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Daily News

June 14, 2019

Former FDA Commissioner Scott Gottlieb defended drug maker Pfizer’s choice to not investigate signals that its anti-inflammatory drug Enbrel appeared to reduce the risk of Alzheimer’s, as the Washington Post reported on June 4.

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FDA asks a Maryland court to give makers of all e-cigarettes and electronic nicotine delivery system (ENDS) products at least 10 months to submit premarket applications.

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Congressional Medicaid advisers on Friday (June 14) released their June report recommending statutory changes intended to reduce government spending on prescription drugs in Medicaid, give states more time to cover new drugs, and tighten the definition of the so-called Medicaid shortfall.

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CMS will allow Washington to enter outcomes-based contracts with drug makers in Medicaid under a State Plan Amendment that facilitates use of a subscription model for purchasing hepatitis C drugs, the agency announced Wednesday (June 12).

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Sen. Bill Cassidy (R-LA) is working on a bill to tighten privacy protections for health data integrated into third-party applications, including fertility or weight loss mobile apps, according to his office.

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June 13, 2019

The Trump administration finalized a rule allowing employers to offer health reimbursement arrangements for employees to enroll in the individual market or in short-term plans beginning in the 2020 plan year.

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Former Senate Majority Leader Tom Daschle (D-SD) said the Bipartisan Policy Center’s rural health task force plans to release policy recommendations in 2020 and hopes to bring rural health issues to the forefront of candidates’ agendas -- but two former GOP lawmakers on the task force said rural health proposals shouldn't become a part of a presidential debate or they could become too divisive to get through Congress.

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Drug pricing is the top priority for House liberals for the next two to four weeks as they try to pull policies to the left before Speaker Nancy Pelosi (D-CA) brings legislation to the floor, Reps. Pramila Jayapal (D-WA) and Mark Pocan (D-WI) said Wednesday (June 12).

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The United States Pharmacopeia, backed by generic drug makers and multiple pharmacist groups, has launched a full-scale effort to quash a proposal by the Senate health committee and Trump administration to remove biologics from USP monograph standards, arguing the proposal would reduce confidence in biosimilars.

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CMS is auditing California, Kentucky and New York — and will soon begin an audit of Louisiana — following reports that those states incorrectly determined Medicaid eligibility for some beneficiaries who received coverage through the Affordable Care Act’s Medicaid expansion, CMS Administrator Seema Verma said in a letter to Senate Finance Committee leaders.

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A device industry lawyer said FDA’s software precertification test plan could help FDA win the statutory authority it needs to implement the pre-cert program, as it could give lawmakers the evidence they need to conclude the program achieves the same level of safety validation as FDA’s traditional review pathways.

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FDA’s decision to center its compounding regulatory program in the drug center’s compliance office represents a shift to a more enforcement-focused approach to compounding, according to a drug compounding lawyer.

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FDA on Wednesday (June 12) issued a call for stakeholders to send pathogen samples to the agency in order to help build a database to support the rapid identification of infectious diseases in patients.

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Sen. Dick Durbin (D-IL) once again took a jab at FDA for “sitting on the sidelines” as the United States grapples with an epidemic of youth use of e-cigarettes, and he laid out the three steps he believes FDA can take right now to stem youth use of the products.

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As part of their investigation into the dangers of illicit fentanyl, much of which comes from China, a bipartisan group of House Energy & Commerce Committee leaders wrote to FDA Acting Commissioner Ned Sharpless and heads of five other federal agencies to request briefings on the effect the opioid epidemic is having on public health and on their solutions for stopping the flow of illicit fentanyl into the United States.

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June 12, 2019

Lawmakers spent most of the House Ways & Means Committee’s hearing on pathways to universal health coverage focusing on partisan Medicare for All talking points, even though the hearing was supposed to give them the opportunity to talk up other proposals to expand government health care.

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CMS Administrator Seema Verma and senior advisor to the president Kellyanne Conway touted efforts by CMS and the Trump administration to improve maternal health in rural areas by extending Medicaid coverage for postpartum women with substance use disorders, but advocates said Medicaid coverage should be extended for all postpartum women and more states should expand Medicaid, speaking at a Kaiser Family Foundation event Wednesday (June 12).

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Beneficiary advocates called on CMS to provide more support for plans to tackle social determinants of health, including information on funding streams and support for community partners in working with Medicare Advantage plans to provide services, with one group saying that harmonizing social determinants data with electronic health records remains a challenge.

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The Center for Medicare Advocacy and Long Term Care Community Coalition ask CMS to make it obvious on the Nursing Home Compare website when a facility is a candidate for the Special Focus Facility program, noting the agency said it plans to make that list public.

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The American Medical Association announced Tuesday (June 11) that its House of Delegates adopted policies aimed at supporting and creating alternative pay models focused on high-risk and vulnerable populations, as the group says current APMs may inadvertently discourage doctors from caring for those individuals.

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