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Centers for Medicare & Medicaid Services (CMS) Compliance Pharmaceutical Industry

Paul Hastings LLP

CMS Proposes Major ASP Reporting Overhaul — Implications for Fair Market Value and Bona Fide Service Fees

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The Centers for Medicare & Medicaid Services (CMS) recently published its Proposed 2026 Physician Fee Schedule Rule (Proposed Rule), with extensive implications for drug pricing, Average Sales Price (ASP) calculations, and...more

ArentFox Schiff

Medicare 2026 Proposed Rules, Major Drug Pricing Updates, and What Stakeholders Need to Know

ArentFox Schiff on

Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules that set Medicare reimbursement and shape the administration of the Medicare Part B program for the upcoming calendar year. These...more

Mintz

Mintz IRA Update — Duplicate Discounts Between the 340B Program & Medicare Drug Price Negotiation Program

Mintz on

The 340B Drug Pricing Program (340B Program) is no stranger to controversy. We have previously covered the ongoing contract pharmacy legal battles and the new alternative dispute resolution process. And now, a new 340B hurdle...more

Gardner Law

Sunshine Act Compliance: How to Take Action to Meet Reporting Requirements and Avoid Costly Penalties

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The clock is ticking for medical device and pharmaceutical companies to fulfill their obligations under the Physician Payments Sunshine Act (the "Sunshine Act"). With the reporting deadline of March 31 looming and CMS...more

Troutman Pepper Locke

Q4 2024 Health Care Conference Roundup: AI and Government Enforcement Are on the Rise

Troutman Pepper Locke on

Last quarter, our attorneys had the privilege of attending three prominent health care conferences, each of which offered a wealth of knowledge and insights into the current and future landscape of the health care industry. ...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - May 9th - 10th, San Juan, Puerto Rico

Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education on a wide variety of current and emerging topics...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] 2023 Healthcare Enforcement Compliance Conference - November 5th - 7th, Washington, DC

Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more

Goodwin

Pharma Manufacturer Federal Government Price Reporting: Recent Litigation and Settlements

Goodwin on

​​​​​​​Litigation involving drug price reporting under the Medicaid Drug Rebate Program (MDRP)  has been very active in 2022. Most recently, on August 3, 2022, an Illinois federal jury levied a $61 million verdict against Eli...more

Sheppard Mullin Richter & Hampton LLP

On Your Mark, Get Set, Go: Life Science Companies Face A Challenging Year For Compliance With New Open Payment Program Data...

The Physician Payment Sunshine Act (the “Sunshine Act”) – a federal law first adopted as Section 6002 of the Patient Protection and Affordable Care Act of 2010 (“PPACA”) – requires the Centers for Medicare and Medicaid...more

Health Care Compliance Association (HCCA)

[Event] Managed Care Compliance Conference - January 26th - 29th, Lake Buena Vista, FL

Delve into compliance hot topics and issues, including risk adjustment, CMS compliance, ethical leadership, data security, audits, and the challenges of the job. You’ll learn the latest practices, share strategies, and...more

K&L Gates LLP

K&L Gates Triage: Triage in 2018: Health Care Topics to Watch in the New Year

K&L Gates LLP on

We expect 2018 to be another year of rapid change within the health care industry. In this episode, Mary Beth Johnston highlights some of the key topics that the health care practice group will monitor in the coming year,...more

Bradley Arant Boult Cummings LLP

False Claim Act: 2013 Year in Review

Last year continued the trend of robust False Claims Act (FCA) enforcement by the U.S. Department of Justice (DOJ) and proliferating qui tam lawsuits brought by whistleblowers on behalf of the United States. In 2012, DOJ...more

Saul Ewing Arnstein & Lehr LLP

Highlighting Transparency Through The Federal Sunshine Act Regulations

The final regulations implementing the Physician Payments Sunshine Act take effect April 9, 2013. Pharmaceutical manufacturers, group purchasing organizations, academic medical centers and physicians need to be ready to...more

Mintz - Health Care Viewpoints

CMS Publishes Final Sunshine Act Rule; Data Collection to Begin on August 1, 2013

The long-awaited final rule (the Final Rule) implementing the Physician Payments Sunshine Act (Sunshine Act) has arrived at the Federal Register. It amends key definitions and adds new terms; retains broad reporting...more

Holland & Knight LLP

CMS Issues Final Physician Payment Sunshine Rule

Holland & Knight LLP on

In an action that will have broad implications for drug and device manufacturers, researchers, distributors, teaching hospitals and physicians, on February 1, the Centers for Medicare and Medicaid Services (CMS) publicly...more

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