enthusiastic about the idea of giving states a grace period before covering newly approved drugs and lifting the Medicaid rebate cap.

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FDA is facing pressure to eliminate the requirement that biosimilar sponsors conduct confirmatory powered clinical studies.

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