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Reporting Requirements Pharmaceutical Industry Healthcare

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

Bass, Berry & Sims PLC

2024 Healthcare Private Equity Outlook & Trends

W ith various headwinds resulting in down volume in 2023, buyers and sellers alike find themselves asking whether 2024 will see a rebound in deal activity. As we begin 2024, we have highlighted the issues and trends that...more

Quarles & Brady LLP

New DEA Form 106 Theft & Loss Reporting Deadlines and Submission Requirements

Quarles & Brady LLP on

On June 22, 2023, DEA published a final rule regarding the timing with which registrants are required to report the theft or loss of controlled substances (the “Final Rule”). 88 FR 40707. DEA’s regulations have always...more

Quarles & Brady LLP

California Board of Pharmacy Changes

Quarles & Brady LLP on

Over the last few months the California Board of Pharmacy has been busy considering several changes to its current rules and how it regulates various entities under its purview....more

Mintz - Health Care Viewpoints

Sunshine Act Expands to Advance Practice Nurses and Physician Assistants

Drug and device manufacturers will need to update their reporting systems and provide new training to their sales staff in the coming years based on changes to the Physician Payment Sunshine Act included in the final opioid...more

Robinson+Cole Data Privacy + Security Insider

FDA Guidance on Cybersecurity in Medical Devices

On December 28, 2016, the Food and Drug Administration (FDA) issued guidance on Postmarket Management of Cybersecurity in Medical Devices. The guidance clarified aspects of the reporting requirements under Part 806 (21 CFR...more

Polsinelli

New Clinical Trial Rule Alters Reporting Requirements

Polsinelli on

New federal requirements for posting of clinical trials information address how data collected in clinical trials are submitted for public consumption. The requirements were revealed on Sept. 16 when the Department of Health...more

Holland & Knight LLP

OIG Report Raises Serious Medicare Part D Fraud, Waste and Abuse Concerns

Holland & Knight LLP on

Last month, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services released a comprehensive report and data brief detailing its concerns about the ability of Medicare Part D sponsors – as...more

Troutman Pepper

OIG Work Plan Midyear Update Adds Activities Related to Medicare Part D and Medicaid Rebates

Troutman Pepper on

The update to the Fiscal Year 2015 Annual Work Plan includes new initiatives that may affect pharmaceutical companies and Medicare Part D payors and pharmacies. Annually, the Department of Health and Human Services...more

Cooley LLP

Blog: Vermont AG Announces Another Disclosure Law Enforcement Action

Cooley LLP on

the Vermont Office of the Attorney General (“VT AG”) previously published several enforcement actions taken against manufacturers of pharmaceutical, biological and medical devices for failing to comply with the state’s...more

Mintz - Health Care Viewpoints

Front End Changes and, Again, More DIR Columns

Since the beginning of the Medicare Part D program, CMS has introduced many reporting mechanisms for trying to understand drug pricing, price concessions, and the cost of providing services to Part D members. The tool CMS...more

Sheppard Mullin Richter & Hampton LLP

Cloudy Skies Ahead for Providers? CMS’ Release of Medicare Billing Data Combined with Physician Payment Sunshine Act Data May...

In February 2013, we reported (on our Healthcare Law Blog) that the Centers for Medicare and Medicaid Services (CMS) announced the final rule for the Physician Payments Sunshine Act. In the interest of providing more...more

King & Spalding

European Federation of Pharmaceutical Industries and Associations (EFPIA) Launches New Financial Relations Disclosure Code

King & Spalding on

Member Organizations Will Have Tracking and Reporting Obligations for Certain “Transfers of Value” to HCPs and HCOs - On July 2, 2013, the European Federation of Pharmaceutical Industries and Associations (EFPIA or “the...more

Perkins Coie

Getting Ready For The Physician Payment ‘Sunshine’ Rule

Perkins Coie on

Originally Published in BNA Bloomberg, Medical Devices Law & Industry Report on March 20, 2013. On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited final regulations for...more

Morgan Lewis

Final Sunshine Act Arrives: Now the Hard Part

Morgan Lewis on

The Centers for Medicare and Medicaid Services (CMS) issued the final regulations on the U.S. Sunshine Act on February 8, 2013. Transparency Reports and Reporting of Physician Ownership or Investment Interests, 78 Fed. Reg....more

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