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Health Care Providers Reporting Requirements Pharmaceutical Industry

Husch Blackwell LLP

HHS Unveils 340B Drug Rebate Pilot Program

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On July 31, 2025, the U.S. Department of Health and Human Services (HHS) announced that it will conduct a pilot program testing out a rebate model for 340B drug purchases. Under the program, drug manufacturers will be allowed...more

Dinsmore & Shohl LLP

Ohio Board of Pharmacy Takes Aim at Dispensing Errors

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The Ohio Board of Pharmacy (“Board”) published two new rules aimed at preventing and rooting out dispensing errors. The first new rule requires pharmacies to implement quality assurance programs for dispensing errors. The...more

McCarter & English, LLP

New Jersey Regulatory Update Part II - February 2025

We continue our New Jersey Regulatory Update with this Part II, which focuses on regulations that were finalized in the second half of 2024 and impact healthcare. For example, as a continuation of price transparency efforts,...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

Epstein Becker & Green

Massachusetts Governor Maura Healey Signs into Law a Sweeping Health Care Market Oversight Bill

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On January 8, 2025, Massachusetts Governor Maura Healey signed into law House Bill No. 5159, “An Act enhancing the health care market review process” (“H. 5159”), which was passed by the Massachusetts legislature in the last...more

Husch Blackwell LLP

Massachusetts Legislature Passes Bill Expanding Healthcare Industry Oversight

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On December 30, 2024, the Massachusetts Legislature passed House No. 4653, “An Act Enhancing the Health Care Market Review Process.” This bill includes sweeping changes focused on increased regulatory oversight and healthcare...more

Cornerstone Research

5 Questions with Sayeh Nikpay: The 340B Drug Pricing Program

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A periodic feature by Cornerstone Research, in which our affiliated experts, senior advisors, and professionals, talk about their research and findings. We interview Professor Sayeh Nikpay of the School of Public Health,...more

Mintz - Health Care Viewpoints

Connecticut Law Imposes New Requirements on Pharmaceutical Manufacturers, Defined to Include Device and Cosmetic Manufacturers,...

Public Act No. 23-171: An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs (Act) took effect in Connecticut on October 1, 2023. Under the Act, a pharmaceutical manufacturer (PM) that employs...more

Goodwin

Government Continues to Explore Role of 340B Contract Pharmacies

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The 340B Drug Pricing Program (the “Program”) allows certain healthcare providers (“covered entities”) to purchase pharmaceuticals from drug manufacturers at discounted rates. Some covered entities do not have an internal...more

Holland & Knight LLP

Holland & Knight Health Dose: July 12, 2022

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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. This week's topics include: ...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 6. In This Month’s E-News: June 2021

Report on Research Compliance 18, no. 6 (June 2021) - Clemson University is pushing back against recommendations by auditors for the National Science Foundation Office of Inspector General (OIG) that it repay $276,440,...more

Hinshaw & Culbertson - Health Care

Attention Pharmacies and Prescribers: New California Controlled Substances Prescription Form and CURES Reporting Requirements Are...

Compliance with prescription drug controlled substances prescribing and dispensing rules is essential for pharmacies and prescribers, as penalties for non-compliance are severe and can result in State Board of Pharmacy and...more

Bass, Berry & Sims PLC

Significant Change to ClinicalTrials.gov Reporting Requirements: Ten Years' Worth of Back Data Owed

The National Institutes of Health (NIH) has warned clinical trial sponsors – including not only drug and device companies, but also universities and hospitals with investigator-initiated trials – to submit significant...more

K&L Gates LLP

K&L Gates Triage: Recent Developments in the 340B Drug Pricing Program

K&L Gates LLP on

In this episode, Richard Church, Andrew Ruskin, and Victoria Hamscho discuss recent developments in the 340B Drug Pricing Program, including recent actions by drug manufacturers to limit contract pharmacy access to 340B...more

Akin Gump Strauss Hauer & Feld LLP

CMS Issues Proposed Revisions to Open Payments/Sunshine Act Reporting Requirements

• On July 29, 2019, CMS released its proposed 2020 Physician Fee Schedule rule, which includes the much anticipated proposed regulatory changes to the Sunshine Act/Open Payments program (“Open Payments”). The proposed...more

Jones Day

Sunshine Act Reporting Requirements Expanded to Physician Assistants and Advance Practice Nurses

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Applicable manufacturers will need to update their methods of documenting payments and transfers of value to include the newly expanded list of providers. A bill recently signed into law expands the reporting requirements...more

Cooley LLP

Blog: Federal Sunshine Act Reporting Requirements Expanded to Other Prescribers

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Currently, the federal Physician Payments Sunshine Act (Sunshine Act) requires certain manufacturers of drugs, biologics, medical devices and medical supplies for which payment is available under Medicare, Medicaid or the...more

Holland & Knight LLP

CMS Issues Proposed Rule on Medicare Physician Payment in 2019

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The Centers for Medicare & Medicaid Services (CMS) on July 12, 2018, published the CY 2019 Proposed Rule for the Medicare Physician Fee Schedule (PFS). While in previous years regulations for the Quality Payment Program (QPP)...more

Butler Snow LLP

Pro Te: Solutio Vol. 11 No. 1 – A Reflection on the First Ten Years

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It’s hard to believe a decade has passed since we delivered our first edition of Pro Te: Solutio to your door. Those years have brought enormous changes in the world and in our industry. Innovation has driven everything we...more

Foley & Lardner LLP

Florida’s New Law Changes Physician Responsibilities for Opioid Dispensing

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Florida’s House Bill (HB) 21, enacted to help combat opioid abuse, contains several noteworthy changes to Florida law that impact the dispensing of opioids. Effective July 1, 2018, dispensing providers must consult...more

Mintz - Health Care Viewpoints

New Bill Would Expand the Sunshine Act to Cover Physician Assistants and Advance Practice Nurses

Late last month, Senators Grassley (R-IA), Brown (D-OH), and Blumenthal (D-CT) introduced the Fighting the Opioid Epidemic with Sunshine Act, a bill that would expand Physician Payment Sunshine Act reporting requirements to...more

Bricker Graydon LLP

Prescriber rules for opioids

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On March 30, 2017, Ohio Governor John Kasich issued a policy statement imposing new limits on prescribing opiates, which became effective August 31, 2017. ...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - May 2017

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

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