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Healthcare Regulatory Check-Up Newsletter | April 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2025, including Centers for Medicare & Medicaid Services (CMS) updates to Medicare Advantage (MA) and other Medicare programs....more

Healthcare Regulatory Check-Up Newsletter | August 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for August 2024. We discuss several enforcement actions pertaining to healthcare fraud, including alleged violations under the False...more

Special Report: Was 2023 The Return Of The Stark Law?

The year 2023 was historic from a Stark Law enforcement perspective, as we witnessed a resurgence of False Claims Act (FCA) enforcement actions predicated on Stark Law violations. This increase was capped off in December 2023...more

OIG Issues General Compliance Program Guidance Updates

On November 6, 2023, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published the General Compliance Program Guidance (GCPG) as a revised reference guide for the healthcare compliance...more

HHS Finalizes Sweeping Changes to Stark Law, Anti-Kickback Statute Regulations

On November 20, 2020, the US Department of Health and Human Services (HHS) released final rules amending the regulations to the physician self-referral law (Stark Law) (Stark Rule) and the Anti-Kickback Statute (AKS) and...more

Special Fraud Alert: OIG Raises Concerns with Speaker Programs

In its November 16, 2020, Special Fraud Alert, the HHS Office of Inspector General drew attention to potential fraud and abuse risks of speaker programs hosted by pharmaceutical companies and medical device manufacturers....more

CMS Issues Explanatory Guidance on Nationwide Blanket Stark Law Waivers

On April 21, 2020, the Centers for Medicare and Medicaid Services (CMS) issued explanatory guidance on the scope and application of a series of nationwide Section 1135 waivers of the physician self-referral law (Stark Law)...more

CMS Issues Nationwide Blanket Waivers of Stark Law and OIG issues an AKS Policy Statement

This On the Subject was updated on April 7, 2020, to address the Department of Health and Human Services Office of Inspector General’s (OIG’s) April 3, 2020, Policy Statement and its potential impact as well. The Centers...more

Special Report - Untangling VBEs, ACOs and CINs - What to Know about CMS and OIG's Proposed Regulations - December 2019

The Centers for Medicare & Medicaid Services and the Office of Inspector General recently released notices of proposed rulemaking relating to the Stark Law and the Anti-Kickback Statute. We break down the new proposed...more

[Webinar] Regulatory Sprint To Coordinate Care - November 19th, 21st, and December 5th, 12:30 pm ET

To help accelerate the transformation of the US healthcare system from a fee-for-service to a value-based system, the US Department of Health & Human Services (HHS) launched its “Regulatory Sprint to Coordinated Care”...more

Stark Law Proposed Change Affects Group Practice Special Rules for Productivity Bonuses, Profit Shares

On October 9, 2019, the US Department of Health and Human Services Centers for Medicare and Medicaid Services (CMS) published proposed changes to the physician self-referral law (Stark Law). Physician practices are subject to...more

HHS Proposes Substantial Changes to Stark Law and Anti-Kickback Statute Regulations

The Department of Health & Human Services’ (HHS) proposed changes to the Stark Law, the Anti-Kickback Statute, and the Civil Monetary Penalty Law, released today as part of the Regulatory Sprint to Coordinated Care, would...more

CMS Publishes Proposed Amendments to Stark Law Advisory Opinion Regulations

On July 29, 2019, the Centers for Medicare & Medicaid Services (CMS) published the CY 2020 Medicare Physician Fee Schedule Proposed Rule, which included substantial changes to the physician self-referral law (Stark Law)...more

Third Time Might Be the Charm: District Court Orders HHS to Clear the Medicare Appeals Backlog by 2022

The US District Court for the District of Columbia issued a mandamus order on November 1 requiring HHS to clear the Medicare administrative appeals backlog by the conclusion of 2022. A dedicated $182.3 million appropriation,...more

A Blast from the Past - Potentially Incorrect 1983 Medicare Reimbursement Rate Calculations May Have Significant Impact for...

In St. Francis Medical Center v. Azar, 277 hospitals challenged Medicare payment decisions over the past two decades. This recent DC Circuit Court remand may open the door to hospitals receiving additional reimbursement from...more

8/10/2018  /  Hospitals , Medicare , Reimbursements

CMS Proposes a 100 Percent Claims Review Demonstration for Home Health Agencies

On May 31, 2018, the Centers for Medicare and Medicaid Services (CMS) published a proposing to reinstate a controversial claim review demonstration project whereby CMS would review 100 percent of home health agency (HHA)...more

CMS Announces New Settlement Initiative Addressing Medicare Appeals Backlog, Enhancing Provider Appeal Options

In a Medicare Learning Network call on January 9, the Centers for Medicare and Medicaid Services provided specifics related to its new “Low Volume Appeals Settlement” initiative, allowing qualifying providers to settle...more

CMS Cuts Payments for Most 340B Drugs

On November 1, 2017, the US Department of Health and Human Services released a Final Rule implementing a payment reduction for most covered outpatient drugs billed to Medicare by 340B-participating hospitals from the current...more

Medicare Appeals Backlog: A Setback and New Opportunities for Providers

As of June 2017, the Office of Medicare, Hearing and Appeals (OMHA) had 607,402 appeals pending with a current estimated wait time of three years for an Administrative Law Judge to process a provider’s appeal. At this rate,...more

When Is a Hospital Not a Hospital? New Guidance Sheds (Some) Light on the Definition

The Centers for Medicare and Medicaid Services released guidance on September 6, 2017, intended to clarify the definition of “hospital.” The guidance provides factors that may be considered to determine whether a hospital is...more

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