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Congress

January 03, 2019 | Daily News

Medicare beneficiaries start 2019 with a new Medicare Advantage open enrollment period, lobbyists and stakeholders continue to pore over the administration’s revamp of the Accountable Care Organization program unveiled late in December and others are waiting on interoperability and electronic health records rules that at the start the new year are still under White House Review.

January 03, 2019 | Daily News

The Trump administration is expected to keep drug pricing on center stage in 2019 following a flurry of action last year. In 2018, the administration released a 44-page blueprint with ideas and questions on potential ways to lower drug prices and reduce out-of-pocket costs, and HHS, FDA and CMS proposed a torrent of regulations and notices.

January 03, 2019 | Daily News

Over the holidays and the first days of January, FDA Commissioner Scott Gottlieb issued a steady stream of tweets in a bid to answer stakeholders’ questions about which agency activities are on hold during the partial government shutdown, including user fee-related application reviews, certain medical and over-the-counter product reviews, and non-emergency work on certain biologic products.

January 03, 2019 | Daily News

As the government shutdown continues into its second week and Congress works to reach a spending deal, it is still unclear what will happen to a legislative package that would reform FDA’s over-the-counter (OTC) drug oversight and reauthorize a number of hazard preparedness programs at HHS.

January 02, 2019 | Daily News

The House speaker would have permission to intervene in any court case over the Affordable Care Act, including the high-profile Texas case, under the new rules package Democrats unveiled late Tuesday (Jan. 1).

January 02, 2019 | Daily News

The judge overseeing a challenge to CMS’ approval of Medicaid work requirements in Arkansas agreed to give the federal government more time to respond to the challengers’ legal arguments due to the partial government shutdown.

January 02, 2019 | Daily News

It’s going to be more difficult for brand drug makers to get Congress to lower their share of seniors’ Part D donut-hole costs now that Democrats control the House, and the industry also exposed itself to billions of dollars in offsets while trying to roll back the donut hole policy in 2018, which Congress could use in 2019 to fund other health sector priorities.

December 28, 2018 | Daily News

CMS is automating the system that determines whether drugs are properly classified in the Medicaid Drug Rebate Program as Congress gets closer to giving CMS the power to force drug reclassifications to recoup Medicaid rebates, according to a letter CMS sent earlier this year to Sen. Chuck Grassley (R-IA), who wrote the Medicaid-rebate bill.

December 27, 2018 | Daily News

The Department of Commerce recommended the federal government clarify that march-in rights should not be used to strip pharmaceutical manufacturers of patent exclusivity because of high drug prices in a report released in early December.

December 26, 2018 | Daily News

Civica Rx, the non-for-profit generic drug maker founded by hospitals, supports Sen. Elizabeth Warren’s bill to let the government make generic drugs, and Civica Rx President and CEO Martin Van Trieste said a government generic drug maker would complement the work Civica is doing to stop drug shortages and price spikes.

December 21, 2018 | Daily News

HHS released a contingency staffing plan in anticipation of a possible government shutdown that showed, out of FDA’s 17,397 staff members, 41 percent or 7,053 employees would be furloughed.

December 21, 2018 | Daily News

A bill that would have expanded the government’s definition of “natural cheese” to include additives and artificial ingredients, as well as exclude certain pasteurized process cheeses and plant-based cheeses from the definition, failed in the House on Thursday (Dec. 20) a few hours after Rep. Frank Pallone (D-NJ) called on fellow members to oppose the bill, which he said crossed into FDA's jurisdiction.

December 20, 2018 | Daily News

The House on Thursday  passed legislation that delays or repeals several of the taxes in the Affordable Care Act, including the so-called Cadillac tax, the medical device tax and the tax on health insurance plans.

December 20, 2018 | Daily News

With one day left in the 115th session of Congress, the House on Thursday (Dec. 20) passed a legislative package that combines the pandemic preparedness bill with legislation that would reform the way FDA regulates over-the-counter drugs.

December 20, 2018 | Daily News

Senate Finance Committee Chairman Chuck Grassley (R-IA) announced his incoming permanent health policy staff for the next Congress, consisting of a combination of returning and new health policy staffers.

December 20, 2018 | Daily News

Legislation to recoup unpaid Medicaid drug rebates has run into trouble in the Senate, even though observers had been optimistic just days ago that the upper chamber would pass the measure.

December 19, 2018 | Daily News

Sen. John Barrasso (R-WY) blocked a resolution introduced by Senate Democrats that would have authorized the Senate to intervene in the high-profile Texas lawsuit that overturned the Affordable Care Act.

December 18, 2018 | Daily News

Odds are decent that the Senate will vote this year on a House package of Medicare and Medicaid bills that includes a measure aimed at stopping drug companies from gaming the Medicaid rebate system, but sources say first the upper chamber must deal with concerns from a couple of fiscal conservative GOP senators over a separate provision that would increase federal Medicaid funding to help states establish health homes for kids with complex needs.

December 18, 2018 | Daily News

Sen. Cory Booker (D-NJ) will introduce a bill this week that would require drug manufacturers to report perks given to pharmacists and others who serve on boards that determine which drugs end up on states’ Medicaid preferred drug lists, National Public Radio first reported Monday (Dec. 17).

December 17, 2018 | Daily News

Texas federal district Judge Reed O’Connor’s initial ruling that the Affordable Care Act is unconstitutional may be one of the most extreme cases of judicial activism in recent memory, experts across the political spectrum say in their initial analyses of the Friday (Dec. 14) decision that sent shock waves through the health care sector.

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