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Keeping you afloat admidst the rising sea of regulations

Final 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. The rule is effective April 1, 2016, with a compliance date of April 1, 2017. The Arent Fox team will subsequently issue a comprehensive Client Alert. Stay tuned!

Final Average Manufacturer Price (AMP) Rule Released Once Again By Office of Management and Budget

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 Medicare & Medicaid Services (CMS). The precise time of the public release by CMS is anyone guess but it is expected to be imminent.

Final Average Manufacturer Price (AMP) Rule Back at Office of Management and Budget

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 Management and Budget for review.  The Final AMP Rule was originally reviewed and released by the OMB on December 11, 2015.   The return of the Final AMP Rule from CMS to OMB technically triggers another 90-day OMB review cycle.  However, it is unclear whether OMB will require a full 90 day review or whether the changes made by CMS were technical and can be reviewed more quickly.  As we previously note

OMB 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 AMP Rule aimed at implementing changes to the AMP calculation as set forth in the Affordable Care Act. The Arent Fox team will promptly post once the Final AMP Rule is release and subsequently issue a comprehensive Client Alert. Stay tuned!

Texas Medicaid Transitioning to National Average Drug Acquisition Cost (NADAC)-Based Pharmacy Reimbursement

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 fee-for-service Medicaid program, currently based on Estimated Acquisition Cost, with Acquisition Cost based on NADAC, Long Term Care Acquisition Cost and Specialty Pharmacy Acquisition Cost.  In addition, the proposed regulation would repeal burdensome price reporting requirements for drug manufacturers, and instead requir

CMS 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 Medicaid contacts emphasizing appropriate access to, and coverage of, direct-acting antiviral (DAA) drugs used to treat individuals with the hepatitis C virus (HCV).

Pharmaceutical 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 debts by suspending the debt limit through March 2017. The Act also contains several provisions that will have a direct impact on the pharmaceutical industry. Specifically, manufacturers should take note of the following:

HRSA 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 in the Federal Register on August 28, 2015. Arent Fox’s Health Group attorneys are reviewing the release, and an in-depth analysis will be posted to Health Care Counsel Blog shortly. Stay tuned!

US 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 Pharma Inc. v United States Food and Drug Administration (August 7, 2015), granted Amarin’s motion for preliminary injunction, prohibiting FDA from prosecuting the company for making truthful and not-misleading statements to physicians about unapproved uses of one its products. This decision grows out of the landmark decision in United States v. Caronia, 703 F.3d 149 (2d Cir.