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Expedited breakthrough device coverage, “reasonable and necessary” definition delayed until Dec. 15

On May 14, 2021, the Centers for Medicare & Medicaid Services (CMS) released a display copy of a Final Rule (Final Rule) further delaying the effective date of the Medicare Coverage of Innovative Technology (MCIT) and...more

CMS finalizes “reasonable and necessary” definition, expedited breakthrough device coverage process

On January 14, 2021, the Centers for Medicare & Medicaid Services (CMS) published a final rule that, for the first time, adopts a regulatory standard for determining whether a particular item or service is “reasonable and...more

Medicare links Part B payment rates to international prices: Most Favored Nation Model

On November 20, 2020, the U.S. Centers for Medicare & Medicaid Services (CMS) issued an interim final rule (IFR) with comment period implementing a mandatory “Most Favored Nation” demonstration model (MFN Model) to test...more

CMS proposes “reasonable and necessary” definition, expedited breakthrough device coverage process

On Tuesday, September 1, 2020, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule addressing the Medicare coverage standard and expedited coverage for certain medical devices. If finalized, the...more

CMS Radiation Oncology Model proposed rule – summary and early insights

Last week, the Centers for Medicare & Medicaid Services (CMS) announced new details of a proposed bundled payment model for radiation oncology services (RO Model), which would make fundamental (but temporary) changes to the...more

CMS releases annual health insurance exchanges final rule

On 18 April 2019 the Centers for Medicare & Medicaid Services (CMS) released the Notice of Benefit and Payment Parameters final rule for 2020 (2020 Payment Notice) applicable to qualified health plans (QHPs) offered on health...more

Trump administration proposes ambitious AKS rewrite on drug rebates, but needs answers to big questions

In a significant step towards implementing its American Patients First blueprint for lowering prescription drug prices and patient out-of-pocket costs, the Trump administration has proposed a series of changes to the...more

CMS Releases Major MA/Part D Proposed Rule

CMS released the first major MA/Part D rulemaking in several years, proposing a number of significant changes to the Part D program, including required pass-through of pharmaceutical company rebates to lower patient...more

Draft Senate Health Bill Finally Revealed – Vote Could Take Place as Early as Next Week

On June 22, 2017, Republican Senators released a “discussion draft” of the Better Care Reconciliation Act (BCRA). The draft is the first public glimpse at the Senate version of the American Health Care Act bill, which...more

Health Care Reform Bill Clears the House, but Could Hit a Wall in the Senate

On 4 May 2017, the American Health Care Act (AHCA), a bill that would repeal and replace key portions of the Affordable Care Act (ACA), narrowly passed the House of Representatives. The bill, however, faces an uncertain...more

First Steps: Trump Administration's Initial Executive Actions Target the Affordable Care Act and Obama Administration's Midnight...

On Friday, January 20, 2017—within hours of President Trump’s inauguration—the new Administration took its first executive actions. These executive actions included: President Trump's issuance of an Executive Order...more

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