News & Analysis as of

Department of Justice (DOJ) Medicare Part D Centers for Medicare & Medicaid Services (CMS)

Baker Donelson

Looking Back at 2024: Key Health Care Regulatory Legal Developments in Fraud and Abuse, Compliance, and Enforcement

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The health care regulatory space realized significant regulatory and enforcement developments in 2024 that are influencing how providers and industry stakeholders approach various compliance measures and enforcement...more

Mintz - Health Care Viewpoints

EnforceMintz — Medicare Advantage and Part D Programs to Remain in the Enforcement Spotlight in 2025

As government scrutiny and enforcement targeting the Medicare Advantage (Medicare Part C) program continued in 2024, the industry’s response to agency actions escalated. Last year also resulted in the first sizable Part D...more

Holland & Knight LLP

Holland & Knight Health Dose: March 5, 2024

Holland & Knight LLP on

Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more

Mintz - Health Care Viewpoints

EnforceMintz — Significant 2022 Regulatory and Policy Developments

From an agency guidance and regulatory developments perspective, 2022 was fairly quiet until the latter part of the year. Consistent with past practice, the Office of Inspector General for the Department of Health and Human...more

Mintz - Health Care Viewpoints

CMS Proposed Rule for Refunding Overpayments Would Align With False Claims Act “Knowledge” Standard

The Centers for Medicare & Medicaid Services (CMS) proposed a rule late last year to harmonize the standard it would apply for providers to identify and refund overpayments with the “knowledge” standard under the False Claims...more

Foley & Lardner LLP

Will CMS’s Proposed Rule on “Identified Overpayments” Increase Reverse FCA Cases?

Foley & Lardner LLP on

On December 27, 2022, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule which, in part, seeks to amend the existing regulations for Medicare Parts A, B, C, and D regarding the standard for when an...more

King & Spalding

OIG Releases Semiannual Report to Congress

King & Spalding on

On May 28, 2021, OIG released its Semiannual Report to Congress (the Report). The Report describes OIG’s work during the 6-month semiannual reporting period of October 1, 2020, through March 31, 2021 (the Semiannual Reporting...more

ArentFox Schiff

Investigations Newsletter: Court Rules Prescription Drug Event and Enrollee Encounter Data Are 'Claims for Payment' Under the...

ArentFox Schiff on

Court Rules Prescription Drug Event and Enrollee Encounter Data Are 'Claims for Payment' Under the False Claims Act - US District Judge Noel L. Hillman approved a whistleblower’s request to file a Fourth Amended Complaint...more

Epstein Becker & Green

Deadline Looms for Responding to DEA’s Proposed Aggregate Production Quotas for 2021

Epstein Becker & Green on

On Tuesday, September 1, 2020, the Drug Enforcement Agency (“DEA”) proposed 2021 aggregate production quotas (APQs) for controlled substances in schedules I and II of the Controlled Substances Act (“CSA”) and an Assessment of...more

Clark Hill PLC

Window On Washington - Vol. 2, Issue 35

Clark Hill PLC on

Outlook for This Week in the Nation's Capital - Congress Returns. Clark Hill hopes that everyone had a safe and happy Labor Day weekend. ...more

Clark Hill PLC

Window on Washington - Vol. 2, Issue 5

Clark Hill PLC on

Another Shutdown? Congress needs to pass another short-term spending bill by Friday in order to keep the government open, but some House Republicans are against the plan for a fifth continuing resolution that would fund the...more

Holland & Knight LLP

Healthcare Law Update: September 2017

Holland & Knight LLP on

OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more

McGuireWoods LLP

Washington Healthcare Update

McGuireWoods LLP on

This Week: Congress remains in recess, but members write letters on Mylan’s EpiPen…CBO says repealing Part B Demo would cost $395 million…CMS releases data on hospice utilization and finds spending and utilization vary in...more

Alston & Bird

A&B Healthcare Week in Review

Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more

BakerHostetler

Kane and the “60-Day Rule”: The Unforgiving World of Medicare and Medicaid Overpayments

BakerHostetler on

The Southern District of New York has spoken on one of the first issues to confront those seeking compliance with the new “60-day rule” under the Affordable Care Act (ACA), and it does not bode well for defendant hospitals...more

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