In a Federal Register notice scheduled to be published on March 20, 2017, the Health Resources and Services Administration (HRSA) announced that it will delay the effective date of the January 5, 2017 final rule (the Final Rule) that provided guidance on the calculation of drug ceiling prices and the imposition of civil monetary penalties on certain drug manufacturers participating
Wholesaler & Pharmacy Benefits Compliance
Entities within the pharmaceutical supply chain, including pharmacies, wholesalers and pharmacy benefit managers, face many regulatory, reimbursement and compliance challenges. In addition, they must deal with commercial and operational challenges within pharmaceutical distribution networks.
Arent Fox helps these companies navigate these challenges by providing:
- Fraud and abuse assessments and counseling
- Advocacy to FDA, CMS, and state agencies involving regulatory proposals that may significantly impact pharmacy and pharmacy benefit operations
- Compliance program design and implementation
- Negotiation of rebates agreements, in-network pharmacy provider agreements, and pharmacy benefit management services agreements
- Counsel on commercial and statutory pricing issues, including Average Wholesale Price, Maximum Allowable Cost methodologies, Actual Acquisition Cost, National Average Drug Acquisition Cost, Medicaid Drug Rebate Program, and the Federal Upper Limit
- Assistance with formulary development and plan design in accordance with Medicare Part D, the Affordable Care Act, and state statutory and regulatory requirements
- Counsel on therapeutic interchanges in long-term-care facilities and otherwise
- Consultation on the development of medication therapy management or patient adherence programs and the legal and compliance implications that are associated
- Assistance in the design of generic substitution and drug utilization management programs
- Assistance with pharmacy licensure, third party administrator, and utilization review agency licensure
- Counsel on e-prescribing requirements
- Counsel on 340B program administration and requirements
- Advise on FDA, FTC, and state regulatory compliance for private label products
- Counsel on state licensure issues
- Defense of enforcement actions initiated by state Boards of Pharmacy
Medicare Part D
Arent Fox advises and counsels pharmaceutical manufacturers, pharmacy benefit managers, pharmacies, and others in the pharmaceutical supply chain on a wide range of complex legal, regulatory, and legislative issues, many of which stem from the Medicare Prescription Drug Improvement and Modernization Act of 2003. Our advice extends to various program requirements, including:
- Fraud, waste and abuse
- Compliance Program development
- Plan design and formulary development
- Marketing practices
- Relationships with first tier, downstream, and related entities
- Beneficiary rights and safeguards, such as appeals and grievances
- The Coverage Gap Discount Program
- Development and implementation of corrective action plans
We advocate on behalf of our clients before CMS and help clients prepare for and respond to CMS and OIG audits and inquiries.
In a ruling that could, if adopted by other courts, expose all pharmaceutical discount and rebate arrangements to anti-kickback liability, on August 23, 2016, Judge Rya Zobel in the United States District Court for the District of Massachusetts denied Omnicare, Inc.’s motion for summary judgment in United States ex rel. Banigan v.
On July 6, CMS issued a set of Frequently Asked Questions to respond to questions raised by the Covered Outpatient Drug Final Rule that was published on February 1, 2016. The FAQs can be accessed here; our January 28 article analyzing the final rule can be accessed here and our analysis of the delayed implementation of the revised 5i AMP methodology and 70/30 test can be found here.
Texas Health and Human Services Commission (HHSC) has finally issued final regulations transitioning to the use of the National Average Drug Acquisition Cost (NADAC) to establish Medicaid ingredient cost reimbursement instead of utilizing manufacturer-reported prices.
The Department of Justice recently announced it has reached a more than $780 million settlement with Pfizer Inc. and its subsidiary Wyeth to resolve allegations that from 2001 through 2006, Wyeth reported false prices to the government on two of its proton pump inhibitor drugs, Protonix Oral and Protonix IV, in violation of the False Claims Act.
The Department of Veterans Affairs (VA) recently announced a significant policy change that will now require drug manufacturers to make drugs that are “covered drugs” under the Veterans Health Care Act (VHCA) available to the VA under the manufacturer’s Federal Supply Schedule (FSS) contract, even if those drugs are not compliant with the requirements of Trade Agreements Act (TAA). The announcement from the VA establishes aggressive deadlines for compliance, which manufacturers should note.
Today, the Department of Health and Human Services (HHS) announced that they are re-opening the comment period on its June 17, 2015 proposed rule (the Proposed Rule) concerning establishment of the “Ceiling Price” for covered outpatient drugs (340B drugs) and assessment of penalties against manufacturers for violation of 340B pricing rules. Arent Fox LLP previously provided an analysis of the Proposed Rule on our blog, Health Care Counsel, which you can access
The US Drug Enforcement Administration recently announced that it is evaluating whether to downgrade the classification of marijuana under the Controlled Substances Act, which could allow more research into its potential medicinal benefits. A decision is expected this summer.
ABOUT ARENT FOX LLP
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.