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Daily News

November 26, 2018

FDA Commissioner Scott Gottlieb called low prices and CMS reimbursement for generic prescription drugs a “root cause” of drug shortages in a blog post he co-authored with the agency’s drug center chief, Janet Woodcock, last week.

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The National Association for Home Care and Hospice told the White House Office of Management and Budget and CMS that the decline in the home health improper pay rate in traditional Medicare shows that CMS’ planned Review Choice Demonstration isn’t needed.

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CMS said the most recent improper pay rates show that, for the first time since the data has been reported, improper payment rates went down in Medicare fee-for-service, Medicare Advantage, Medicaid and the Children’s Health Insurance Program, and the fiscal 2018 Medicare fee-for-service improper pay rate is at the lowest since the 2010 rate.

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November 21, 2018

A state judge in Maine on Wednesday (Nov. 21) told the administration of outgoing Gov. Paul LePage (R) that it has two weeks to adopt rules to implement Medicaid expansion.

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Oklahoma and CMS officials are scheduled to talk this week about whether the scope of the state’s Medicaid agreement allows for drug reimbursement over time, according to Becky Pasternik-Ikard, chief executive officer of Oklahoma's Medicaid agency.

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As pharmacy and other health care stakeholders convened last week to discuss myriad issues surrounding illegal online sales of prescription drugs, one FDA official called for companies that manage and sell internet domain names to ramp up enforcement of their terms of use agreements and stop allowing violative website operators to continue leasing domains under different website names. This, the official said, would help fix the whack-a-mole issue on FDA’s side of enforcement.

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One industry lawyer found that FDA has put out many more new rules for the food and medical device industries over the past six years than it has for other industries, such as drugs, biologics, cosmetics and animal feed.

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CMS on Tuesday (Nov. 20) re-approved a plan to allow Medicaid work requirements in Kentucky, five months after a federal judge struck down the agency’s initial approval of the program. Advocates for beneficiaries immediately pledged to challenge the new approval in court.

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November 20, 2018

FDA Commissioner Scott Gottlieb on Monday (Nov. 19) introduced a new risk-based framework for how the agency will regulate software products that are designed to be used in conjunction with prescription drugs, also known as prescription drug-use-related software.

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The Department of Justice asked Maryland to both withdraw its lawsuit to protect the Affordable Care Act and to dismiss its request that acting Attorney General Matthew Whitaker be removed from the case, arguing that Maryland doesn’t have a legal right to determine the law’s constitutionality.

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The Department of Justice in a Nov. 16 motion asked a district court in Maryland to dismiss the state’s lawsuit to protect the Affordable Care Act, arguing that Maryland doesn’t have a legal right to determine the law’s constitutionality.

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FDA device center chief Jeff Shuren says that his agency, in order to consistently be the best in the world at identifying and responding to device safety signals, will need more resources to fuel its real-world evidence-gathering apparatus, the National Evaluation System for health Technology (NEST) and its coordinating center (NESTcc).

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SAN FRANCISCO -- CMS director of exchange policy Randy Pate told state regulators that the agency will provide more specific examples of potential waivers under the new 1332 guidance but continued to stress state officials should bring ideas to the table.

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Sen. Bernard Sanders (I-VT) and Rep. Ro Khanna (D-CA) on Tuesday (Nov. 20) unveiled a prescription drug-pricing bill that blends Republican and Democratic proposals: The legislative plan would expand the Trump administration’s international reference pricing concept to span the entire U.S. drug market and includes a Democratic proposal to give the government power to invalidate brand-drug makers’ exclusivity if their drug prices are deemed excessively high.

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FDA is proposing to try out a minimally invasive dog drug study that the agency hopes will encourage industry to pursue similar studies, or ones that do not involve live dogs at all.

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November 19, 2018

Maine Deputy Attorney General Susan Herman says that the state’s outgoing Republican Governor Paul LePage does not have the authority to represent the interests of Maine as a plaintiff in the controversial court case that could determine the fate of the Affordable Care Act, Texas v. United States, because Maine Attorney General Janet Mills said she never consented to let the state be represented by the attorney general of Texas.

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House and Senate Democratic leaders on health committees are calling for the Trump administration to withdraw its new guidance changing the purpose of 1332 waivers, arguing the guidance is inconsistent with congressional intent and could reduce patients’ access to care, especially for those with preexisting conditions, and increase health care costs by expanding the use of short-term plans.

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Some lawmakers and congressional staff don’t expect a big legislative push for 340B reform in the next Congress, but Rep. Buddy Carter (R-GA) says he is optimistic his legislation to boost the program’s transparency and reporting could gather bipartisan support.

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Kaleo CEO Spencer Williamson offered to lower the $4,100 price of the opioid overdose reversal drug Evzio as long as insurers give patients greater access to it, during his appearance on CBS’ “60 Minutes” on Sunday.

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DaVita officials tells investors that the dialysis company assumes it will increase its lobbying budget by $30 million to beat back continued initiatives aimed at lowering dialysis pay as the industry’s battle with unions and other stakeholders continues.

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