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Reporting Requirements Prescription Drugs

Hinshaw & Culbertson - Health Care

Don’t Jeopardize Your License: Ensure Compliance With California State Board of Pharmacy Notification and Reporting Obligations

Pharmacies, wholesalers, third-party logistics providers, outsourcing facilities, clinics, and pharmacists must obtain the California State Board of Pharmacy’s (the “Board”) approval or otherwise notify the Board about...more

Goodwin

FDA Issues Draft Guidance on Postapproval Manufacturing Changes to Biosimilar Products

Goodwin on

​​​​​​​On July 23, 2024, the FDA issued a draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers.”...more

Venable LLP

June 1 Prescription Drug Reporting Deadline for Group Health Plans

Venable LLP on

Employer group health plans must make an annual disclosure of the plan's prescription drug and healthcare spending to the Centers for Medicare & Medicaid Services (CMS). The disclosure, called the Prescription Drug Data...more

Wiley Rein LLP

Proposed State and Federal PBM Legislation: Is There Reason for Action Now?

Wiley Rein LLP on

Legislation aiming to reform the regulation of pharmacy benefit managers (PBMs) remains on the horizon on both the federal and state levels. In particular, 2023 was a fertile year for PBM legislative initiatives....more

Verrill

RxDC Reporting in Light of June 1, 2024 Deadline and Recent PBM Litigation

Verrill on

Under the Consolidated Appropriations Act of 2021 (“CAA”), employer-sponsored group health plans, including medical-only plans, must submit information about their prescription drugs and health care spending. This submission...more

Husch Blackwell LLP

California Enacts First-in-Nation Pharmacy Medication Error Reporting Law

Husch Blackwell LLP on

On October 8, 2023, Governor Gavin Newsom signed Assembly Bill 1286 (AB 1286), a sweeping pharmacy measure with several components aimed at promoting patient safety. Chief among AB 1286’s mandates is a new law requiring that...more

Akin Gump Strauss Hauer & Feld LLP

The Road Ahead for Private Equity: Reflections and Predictions

The year 2023 will be remembered as a challenging one for private equity (PE), with complexities to navigate on many fronts. Traditional debt financing was expensive and scarce, expectations on valuations were tricky to...more

Sheppard Mullin Richter & Hampton LLP

Oregon Prescription Drug Price Transparency Act in Limbo

On February 16, the U. S. District Court for the District of Oregon struck down the state’s drug price transparency law—The Prescription Drug Price Transparency Act (the “Act”)—ruling that the Act’s annual price increase...more

ArentFox Schiff

Federal Court Ruling Suspends Compliance with Certain Reporting Obligations Under Oregon Drug Price Transparency Program

ArentFox Schiff on

Earlier this month, the US District Court for the District of Oregon issued a declaratory judgment invalidating a key component of the Oregon Drug Price Transparency Program. The Oregon Drug Price Transparency Program was...more

Cornerstone Research

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

Cornerstone Research on

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

Ballard Spahr LLP

CO and NY enact laws to prevent reporting of medical debt to credit bureaus

Ballard Spahr LLP on

Colorado and New York are not waiting for the Fair Credit Reporting Act rulemaking to eliminate creditor use of medical debt announced by the CFPB in September 2023. As we previously blogged, in the past two years, Equifax,...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

Sheppard Mullin Richter & Hampton LLP

Connecticut Follows in the Footsteps of Other Jurisdictions Requiring Registration of Pharmaceutical Representatives

Connecticut is the latest state to join the efforts of jurisdictions such as Oregon, Nevada, Washington D.C., and the City of Chicago, Illinois, in further regulating the activities of pharmaceutical representatives. In June,...more

Goodwin

Government Continues to Explore Role of 340B Contract Pharmacies

Goodwin on

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

Morgan Lewis

New Jersey Latest to Join States Signing Drug Price Transparency Reporting Measures into Law

Morgan Lewis on

Following in the footsteps of other states, New Jersey’s state legislature has recently signed into law three bills for containing prescription drug costs. One bill—Senate Bill 1615—is likely to have a particularly sweeping...more

Mintz - Health Care Viewpoints

Pharmacy Benefit Managers are on the Federal Government’s Radar: Senate, House, and Agency Proposals Seek to Increase PBM...

In conjunction with the surge in state legislative efforts to regulate the pharmacy benefit manager (PBM) industry, Congress and federal agencies have ramped up PBM oversight efforts as part of the ongoing battle to lower...more

Proskauer - Employee Benefits & Executive...

Here We Go Again: Prescription Drug Reporting Due by June 1st

“Didn’t we just do this?” might be the first question asked by many health plan sponsors and administrators when gearing up to complete 2022 prescription drug reporting by June 1, 2023.  The answer to that question is both...more

Woodruff Sawyer

Agencies Release Revised Instructions for 2022 Reference Year RxDC Reporting

Woodruff Sawyer on

On March 3, 2023, federal agencies released revised Prescription Drug Data Collection (RxDC) Reporting Instructions applicable to the 2022 reference year. RxDC reporting for the 2022 reference year is due on or before June 1,...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

CMS Updates Could Help Employers on Second Round of Drug Cost Reporting

Employers facing a June 1, 2023, deadline for 2022 prescription drug cost reporting have important new clarification on issues such as plans that cover more than one employer, average monthly premium calculations, and medical...more

Manatt, Phelps & Phillips, LLP

[Webinar] In the Shadow of Drug Pricing Reform: New Developments for Pharmaceutical Price Reporting - March 23rd, 1:00 pm - 2:00...

With the enactment of major drug pricing reform—including the Inflation Reduction Act (IRA), which arguably made the most significant changes to U.S. prescription drug pricing regulations in history—the reporting of drug...more

Blank Rome LLP

Nevada Publishes 2023 Drug Price Transparency Lists

Blank Rome LLP on

On January 31, 2022, the Nevada Department of Health and Human Services (“DHHS”) released its annual drug lists in accordance with its Drug Transparency Reporting Program. DHHS published four drug lists: List #1 Essential...more

Jones Day

FDA Proposes IND Exemptions for Drug Studies of Foods, Supplements, or Cosmetics

Jones Day on

Under the proposed regulation, sponsors and sponsor-investigators whose planned study falls within an exemption will not be required to submit an Investigational New Drug application ("IND") or comply with IND reporting...more

Stinson - Benefits Notes Blog

Departments Provide Relief for 2020 and 2021 Prescription Drug Reporting

On December 23, 2022, the Departments of Labor, Health and Human Services and Treasury (the “Departments”) issued FAQs providing relief from prescription drug and health care spending reporting requirements. The FAQs are...more

Woodruff Sawyer

Compliance Alert: Agencies Extend RxDC Reporting Deadline to January 31, 2023

Woodruff Sawyer on

On December 23, 2022, federal agencies released ACA and CAA Implementation FAQ Part 56, which extends the December 27, 2022 deadline for Prescription Drug Data Collection Reporting (“RxDC Reporting”) through January 31, 2023,...more

Faegre Drinker Biddle & Reath LLP

Holiday Rush Brings Health Plans Eagerly Awaited RxDC Reporting Guidance and Relief

In FAQs Part 56, issued on December 23, 2022, the Treasury Department and the Departments of Labor and Health and Human Services (collectively, Departments) issued important guidance on prescription drug benefit and cost...more

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