News & Analysis as of

Medicare Part D Compliance

Patterson Belknap Webb & Tyler LLP

The Fourth Circuit Broadly Interprets “Inducement” and “Remuneration” Under the Anti-Kickback Statute and Creates a Circuit Split

On January 23, 2025, in Pharmaceutical Coalition for Patient Access v. United States, the Fourth Circuit held that a proposed patient assistance program, which would help cancer patients afford certain oncology drugs, would...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

ArentFox Schiff

FCA Enforcement & Compliance Digest — Fall 2024 False Claims Act Newsletter

ArentFox Schiff on

Welcome to the Fall 2024 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and compliance...more

Williams Mullen

Annual Employee Benefits Compliance Checklists - Plan Administrators

Williams Mullen on

Plan administrators should review the following actions to be taken before the end of 2024 and focus on what to expect for 2025. The following checklist addresses plan amendments, notices, and other considerations for...more

Ankura

New Health Information Technology Standards for Medicare Part D

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On June 17, 2024, the final rule for Medicare Part D introduced new health IT standards, mandating the adoption of NCPDP SCRIPT Standard version 2023011 by January 1, 2028, while the NCPDP Formulary and Benefit (F&B) Standard...more

Holland & Knight LLP

Court Upholds OIG Advisory Opinion Shooting Down a Patient Assistance Program

Holland & Knight LLP on

Healthcare compliance risks exist even when a company takes steps to structure its business activities to follow the government's own statements. A recent decision by the U.S. District Court for the Eastern District of...more

Health Care Compliance Association (HCCA)

[Event] 2024 Managed Care Compliance Conference - January 29th - 30th, Coronado, CA

Explore the unique issues that are pertinent to managed care professionals! This annual event dedicated to compliance management for health plan providers is returning to an in-person format for 2024. Join your peers and...more

Ankura

Behind the Expert: Applying a Proactive Approach to Healthcare Compliance with Nancy Waltermire

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"Rather than reacting, you must be proactive and preventive. By doing this, you will not only be prepared for the potential obstacles that face your company, but you will most likely eliminate obstacles before they appear." ...more

Sheppard Mullin Richter & Hampton LLP

Healthcare Reforms Under the IRA: Expanding Access to Care

The Inflation Reduction Act (“IRA”) was signed into law by President Biden on August 16, 2022. The expansive legislation includes key health care provisions, including drug pricing reforms, inflationary rebates, Medicare Part...more

Sheppard Mullin Richter & Hampton LLP

CMS Issues Contract Year 2023 Final Rule for Medicare Advantage Organizations and Prescription Drug Sponsors

On April 29, 2022, the Centers for Medicare and Medicaid Services (“CMS”), issued the final rule on Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2022 Managed Care Compliance Conference - February 8th - 9th, 8:25 am - 3:45 pm CST

Can’t attend the conference in-person? The virtual Managed Care Compliance Conference, February 8–9, allows you to hear from industry professionals just like you—all from the comfort of your home or office. Geared towards...more

Health Care Compliance Association (HCCA)

[Event] 2022 Managed Care Compliance Conference - January 30th - February 1st, Phoenix, AZ

Attend our annual event for those who manage compliance at health plan providers. Explore topics and issues that are pertinent to industry professionals like you. Learn the latest practices, share strategies, and connect with...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2021 Managed Care Compliance Conference - February 1st - 3rd, 9:30 am - 3:45 pm CST

The first ever VIRTUAL Managed Care Compliance Conference will have the great speakers and content you have come to expect from the in-person event. Each year, we look forward to hosting compliance professionals at our...more

Baker Donelson

OIG Work Plan – September 2017 Update

Baker Donelson on

Beginning in June 2017, the OIG began making monthly Work Plan updates. These monthly updates create some practical challenges for health care providers and compliance professionals trying to make operational and compliance...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

Cadwalader, Wickersham & Taft LLP

In Closely Watched Case, Federal Court Upholds the Government’s Position on Provider Mandate to Report and Return Medicare and...

The Patient Protection and Affordable Care Act (“PPACA”), signed into law on March 23, 2010, included a provision (the “Report and Refund Mandate”), broadly requiring health care providers, suppliers, Part D plans and managed...more

Stinson LLP

Health & Human Services, Office of Inspector General, Proposes New Fraud and Abuse Rules

Stinson LLP on

The U.S. Department of Health & Human Services, Office of Inspector General (OIG) published 79 Fed. Reg. 59717 on October 3, 2014. This proposed rule has the potential to have an impact on a broad array of financial...more

McDermott Will & Emery

CMS Medicare MLR Final Rule Creates New Obligations and Risks

The Centers for Medicare & Medicaid Service’s release of the final Medicare medical loss ratio regulations allows Medicare Advantage Organizations and Part D Plan Sponsors to evaluate their operations in order to come into...more

Brownstein Hyatt Farber Schreck

CMS Announces Proposed Rule Implementing the ACA's MLR Requirements for MA and Prescription Drug Plans

On February 15, the Centers for Medicare & Medicaid Services (CMS) released its Proposed Rule, effective calendar year (CY) 2014, implementing the Medical Loss Ratio (MLR) requirements for Medicare Advantage (MA)...more

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