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Daily News

August 21, 2019

CMS on Wednesday (Aug. 21) approved Delaware’s request to tweak marketplace rules to set up a five-year reinsurance program through a state innovation waiver in 2020, marking the tenth state to establish such a program since the Affordable Care Act waiver provision went into effect.

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The pharmaceutical industry, including GW Pharmaceuticals, the producer of cannabidiol-containing drug Epidiolex, warns FDA that allowing CBD in consumer products could freeze research and development on use of CBD in prescription drugs.

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HHS will appeal a court decision that struck down a Trump administration rule requiring drug makers to disclose list prices in television advertisements, the department said in a court filing on Wednesday (Aug. 21).

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CMS agreed to clarify diagnostic code requirements, assist states Medicaid agencies in correctly reporting the National Provider Identifiers (NPIs) of providers who prescribe opioids and ensure all beneficiaries can be uniquely identified in the national Medicaid claims database after an HHS Office of Inspector General (OIG) report said that national data are incomplete.

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Women’s health experts, including former FDA chief Jane Henney and Planned Parenthood, argue FDA should drop its dispensing restrictions on “abortion pill” mifepristone as those restrictions continue to severely limit patient access to medication that health care provider groups already agree is safe.

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The White House Office of National Drug Control Policy issued advisories that explain how pharmaceutical and chemical supply companies can identify illicit fentanyl manufacturing and redistribution and prevent movement of fentanyl and other synthetic opioids into and within the United States.

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August 20, 2019

Two new lawsuits, including one brought by health care providers, are seeking to block the Trump administration’s so-called public charge rule, which aims to make it harder for legal immigrants to become permanent U.S. residents if they use Medicaid or other forms of public assistance.

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Provider groups praised a pilot unveiled last month by CMS that will give providers Medicare claims data, but at least one group worries that the pilot will increase provider burden.

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Opioid maker Endo International’s subsidiaries, including Endo Pharmaceuticals and Par Pharmaceutical, have settled for $10 million with the plaintiffs in the ongoing multidistrict opioid litigation, the company announced Tuesday (Aug. 20).

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Three Democratic senators are urging their colleagues to ramp up the traditional Medicare program to include more benefits, some of which are already offered by private Medicare Advantage plans, and the Center for Medicare Advocacy suggests that could be done by reinvesting what it calls wasteful spending on MA plans into new fee-for-service benefits.

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FDA’s pediatric advisory committee will meet late next month to discuss the safety of opioids to manage pain in children, and to share the results of a study on the neuropsychiatric effects of an asthma drug called montelukast, more commonly known as Singulair.

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FDA on Monday (Aug. 19) announced the approval of a first-in-class antibiotic to treat adults with community-acquired bacterial pneumonia, which means the pneumonia was acquired outside of a hospital.

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August 19, 2019

The August recess has provided congressional staffers no reprieve from the onslaught of lobbying over surprise billing legislation as stakeholders continue to make their case for and against bills that set benchmark rates, which moved through House and Senate committees prior to the break.

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CMS on Monday (Aug. 19) announced plans to update the way it calculates overall hospital quality star ratings -- with which hospitals have long raised concerns -- but, as it works on the changes, the agency will refresh the star ratings using the current methodology in early 2020, to hospitals’ disappointment.

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Many of the people who gained coverage after the enactment of the Affordable Care Act did so by enrolling in Medicaid despite apparently having incomes that should have disqualified them from the program, according to a new study released by the National Bureau of Economic Research.

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FDA on Friday (Aug. 16) announced the first-ever approval of a spinal tether device designed to treat a common form of scoliosis in children and adolescents.

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CMS Administrator Seema Verma on Thursday (Aug. 15) said there are some areas of Medicare that scream for more utilization oversight -- and thus prior authorization -- but she also said prior authorization shouldn’t interfere with the practice of medicine or delay patient care, both issues about which providers have long complained.

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America’s Health Insurance Plans defends prior authorization and tells CMS it is working with other stakeholders to streamline and improve the process -- though, unlike providers, the group doesn’t offer any suggestions for how CMS could help.

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Providers are urging CMS to curb or streamline the use of prior authorization by Medicare Advantage plans, particularly through increased electronic prior authorization procedures, in response to the agency’s latest request for advice on how to cut back on administrative burdens.

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August 17, 2019

Senate Finance Chair Chuck Grassley said Friday (Aug. 16) that Senate staff are pre-negotiating with House Democrats on drug-pricing legislation that could pass the lower chamber in a bid to pressure Senate Majority Leader Mitch McConnell (R-KY) to hold a Senate vote.

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