Pitch Supplement - Regulatory Experience - Federal, State and Enforcement Agencies

Regulatory experience working with federal (e.g., CMS, OIG, HRSA, FDA, etc.) and state (e.g., CDPH, DHCS, DMHC, etc.) agencies and enforcement authorities

Health & Human Services/Centers for Medicare & Medicaid Services

As a leading healthcare practice, Venable has significant experience in working with the Centers for Medicare & Medicaid Services (CMS). Our attorneys regularly negotiate with HHS/OIG and CMS over exclusions to Medicare and Medicaid, conditions of participation, fraud and abuse, and Medicare self-referral disclosure protocols. We are knowledgeable about the myriad of CMS regulations, and are able to anticipate how those regulations may affect the operation of our clients, particularly with regard to the Stark law, HIPAA, EMTALA and CLIA.

Venable’s attorneys have significant experience in interpreting new legislation and advising clients with regard to the impact of the application of new regulations on our healthcare client operations. This experience has become especially important in light of the recent healthcare reform and the flood of regulations that have followed it. Venable has concentrated its efforts to advise clients and its attorneys by implementing a Health Care Initiative. Our attorneys have presented several webinars and hosted informational presentations regarding some of the most critical parts of healthcare reform. Venable attorneys have also worked extensively in advising clients with regard to the CMS’s Final Rule to implement the Deficit Reduction Act. We work effectively to provide clients with the legal framework for the development and implementation of plans designed to bring the client into compliance with new regulations. We also have several HIPAA experts on our team to help clients understand how new regulations and guidance may affect a client's existing practices and business.

Office of the Inspector General

Our attorneys have a broad range of experience in helping clients respond to investigations and enforcement actions imposed by the OIG, and to mitigate the severity of imposed sanctions. Members of our team have represented clients engaged in OIG investigations conducted by a wide range of federal agencies, including the Department of Labor, Department of Education and the U.S. Department of Health.

In addition, Venable attorneys have negotiated with the OIG regarding permissive and mandatory exclusion of physicians from federal healthcare programs, and reinstatement following exclusion. We have represented both small and large healthcare providers in dealings with the OIG for alleged inappropriate reimbursement claims, and provided advice to healthcare clients on how to proactively deal with and avoid reimbursement investigations and audits by the OIG. Finally, we worked with the Centers for Disease Control and the federal Occupational Safety and Health Administration in connection with Hepatitis B vaccination programs for healthcare workers, following the creation of a blood-borne vaccine and a DNA recombinant vaccine.

Venable also has represented several community hospitals in OIG enforcement actions, including false claims and qui tam actions, and has represented a durable medical equipment supplier in connection with OIG enforcement action.

Food and Drug Administration

Venable attorneys have decades of experience in representing clients whose businesses are regulated by the FDA. Our clients include manufacturers and distributors of pharmaceuticals, vaccines, biologics and medical devices, and cosmetics, as well as food and dietary supplements. Our attorneys guide clients throughout the product developmental, approval, production and marketing stages to ensure regulatory compliance, every step of the way. We also assist clients with FDA import detentions, inspections and recalls; seizures, injunctions and other enforcement actions brought by the FDA; and government challenges before the FDA.

Our understanding of the regulatory and policy components of the FDA, the relationship between the FDA and Congress, and how to advocate and litigate in support of or in opposition to the FDA, enables Venable attorneys to provide uniquely valuable counsel to FDA-regulated companies.

Our experience includes product labeling; advertising of prescription products; scientific and educational activities; promotion of off-label uses; prescription-to-OTC transitions; clinical research; approvals and licensing of therapeutic products; Hatch-Waxman exclusivities, patent listings and certifications, and litigation; orphan exclusivity; product life-cycle management; Lanham Act litigation; validity of claims, ingredients, etc.; importation and exportation issues; registration of food facilities; transportation; bioterrorism and homeland security; copyright, trademark and patent protection; compliance counseling; hearings before the agency; crisis management; regulations and policy development; and representation before Congress.

Federal Trade Commission

Venable helps clients respond to civil investigative demands and subpoenas from the FTC, state Attorneys General, and other law enforcement agencies. Our attorneys, including several former FTC staffers, have helped hundreds of clients respond to requests for claim substantiation from the FTC, the Food & Drug Administration, and state Attorneys General.

Venable's experience with the FTC is wide and varied. With respect to academic medical centers, Venable represented a multi-national vertically-integrated healthcare provider and insurer in a complex antitrust investigation brought by the U.S. Department of Justice for potential Sherman Act violations involving an alleged conspiracy to restrict healthcare competition. Venable succeeded in getting the three-year investigation closed without any action against its client. Venable has also defended a multi-national pharmaceutical company in multiple FTC investigations for alleged antitrust violations involving patent litigation settlements. Venable attorneys successfully defended a client whose scientific substantiation for its serum testosterone-enhancing supplement was questioned by the FTC as well as a former baseball player in the FTC’s first litigated case involving the liability of a celebrity spokesperson. After a lengthy court battle, the Ninth Circuit Court of Appeals agreed that a celebrity was “merely a spokesperson,” and therefore, not liable for the content of the ads. The case, involving a weight loss supplement, set the standard for liability of celebrity spokespersons.

Department of Justice

Venable attorneys represent clients in DOJ investigations, enforcement actions and litigation covering such diverse areas as FCPA violations, antitrust, tax, money laundering and other allegations. We represent clients at every stage of criminal enforcement, including responding to search warrants and grand jury subpoenas, dealing with investigators and prosecutors, negotiating plea agreements and, if necessary, handling matters through trial, sentencing and appeal. In addition, spearheaded by former high-ranking environmental officials at the DOJ, Venable has a group of attorneys who focus exclusively on representing corporations and individuals under investigation for possible criminal violations of environmental laws. A recently retired Venable partner served as the United States Attorney General.

Venable's extensive experience with the DOJ includes representing a major medical center in a qui tam action and negotiation with the DOJ and U.S. Attorney's office to resolve the case. Venable has also rpresented a large international pharmaceutical company in whistleblower actions before the DOJ. In addition, our highly acclaimed white collar investigation and antitrust teams routinely represent major companies before the DOJ in a variety of investigations and proceedings.

State Attorneys General

Venable represents companies and individuals in attorney general investigations throughout the country. We have direct experience in handling both sides of an investigation and are uniquely qualified to assist UC, if the University becomes the subject of probe by a State Attorney General’s Office. We have a record of successful outcomes in both single-state and multi-state investigations. Our team includes a former U.S. Attorney General, former assistant U.S. attorneys and former assistant attorneys general from several states.

For example, Venable partner Constance H. Baker represented a physician before Maryland Board of Physicians regarding voluntary surrender of license, and before the DEA and the Department of Justice regarding allegations of improper prescribing. In another case, when the State of Maryland refused to turn over records of state police investigations of racial-profiling complaints against its troopers, we represented the NAACP pro bono in litigation against the attorney general to force the state to uncover the records. The case is now on appeal. In addition, the District of Columbia attorney general sought to shut down a solid waste transfer facility – one of only two remaining in the district. Our attorneys represented the facility through a lengthy court battle, eventually securing a favorable settlement that allowed the facility to continue in operation in exchange for improvements to its physical plant.

State Boards of Pharmacy

Venable represents medical professionals and other healthcare industry clients in investigations and in disciplinary proceedings before State Boards of Pharmacy. Our legal services also extend to appeals of Board rulings.

For example, Venable partner Constance Baker has represented pharmacies and pharmacists before several state licensing boards, regarding challenges to licenses to practice pharmacy and as a wholesale distributor, including specialized nuclear pharmacy issues and compounding pharmacies. Recently, Ms. Baker was involved in the passage of state legislation and regulations permitting pharmacies to provide remote automated medication systems in nursing homes, over the express objection of the State Board of Pharmacy. Venable has also successfully represented pharmacy chains and pharmacists before State Board of Pharmacy proceedings regarding switch of medications.