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 Care Act (ACA).
Prescription Drug Pricing & Government Price Reporting
Arent Fox is one of only a handful of US firms that can provide sophisticated counsel to the prescription drug industry on the full range of complex pricing issues, including AWP and WAC reporting to the compendia, ASP reporting to Medicare, AMP and Best Price reporting to Medicaid, ceiling and sub-ceiling price reporting to support the Public Health Service 340B program, and non-FAMP and FCP reporting to FA/FSS. We also assist pharmaceutical manufacturers in navigating the Coverage Gap Discount Program under Medicare Part D, NADAC, and the AAC methodologies currently being adopted by state Medicaid programs. Our advice reflects experience gained from supervising government pricing systems audits, handling restatements and voluntary disclosures with CMS, the Office of Pharmacy Affairs at HRSA and the VA, and representing clients facing enforcement actions tied to their price reporting obligations.
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!
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.
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 quickl
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!
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
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).
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:
DHHS has announced a public forum to explore pharmaceutical innovation, access and affordability. The forum will hear from various stakeholders, including manufacturers, consumers, and representatives from state and federal government, on how to improve patient access to affordable prescription drugs.
On October 14, 2015, the United States District Court for the District of Columbia (the Court) issued a ruling which could have significant positive implications for those drug manufacturers unhappy with a particular Department of Health and Human Services Health Resources and Services Administration’s (HRSA) interpretive rule – namely, the July 2014 rule extending deeply discounted prices under section 340B of the Public Health Services Act (PHSA) to certain entities for “orphan drugs,” when used by qualifying patients for treatment of conditions beyond those that originally qualifie
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Arent Fox LLP, founded in 1942, is internationally recognized in core practice areas where business and government intersect. With more than 350 lawyers, the firm provides strategic legal counsel and multidisciplinary solutions to clients that range from Fortune 500 corporations to trade associations. The firm has offices in Los Angeles, New York, San Francisco, and Washington, DC.