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Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
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Healthcare Industry Segment-Specific Compliance Program Guidances (ICPGs)
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Daily Compliance News: March 20, 2025, The Fluid Edition
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On July 14, 2025, the Centers for Medicare and Medicaid Services (CMS) released the 2026 calendar year (CY 2026) Medicare Physician Fee Schedule (Proposed Rule). Among the many changes proposed, the Proposed Rule includes...more
On July 14, 2025, the Centers for Medicare & Medicaid Services (“CMS”) released the proposed rule for the Calendar Year (“CY”) 2026 Medicare Physician Fee Schedule (“PFS”), formally titled CMS-1832-P....more
On July 14, 2025, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2026 Revisions to Payment Policies Under the Physician Fee Schedule (PFS) and Other Revisions to Medicare Part B [CMS-13271]...more
Decisions, decisions, decisions. The Centers for Medicare & Medicaid Services (CMS) under the Trump Administration will have its hands full making decisions about Center for Medicare and Medicaid Innovation (CMMI) models...more
While we all are focused on the election results, let’s take a quick break to digest some regs and eggs. The Centers for Medicare & Medicaid Services (CMS) “spoiled” all of us in the health policy world with a huge buffet of...more
On November 1, 2022, the Centers for Medicare & Medicaid Services (CMS) issued changes to the Medicare Shared Savings Program to advance CMS’ broader strategy of growth, alignment, and equity. To improve the overall...more
On November 1, 2022, the Centers for Medicare & Medicaid Services (CMS) issued final rules concerning the 2023 Hospital Outpatient Prospective Payment System (OPPS) payment rates and 2023 Medicare Physician Fee Schedule...more
With CMS’s continued “regulatory sprint to coordinated care,” the new Medicare Shared Savings Program regulations expand the playing field for ACOs to offer beneficiary incentive programs to encourage healthy outcomes. Termed...more
On December 21, 2018, CMS announced a final rule, subsequently published in the December 31 issue of the federal register, significantly overhauling the Medicare Shared Savings Program (“MSSP”). Among the important changes in...more
A live webinar presented by Smith Anderson health care lawyers Julian "Bo" Bobbitt, Robert Shaw and Shawn Parker. On December 21, 2018, CMS published “Pathways to Success,” the final rules overhauling Medicare’s ACO...more
The Centers for Medicare and Medicaid Services (CMS) issued a final rule (the Rule) on December 21, 2018, which reshapes the Medicare Shared Savings Program (MSSP). Termed “Pathways to Success,” the Rule, among other things, ...more
On Aug. 9, 2018, Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would update the Medicare Shared Savings Program (MSSP). Called "Pathways to Success," the proposal significantly alters the...more
On November 2, 2016, the Centers for Medicare and Medicaid Services (CMS), released the 2017 Medicare Physician Fee Schedule (MPFS) final rule, which finalized a number of new policies designed to improve Medicare payment for...more
On the heels of the release of its final rule implementing the Medicare Access and CHIP Reauthorization Act (MACRA), the Centers for Medicare and Medicaid Services (CMS) released its 2017 list of Advanced Alternative Payment...more
On Oct. 14, the Centers for Medicare & Medicaid Services (CMS) published a final rule with comment period implementing the bipartisan Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The nearly 2,400 pages of...more
On Thursday, October 29, 2015, the Centers for Medicare & Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) jointly issued a rule (the “Final Rule”) to finalize five (5) waivers of certain fraud and abuse...more
Accountable Care Organizations (ACOs) can share costs of telehealth and remote patient monitoring services among their hospitals, providers/suppliers, and other ACO participants, according to federal regulations under the...more
The Centers for Medicare and Medicaid Services (CMS) and the Office of Inspector General (OIG) of the Department of Health and Human Services just issued a final rule setting forth waivers of specified fraud and abuse laws...more
Final ACO Fraud Waiver Under OMB Review – The White House Office of Management and Budget (OMB) reported on September 9, 2015, that it began its review of the final rule (CMS-1439-F; RIN 0938-AR30), titled “Medicare Shared...more
The federal physician self-referral ban or Stark law has been a part of the legal landscape for almost 25 years. The breadth of the law’s prohibitions, its strict liability formulation and draconian remedies have made it the...more
This is the fourth post in Health Care Law Today’s series on the final rule. This post addresses how CMS assigns beneficiaries to an ACO participating in the MSSP. In the MSSP ACO Final Rule, CMS finalized new...more
In This Issue: - ACO Eligibility Requirements - Establishing and Maintaining the ACO Participation Agreement - Data Sharing and Assignment of Beneficiaries - Shared Savings and Losses - Waivers of...more
This is the third post in Health Care Law Today’s series on the final rule. This post addresses changes to sharing of beneficiary identifiable data. In its December 8, 2014 proposed rule revising the Medicare Shared...more
This is the second post in Health Care Law Today’s series on the final rule. This post addresses Eligibility Requirements, and the Application and the Renewal Process. ACO Eligibility Requirements - Under the...more
An Overview of the Medicare Shared Savings Program/Accountable Care Organization Final Rules - The Centers for Medicare and Medicaid Services (CMS) recently released a final rule (Final Rule) that makes changes to the...more