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HHS finalizes changes to Section 1557 regulations strengthening anti-discrimination protections

On April 26, 2024, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and the Centers for Medicare & Medicaid Services (CMS) finalized updates to regulations implementing Section 1557 of the...more

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

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

Republicans Release Much Anticipated ACA "Repeal and Replace" Bill, But Will it Fly Under the Byrd Rule?

On March 6, 2017, House Republicans in the Committee on Ways and Means and the Committee on Energy and Commerce introduced the American Health Care Act (AHCA), a bill that would repeal and replace key portions of the...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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