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Daily News

August 23, 2017

Stakeholders are pushing the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act as an offset for renewing CHIP funding, multiple industry stakeholders tell Inside Health Policy.

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Governors Charlie Baker (R-MA), Steve Bullock (D-MT), Bill Haslam (R-TN), Gary Herbert (R-UT) and John Hickenlooper (D-CO) will testify at the second of two planned Senate health committee hearings on stabilizing the individual insurance market slated for early September, the committee announced Wednesday (Aug. 24).

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The insurance industry is hitting back at a new campaign that aims to make a point that medical management techniques, like step therapy and prior authorization, impair consumer access to medication.

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Thirty states have drafted more than 60 drug price transparency bills aimed at identifying drug maker expenses and unveiling business practices of pharmacy benefit managers, according to an analysis by the National Academy for State Health Policy.

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Nursing homes welcomed guidance released last month changing how penalties are levied against nursing homes, but beneficiary advocates expressed concern that the guidance is a way to weaken nursing home oversight and will make the penalties less frequent and less costly.

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Public interest groups are fighting the Department of Justice's novel claim that showing harm to the groups' ability to comment on regulatory repeals is not enough to give them standing to sue over President Donald Trump's executive order (EO) directing agencies to identify two rules to repeal for every new rule they issue, countering that DOJ's argument would limit citizens' ability to challenge a host of constitutional violations.

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August 22, 2017

CMS' Advisory Panel on Hospital Outpatient Payment recommended Monday (Aug. 21) the agency drop a proposal to cut hospitals' Medicare reimbursement for drugs purchased through the 340B discount program.

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FDA has issued fewer guidance documents and delayed some key rules during Scott Gottlieb's first 100 days as agency chief, but has yet to chop any major existing regulations despite the strong deregulatory press by a Trump White House intent on scaling back federal regulations.

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The vocal bipartisan gubernatorial duo -- John Kasich (R-OH) and John Hickenlooper (D-CO) -- said they will soon release their own health care proposal in a joint interview on Colorado Public Radio Monday (Aug. 21).

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CMS officials have been working on a Request For Information on the direction of the Center for Medicare and Medicaid Innovation, according to sources familiar with the RFI.

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Republican health reform efforts may have stalled but Democrats are moving forward on a number of proposals that aim to build on the existing infrastructure in a move toward universal coverage and Independent Sen. Bernie Sanders (VT) will soon introduce legislation that would expand Medicare to all Americans.

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State insurance commissioners will testify before the Senate health committee on Sept. 6 and governors will follow up on Sept. 7 as Committee Chair Lamar Alexander (R-TN) and Ranking Democrat Patty Murray (WA) lead the effort on a stabilization package for the individual markets in 2018.

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August 21, 2017

States and navigators face extra challenges in promoting their exchanges as they head into open enrollment: They don't know what kind of federal support and outreach to expect; the enrollment period has been cut in half (an abbreviation that wasn't supposed to take effect until next year); and Congress' tumultuous attempts to overturn the Affordable Care Act has confused the general public, leading some enrollees to believe the law and its coverage no longer exists.

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In a newly published New England Journal of Medicine article, FDA Commissioner Scott Gottlieb expanded on how FDA will move forward with establishing a regulatory framework to lower nicotine levels in combustible cigarettes, including considering peer-reviewed studies to determine a maximum nicotine level, looking into how lowering nicotine will affect current smokers' behavior and investigating the potential for smokers to turn to alternative tobacco products.

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State insurance commissioners are pushing the Trump administration to embrace a slew of recommendations they say would help stabilize the health insurance market, improve choice and affordability for consumers, and affirm states’ regulatory authority, in response to CMS’ request for stakeholders’ suggestions.

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Durable medical equipment suppliers say legislation to provide “long-term relief” from Medicare pay cuts for suppliers in rural and non-competitive bid areas as well as address fee schedule cuts for stationary oxygen and allow an exemption from competitive bidding for accessories for manual complex rehabilitation technology could be introduced when lawmakers return from August recess.

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FDA's Pediatric Advisory Committee will weigh the safety and benefits of using opioid products to treat cough in children as part of a two-day meeting next month that will also include discussion on whether several other drugs and devices can safely be used for children.

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After receiving an unsatisfactory response to a citizen petition calling for FDA action on formaldehyde in keratin hair straighteners, two environmental groups are suing FDA in an attempt to force the agency to make a decision, within a set time period, on whether to ban the ingredient.

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August 18, 2017

President Donald Trump signed Friday (Aug. 18) the FDA Reauthorization Act of 2017, a White House spokesperson tells Inside Health Policy.

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CMS' proposal to cancel mandatory bundling demonstrations would have a small impact on the new Medicare physician pay system, provider lobbyists say, because although that system aims to get doctors to join alternative pay models, the pay models CMS wants to cancel are designed for hospitals.

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