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Daily News

December 02, 2019

A recent Government Accountability Office report detailing problems with hospice care is increasing the urgency for additional CMS oversight as Sens. Rob Portman (R-OH) and Ben Cardin (D-MD) seek to attach their bill aimed at giving CMS those tools to an end-of-year spending package, according to a Cardin spokesperson.

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A federal judge on Tuesday (Nov. 26) blocked the Trump administration from implementing an October proclamation that seeks to deny entry to legal immigrants if they cannot demonstrate that they will have health insurance.

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CMS on Wednesday (Nov. 27) opened the federal public comment period on Tennessee’s controversial 1115 waiver proposal to convert some of its federal Medicaid funding into a block grant.

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November 27, 2019

The House Energy & Commerce health subcommittee has scheduled a Dec. 4 hearing on legislation to reform FDA’s oversight of cosmetic products, E&C Committee Chair Frank Pallone (D-NJ) and health subcommittee Chair Anna Eshoo (D-CA) announced Wednesday (Nov. 27).

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Wide-ranging stakeholders are continuing to press Congress to again delay or to repeal the Affordable Care Act’s fees on health insurance and medical devices, and are strongly pushing lawmakers to fully repeal the forthcoming 40% excise tax on high-cost plans, or the “Cadillac tax,” prior to the end of the year.

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The Trump White House is pressing conservative lawmakers to move on surprise billing legislation and ignore outside interest groups’ influence on the debate.

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The Senate health committee’s proposal to end air ambulance surprise billing could lead to lower private reimbursement rates for air ambulance providers, and a decrease in private pay rates without an increase in government pay rates could threaten the entire industry, Moody's Investors Service warns.

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Global Blood Therapeutics said it is working with public and commercial payers to get broad coverage for its newly approved sickle cell drug Oxbryta (voxelotor) by the end of 2020.

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As Trump tweets that drug importation is nigh, groups that oppose allowing states to import Canadian drugs are holding meetings with the White House, and the Congressional Research Service says it’s unclear whether expanding legal drug importation would lower drug costs for consumers.

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The House Judiciary Committee unanimously approved two bills aimed at fighting drug companies’ misuse of patents.

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November 26, 2019

The Senate health committee will vote Dec. 3 on whether to send Stephen Hahn’s nomination for FDA chief to the Senate floor, the committee announced Tuesday (Nov. 26).

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Researchers in a study released Thursday (Nov. 21) suggested reforming Medicare by building a premium-support type system based solely on Medicare Advantage as an alternative to Democrats’ Medicare for All built off the current system, but the researchers said a premium support system should be set up without a public option and MA risk adjustment would need to be retooled first.

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FDA on Monday (Nov. 25) indicated it has not concluded that cannabidiol (CBD) is generally recognized as safe (GRAS) to use in human or animal food.

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November 25, 2019

FDA has reversed its stance that certain comparative clinical studies, including switching studies, are needed to prove interchangeability for insulin products, in a move that could speed access to less expensive insulin products.

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The House Ways & Means Committee will soon release surprise billing legislation that attempts to appease both providers and insurers, and eliminates billions in savings compared to other bills by driving up payment rates.

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FDA on Monday (Nov. 25) announced a series of steps to spur development of new ways to sterilize medical devices that don’t rely on ethylene oxide, including a voluntary pilot program under which companies that use ethylene oxide would submit a master file when changing locations or sterilization processes.

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FDA on Monday (Nov. 25) granted accelerated approval to Oxbryta (voxelotor), an oral once-daily treatment for sickle cell disease in adults and patients 12 years old and older. The drug inhibits red blood cell sickling, which is the central abnormality in sickle cell disease.

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Georgia GOP Gov. Brian Kemp continues to tout his proposal to use the Affordable Care Act’s Section 1332 waiver provision to essentially get a block grant of ACA subsidies that could then be used by consumers to purchase non-compliant products outside of the healthcare.gov, but consumer advocates have myriad questions about the concept and wonder whether Kemp could get approval from CMS.

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When President Donald Trump took to Twitter Friday (Nov. 22) to weigh in on drug pricing reforms, he gave House Republicans cover to vote against House Democrats’ bill to let Medicare negotiate drug prices, instead of leaning on Senate Republicans to support the less-aggressive bipartisan drug pricing legislation in that chamber, even though White House adviser Joe Grogan said recently that the administration backs the Senate bill.

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November 22, 2019

Tensions flared during a White House vaping roundtable Friday (Nov. 22) where key stakeholders tried to pull President Donald Trump in competing directions on the role the government should play in regulating the vaping industry.

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