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Daily News

November 19, 2018

CMS should provide more guidance to states to help them submit accurate encounter data from Medicaid managed care plans, the Government Accountability Office said in a report released Monday (Nov. 19).

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FDA Commissioner Scott Gottlieb said the agency hopes to boost its use of real-world evidence and other tools to analyze drug performance and support new indications, and he announced FDA will issue a framework to evaluate the use of RWE.

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November 16, 2018

After months of deliberation and public meetings, FDA and the U.S. Department of Agriculture officially announced they will share the responsibility for regulating cell-based meats, where food resembling meat, poultry and seafood is produced using small amounts of cells from the animal that the food product is supposed to resemble.

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Incoming Senate Finance Committee chairman Charles Grassley (R-IA) and Senate Democratic Whip Dick Durbin (D-IL) on Friday asked the Trump administration to put in place by year’s end its proposal to require drug manufacturers disclose list prices in direct-to-consumer advertising, and they also called on HHS and CMS to adopt additional drug-price disclosure measures.

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The American Medical Association is recommending processes and parameters for prior authorization, which the doctor group says are aimed at improving the experience of Medicare and Medicaid patients while making things easier for doctors.

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Sen. Charles Grassley (R-IA) is returning to chair the Finance Committee after a hiatus as Judiciary chair, and the move gives advocates for lower drug prices an ally on the committee with jurisdiction over Medicare and Medicaid that they do not have in the current Finance Chair Sen. Orrin Hatch (R-UT), who is retiring.

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The White House budget office on Tuesday (Nov. 13) began reviewing HHS’ request for feedback on ways to revamp the Health Insurance Portability and Accountability Act to boost efforts to coordinate care.

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Lead sponsors Sens. Charles Grassley (R-IA) and Patrick Leahy (D-VT) are divided on whether they would still back a bill to support generic drug development if a pro-pharma provision were added to reverse changes Congress made to Medicare Part D payments in the coverage gap.

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Republican senators who introduced a bill to protect the Affordable Care Act’s coverage of preexisting conditions are waiting on a ruling in the controversial ACA case in Texas before charting their next steps, which could include adding a severability clause to the health law.

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November 15, 2018

In a highly anticipated move, FDA Commissioner Scott Gottlieb on Thursday (Nov. 15) announced a number of new tobacco-related initiatives the agency is undertaking, including revisiting the deeming rule compliance policy to restrict access to flavored electronic nicotine delivery systems (ENDS).

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In a slate of tobacco-related policy proposals issued Thursday (Nov. 15), FDA Commissioner Scott Gottlieb said the agency will move forward with a proposed ban on menthol in combustible tobacco products, including cigars and cigarettes, as well as a ban on all flavored cigars.

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HHS Secretary Alex Azar doubled down on the Trump administration’s controversial plan to lower Medicare Part B drug costs by relying on international reference prices in a speech to the Commonwealth Fund International Symposium on Health Care Wednesday.

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Potential incoming Energy & Commerce health subcommittee chair Rep. Anna Eshoo (D-CA) wants to hold hearings before developing her prescription drug policy priorities, she told Inside Health Policy on Tuesday (Nov. 13).

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The White House Office of Management and Budget is reviewing a proposed rule aimed at reducing the administrative burden on long-term care facilities in Medicare and Medicaid.

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Another 3,815 Medicaid beneficiaries in Arkansas will be kicked off the program for failing to meet the state’s new work requirements, bringing the total to more than 12,000 people who have lost coverage since the work requirements kicked in this summer.

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FDA drug center director Janet Woodcock said rising drug prices are changing the nature of debate surrounding the agency’s drug development requirements.

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Scott Whitaker, the president and CEO of Advanced Medical Technology Association (AdvaMed), said he is confident there are enough Senate votes to pass a medical device tax repeal bill before the end of this session of Congress, so long as lawmakers find a legislative vehicle.

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FDA Commissioner Scott Gottlieb tried to assure a National Academies of Sciences, Engineering and Medicine (NASEM) committee that while the agency plans to develop and publish prescribing guidelines for acute pain, the agency does not intend to regulate the practice of medicine.

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FDA on Tuesday (Nov. 13) moved toward fulfilling provisions in the 21st Century Cures Act that allow FDA to waive or alter informed consent regulations for minimal risk clinical investigations as long as there are appropriate human subject protections in place.

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November 14, 2018

The new director of the Center for Medicaid and CHIP Services touted CMS’ commitment to work requirements in Medicaid in a speech Wednesday (Nov. 14), and said the agency is seeing “exciting results.”

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