Health Care Counsel

Arent Fox's health care law blog offers news, analysis, and insights for the health care industry.

Health Care Counsel

Pharmaceutical & Device Compliance

The pharmaceutical and medical device industries are increasingly subject to intense government scrutiny. Arent Fox helps these companies navigate the rough waters by providing fraud and abuse risk assessments related to the sales and marketing of prescription drugs and medical devices under both federal and state fraud and abuse laws, as well as compliance program development, monitoring, auditing, and training tailored for the drug and device arena. We assist with “Sunshine Act” compliance, both under the federal Physician Sunshine Act and under state laws mandating reporting of advertising and marketing costs. We counsel companies related to all forms of patient assistance programs, including free goods, charities, and manufacturer-sponsored “coupon” or co-payment assistance programs. We also track state law developments relating to price reporting, registering of clinical trials and reporting of trial results, limitations on prescription data-mining and licensing or other oversight of field sales representations.


Pharmaceutical, Chemical & Biotech Litigation: Year In Review

As in previous years, 2015 brought a combination of expected and unexpected holdings by the Supreme Court and the Federal Circuit.
On the expected side of the ledger, the Supreme Court continued its pattern of reversing the Federal Circuit, this year regarding claim construction and induced infringement. Also, true to past history, the Federal Circuit on remand took the Supreme Court’s holdings setting forth new tests on both indefiniteness and claim construction, and reached the same result.

CMS Delays Implementation of Revised 5i Average Manufacturer Price (AMP) Methodology and 70/30 Test until July 1, 2016

On March 31, 2016, CMS published a Manufacturer Release delaying implementation of the revised 70/30 test which manufacturers are to utilize to assess whether a 5i drug is generally dispensed at retail, as well as the 5i AMP methodology prescribed in the final AMP rule and codified at 42 CFR 447.504, until July 1, 2016.


Alternative, Value Based Payment Models Reach Part B Drugs

The Centers for Medicare & Medicaid Services (CMS) released a proposed rule on March 8, 2016 (published in the Federal Register on March 11, 2016) which could fundamentally change the way in which drugs administered in the physician office or hospital outpatient department settings (generally referred to here as Part B Drugs) are reimbursed by the Medicare program.


CVS Settles Controlled Substances Act Claim for $8 Million

As part of the federal government’s multi-front attack on opioid abuse, the Department of Justice announced on Friday, February 12 that CVS Pharmacy, Inc. has agreed to pay $8 million to settle allegations that it violated the Controlled Substances Act (CSA).


New Law Allows Texas State Board of Pharmacy to Scrutinize Compounding Pharmacies’ Relationships with Physicians

The federal government has focused on compounding pharmacies and pharmacists for fraud and abuse investigations in recent years, and now the great state of Texas has joined in.


A 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 regulatory guidance with a special focus on the needs and considerations of generic manufacturers.

Topics will include:


The 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 Care Act (ACA).


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 quickl


Subscribe to RSS - Pharmaceutical & Device Compliance


Add the Arent Fox Health Care Law blog to your RSS feed reader.

Arent Fox In Your Inbox
To subscribe to Arent Fox Alerts and other news, click here.


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.