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Daily News

April 17, 2019

CMS Administrator Seema Verma on Monday (April 15) touted the agency’s work on improving quality, oversight and transparency in nursing homes while the Government Accountability Office raised concerns that the agency isn’t completely sure if the state survey agency process is working in all states and CMS failed to deal with the fact that Oregon was not following federal requirements for abuse and complaint investigations for years.

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CMS is seeking an accelerated appeal in the litigation over Medicaid work requirements because, according to the agency, a district judge’s recent rulings that invalidated work requirements in Arkansas and Kentucky will cause “significant disruption to the detriment of the states and the federal government.”

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Kentucky’s Cabinet of Health and Family Services touted an independent evaluator’s plan to use a randomized control population to evaluate the state’s controversial work requirements program, but the evaluation’s approval is now on hold as CMS appeals a pair of judicial decisions that blocked Medicaid work requirements in Arkansas and Kentucky.

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April 16, 2019

The Congressional Research Service (CRS) warned federal lawmakers that any forthcoming surprise billing legislation should consider state laws on the subject as well as the potential for litigation over any set payment rates.

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The Trump administration has told a Texas district court it supports an argument that the Obama-era rule implementing the Affordable Care Act’s Section 1557 violated federal law by prohibiting discrimination based on transgender status or for the termination of a pregnancy, and HHS’ Office of Civil Rights is expected to unveil an updated rule that reflects that stance by the end of the month.

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Newly minted FDA Acting Commissioner Ned Sharpless said he will not stray far from FDA’s current goals, especially those that were laid out under former commissioner Scott Gottlieb’s leadership.

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A bipartisan group of House lawmakers Wednesday (April 10) reintroduced legislation to give CMS the authority to exempt alternative pay models and those under development from some Stark, or physician self-referral, law provisions, shortly after HHS Deputy Secretary Eric Hargan assured attendees at the American Hospital Association that the department would issue rules as fast as it can easing the Stark and anti-kickback statutes’ restrictions on value-based pay.

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FDA took several steps towards ramping up its regulation of dietary supplements on Tuesday (April 16), when the agency launched a list of unlawful dietary supplement ingredients and sent warning letters to 11 companies for using ingredients that either do not meet the statutory definition of a dietary ingredient or for which the company had not sent in a new dietary ingredient (NDI) notification.

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The generic drug and pharmacist lobbies are concerned about the burdens that could be imposed on the generic drug industry and health care stakeholders, respectively, should FDA finalize in its current form recent draft guidance that explains how sponsors can gauge the effect risk mitigation strategies have on patient access and the health care delivery system.

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April 15, 2019

Stakeholders have been invited to a discussion on primary care and chronic illness with CMS’ innovation center at the American Medical Association next Monday (April 22).

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A measure to continue Montana’s Medicaid expansion and add work requirements to the program cleared a key legislative hurdle Monday (April 15).

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A provision in the Trump administration’s point-of-sale rebate proposal questioning whether formulary placement-related rebates are protected by the anti-kickback statute generated strong reactions from the generic drug and pharmacy benefit manager lobbies, which are at odds on the issue.

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The Idaho Department of Insurance plans to release an updated version of its state-based health plans by early May that will comply with the Trump administration’s original recommended changes to the proposal but will ignore two recent requests from the CMS, state Insurance Commissioner Dean Cameron told Inside Health Policy.

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House and Senate Republicans recently unveiled legislation that would codify the Trump administration’s final rule expanding association health plans (AHPs) in the wake of a recent court ruling that invalidated key provisions in the rule.

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A large employer group that earlier backed a critical Supreme Court decision that stymied state-level all-payer claims databases is now calling on Congress to consider leveraging the Department of Labor’s existing authority to set up a nationwide system that could collect claims from large, self-insured employers without preempting the Employee Retirement Income Security Act.

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Hospice providers are asking CMS to enhance hospice services with a longer life expectancy, more access to palliative care and the ability for beneficiaries to receive curative and hospice care at the same time under a new benefit that will be offered in 2021 as part of the expanded Value-Based Insurance Design demonstration.

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April 12, 2019

Sen. Elizabeth Warren (D-MA), along with several other 2020 Democratic presidential primary candidates, reintroduced a wide-ranging bill to reform the Affordable Care Act exchanges.

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Sources say a memo by the White House Office of Management and Budget that requires federal agencies submit non-binding guidance to the Office of Information and Regulatory Affairs -- and potentially to Congress -- could throw a wrench in FDA’s usual guidance-making process, which could negatively affect both the agency and industry.

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HHS should issue guidance to help states understand what therapeutic foster care services can be covered under Medicaid and improve the coordination of those services, federal Medicaid advisers said Thursday (April 11).

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Federal Medicaid advisers expressed general support for CMS’ goal to encourage better sharing of electronic health records through its recent proposed rule on interoperability, but they declined Friday (April 12) to weigh in with any formal comments on the proposed rule, even as a few commissioners worried that the rule’s timeline for implementing new data-access requirements is too aggressive.

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