OIG Issues Favorable Advisory Opinion to Pharmaceutical Manufacturer on...
On July 28, 2014, the US Department of Health and Human Services’ Office of Inspector General (OIG) issued a favorable opinion concerning a drug manufacturer’s program to offer a certain branded drug...
View ArticleOIG Issues First Charitable Patient Assistance Program Advisory Opinion...
On January 5, 2015, the Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion No. 14-11 (Advisory Opinion) addressing a charitable foundation’s request to...
View ArticleUnsealed False Claims Act Suit Asserts that Reverse Payment Settlements...
Pharmaceutical manufacturers could face a new line of attack related to Hatch-Waxman reverse payment settlement agreements (so-called, "pay-for-delay" settlements). The FTC has challenged these...
View Article'Disguised' Discounts Lead Medco to Settle False Claims Allegations
On May 20, 2015, the United States Department of Justice (DOJ) announced that pharmacy benefits manager Medco Health Solutions Inc. (Medco) agreed to pay the government $7.9 million to resolve...
View ArticleHRSA Proposed Rule on Calculating the 340B Ceiling Price and Penalties...
On June 17, 2015, the Health Resources and Services Administration (HRSA) published a long-awaited proposed rule setting forth revisions to the current regulations governing the 340B Drug Discount...
View ArticleThe Internal Threat: Cyber Security and Medical Devices
A recent blog post in the IEEE Spectrum, “Hackers Invade Hospital Networks Through Insecure Medical Equipment,” focused attention on something known for a while: medical devices can open a door to...
View ArticleLong-Anticipated Average Manufacturer Price Final Regulations Being Reviewed...
On August 4, 2015, the long-awaited final rule from CMS implementing the Affordable Care Act changes to the calculation of Average Manufacturer Price (AMP) went over to the Office of Management and...
View ArticleOIG Issues Favorable Advisory Opinion to Pharmaceutical Manufacturer Related...
On August 5, 2015, the Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion No.
View ArticleUS District Court Affirms First Amendment Protection of Off-Label Drug Promotion
On August 7, 2015, the US District Court for the Southern District of New York issued a significant decision concerning FDA’s regulation of off-label promotion of approved drugs. The decision, Amarin...
View ArticleHRSA Releases Long Awaited Draft 340B Guidance
An advance copy of the long-awaited 340B Drug Pricing Program Omnibus Guidance has been released by the Health Resources and Services Administration. The official version is scheduled to be published...
View ArticleLong-Awaited 340B Program Guidance Now Available for Comments: What...
For a PDF of this alert, please click here.
View ArticlePharmaceutical Manufacturers Should Take Note of Bipartisan Budget Act
On November 2, 2015, President Obama signed the Bipartisan Budget Act of 2015 into law. The two year budget deal increases overall spending limits and prevents the United States from defaulting on its...
View ArticleCMS Reminds States of Coverage Obligations for Hepatitis C Drugs
On November 5, 2015, the Center for Medicaid and CHIP Services, a division of the Centers for Medicare & Medicaid Services (CMS), issued a Medicaid Drug Rebate Program notice (the Notice) to state...
View ArticleTexas Medicaid Transitioning to National Average Drug Acquisition Cost...
The October 30, 2015 Texas Register contained a proposed regulation published by the Texas Health and Human Services Commission (HHSC) that would replace pharmacy reimbursement under the Texas...
View ArticleOMB Clears Final Average Manufacturer Price (AMP) Rule
The Medicaid Covered Outpatient Drugs Final Rule completed review by the Office of Management and Budget late on Friday, December 11. It has been almost 4 years since publication of the 2012 Proposed...
View ArticleFinal Average Manufacturer Price (AMP) Rule Back at Office of Management and...
On January 5, 2016, the Centers for Medicare & Medicaid Services (CMS) sent the Medicaid Covered Outpatient Drugs Final Rule (commonly referred to as the Final AMP Rule) to the Office of...
View ArticleFinal Average Manufacturer Price (AMP) Rule Released Once Again By Office of...
On January 19, 2016, the Office of Management and Budget once again released the Medicaid Covered Outpatient Drugs Final Rule (commonly referred to as the Final AMP Rule) back to the Centers for...
View ArticleFinal Average Manufacturer Price (AMP) Rule Released!
On January 21, 2016, the Centers for Medicare & Medicaid Services released the Medicaid Covered Outpatient Drugs Final Rule (commonly referred to as the Final AMP Rule), which is available here....
View ArticleThe Final AMP Rule: An Overview for Stakeholders
On January 21, 2016, the Centers for Medicare & Medicaid Services (CMS) released the long-awaited Final Rule implementing changes to the Medicaid Drug Rebate Program (MDRP) under the Affordable...
View ArticleA Closer Look at AMP and Other Regulations: The Impact on Generics
On Thursday, February 18, please join Arent Fox partner Stephanie Trunk and Deloitte Senior Manager Rick Moore for a webinar that will break down the provisions of the AMP final rule and other...
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