FDA

FDA

At FIDJ, we understand the unique challenges businesses face when operating in FDA-regulated industries. Whether our clients are launching new products, navigating complex enforcement actions, or pursuing critical litigation, we bring unmatched regulatory insight and strategic legal acumen to the table. Our firm is known for taking on high stakes matters involving the FDA and other federal agencies, and we are committed to achieving results that protect our clients’ operations, reputations, and futures.

FOOD & DRUG LAW

Food & Drug Law

At FIDJ, we represent clients in highly regulated, competitive industries, including food, drugs, medical devices, cosmetics, agriculture, imports, exports, and international trade. In these complex environments, litigation is sometimes unavoidable—especially when dealing with powerful federal agencies like the FDA.

We don’t back down from regulatory litigation. If going to court is the best way to protect our clients’ interests, we litigate aggressively and strategically.
Our firm has a strong track record representing individuals and companies around the world in civil and criminal matters involving the FDA. We have defended clients against compliance enforcement actions and have taken the fight directly to the FDA and other federal agencies when necessary—filing lawsuits to challenge unlawful or overreaching regulatory conduct. This kind of high-stakes FDA litigation is a defining strength of FIDJ.

Mitchell Fuerst and Andrew Ittleman have led litigation against the FDA on numerous occasions. This FDA litigation is a distinguishing characteristic of FIDJ. We have represented clients worldwide, providing defense for individuals and companies charged with civil and criminal violations by the FDA, including compliance enforcement actions. We have likewise sued the FDA and various other federal agencies when we, together with our clients, had determined that litigation was the only way possible to attain the result that our clients deserved.

FDA Litigators

FIDJ brings deep legal knowledge and courtroom experience to every FDA case. We are known for our relentless advocacy—both in litigation and in administrative proceedings. Whether pursuing a judicial or regulatory remedy, our attorneys leverage their expertise to protect our clients’ interests and achieve meaningful results. Our reputation is built on skill, strategy, and an unwavering commitment to those we represent.

FDA Enforcement Actions: Warning Letters and Untitled Letters

FIDJ, PL represents a wide array of FDA-regulated businesses, including those engaged in the manufacture, distribution, import and export of foods, drugs, biological products, medicines, cosmetics, anti-aging products and a host of others. FDA keeps a close watch over the industries it regulates, and has many options when launching enforcement actions against any particular company or individual. The FDA’s most frequently used enforcement mechanisms are advisory communications that are issued in one of two forms: Warning Letters and Untitled Letters.

A Warning Letter identifies a perceived violation, indicates that correction is necessary, specifies if there are any specific actions FDA wishes the firm or individual to take, and provides a number of days (typically 15 days) for the firm or individual to take corrective action and respond to the letter. More severe enforcement action can be imposed if no response is submitted to FDA. However, if FDA finds that a company or individual adequately responds to a Warning Letter and takes appropriate corrective action, FDA may issue a Close-Out Letter stating the Warning Letter violations have been addressed. However, FDA is not required to issue a Close-Out Letter and does not do so in every situation.

An Untitled Letter is initial FDA correspondence to a regulated party citing infractions of federal food and drug law that FDA deems to be less severe and not warranting a Warning Letter. An Untitled Letter is different from a Warning Letter in that an Untitled Letter will not include a caution from FDA that failure to take corrective action could result in enforcement action. Further, an Untitled Letter requests, rather than requires, a response. Failure to take action or respond to an Untitled Letter, however, could eventually lead to further enforcement action by the agency.

In many cases, FDA publishes Warning Letters and Untitled Letters to the World Wide Web even before they are received by the targeted firm, making the firm’s timely response all the more critical. Responding to Warning Letters and Untitled Letters are unquestionably daunting, but FIDJ’s FDA attorneys have years of experience guiding clients through FDA enforcement actions and responding to Warning Letters and Untitled Letters under even the most pressing of circumstances.

FIDJ Services

FIDJ’s legal and regulatory services regarding FDA, FTC, and USDA enforcement actions and litigation include:

Assisting clients in responding to and complying with FDA Warning Letter and Untitled Letters.
Handling FDA inspections and responding to 483s.
Litigating, as necessary, against the FDA, FTC, and USDA.
Assisting clients with product recalls or agency injunctions.
Responding to FTC complaints.

FDA Establishment Registration

FIDJ, PL represents a wide array of FDA-regulated business, including those engaged in the manufacture, distribution, import and export of foods, drugs, biological products, medicines, cosmetics, anti-aging products and a host of others. In an effort to maintain oversight over the various industries it regulates, FDA requires nearly all companies engaged in the manufacture, storage, distribution, packaging, and labeling, re-packaging or re-labeling to register with the agency in an FDA approved format.

Without proper registration, FDA-regulated companies risk FDA enforcement action, recalls, and potential state-level enforcement actions. Most companies are required to update their registration every year, and the failure to do so can result in added costs and inconveniences to the companies.

FIDJ has years of experience assisting all types of FDA-regulated businesses maintain compliance with FDA regulations, including firm registration. We likewise assist clients in understanding how they must register with the FDA, and in many cases, we can complete the FDA registration on our clients’ behalf.

If you are an FDA-regulated business in need of registering with FDA, contact us today for a free consultation.

Compounding Pharmacies

Compound pharmacies are facilities operated by licensed pharmacists or physicians that combine, mix, or alter ingredients of drugs to create medications designed to meet the needs of particular patients.

Compound pharmacies are regulated by a complex set of federal and state laws and operate in a rapidly evolving regulatory environment. For the past several years, the laws, regulations and policies governing the operation of compound pharmacies have changed dramatically. Not only have state pharmacy boards taken an increasingly aggressive role in regulating compound pharmacies, but the federal Food, Drug and Cosmetic Act (FDCA) has changed drastically too. For starters, federal law now recognizes two types of compound pharmacies, the trade compound pharmacies and the “outsourcing facility.” Both types of compounding pharmacies are regulated by FDA, as well as state agencies, and must be cognizant of the specific requirements and regulations that are applicable to them. For instance, compounders operating as outsourcing facilities may qualify for certain exemptions from the FDCA but also must comply with registration and good manufacturing practices requirements.

FIDJ’s FDA attorneys have years of experience representing compound pharmacies of all varieties in a wide array of contexts, including regulatory compliance, state and federal enforcement actions, civil and criminal litigation and commercial transactions.

Food, Drug and Life Sciences Practice Group

Fuerst, Ittleman, David, and Joseph’s food, drug and life sciences practice group is adept at addressing the specialized needs of clients doing business in FDA-regulated industries. Our attorneys are sensitive to the unique regulatory and business needs of clients who manufacture and distribute a host of FDA-regulated products, including foods, drugs, medical devices, supplements and medical foods, among others. From initial product ideation to raising investor capital through marketing and distribution, clients must balance their business strategies and risks with the legal and regulatory requirements imposed by state and federal governments. Fuerst, Ittleman, David, and Joseph is well-equipped to help clients achieve their business goals while maintaining regulatory compliance with the appropriate regulatory agencies, including the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), the U.S. Department of Agriculture (USDA), and state and local agencies.

Our food, drug, and life sciences practice group services and the industries we serve include:

Animal and Veterinary Products

Devices
Drugs
Pet food and animal feed

Food and Drug Industries

Medical Tourism

Combination Products

Life Sciences

Advertising and Consumer Law

FTC advertising compliance
FDA labeling and marketing compliance
FTC and FDA litigation

Agency Enforcement Actions and Litigation

FDA Warning Letters
FDA inspections and 483s
USDA inspections
FDA, FTC, USDA litigation
Product recalls and injunctions

Animal and Veterinary Products

Animal drugs
Devices
Marketing and labeling
Minor species products
Pet food and animal feed

Biologics and HCT/Ps

BLA Applications
FDA Warning Letters, Untitled Letters, and other enforcement actions
Litigation
cGMPS and GCPs
FDA registration
Import and export
Clinical research and IRB oversight

Corporate Services

Retail and distribution agreements
Transactional matters
Insurance policy reviews
Partnership and corporate agreements

Cosmetics

FDA labeling compliance
Ingredient review
Color additives
Claims and marketing

Drugs

OTC monographs
Homeopathic monographs
Registration and listing
Competitor market discipline
cGMPs

Food, Beverages and Supplements

Import/Export

Medical Devices

Medical Tourism

Advertising and marketing
FDA and FTC compliance
Corporate structure and tax compliance

Medical Devices

The medical device industry is fast-paced, quickly evolving, and highly regulated. FIDJ attorneys have vast experience handling the intricacies of medical device regulation. FDA’s Center for Device and Radiological Health (CDRH) is the primary center within the FDA responsible for medical device regulation and oversight. FDA’s Center for Biologics Evaluation and Research (CBER) also shares jurisdiction with CDRH regulating devices related to cellular and blood products. Fortunately, FIDJ has extensive experience navigating medical device regulatory issues, regardless of whether CDRH or CBER is the FDA center in charge.

Our firm represents medical device firms, including manufacturers, distributors, and importers, in all facets of device regulation and compliance. FIDJ is a versatile firm representing a wide range of clients in the device industry, from the small, start-up venture to the large, veteran corporation.

Obtaining FDA Approval and Getting to Market

The medical device industry is huge, encompassing products that range from tongue depressors and x-ray machines to implantable pacemakers. The FDA organizes these products into different classes based on the risk level they present. The device application process is also driven by the class of the device as determined by the FDA. A low-risk device, like a tongue depressor, is deemed a Class I device requiring no pre-market approval and very little barrier to the marketplace. On the other end of the spectrum, a high-risk device, like an implantable pacemaker, is categorized as a Class III device requiring extensive testing, validation and research prior to marketing and distribution. The FDA requires a submission process called a Premarket Approval (PMA) for Class III devices.

Approximately 43 percent of all medical devices are medium-risk devices, which are deemed Class II and require a Premarket Notification to FDA called a 510(k). This submission requires the device manufacturer or distributor to demonstrate that its new device is just as safe and effective as a device that is already in the U.S. market, called a predicate device. To demonstrate safety and effectiveness, the manufacturer or distributor must show that its device uses the same technology and same intended use as the predicate device. Once a manufacturer or distributor has demonstrated this “substantial equivalence,” the FDA will clear the device’s 510(k) and it can be legally imported, marketed, or sold in the United States. Examples of these devices include, among others, powered wheelchairs, acupuncture needles, some powered muscle stimulators, and some centrifuge devices.

FIDJ helps clients understand where their products fall in the FDA’s classification scale and what steps need to be taken to pursue the appropriate regulatory pathway. We assist our clients in compiling 510(k) and PMA submissions, including identifying predicate devices and facilitating relationships with outside consultants as necessary for testing and validation. Our attorneys work with our clients in drafting and submitting the submission packages appropriate to their devices. We facilitate pre-submission meetings with the FDA, as necessary, and assist our clients with follow-up and responses to FDA requests for additional information.

Our firm can help you with your company’s submission to FDA. We are ready to help you with any of the following:

Premarket Approval Applications (PMAs)
Premarket Notifications (510(k)s)
De novo petitions
Investigational Device Exemption (IDE) Applications
Combination products Request for Designation (RFD)

Medical Device Manufacturing

Manufacturers and importers of medical devices marketed and sold in the United States must register their establishments with the FDA. Additionally, manufacturers must list with the FDA the medical devices they produce. The FDA has also promulgated extensive regulations regarding how medical devices must be manufactured. These regulations are called Quality System (QS) regulation, and are sometimes referred to as good manufacturing practices (GMPs). All of these manufacturing, registration, and listing requirements apply to foreign and domestic companies and individuals. FIDJ’s attorneys are knowledgeable and familiar with these requirements and can help your company comply with the FDA’s manufacturing and registration regulations.

Labeling and Marketing

FIDJ’s approach to assisting clients with medical device regulation and compliance goes the extra mile. We are seasoned in advising and guiding clients in all aspects of labeling, advertising, and promotion of medical devices. Our compliance and regulatory team has extensive experience reviewing product labeling, including packaging, product inserts, and instructional manuals as well as assessing advertising and promotional materials like website pages and video and print advertisements to ensure total legal compliance. We are well-versed in analyzing and evaluating medical device claims to make sure that all claims and statements conform with FDA and FTC regulations.

FDA Enforcement and Dispute Resolution

In a highly regulated sector like the medical device industry, agency disputes and agency actions occur. When dispute resolution or reaction to FDA enforcement action needs to be addressed, it is critical that manufacturers, importers, and distributors engage experienced counsel to assist. For example, a medical device manufacturer may believe that its 510(k) or PMA was wrongly denied by the FDA. An experienced attorney can advise on the options available after such a denial. Likewise, a knowledgeable regulatory can advise a device distributor on a FDA Warning Letter received for a violation perceived by the agency. That type of enforcement action requires a written response within a specific time period to avoid negative consequences. Our attorneys have extensive experience advising medical device companies in these types of enforcement actions and resolutions of agency disputes. We are well-versed in handling:

FIDJ is familiar and comfortable working with the FDA to ensure our clients’ products, operations, and business interests are served and protected.

Importing and Exporting Medical Devices

The global economy has created unique obstacles to the import and export of medical devices. Terrorism concerns and the manufacture of products abroad have led to stricter regulation. Additionally, the number of government agencies involved in the enforcement of import and export regulations surrounding medical devices can make the process of selling and buying these medical products internationally exceedingly complicated.

FIDJ has experience working and communicating with Customs and Border Patrol (CBP) and the FDA’s Division of Import Operations and Policy (DIOP) to assist clients in the efficient import and export of medical devices. We understand the necessity and intricacies of doing business internationally and are very capable of helping our clients succeed in the international market.

Biologics

Biological products, or “biologics,” are medical products derived from living human, animal, or microorganism sources that are intended to prevent, diagnose, or treat diseases. Today, biologics are on the forefront of medical science and research because they can replicate natural substances in the human body such as enzymes, antibodies, or hormones. Examples of biologics include vaccines, blood and blood components, cellular and gene therapies, and human cells and tissues, including stem cells, used for transplantation or treatment. Biologics are regulated under a complex regulatory framework and require specialized understanding of the laws and regulations that apply to each complex biological mixture.

FIDJ understands that introducing a biologic to the world market requires navigating sophisticated and complex laws and regulations, including the Food, Drug, and Cosmetic Act and Public Health Services Act. Our firm helps clients understand the development and application processes and offers essential advice to allow for efficient approval. The attorneys at FIDJ are deeply familiar with the wide range of scientific, legal, and regulatory issues that often arise throughout the life cycles of biologics. With this knowledge and expertise, we provide clients with comprehensive strategies for product development, approval, commercialization, and life cycle management that are specifically tailored to each unique product.

Our attorneys work closely with clients to provide in-depth assistance in the earliest development stages to protect innovation and preserve our clients’ positions in the market. In addition to helping clients understand how to comply with the legal and regulatory standards that apply to their biologics, we counsel clients on advantageous approval and marketing strategies, from the investigational stage through expedited approval options such as fast track, accelerated approval, and treatment investigational new drugs. We also assist clients in structuring and negotiating corporate licenses, drafting research and clinical trial contracts, and preparing for FDA inspections or audits.

At the end of the initial product development phase, the firm’s Life Sciences Practice Group assists with drafting and filing Biologics License Applications (BLAs) and Investigational New Drug (IND) applications. FIDJ is highly experienced in representing clients through all stages of the application process, including meetings with FDA, internal appeals, administrative proceedings, and enforcement actions and litigation.

We are also well-versed in the manufacturing and marketing requirements applicable to our clients’ unique and cutting edge products. We routinely review proposed labeling, advertising, and promotional materials to ensure compliance with FDA and FTC regulations and policies. Once a product has been introduced to the market, clients turn to us to assist them with adverse event reporting, Field Alert and Biological Product Deviation Reports, and managing product recalls. Our attorneys are experienced in counseling clients through post-market concerns and working with them to develop comprehensive crisis management programs and implement responsive action plans.

Biologics and biotechnology represent the future of medicine. FIDJ is here to help you launch your innovative new healthcare solutions and emerging therapies onto the market.

Stem Cells and Regenerative Medicine

FIDJ is one of the country’s leading law firms for the stem cell and regenerative medicine industry. The firm has litigated extensively against the FDA regarding its jurisdiction to regulate procedures involving the autologous use of patients’ cells and tissue, and has lectured on dozens of occasions for industry trade groups across the United States and internationally.

Today, FIDJ boasts a stem cell and regenerative medicine clientele composed of public and private companies, drug manufacturers, medical device manufacturers, doctors, hospitals and universities, and the firm’s clients are both domestic and international.

The firm has also consulted with foreign governments seeking to implement their own stem cell and regenerative medicine laws and regulations, and the firm has helped a number of its clients become licensed internationally to provide stem cell and regenerative medicine treatments abroad. The firm’s stem cell and regenerative medicine practice is at the core of the firm’s robust medical tourism practice.

The firm’s FDA practice group is deeply familiar with the manner by which the agency regulates stem cell and regenerative medicine products and services, and has advised clients regarding how the FDA regulates HCT/Ps derived from bone marrow, blood, adipose tissue (fat), placenta, and a number of other sources. In advising clients on these issues, the firm’s research begins at 21 CFR § 1271.10, where the FDA has created a three-part test which explains how the FDA will regulate human cells, tissues, or cellular or tissue-based products (“HCT/Ps”), both allogeneic (from a donor to a third party recipient) and autologous. In short, as it relates to autologous tissue and cells, the FDA has made it clear that unless the cells and tissue are a) “minimally manipulated” and b) used for a “homologous” purpose, the FDA will subject the medical procedure to the full scope of its biological drug regulations, including the submission of a Biologics License Application or an Investigational New Drug Application. The firm routinely advises its clients on the meaning of “minimal manipulation” and “homologous use,” and likewise helps clients understand whether their medical procedures are exempt from regulation by virtue of being a “same surgical procedure” as defined by 21 C.F.R. § 1271.15.

Pulling from its vast experience, the firm’s FDA practice group is able to assist its stem cell and regenerative medicine clients at every stage of the corporate lifespan. First, universities and other researchers seeking to develop new stem cell lines, medical procedures, medical devices and other regenerative medicine products and procedures can turn to the firm for advice regarding how, once the product or procedure under investigation has been fully developed, the FDA’s Part 1271 regulations will apply. Second, firms ready to interface with the FDA can count on the FIDJ FDA practice group to aggressively pursue Investigational New Drug Applications, Biologics License Applications, and for medical devices, Premarket Approval Applications and 510(k) Notifications. Alternatively, if the client’s product or procedure is regulated solely by the FDA’s Part 1271 regulations, the client can count on the firm’s FDA practice group for advice regarding how to most effectively comply. Finally, for clients seeking to avail themselves of more favorable regulatory climates abroad, the firm can lend its advice regarding the long arm jurisdiction of the United States government, international tax and corporate issues, international licensing agreements, Customs and international shipping issues, and a host of others.

Our holistic approach to the stem cell and regenerative medicine industries is the prime example of how we provide comprehensive representation to clients operating in highly regulated industries.

Food, Beverages, and Dietary Supplements

Food, beverages, and dietary supplements collectively comprise a multi-billion dollar industry, which is fast-paced, innovative, and highly regulated on federal and state levels by multiple regulatory agencies. FIDJ attorneys are experienced in counseling our food, beverage, and dietary supplement clients on the numerous regulatory frameworks that apply to the myriad of products in these industries. From initial concept, registration and labeling to marketing, manufacturing and post-market activities, our firm is well-positioned to assist our clients, both foreign and domestic, in meeting the legal and regulatory requirements set by state and federal agencies, including the FDA, USDA, and FTC.

Labeling Compliance

The FDA regulates the labeling of food, beverages, and dietary supplements on a federal level. While all three of these industries are regulated by FDA’s Center for Food Safety and Applied Nutrition (CFSAN), each of these has unique legal labeling requirements. Our attorneys are well-versed in helping our clients understand the requirements applicable to their particular products and in creating product labeling that is compliant with all applicable laws while maintaining the overall brand and marketing message strategized by the business plan. Many individual states, such as California, also have regulations regarding food, beverage, or supplement labeling, and we help our clients maintain compliance with these regulations as well.

Marketing and Claims Review

The FDA and FTC work together to regulate food, beverage, and supplement marketing and promotional materials. Both of these agencies evaluate website pages, product brochures, and infomercials for compliance with federal laws. Additionally, the individual states employ their own “mini-FTC Acts” to police food, beverage, and supplement makers, and distributors and the marketing claims they make. While it can be daunting for clients to comply with the regulations and policies for all of these agencies, our attorneys are highly experienced in helping to develop marketing strategies in compliance with all applicable requirements. With private litigation and federal and state agency enforcement action on the rise against food, beverage, and dietary supplement manufacturers and distributors, it is critical to have capable attorneys who are knowledgeable about these industries and regulations in your corner to help you establish, maintain, and defend your brand. Our attorneys are available to work with you to review and revise the marketing materials you utilize in promoting your food, beverages and supplement products.

Ingredients

Laws and regulations applicable to ingredients can differ for food, beverages, and dietary supplements. Individual states may also implement their own regulations for ingredients in these types of products. It is important for clients doing business in the food, beverages, and dietary supplement industries to understand the laws applicable to the ingredients they choose for their products. The regulatory lawyers at FIDJ will review the ingredients in your products for compliance with these various regulations and policies to determine whether any formulation changes should be suggested, and to determine if the ingredients are properly labeled on the products.

Medical Foods

Medical foods are a unique category of food products recognized by the FDA that are subject to a very distinct set of regulatory requirements. The FDA has established specific labeling, ingredient, marketing, and substantiation regulations and policies for medical foods, and has taken enforcement action against those companies marketing and distributing medical foods in violation of those regulations and policies. Our firm has worked with a variety of medical food manufacturers and distributors in the past and has advised them on the legal requirements applicable to this unique set of products. We have helped our clients navigate this complex regulatory arena and maintain compliance with the federal and state regulations applicable to this niche industry.

For more information, please contact us at contact@fidjlaw.com or call us directly at (305) 350-5690

Import and Export of FDA-Regulated Products

The U.S. Food and Drug Administration (FDA) regulates approximately 10 to 15 percent of all imports into the United States. These products come from more than 300,000 facilities based in over 150 different countries. As FDA-regulated industries become more globalized, clients doing business in this arena must be conscious of the regulations and statutes applicable to products imported and exported to, and from, the U.S. Fuerst, Ittleman, David, and Joseph’s attorneys are well-versed in helping clients import and export FDA-regulated products.

Imports

The FDA has the power to inspect, detain, and refuse all imported food, drugs, biologics, cosmetics, and medical devices entering the United States under its jurisdiction. These imported products must comply with the appropriate FDA rules and regulations and may be detained or refused entry into the United States if the products even appear to be in violation of United States law.

Fuerst, Ittleman, David, and Joseph has experience helping companies take a more proactive role and avoid detentions by the FDA by ensuring fully compliant products prior to entry. For those clients with products already detained by CBP or FDA due to an Import Alert or other reason, we work with the agency and our clients to pursue release through submission of testing and other documentation to rectify alleged violations to counter the government’s conditions for detaining or refusing the products.

It is critical for all importers to fully comply with FDA rules and regulations. Once a product is refused entry by the FDA, it is extremely difficult to achieve release of the product and, in many circumstances, the importer must export or destroy the products, which results in losses that impact the corporate bottom line. For example, detentions of perishable items not dealt with promptly can result in those items no longer being salable at the end of the detention period. Likewise, if the product is seized, the result is complete forfeiture of the goods. That translates into a loss of profit, time, product and even customers who went elsewhere to fulfill their need of your imported product.

Products are detained and refused by FDA for many reasons including FDA Import Alerts. Import Alerts result in automatic detention of products listed on the Import Alert. If the FDA detains a product due to an Import Alert, the importer must demonstrate that the products are compliant and not violative. Import Alerts are issued for all types of products, ingredients, manufacturers, country of manufacture, and many other reasons. We have worked successfully with the FDA Division of Import Operations and Policy (DIOP) to have clients removed from Import Alert or placed on an exemption list (called “Green List”) so that their imported products are no longer automatically subject to FDA detention.

Exports

Doing business internationally is highly competitive and particularly complicated when exporting FDA-regulated products from the United States. The attorneys at FIDJ advise clients on legal issues and business strategies related to exporting products abroad. We are skilled and knowledgeable in federal, state, and international regulations and FDA and CBP programs. FIDJ assists clients with many issues involved with exporting goods and merchandise out of the United States including:

The Import for Export (IFE) program
Export certificates, including Certificates of Pharmaceutical Products (CPP) and Certificates of Free Sale
Foreign firm registration
Labeling requirements
Good manufacturing practices (GMPs)
Inspections
General export regulation compliance

Import for Export Program

The FDA Export Reform and Enhancement Act of 1996, combined with certain provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act), has led to the implementation of the FDA program known as the Import for Export (IFE) program. The IFE program allows for the importation of certain noncompliant articles, such as drugs or drug components, devices, food additives, color additives, and dietary supplements, into the United States. The program allows importers to further process the articles or incorporate them into another item for the exportation of the final product to other countries. The main caveat to this program is that these noncompliant articles be further processed or incorporated into another product and then exported. These final products never enter into United States commerce and FDA regulations require extremely strict record keeping and documentation throughout the entire process.

FIDJ is knowledgeable of this unique program and familiar with utilizing it to meet the needs of our domestic and international clientele. Our regulatory team is experienced in guiding clients interested in taking advantage of the IFE program from the initial import of the articles through the processing and documentation to the final export of the products. Our team assists clients in educating and training their personnel on IFE regulations, creating record-keeping systems, firm registration, and handling FDA facility inspections and inquiries. We are well-versed in the legal requirements of the IFE program and very comfortable working with the FDA and CBP to ensure our clients’ needs are being met.

Advertising and Consumer Law

For many clients doing business in FDA-regulated industries, diverse marketing campaigns are a top priority. Every marketing plan has many regulatory considerations including pricing, advertising, packaging and labeling, distribution and customer service. Entering the marketplace without a solid understanding of misleading, untruthful, or deceptive advertising can result in costly penalties and poor public relations that can cripple a brand overnight.

FIDJ’s lawyers have been counseling clients about the Federal Trade Commission Act (FTC Act) and individual state “Mini-FTC Acts” aimed at protecting consumers. Clients have sought out our attorneys for advice on FTC issues including:

Crafting compliant marketing claims
Structuring rules and regulations for sweepstakes or special promotions marketing
Building a proper substantiation file to support advertising claims
Collecting and using testimonials
Handling complaint letters from the FTC, FDA, State Attorney General, and other groups and organizations

Our attorneys understand that advertisers like to be assertive and have assembled a team skilled in advising clients on the comparative and competitive laws under the Lanham Act and the FTC Act. They are well versed in quasi-government groups and self-regulatory bodies such as the National Advertising Division (NAD) of the Better Business Bureau (BBB) and the Electronic Retailing Self-Regulatory Program (ERSP) of the Electronic Retailing Association (ERA).

The choice of media is yours. Our attorneys have reviewed a plethora of promotions, contests, giveaways and countless pages of print and web advertising; thousands of hours of television short-form advertising, along with dozens of direct response long-form infomercials and radio spots in addition to drafting numerous privacy policies, procedures for web 2.0 websites and promotions such as guidelines governing user-generated content (UGC) and online communities as well as general terms of use.

Our attorneys have experience advising food, drug, cosmetic and consumer products manufacturers, marketers and importers on advertising compliance. Past and present FIDJ clients include U.S. and foreign companies, cosmetics formulators, weight loss and exercise marketers, inventors, chefs, physicians and others with issues related to a wide variety of products such as food, dietary supplements, medical devices, technology, animal products, color cosmetics, exercise equipment and weight-loss products and programs.

FIDJ’s attorneys get to know their clients’ businesses and help to detect, classify and reduce risks, respond timely and effectively to FDA or FTC investigations and have successfully and artfully litigated against regulators. From marketing brainstorming to advertising campaign launch, our team of regulatory counsel partner with clients to help meet their objectives without losing sight of their creativity and the bottom line.

Medical Tourism

According the Center for Disease Control (CDC), it is estimated that nearly 750,000 people from the United States travel to another country each year for medical care. An entire industry has grown around this “medical tourism” for many reasons, including the increasing cost of healthcare in the United States, the approval or allowance of procedures in other countries that are not permissible in the stateside, and the quality of care provided by facilities in other countries. In addition to patients traveling abroad to receive healthcare services, more physicians and facilities are moving out of the United States to establish businesses offering healthcare services to U.S. residents seeking treatment abroad.

Those physicians and companies seeking to get involved in this rapidly growing, innovative industry are often faced with a host of questions regarding the legal, regulatory, and business aspects of setting up a medical tourism facility or practice in a foreign country. The attorneys at Fuerst, Ittleman, David, and Joseph are well-versed in the unique challenges faced by these medical practitioners and facilities, particularly those in the regenerative medicine industry. These challenges include where and how to market and advertise in the United States; how the FDA and FTC may regulate any activities conducted in the U.S. or abroad; and creating a corporate structure, business plan and tax plan advantageous to the overall strategy of the company and in compliance with both U.S. laws and the laws of the country in which the business is formed. Our attorneys are exceptionally experienced in assisting clients entering this industry.

Advertising and Marketing

The Federal Trade Commission (FTC) regulates advertising and marketing done in the United States. Any advertising of services or treatments offered outside of the United States will be regulated by the FTC. The FTC is concerned with the veracity of advertisements to residents in the United States and has taken enforcement action, sometimes in conjunction with foreign governments, against companies offering medical treatments in foreign countries.

When crafting advertising and marketing campaigns for healthcare services offered abroad, medical tourism companies must take care to substantiate their claims, properly contextualize the claims made about their services, and ensure that procedures or treatments offered are in compliance with the countries in which they are offered. Our attorneys have worked with clients providing overseas healthcare services to develop and craft marketing strategies that advance our clients’ business goals while complying with the requisite regulatory schemes applicable to these unique business models.

FDA Regulatory Compliance

While FDA’s extraterritorial jurisdiction is somewhat limited, the agency’s regulatory reach does extend to any portions of healthcare services offered within the United States and, at times, can reach beyond its borders. It is important for clients offering services both in the United States and abroad to understand when and how they must comply with FDA regulations and policies. Fuerst, Ittleman, David, and Joseph has assisted clients in developing policies and procedures that govern the conduct of the international business domestically and abroad, and fully comply with all applicable FDA regulations.

Corporate Structure and Tax Compliance

When physicians and companies make the decision to establish a medical tourism facility or practice in a foreign country, many complex corporate and tax considerations come into play. It is critical for individuals and businesses to understand these factors and to properly plan for both domestic and foreign laws, regulations, and policies. The corporate and tax attorneys at Fuerst, Ittleman, David, and Joseph have advised clients establishing healthcare services and practices in foreign countries and are experienced in helping clients understand their options and obligations given the corporate and tax laws applicable to these types of business models.

From a corporate perspective, our clients need to be focused on both meeting foreign regulatory requirements on establishing medical practices and laboratories, and on limiting their own corporate and medical liabilities here in the United States. To do so, many clients establish either new companies in these foreign jurisdictions or enter into joint venture agreements – often with a local entity in the foreign country – to form the medical tourism business.

Creating a presence outside of the United States triggers several tax implications, many of which touch upon the most complex provisions of the Internal Revenue Code and Treasury Regulations. From a tax standpoint, clients should be mindful of sourcing of income rules, controlled foreign corporations, and possible subpart F income.

Fuerst, Ittleman, David, and Joseph’s corporate and tax attorneys have helped clients establish companies and joint ventures throughout the Caribbean, Latin America, and Europe. We have also worked with local counsel to ensure that these new businesses meet the foreign legal requirements for medical and laboratory practices in addition to being tax compliant.

Our attorneys are well-versed at negotiating, drafting, and executing contracts that can protect your intellectual property and your medical licenses here in the U.S., and limit the liability of the individual physicians as well as U.S. companies for these foreign operations. We also have extensive experience helping international businesses navigate the complexities of the Internal Revenue Code and the regulations promulgated thereunder.

Cosmetics

Animal and Veterinary Products

The two most significant laws governing cosmetics marketed in the U.S. are the Food Drug and Cosmetic Act (FDCA) and the Fair Packaging and Labeling Act (FPLA). The FDCA prohibits both the marketing of adulterated or misbranded cosmetics and the marketing of cosmetics that are improperly labeled. Under the authority of the FPLA, FDA requires an ingredient declaration on all cosmetics and specific warnings on certain cosmetic products. Our attorneys are well-versed and knowledgeable in all areas of cosmetic regulation including:

Product label reviews, including labeling claims and substantiation
Ingredient reviews including reviews of color additives
Importation and exportation
Import Alerts
Shipment detentions
Consumer complaints
FDA recalls and warning letters

Claims, Advertising, and Labeling

Claims made about a product, whether in advertising or labeling, can be the difference between whether the product is regulated by the FDA as a drug, a cosmetic, or both. Fuerst Ittleman David & Joseph helps clients formulate claims for products that are permissible and appropriate for cosmetic marketing. We are equipped to assist clients in ensuring there is adequate data and information to substantiate product claims and the safety of product ingredients. The attorneys at Fuerst Ittleman David & Joseph are also experienced in conducting reviews of product labels and labeling materials to ensure these meet the requirements established by the FPLA and FDCA. We also assist clients in crafting advertising campaigns that are compliant under FTC and FDA regulations.

Import and Export

Fuerst Ittleman David & Joseph attorneys have significant experience handling issues involving Customs and Border Patrol (CBP), and assisting clients in the importation of cosmetic products into the U.S. We help importers ensure imported products are in compliance with all state, federal, and international labeling regulations. Our team is familiar with FDA Import Alerts and regularly works with CBP and FDA personnel on shipment detentions and exporting cosmetic products internationally.

Ingredients and Color Additives

FDA regulations prohibit, or restrict, the use of certain ingredients and color additives in cosmetic products. Fuerst Ittleman David & Joseph helps clients ensure that only legal ingredients and color additives are present in their cosmetic products through formulation and label reviews.

FDA Enforcement Action

Fuerst Ittleman David & Joseph is experienced in working and communicating with FDA and CBP personnel regarding detentions of cosmetic shipments and FDA inspections. We have experience negotiating with the FDA on behalf of our clients regarding shipment detentions and Import Alerts, and we have represented clients in litigation involving cosmetics against both the FDA and private parties.

For more information, please contact us at contact@fidjlaw.com or (305) 350-5690 for a free consultation.

Prescription Pharmaceuticals

FIDJ serves a wide variety of public and closely held companies operating in the over-the-counter (OTC), homeopathic, and prescription pharmaceutical industries. The firm is also highly experienced in handling matters for clients involved in the rapidly evolving biologics industry. Our services include:

Assisting clients with understanding OTC monographs and homeopathic monographs
Registration and listing
Product labeling and advertising
Product labeling and advertising
Market discipline and competitor complaints
cGMPs
Advising clients regarding clinical research including working with clinical trials and complying with FDA’s rules for INDs, NDAs, and BLAs
FDA and FTC enforcement actions and litigation

Over-the-Counter (OTC) Drugs

Non-prescription drugs, also referred to as over-the-counter or “OTC” drugs, are an important health resource. These products represent a tightly regulated industry, subject to FDA scrutiny and oversight. If you are looking for counsel to assist you in matters involving OTC drugs, FIDJ’s FDA regulatory attorneys bring a wealth of experience and knowledge on non-prescription drug regulation. We assist clients by performing label reviews to ensure full compliance with FDA regulations, particularly OTC monographs. We counsel on current Good Manufacturing Practices (cGMPS) and proper operating requirements. We evaluate drug advertisements and promotional materials for FDA and FTC compliance.

Our lawyers understand the complex regulatory framework involving OTC drugs and how it differs from dietary supplements, homeopathic drugs, medical foods, and prescription drug products. If you are launching a new product and looking for the correct regulatory scheme, let FIDJ guide you. Whether it’s filing an NDA, navigating the monograph system of approval or seeking an Rx to OTC switch, we can provide a judicious and efficient path to protection. FIDJ can also assist with Time and Extent Applications (TEA) for amendments to an OTC monograph. Furthermore, our attorneys understand the post-approval requirements for OTC drugs including adverse event reporting and the ancillary regulations involved such as wholesaling, drug recalls, tamper-evident requirements, and National Drug Code (NDC) directory matters.

Homeopathic Drugs

Homeopathy is based on the principle that “like cures like,” that the more diluted a drug is, the more potent it becomes, i.e. “The Law of Infinitesimals.” Homeopathic drugs have a long and storied tradition in the United States and include a myriad of products, dilutions, and potencies. Homeopathic drugs have a unique regulatory framework with specific requirements that pose important challenges in manufacturing and marketing, distinct from allopathic drugs, dietary supplements, and medical foods. In fact, homeopathic drugs include a number of critical requirements separate from other products that demand specific counsel.

FIDJ assists clients in understanding the manner in which FDA regulates this growing market of products. Our food, drug, and life sciences practice group helps a wide array of clients in the homeopathic industry understand the parameters applicable to them in marketing and advertising, registration and listing, and product formulation. We can assist with matters involving the need for pre-market approval and post-marketing regulation (current Good Manufacturing Practices (cGMPS), marketing, and sales). FIDJ also has extensive experience and skill directing product labels, advertising, reimbursement, prescribing, extemporaneous compounding, importation, state regulation of homeopathic drugs and responding to FDA Warning Letters.

Prescription Pharmaceuticals

For our clients doing business in the prescription drug industry, FIDJ can provide invaluable assistance early on in the research and development process and throughout post-approval obligations including a myriad of ancillary responsibilities and regulatory requirements.

Research and development of prescription drugs can be a complicated and costly endeavor. Our attorneys are available throughout the process to help clients successfully navigate the process and properly position themselves for efficient approval. We can help determine the need for an Investigational New Drug Application (IND) and facilitate pre-IND meetings with FDA officials. We can advise on Phase I, Phase II, Phase III, and Phase IV research studies for compliance with state and federal rules and regulations, including the Common Rule (45 C.F.R. Part 46) and local institutional review boards (IRBs).

We routinely advise clients on labeling, current good manufacturing practices (cGMPs), FDA review dates and accelerated approval pathways. FIDJ also understands the complex regulatory scheme under the Hatch-Waxman Act including authorized generics, therapeutic equivalents, patent listing in the Orange Book, Paragraph IV Certifications, and the application of pediatric exclusivity requirements. Our tax practice helps clients realize the tax benefits of orphan drug designation and the costs incurred with the Prescription Drug User Fee Act (PDUFA). FIDJ can also counsel clients on veterinary drug applications including NADA, ANADA and CNADA.

Let FIDJ assist you. Our attorneys understand the drug distribution process and can counsel clients on wholesale distribution, importation and re-importation, drug pedigrees and counterfeit drugs. We can help establish required standard operating procedures (SOP) for manufacturer facilities and help meet the requirements of the Application Integrity Policy (AIP). Additionally, FIDJ’s associates help clients navigate drug recalls including developing a comprehensive strategy from risk assessment and proper communication through effectiveness evaluation.

Food & Drug Law

FIDJ, PL clients operate in highly regulated, competitive industries, including, but not limited to, food, drug, medical devices, cosmetics, agriculture, and imports, exports, and trade. In these environments, litigation is sometimes necessary. When faced with litigation against regulatory giants like the FDA, FIDJ, PL will not back down or settle unless it is in the best interest of our client. If advocating for our clients requires litigation, FIDJ, PL will go to court and fight on our clients’ behalf.

Mitchell Fuerst and Andrew Ittleman have led litigation against the FDA on numerous occasions. This FDA litigation is a distinguishing characteristic of FIDJ, PL. We have represented clients worldwide, providing defense for individuals and companies charged with civil and criminal violations by the FDA, including compliance enforcement actions. We have likewise sued the FDA and various other federal agencies when we, together with our clients, had determined that litigation was the only way possible to attain the result that our clients deserved.

FDA Litigators

Our law firm has an extensive understanding of the law and litigation process and we use our solid courtroom experience to diligently advocate for our clients. Both in the courtroom and out, FIDJ, PL is highly respected and known for seriously and effectively advocating for its clients. Whether seeking a judicial or administrative remedy, the attorneys at FIDJ, PL use their exceptional skills, knowledge, and abilities to serve their clients and fight for their interests.

FDA Enforcement Actions: Warning Letters and Untitled Letters

FIDJ Services

FIDJ’s legal and regulatory services regarding FDA, FTC, and USDA enforcement actions and litigation include:

Assisting clients in responding to and complying with FDA Warning Letter and Untitled Letters.
Handling FDA inspections and responding to 483s.
Litigating, as necessary, against the FDA, FTC, and USDA.
Assisting clients with product recalls or agency injunctions.
Responding to FTC complaints.

FDA Establishment Registration

If you are an FDA-regulated business in need of registering with FDA, contact us today for a free consultation.

Compounding Pharmacies

Food, Drug and Life Sciences Practice Group

Our food, drug, and life sciences practice group services and the industries we serve include:

Industries Served

Animal and Veterinary Products

Devices
Drugs
Pet food and animal feed

Food and Drug Industries

Medical Tourism

Combination Products

Life Sciences

Legal Services

Advertising and Consumer Law

FTC advertising compliance
FDA labeling and marketing compliance
FTC and FDA litigation

Agency Enforcement Actions and Litigation

FDA Warning Letters
FDA inspections and 483s
USDA inspections
FDA, FTC, USDA litigation
Product recalls and injunctions

Animal and Veterinary Products

Animal drugs
Devices
Marketing and labeling
Minor species products
Pet food and animal feed

Biologics and HCT/Ps

BLA Applications
FDA Warning Letters, Untitled Letters, and other enforcement actions
Litigation
cGMPS and GCPs
FDA registration
Import and export
Clinical research and IRB oversight

Corporate Services

Retail and distribution agreements
Transactional matters
Insurance policy reviews
Partnership and corporate agreements

Cosmetics

FDA labeling compliance
Ingredient review
Color additives
Claims and marketing

Drugs

OTC monographs
Homeopathic monographs
Registration and listing
Competitor market discipline
cGMPs

Food, Beverages and Supplements

Import/Export

Medical Devices

Medical Tourism

Advertising and marketing
FDA and FTC compliance
Corporate structure and tax compliance

Medical Devices

Obtaining FDA Approval and Getting to Market

Our firm can help you with your company’s submission to FDA. We are ready to help you with any of the following:

Premarket Approval Applications (PMAs)
Premarket Notifications (510(k)s)
De novo petitions
Investigational Device Exemption (IDE) Applications
Combination products Request for Designation (RFD)

Medical Device Manufacturing

Labeling and Marketing

FDA Enforcement and Dispute Resolution

FIDJ is familiar and comfortable working with the FDA to ensure our clients’ products, operations, and business interests are served and protected.

Importing and Exporting Medical Devices

Biologics

Biologics and biotechnology represent the future of medicine. FIDJ is here to help you launch your innovative new healthcare solutions and emerging therapies onto the market.

Stem Cells and Regenerative Medicine

Our holistic approach to the stem cell and regenerative medicine industries is the prime example of how we provide comprehensive representation to clients operating in highly regulated industries.

Food, Beverages, and Dietary Supplements

Labeling Compliance

Marketing and Claims Review

Ingredients

Medical Foods

For more information, please contact us at contact@fidjlaw.com or call us directly at (305) 350-5690

Import and Export of FDA-Regulated Products

Imports

Exports

The Import for Export (IFE) program
Export certificates, including Certificates of Pharmaceutical Products (CPP) and Certificates of Free Sale
Foreign firm registration
Labeling requirements
Good manufacturing practices (GMPs)
Inspections
General export regulation compliance

Import for Export Program

Advertising and Consumer Law

Crafting compliant marketing claims
Structuring rules and regulations for sweepstakes or special promotions marketing
Building a proper substantiation file to support advertising claims
Collecting and using testimonials
Handling complaint letters from the FTC, FDA, State Attorney General, and other groups and organizations

Medical Tourism

Advertising and Marketing

FDA Regulatory Compliance

Corporate Structure and Tax Compliance

Cosmetics

Animal and Veterinary Products

Product label reviews, including labeling claims and substantiation
Ingredient reviews including reviews of color additives
Importation and exportation
Import Alerts
Shipment detentions
Consumer complaints
FDA recalls and warning letters

Claims, Advertising, and Labeling

Claims made about a product, whether in advertising or labeling, can be the difference between whether the product is regulated by the FDA as a drug, a cosmetic, or both. FIDJ helps clients formulate claims for products that are permissible and appropriate for cosmetic marketing. We are equipped to assist clients in ensuring there is adequate data and information to substantiate product claims and the safety of product ingredients. The attorneys at FIDJ are also experienced in conducting reviews of product labels and labeling materials to ensure these meet the requirements established by the FPLA and FDCA. We also assist clients in crafting advertising campaigns that are compliant under FTC and FDA regulations.

Import and Export

FIDJ attorneys have significant experience handling issues involving Customs and Border Patrol (CBP), and assisting clients in the importation of cosmetic products into the U.S. We help importers ensure imported products are in compliance with all state, federal, and international labeling regulations. Our team is familiar with FDA Import Alerts and regularly works with CBP and FDA personnel on shipment detentions and exporting cosmetic products internationally.

Ingredients and Color Additives

FDA regulations prohibit, or restrict, the use of certain ingredients and color additives in cosmetic products. FIDJ helps clients ensure that only legal ingredients and color additives are present in their cosmetic products through formulation and label reviews.

FDA Enforcement Action

FIDJ is experienced in working and communicating with FDA and CBP personnel regarding detentions of cosmetic shipments and FDA inspections. We have experience negotiating with the FDA on behalf of our clients regarding shipment detentions and Import Alerts, and we have represented clients in litigation involving cosmetics against both the FDA and private parties.

For more information, please contact us atcontact@fidjlaw.com or (305) 350-5690 for a free consultation.

Prescription Pharmaceuticals

Assisting clients with understanding OTC monographs and homeopathic monographs
Registration and listing
Product labeling and advertising
Product labeling and advertising
Market discipline and competitor complaints
cGMPs
Advising clients regarding clinical research including working with clinical trials and complying with FDA’s rules for INDs, NDAs, and BLAs
FDA and FTC enforcement actions and litigation

Over-the-Counter (OTC) Drugs

Homeopathic Drugs

Prescription Pharmaceuticals

Anti-Money Laudering

FIDJ’s Anti-Money Laundering practice covers a wide range of businesses and legal issues. Primarily, our AML attorneys advise domestic and international financial institutions regarding their anti-money laundering requirements as set forth by the Bank Secrecy Act and individual state laws. This advice can be delivered in a variety of forms, but typically involves explaining how the individual institution is defined by federal law, and then teaching the institution regarding its unique federally mandated compliance requirements. However, our clients often have more wide-ranging legal needs. Accordingly, our AML lawyers routinely assist clients in matters involving commercial litigation, white collar criminal defense, regulatory enforcement actions, and commercial transactions, as well as IRS-BSA audits, OFAC licensing issues, grand jury investigations, state investigations, criminal and civil litigation, and commercial transactions. Our anti-money laundering practice recognizes that regulatory compliance must at all times remain at the forefront of every financial institution’s attention, and regardless of the specific legal matter we are asked to address for our financial institution clients, we must also keep our focus on compliance.

In addition to advising banks, credit unions and money services businesses regarding their anti-money laundering obligations, our anti-money laundering attorneys have also advised casinos, pawnbrokers, vehicle and yacht sellers, art dealers, diamond and gold dealers, investment brokers, insurance companies, and real estate companies, as all of these companies have been deemed to be “financial institutions” under United States law. In addition to working closely with our clients so as to render the most precise possible anti-money laundering advice, we also have strategic relationships with third party anti-money laundering consultants to assist in the preparation of our clients’ anti-money laundering programs.

While anti-money laundering programs are critical, they must be narrowly tailored to protect against the unique money laundering and terrorist financing risks posed by the individual financial institution, and they must actually be implemented. Additionally, financial institution employees must be included as part of the program and given instructions regarding how to report suspicious activity. Finally, anti-money laundering programs must be strong enough to withstand not only internal and external reviews, but the scrutiny of federal and state regulators, which may have overlapping jurisdiction over the financial institution and both routinely audit for compliance with the federal and state money laundering laws. We work closely with a wide range of financial institutions on all of these important anti-money laundering issues.

FIDJ, PL’s Anti-Money Laundering Compliance team is captained by Andrew S. Ittleman, Esq., who is a certified Anti-Money Laundering Specialist and frequently lectures to domestic and international audiences on a wide range of anti-money laundering issues.

If you have any questions related to your anti-money laundering compliance obligations, please contact Andrew S. Ittleman, Esq. at aittleman@fidjlaw.com or (305) 350-5690.

Money Services Businesses

“Money Services Business” (MSB) is an umbrella term covering a wide variety of businesses, including money transmitters, check cashers, dealers in foreign exchange (formerly known as currency exchangers and currency dealers), sellers and providers of prepaid access, and issuers, sellers and redeemers of money orders and travelers checks. MSBs are typically required to register with FinCEN and become licensed in the individual states, depending upon the nature of the MSB’s business and the state or states in which it operates, services customers, or has bank accounts. The MSB lawyers at FIDJ, PL are knowledgeable of these requirements and can provide critical assistance on a wide array of legal and regulatory matters, including:

State licensing issues, including license applications and legal opinions regarding state licensing laws;
State and federal compliance audits, including IRS/BSA examinations;
State and federal enforcement actions, including those seeking to impose fines and revoke licenses;
OFAC licensing issues;
Anti-money laundering and Bank Secrecy Act compliance;
Law enforcement and Grand Jury subpoenas and investigations;
White collar criminal defense;
Corporate transactions;
Commercial litigation

Depending upon the nature of the MSB’s business and the state or states in which it operates, services customers, or has bank accounts, MSBs may have burdensome state law requirements which are sometimes vague and inconsistent, but are not to be overlooked as failure to comply with them can lead to devastating consequences. Not only can MSBs be barred from operating in states where they operate, but as an example, money transmitters (and their individual operators) can be criminally prosecuted for operating in a state without a license, regardless of their innocent intent.

FIDJ, PL’s Money Services Business practice is captained by Andrew S. Ittleman, Esq., who is a certified Anti-Money Laundering Specialist and frequently lectures on a wide variety of issues facing the MSB industry to domestic and international trade groups.

If you have any questions related to your money services business, please contact Andrew S. Ittleman, Esq. at aittleman@fidjlaw.com or (305) 350-5690.

Virtual Currencies Compliance

Virtual currencies are ideal means of engaging in commercial transactions online. Virtual currency transactions are instant, immune from chargeback risk, and have developed a reputation for protecting user information in a manner vastly superior to credit cards and bank transfers. In spite of these attributes, virtual currencies have been the subject of intense government scrutiny since they first started circulating circa 1996. Virtual currencies (as well as their central issuers) have also been the targets of commercial lawsuits, civil forfeiture actions, grand jury investigations and criminal prosecutions based on a wide variety of allegations, including money laundering, fraud, unlicensed money transmitting business claims and a host of others. Thus, while there is no disputing the benefits of virtual currencies, they come with great risk, and those who issue virtual currencies or operate as commercial exchangers must always be mindful of their intense compliance obligations.

Today, Bitcoin is the world’s most popular virtual currency, though it is by no means the first. Between the time of its birth and March of 2013, Bitcoin and all other virtual currencies existed in an area of the law where there was no law.

That is not to say that Bitcoin issuers and users were not subject to the money laundering provisions of federal law if they used Bitcoin for unlawful purposes, but up until March 2013 the United States government had not decided how to regulate Bitcoin as a thing. Then, on March 18, the Financial Crimes Enforcement Network (FinCEN) of the Department of the Treasury issued its Guidance entitled, “Application of FinCEN’s Regulations to Persons Administering, Exchanging, or Using Virtual Currencies.” This was a watershed moment for the regulation of Bitcoin and other virtual currencies

A person that creates units of this convertible virtual currency and uses it to purchase real or virtual goods and services is a user of the convertible virtual currency and not subject to regulation as a money transmitter. By contrast, a person that creates units of convertible virtual currency and sells those units to another person for real currency or its equivalent is engaged in transmission to another location and is a money transmitter. In addition, a person is an exchanger and a money transmitter if the person accepts such de-centralized convertible virtual currency from one person and transmits it to another person as part of the acceptance and transfer of currency, funds, or other value that substitutes for currency.

FinCEN’s March 2013 guidance has made the following point crystal clear: if an entity is in the business of exchanging Bitcoin for “real currency” or vice versa, or accepts Bitcoin from one person and transmits the real currency equivalent to another person, that entity is a money transmitter and will be regulated as such in the United States, and will be subject to the criminal provisions of 18 USC 1960 for failing to register with the federal government as a money transmitter or being licensed in any state that would require a money transmitting license.

FinCEN’s regulatory scheme for Bitcoin dealers is also applicable to dealers operating outside of the United States. Thus, even assuming that a Bitcoin exchanger does not have a physical nexus in the United States, so long as the exchanger services people located in the United States, the exchanger will be regulated as a money transmitter. As FinCEN explained on July 18, 2011, and as we blogged shortly thereafter, FinCEN’s rules make foreign-located businesses engaging in MSB activities within the U.S. subject to U.S. law. As a result, even foreign based MSBs with no physical presence in the US can be classified as an MSB and thus subject to the rigorous requirements of the BSA. However, foreign banks as well as foreign financial agencies that engage in activities that if conducted in the US would require them to be registered with the SEC or CFTC are excluded from the definition of an MSB. As noted in the rule, “To permit foreign-located persons to engage in MSB activities within the United States and not subject such persons to the BSA would be unfair to MSBs physically located in the United States and would also undermine FinCEN’s efforts to protect the U.S. financial system from abuse.”

FIDJ, PL has represented a wide array of financial services providers with the following critical legal and regulatory matters including:

State licensing issues, including license applications and legal opinions regarding state licensing laws;
State and federal compliance audits, including IRS/BSA examinations;
State and federal enforcement actions, including those seeking to impose fines and revoke licenses;
OFAC licensing issues;
Anti-money laundering and Bank Secrecy Act compliance;
Law enforcement and Grand Jury subpoenas and investigations;
White collar criminal defense;
Corporate transactions;
Commercial litigation

FIDJ, PL’s Virtual Currencies Compliance team is captained by Andrew S. Ittleman, Esq., who is a certified Anti-Money Laundering Specialist, and frequently lectures on a wide variety of issues facing the MSB industry to domestic and international trade groups.

If you have any questions related to your bitcoin or virtual currency compliance, please contact Andrew S. Ittleman, Esq. at aittleman@fidjlaw.com or (305) 350-5690.

Healthcare

FIDJ’s health care practice group provides comprehensive representation to health care providers in a wide array of forums, including matters involving regulatory issues, business transactions, and complex litigation. Our firm works closely with its clients to evaluate and implement strategies that meet their unique and complex legal needs.

FIDJ’s health care practice group combines experienced lawyers and consultants from several practice areas to provide representation in all aspects of health law. We have successfully represented a wide variety of health care practitioners and facilities, including, but not limited to:

Physicians
Physician practice groups
Home health agencies
Skilled nursing facilities
Pharmacies
Pain management clinics

The health law attorneys at FIDJ have extensive experience handling the various regulatory and compliance issues surrounding the provision of Medicare and Medicaid services, including:

Overpayment appeals
Cost report audit support and appeals
Medicaid Program Integrity audits and investigations
Prepayment reviews
Provider enrollment applications and appeals
AHCA survey appeals
Health care fraud investigations
HIPAA and FIPA compliance

Additionally, FIDJ’s health care, corporate, and tax attorneys work together to represent health care providers in various transactions including:

Practice restructuring and expansions
Mergers and acquisitions
Practitioner employment and Noncompetition Agreements
Incentive compensation arrangements

Our health care attorneys also advise and assist clients to ensure that they are fully compliant with a litany of laws including Anti-Kickback and STARK self-referral laws, among others. When necessary, FIDJ can provide aggressive, experienced litigation services in administrative, civil, and criminal litigation related to all these areas.

FIDJ also provides outside general counsel services to numerous health care entities.

For more information, please contact us at contact@fidjlaw.com, or call us directly at (305) 350-5690.

HIPAA

The health care practice group at FIDJ has experience in assisting clients in HIPAA implementation and compliance.

Our firm can assist your covered entity, or business associate, in ensuring that your company maintains the appropriate operations, policies, procedures, and systems to comply with HIPAA’s regulatory obligations.

Health Insurance Portability and Accountability Act (HIPAA), Pub. L. 104-191, was enacted to establish standards for maintaining the privacy and security of patient health records. HIPAA’s requirements apply to any individual, organization, or agency, which meets the definition of a “covered entity” and those entities’ “business associates,” which help the entities carry out their health care functions. “Covered entities” include health care providers, such as doctors, clinics, nursing homes and pharmacies. A complete definition of “covered entity” and “business associate” can be found at 45 C.F.R. § 160.103.

As part of HIPAA’s reforms, the Secretary of the United States Department of Health and Human Services (HHS) was required to develop regulations to assist in protecting both the privacy and security of certain health information. Towards this end, HHS published two series of regulations commonly known as the Privacy Rule and the Security Rule. The Privacy Rule, located at 45 C.F.R. Part 160 and subparts A and E of Part 164, establishes national standards for protection of personal health information and individuals’ medical records. The Privacy Rule established safeguards to protect the privacy of personal health information and established the circumstances under which disclosures of such information may be made without patient authorization. In addition, the Privacy Rule granted patients certain rights over access to their health information including the right to examine and obtain copies of their medical records and the right to request that corrections be made to mistakes within these records.

The Security Rule located at 45 C.F.R. Part 160, and subparts A and C of Part 164, establishes national standards for protecting electronic personal health information created, received, used, or maintained by a covered entity. The Security Rule works in tandem with the Privacy Rule by establishing the technical and non-technical safeguards that covered entities must have in place to protect electronic protected health information.

Violations of HIPAA can expose an entity to civil and potential criminal penalties. Within HHS, the Office of Civil Rights (OCR) has been given the responsibility of enforcing the Privacy and Security Rules through a variety of measures including the enforcement of civil monetary penalties. Penalties can range from $100 to $50,000 per violation depending on the circumstances of the case. However, prior to the imposition of a penalty, OCR will provide the covered entity an opportunity to submit written evidence on its behalf. Further, if OCR announces its intent to impose a civil monetary penalty, a covered entity has the right to request an administrative hearing. See generally, 45 C.F.R. Part 160 Subpart E.

Additionally, a person who knowingly obtains or discloses individually identifiable health information in violation of HIPAA’s Privacy Rule may face criminal penalties of up to $50,000 and up to one-year imprisonment. These penalties increase to $100,000, and up to five years imprisonment, should a violator’s wrongful conduct involve false pretenses, and to $250,000, and 10 years imprisonment, if the wrongful conduct involves the intent to sell, transfer, or use the identifiable health information for commercial advantage, personal gain, or malicious harm. The Department of Justice is responsible for the prosecution of criminal violations of HIPAA.

FIDJ’s health care practice group has experience in providing assistance to covered entities and their business associates to ensure HIPAA compliance. We also have extensive experience in representing entities in the administrative hearings and appeals process. Further, our white collar criminal practice group can provide aggressive, experienced litigation services regarding any potential criminal investigations or actions.

For more information, please contact us at(305) 350-5690 or contact@fidjlaw.com for a free consultation.

FIPA: Florida Information Protection Act

FIDJ can assist your covered entity in ensuring that your business maintains the appropriate operations, policies, procedures, and systems to comply with the Florida Information Privacy Act (FIPA).

On July 1, 2014, FIPA became effective replacing Florida’s previous data breach notification requirements. FIPA is comprehensive in nature, and addresses what “covered entities” and their “third-party agents” must do to protect “personal information,” and also sets forth what is required of such entities in the event of a breach. While the ideas behind FIPA and HIPAA are similar, the entities and data covered by the two laws are different. Unlike HIPAA, which only applies to health information, FIPA applies to all personal information regardless of what kind, or the nature of the company storing it. Thus, even though an entity may not fall within the federal HIPAA statute, it may nevertheless be governed by FIPA, and be subject to the full scope of the new state statutory scheme designed to protect personal information.

1. Covered Entities, Third-Party Agents and Personal Information

FIPA governs a far more expansive list of “covered entities” than HIPAA. FIPA defines a “covered entity” as a “sole proprietorship, partnership, corporation, trust, estate, cooperative, association, or other commercial entity that acquires, maintains, stores, or uses ‘personal information,’” as per Fla. Stat. § 501.171(1)(b). A “third-party agent” is “an entity that has been contracted to maintain, store, or process personal information on behalf of a covered entity or governmental entity,” according to Fla. Stat. § 501.171(1)(h).

“Personal Information,” states Fla. Stat. § 501.171(1)(g)(1)(a), is defined as an individual’s first name, or first initial, and last name in combination with any one or more of the following data elements for that individual:

1. - A Social Security number
  - A driver’s license or identification card number, passport number, or military identification
  - A financial account number or credit or debit card number with security codes or passwords
  - Any information regarding an individual’s medical history, mental or physical condition, or medical treatment or diagnosis by a health care professional
  - An individual’s health insurance policy number or subscriber identification number and any unique identifier used by a health insurer to identify the individual.

“Personal information” also includes a user name or e-mail address in combination with a password or security question and answer that would permit access to an online account, according to Fla. Stat. § 501.171(1)(g)(1(b). However, FIPA does not apply to personal information that is encrypted, secured, or modified so that the information is unusable in the event of a breach.

1. Data Security Measures

FIPA requires that each covered entity, governmental entity, or third-party agent take reasonable measures to protect and secure data in electronic form containing personal information, as per Fla. Stat. § 501.171(2). Examples of reasonable measures would be encryption of data or de-identifying the data. In addition, FIPA requires covered entities and third-party agents to take all reasonable measures to dispose, or arrange for the disposal, of customer records containing such personal information. As explained in Fla. Stat. § 501.171(8), “such disposal shall involve shredding, erasing, or otherwise modifying the personal information in the records to make it unreadable or undecipherable through any means.”

1. Breach Notification Requirements

FIPA establishes a series of people and authorities which must be contacted in the event of a breach as well as timeframes under which a covered entity or third-party agent must make such notifications. The notification requirements vary based on the size of the breach.

In all cases of a breach, cover entities must notify each individual whose personal information was accessed, or believed to be accessed, within 30 days after the discovery of a breach, states Fla. Stat. § 501.171(4)(a). However, an exemption exists in cases where “after an appropriate investigation and consultation with relevant federal, state, or local law enforcement agencies, the covered entity reasonably determines that the breach has not, and will not likely, result in identity theft or any other financial harm to the individuals whose personal information has been accessed” (Fla. Stat. § 501.171(4)(c). An exemption also exists if law enforcement determines that notice would interfere with a criminal investigation, according to Fla. Stat. § 501.171(4)(b).

When a breach affects 500 or more individuals in the state, covered entities must notify the Florida Department of Legal Affairs within 30 days of discovery of the breach. In such instances, a covered entity may receive an additional 15 days to provide the personal notification required under the statute should good cause exist. Such a requirement exists regardless of whether the covered entity determines that the breach is not likely to result in identity theft or other financial harm to the affected individuals states Fla. Stat. § 501.171(3).

In addition, according to Fla. Stat. § 501.171(5), in cases where the breach affects more than 1,000 individuals, the covered entity shall also notify, “without unreasonable delay,” all consumer credit reporting agencies that compile and maintain files on consumers under the Fair Credit Reporting Act.

In cases where data breaches occur at a third-party agent, the third-party agent shall notify the covered entity of the breach “as expeditiously as practicable, but no later than 10 days following the determination of the breach of security or reason to believe the breach occurred,” explains Fla. Stat. § 501.171(6). Once the third-party agent informs the covered entity, the covered entity shall proceed in providing the statutorily required notice.

It is important for companies who may also be considered covered entities under HIPAA to understand that the timeframes for reporting breaches are different under FIPA and HIPAA. Therefore, entities subject to both statutes must ensure adequate compliance with both in the event of a breach.

1. Penalties

Violations of FIPA are treated as unfair and deceptive trade practices and allows the Florida Department of Legal Affairs to use any, and all, remedies available under Fla. Stat. § 501.207 of the Florida Deceptive and Unfair Trade Practices Act. Fla. Stat. § 501.171(9)(a).

In addition, covered entities face fines under FIPA for failing to provide the statutorily required notice. Here, rather than a per record basis fine structure, such as the one in place for HIPAA, FIPA civil penalties are based on the length of time an entity is not in compliance after a breach. Covered entities face civil penalties of up to $500,000 per breach calculated as follows: 1) $1,000 per day up to the first 30 days following any violation; 2) thereafter, $50,000 for each subsequent 30-day period or portion thereof for up to 180 days (Fla. Stat. § 501.171(9)(b)).

FIPA expressly states that no private cause of action is established by the act. However, this does not mean that covered entities do not face a risk of private litigation in the event of a breach as common law causes of action, such as negligence, breach of contract, and breach of fiduciary duties, may still exist for damages caused by data breaches.

For more information, please contact us at(305) 350-5690 or contact@fidjlaw.com for a free consultation.

Anti-Kickback Regulatory Compliance

FIDJ’s health care regulatory compliance and corporate law attorneys have experience in structuring arrangements and transactions to comply with the Anti-Kickback law. Our firm can also provide assistance with investigating possible violations of the Anti-Kickback law, which exist in your organization and in advising clients on corrective and remedial actions.

Generally speaking, the federal Anti-Kickback law, found at 42 U.S.C. § 1320a-7b(b), is a criminal statute that prohibits the offering, paying, soliciting or receiving of anything of value to induce or reward referrals, or to generate federal health care program business. The Anti-Kickback law is a criminal statute that is broadly defined, and establishes penalties for individuals and entities on both sides of the prohibited transaction.

1. Anti-Kickback Law Prohibited Referrals

The Anti-Kickback law is a criminal statute that prohibits the knowing and willful offer, or payment of, and the knowing solicitation or receipt of “any remuneration directly, or indirectly, overtly or covertly, in cash or in kind,” to induce:

1. 1. referrals of patients
  2. the purchasing, leasing, ordering, or arranging for any good, facility, service or item paid for by a federal health care program (including Medicare and Medicaid).

While the Anti-Kickback law requires a knowing and willful violation of the law to establish liability, with the passage of the Patient Protection and Affordable Care Act, the Anti-Kickback law was amended to make clear that actual knowledge of an Anti-Kickback violation or the specific intent to commit a violation of the Anti-Kickback law is not required for conviction. Although the government is no longer required to prove that a defendant intended to violate the Ant-Kickback law itself, it must still prove that a criminal defendant intended to violate the law.

1. Potential Penalties

Anti-Kickback law violations can subject a violator to criminal, civil, and administrative penalties. The Anti-Kickback law establishes that a violation of the law is a felony and can be punished by up to five years in prison and a fine of $25,000 per violation. Further, violators can be assessed civil monetary penalties of up to $50,000 per violation, and face an additional civil assessment of up to three times the amount of the kickback received.

In addition, Anti-Kickback law violations can result in the Secretary of Health and Human Services excluding a violator exclusion from acting as participating provider in a federal health care program. The effect of such an exclusion is that a provider can no longer receive payment for services from any federal health care program (including Medicare, Medicaid, and Tricare, among others) for services rendered. The Anti-Kickback law provides for mandatory exclusion if a violator is criminally convicted. Even negligent violations, which would not amount to criminal liability, can still result in a provider’s exclusion at the discretion of the Secretary.

1. Anti-Kickback Law Safe Harbors

Due to the potential broad reach of the Anti-Kickback law into numerous transactions, the Office of Inspector General (OIG) of the United States Department of Health and Human Services has been granted authority to promulgate regulations, which exclude certain specific business and financial practices from criminal and civil prosecution under the act. These exclusions, known as “safe harbors,” are found at 42 C.F.R. § 1001.952.

For example, Anti-Kickback safe harbor transactions include, in part:

1. 1. investment interests
  2. space rental
  3. equipment rental
  4. personal services and management contracts
  5. referral services
  6. payments to bona fide employees
  7. physician recruitment efforts.

However, each safe harbor imposes precise and lengthy conditions for compliance in order for a transaction to fall within its scope. Thus, practitioners must evaluate each such transaction to ensure compliance.

Transactions which are neither specifically excluded or covered under a safe harbor regulation are not violations of the Anti-Kickback law per se. Instead, OIG evaluates such transactions on a case-by-case basis. In addition, parties who are uncertain whether their arrangements qualify for a safe harbor can request an advisory opinion from OIG.

Our health care regulatory compliance and corporate law attorneys have experience in structuring arrangements and transactions to comply with the Anti-Kickback law. In addition, FIDJ’s health care regulatory compliance attorneys have experience in reviewing and analyzing proposed transactions and arrangements to identify potential Anti-Kickback law pitfalls. We can also provide assistance with investigating possible violations of the Anti-Kickback law which exist in your organization, and in advising clients on corrective and remedial actions. When necessary, we can provide aggressive, experienced litigation services in civil and criminal actions related to these areas. FIDJ also handles provider acquisitions and offers strategic tax planning advice to health care providers and suppliers.

FIDJ’s health care practice group combines experienced lawyers and consultants from several practice areas to provide comprehensive representation in all aspects of health care law. Let us show you how we can help today.
For more information, please contact us at(305) 350-5690 or contact@fidjlaw.com for a free consultation.

STARK Regulatory Compliance

FIDJ’s health care practice group combines experienced lawyers and consultants from several practice areas to provide comprehensive representation in all aspects of STARK Law compliance.

Generally speaking, the STARK Law, found at 42 U.S.C. § 1395nn, prohibits physicians from referring Medicare beneficiaries to an entity in which they, or an immediate family member, have a financial relationship for designated health services, unless an exception applies.

1. STARK Basics

The STARK Law, which was passed in two parts, “STARK I” and “STARK II,” prohibits physicians from referring their Medicare and Medicaid patients to business entities in which the physicians or their immediate family members have a financial interest. More specifically, STARK prohibits physicians from making referrals to an entity for clinical lab services if the physician had a prohibited financial relationship with the entity. In addition, STARK prohibits physicians from referring Medicare patients for designated health services to an entity with which the physician (or immediate family member) has a financial relationship, unless an exception applies.

“Designated health services,” according to 42 U.S.C. § 1395nn(h)(6), include:

1. 1. Clinical laboratory services;
  2. Physical therapy service;
  3. Occupational therapy services;
  4. Radiology services;
  5. Radiation therapy services and supplies;
  6. Durable medical equipment and supplies;
  7. Parental and enteral nutrients, equipment, and supplies;
  8. Prosthetics, orthotics, and prosthetic devices and supplies;
  9. Home health services;
  10. Outpatient prescription drugs;
  11. Inpatient and outpatient hospital services;
  12. Outpatient speech-language pathology services.
2. Financial Relationships and Prohibited Referrals

In order to understand STARK’s reach, it is important to understand how STARK defines a financial relationship and a referral.

The STARK Law broadly defines “financial relationships to include an ownership or investment interest in an entity or a compensation arrangement, states 42 U.S.C. § 1395nn(a). Compensation arrangement, in turn, is defined as “any arrangement involving any remuneration between a physician (or an immediate family member of such physician) and an entity” (42 U.S.C.§ 1395nn(h)(1)(A)). Remuneration, with certain exceptions not applicable to the instant case, includes, “any remuneration, directly or indirectly, overly or covertly, in cash or in kind” (42 U.S.C. § 1395nn(h)(1)(B)).

Referral, for purposes of the STARK Law, is defined as “the request or establishment of a plan of care by a physician, which includes the provision of designated health services,” states 42 U.S.C. § 1395nn(h)(5)(A). The regulations interpreting the statute also broadly define referral as, among other things, “a request by a physician that includes the provision of any designated health service for which payment may be made under Medicare, the establishment of a plan of care by a physician that includes the provision of such a designated health service, or the certifying or re-certifying of the need for such a designated health service” (42 C.F.R. § 411.351). A referring physician is defined in the same regulation as “a physician who makes a referral as defined in this section or who directs another person or entity to make a referral or who controls referrals made to another person or entity.”

1. Potential Penalties

The STARK Law further provides that should any amounts be billed in violation of the act, the biller shall be liable for the overpayment and must refund that amount to the government, states 42 U.S.C. § 1395nn(g)(2). Violators of the STARK Law are subject to potential civil monetary penalties of up to $15,000 for each service billed.

In addition, violators also face potential False Claims Act (FCA), 31 U.S.C. § 3729 et seq., liability for knowingly submitting prohibited claims. Generally speaking, the FCA empowers private persons, known as relators, to file civil actions known as qui tam lawsuits and recover damages on behalf of the United States from any person who: 1) knowingly presents, or causes to be presented, a false or fraudulent claim for payment; or 2) knowingly makes uses, or causes to be made or used, a false record or statement to get a false or fraudulent claim paid or approved by the government. As it relates to this case, “[f]alsely certifying compliance with the STARK Law in connection with a claim submitted to a federally funded insurance program is actionable under [the FCA].”

1. STARK’s Exceptions for Certain Compensation Arrangements

The STARK Law also provides for several exceptions to the broad general prohibition on compensation arrangements between health care entities and referring physicians. If a hospital’s financial relationship with a physician comes under one of the exceptions, then it is not prohibited under STARK. The complete list of compensation arrangements exceptions are found at 42 U.S.C. § 13955nn(e).

1. Relationships impacted by the STARK Law

Due to STARK’s breadth, numerous health care business relationships can trigger the need for a STARK analysis. Depending on the nature and structure of the transaction, such health care relationships may include:

1. 1. physician employment and independent contractor agreements
  2. medical director agreements
  3. hospital/physician recruitment arrangements
  4. arrangements and agreements between physicians and other designated health service providers
  5. medical equipment and office space leasing agreements

In addition, STARK’s prohibitions also apply within a physician practice group setting. Thus, if a physician practice group provides multiple designated health services within its practice, STARK may be implicated and the relationship between the practice group and the individual physicians must comply with a STARK exception.

The health law attorneys of FIDJ have extensive experience handling the various regulatory and compliance issues surrounding the provision of Medicare and Medicaid services, including False Claims Act (qui tam cases) as well as violations of the Anti-Kickback and STARK self-referral laws, among others. Our health care regulatory compliance and corporate law attorneys have experience in structuring arrangements and transactions to comply with the STARK Law. In addition, FIDJ’s health care regulatory compliance attorneys have experience in reviewing and analyzing proposed transactions and arrangements to identify potential STARK Law pitfalls. We can can also provide assistance with investigating possible violations of the STARK Law which exist in your organization and in advising clients on corrective and remedial actions. When necessary, we can provide aggressive, experienced litigation services in civil and criminal actions related to these areas. FIDJ also handles provider acquisitions and provides strategic tax planning advice to health care providers and suppliers.

For more information, please contact us at(305) 350-5690 or contact@fidjlaw.com for a free consultation.

Surveys / Deficiency Citation Appeals

FIDJ represents nursing homes in connection with state and federal surveys from inception through the appellate process.

Health care providers receiving Medicare and Medicaid reimbursement are subject to state and federal surveys aimed at determining substantial compliance with Conditions for Coverage (CfC) and Conditions of Participation (CoP). At a minimum, skilled nursing facilities (SNF) are subject to annual surveys once every 15 months. Typically, however, even the best SNFs will experience more frequent complaint surveys. In either event, the SNF is advised of its alleged deficient practices (if any) through the surveying agency’s issuance of a Statement of Deficiencies (Form CMS-2567). The provider has 10 calendar days to submit its Plan of Correction in response thereto.

An acceptable Plan of Correction must include five core elements:

How corrective action will be accomplished for those residents found to have been affected by the deficient practice
How the SNF will identify other residents having the potential to be affected by the same deficient practice
What measure will be implemented (or systematic changes) to ensures the that deficient practice will not reoccur
How the SNF plans to monitor its performance to make sure that solutions are sustained
Dates when corrective action will be completed

Since Statements of Deficiency and Plans of Correction ultimately become available for public consumption, it is advisable that SNFs include a disclaimer in the Plan of Correction, where applicable, noting that the SNF denies and disputes the citation(s) and submits its Plan of Correction to comply with applicable state and federal regulations.

In the same 10 calendar days an SNF has to submit its Plan of Correction, it must also request Informal Dispute Resolution (IDR). IDR is the process by which SNFs can informally dispute regulatory deficiencies. It is important to note that neither the submission of a Plan of Correction nor the request for IDR tolls the time within which a Request for Hearing before an Administrative Law Judge (ALJ) must be filed (assuming that the SNF wishes to pursue its appellate rights).

Generally, a SNF has 60 days from receipt of its Statement of Deficiencies (Form CMS-2567) to file a timely Request for Hearing before an ALJ. At the ALJ level, the Centers for Medicare and Medicaid Services (CMS) has the initial burden of making a prima facie case of a regulatory violation. To that end, CMS may rely on the Statement of Deficiencies to make its prima facie case of a deficiency, but only if the factual findings and allegations it contains are specific, undisputed, and not inherently unreliable. If CMS meets its burden, the SNF then bears the burden of persuasion to demonstrate, by a preponderance of the evidence, that the SNF was, in fact, in substantial compliance.

Either CMS or the SNF may appeal an ALJ’s unfavorable decision to the Departmental Appeals Board (DAB). The failure of either party to file a timely appeal renders the ALJ decision final agency action. An unfavorable decision of the DAB may be appealed to the federal district courts and, ultimately, the U.S. Courts of Appeals.

FIDJ’s health care practice group has the experience necessary to guide you through each stage of the survey process, from the issuance of the Statement of Deficiencies through the appellate process. For more information call (305) 350-5690 or email contact@fidjlaw.com .

Outside General Counsel

FIDJ serves as outside general counsel to many of its clients, affording such clients the benefits of an “on-call” attorney with a mutually beneficial fee structure, without the expensive overhead of an in-house attorney.

There comes a time when every business, from the start-up to the large privately-held entity, needs the guidance and counsel of an experienced attorney and the legal expertise necessary to accomplish multidisciplinary transactional work and complex litigation. Yet, many businesses either overlook the importance of having an experienced attorney “on call” or spend significant sums of money on in-house attorneys (including the associated overhead of research materials and support staff), who simply lack the experience necessary to handle all of the businesses’ legal needs.

FIDJ possesses the legal experience necessary to serve as outside general counsel in areas including, but not limited to:

Corporate formation, including the drafting of corporate documents (e.g. operating agreements, shareholder agreements, shareholder resolutions, consts, etc.)
Corporate governance matters, including compliance with state governance laws (e.g. meeting requirements, notice requirements, voting requirements, fiduciary duties, etc.)
Taxation
Mergers and acquisitions
Preparation, review, and negotiation of contracts with customers, partners, vendors, landlords, tenants, etc.
Employment matters, including counseling on discriminatory practices, hiring/firing issues, wage and hour issues, employment contracts, non-compete agreements, and general compliance with all appropriate state and federal regulations
State and federal compliance for the appropriate industry (e.g. counseling skilled nursing facilities on compliance with state and federal regulations concerning patient care, Conditions of Participation, Conditions of Coverage, STARK Law, Anti-Kickback compliance, HIPAA compliance, deficiency citations, civil monetary penalty appeals, etc.)
Day-to-day legal advice and counseling on general and industry-specific matters, with particular expertise in health care, physician medical practices, customs brokers, money services businesses, and other high-regulated businesses
Commercial and civil litigation

FIDJ works with each client to develop a suitable fee structure, which makes the relationship both advantageous and cost effective. When our firm serves as outside general counsel, its clients receive the benefit of a full-service law firm, minus the costs associated with bringing the vast array of legal experience and knowledge in-house. In addition, some fee structures remove the “billable hour” from the equation, thereby permitting clients to pursue their reasonable legal objectives without the worry of unexpected legal invoices.

Let FIDJ show you how it can help your business. For more information, call (305) 350-5690 or email contact@fidjlaw.com .

Home Health Agency Regulatory Compliance

The health law attorneys of FIDJ are knowledgeable about the various regulatory and compliance issues home health agencies face.

Home health agencies play a critical role in the care and treatment of Medicare and Medicaid beneficiaries.

Home health agencies accept patients for treatment with the expectation that the patient’s medical needs can be adequately met by the agency in the patient’s place of residence (42 C.F.R. § 484.18). Home health services include part-time or intermittent skilled nursing care; physical, occupational, and speech therapy; medical social work; and home health aide services. Please refer to the Medicare Benefits Policy Manual, Pub. No. 100-02, Ch. 7, § 40 for additional information.

In order to receive proper payment from Medicare and Medicaid, it is essential that a home health agency maintain adequate documentation of all aspects of a beneficiary’s care, including for example: initial certifications and plans of care, verbal orders, prescriptions, initial and follow-up home health nursing certifications, daily nursing notes, and physical therapy assessments and notes. In addition, section 6407 of the Patient Protection and Affordable Care Act mandates that, prior to certifying a patient’s eligibility for the home health benefit, the physician responsible for performing the initial certification must document that the physician or a permitted non-physician practitioner (“NPP”) (which includes a nurse practitioner, a clinical nurse specialist, a certified nurse-midwife, or a physician assistant) has had a face-to-face encounter with the patient (42 C.F.R. § 424.22). As part of this documentation, the physician or NPP must document that he or she:

saw the patient
the patient’s clinical condition at the time of the encounter supports the patient’s homebound status
the need for skilled services

The face-to-face encounter must occur no earlier than 90 days prior to the start of, and no later than 30 days after the start of, home health care. The certifying physician must document this face-to-face encounter either on the initial certification which the physician signs, or in a separate signed addendum to the initial certification. Inadequate clinical documentation often times can result in payment denials, audits, and subsequent overpayment determinations by Medicare Administrative Contractors (MACs).

The health care practice group of Fuerst, Ittleman, David & Joseph has successfully assisted clients in obtaining reimbursement through a multifaceted approach of ensuring adequate regulatory compliance, billing and coding accuracy, and litigation when necessary. Our Florida health care law firm has successfully represented clients before the Centers for Medicare and Medicaid Services, the Florida Agency for Health Care Administration, and the Department of Justice on a variety of issues including Medicare and Medicaid suspensions, overpayment appeals, prepayment reviews and audits, and health care fraud investigations. When necessary, our Florida health care attorneys will take the fight to CMS and AHCA challenging the validity of the very rules upon which the agencies claim their power. An example of our firm’s previous success in rule challenges can be read here.

As home health agencies increasingly draw the eye of federal and state regulators and law enforcement authorities, it is critical that the home agency and its attorneys have a high level of familiarity with the laws and regulations governing home health agencies. The health care lawyers at FIDJ work with these laws and regulations on a daily basis and are frequently asked by health care clients for advice regarding how to comply. In many cases, our health care attorneys have been asked to litigate regarding these complex issues against the state and federal governments. Our Florida health care law firm has extensive experience litigating health care fraud cases.

Compliance is critical. With health care, tax, corporate, litigation, and white-collar criminal defense practice groups, FIDJ can provide comprehensive legal support for your home health agency.

For more information, please contact us at (305) 350-5690 or contact@fidjlaw.com.

Medicare Overpayment Appeals

FIDJ’s health care practice group has extensive experience in representing clients throughout the Medicare overpayment appeals process.

A Medicare overpayment is a payment which the Centers for Medicare & Medicaid Services (CMS) alleges that a Medicare supplier or provider has received in excess of amounts due and payable under the Medicare Act and its applicable regulation. Once CMS has identified an overpayment, the amount of overpayment is considered a debt owed by the provider/supplier to the federal government.

Identification of Overpayments

Provider and supplier overpayments are often identified through post-payment audits conducted by a Recovery Audit Contractor (RAC) as part of CMS’s Recovery Audit Program.

As described by CMS, “[t]he Recovery Audit Program’s mission is to identify and correct Medicare improper payments through efficient detection and collection of overpayments made on claims of health care services provided to Medicare beneficiaries. . . .” Overpayments may also be identified by Zone Program Integrity Contractors (ZPIC) audits.

Upon identification of an overpayment, the Medicare Administrative Contractor will commence the overpayment recovery process. The overpayment recovery process is typically commenced by the issuance of a notice of overpayment and initial demand letter for repayment by the MAC. If the contractor does not receive payment in full within 40 calendar days after the date of the first demand letter, the contractor will begin recoupment. During recoupment, CMS recovers the overpayment amount owed from current Medicare payments due, and future claims made by the provider until such time that the overpayment is recovered in full. All Medicare payment ceases until the overpayment is satisfied.

However, a provider or supplier may avoid recoupment if it acts quickly to assert its administrative appeals rights.

Appeal Rights for Providers

The Medicare and Social Security Acts set forth a system of administrative appeals, which a provider must use should it disagree with a coverage determination of the secretary. The Medicare overpayment appeals process consists of five stages that can be summarized as follows:

First, the contractor issues an initial determination as to payment, including, but not limited to, whether an individual is entitled to benefits and the amount of benefits available (42 U.S.C. § 1395ff(a); 42 C.F.R. §§ 405.920, 405.924). A provider who is dissatisfied with the initial determination may request that the contractor perform a redetermination within 120 days of receiving the notice of overpayment (42 U.S.C. § 1395ff(b); 42 C.F.R. § 405.940). The provider can prevent recoupment from occurring if the contractor receives a request for redetermination within 30 days of the notice of overpayment. However, it should be noted that although the recoupment process will begin, should a request for redetermination not be received within 30 days, Medicare will cease recoupment efforts at whatever point that a redetermination request is received, but Medicare may not refund any recoupment already taken until such time that a provider establishes that the alleged overpayment was incorrect.

During the redetermination stage, the contractor will conduct an independent review of the initial determination (42 C.F.R. § 405.948). After reviewing the evidence and findings upon which the initial determination was based, as well as any additional evidence submitted by the parties or that the contractor obtains on its own, the contractor renders a decision affirming or reversing, in whole or in part, the revised initial determination (42 C.F.R. §§ 405.948, 405.954). Should the contractor affirm the original overpayment determination, recoupment will commence on the 61st day following the redetermination decision. However, Medicare will again stop recoupment following an unfavorable or partially favorable, redetermination if a provider files for reconsideration (42 C.F.R. § 405.379).

A party to a redetermination who is dissatisfied may request reconsideration by a Qualified Independent Contractor (QIC) within 180 days of the redetermination. A reconsideration consists of an independent, on the record review of an initial determination, which includes the redetermination and all issues related to the payment of a claim (42 U.S.C. § 1395ff(c); 42 C.F.R. §§ 405.960; 405.968). Upon receipt of a timely and valid request for a reconsideration of an overpayment, the Medicare contractor shall cease recoupment of the overpayment. If recoupment has not yet commenced, the contractor is prohibited from initiating recoupment until the QIC has rendered a decision.

A party may appeal an adverse reconsideration to an Administrative Law Judge (ALJ), who holds an evidentiary hearing at which the provider may present testimony to support its claim (42 U.S.C. § 1395ff(b)(1); 42 C.F.R. §§ 405.1000, 405.1002). A party must file its request for administrative hearing, in writing, within 60 days of receipt of an unfavorable, or partially favorable, reconsideration. Medicare ALJ’s are within the Office of Medicare Hearings and Appeals, (OMHA), which is part of HHS, but is not a component of CMS. CMS or its contractors may, but are not required to, participate in the ALJ hearing. The ALJ considers “all the issues brought out in the initial determination, redetermination, or reconsideration,” according to 42 C.F.R. § 405.1032(a). The ALJ may consider a “new issue” if the issue “(i) could have material impact on the claim or claims that are the subject of the request for hearing; and (ii) is permissible under the rules governing reopening of determinations and decisions (42 C.F.R. §§ 405.980, 405.1032(b)).

Parties dissatisfied with an ALJ’s decision may request the Medicare Appeals Council (MAC) to review the ALJ’s decision, states 42 U.S.C. § 1935ff(d)(2); 42 C.F.R. § 405.1100. The MAC conducts a de novo review of the ALJ’s decision considering all the evidence of record and may adopt, modify, or reverse the ALJ’s decision or remand the case to an ALJ for further proceedings (42 C.F.R. §§ 405.1100-405.1128). The decision of the MAC constitutes the final decision of the secretary, according to 42 C.F.R. § 405.1130. Finally, a party dissatisfied with the secretary’s final decision may seek judicial review by commencing a civil action in federal district court (42 U.S.C. §§ 405(g), 1395ff(b)(1)(A); 42 C.F.R. §§ 405.1130, 405.1136).

For more information, please contact us at (305) 350-5690 or contact@fidjlaw.com.

Government Agency Litigation

While some firms pride themselves for maintaining friendly and amicable relationships with federal regulators, FIDJ has distinguished itself for its willingness to take the government to court as necessary to pursue its clients’ best interests. Indeed, sometimes litigation is unavoidable, and in those case the firm has litigated against a variety of government agencies, including IRS, FDA, FTC, USDA, DOJ and a number of state governments. The firm seeks to avoid litigation whenever possible, but if a government agency is regulating beyond its delegated authority or refusing to negotiate in good faith, the firm is ready, willing and able to pursue its clients’ interests in court.

Litigating against the government requires experience and a breadth of knowledge across a wide range of applicable law.

First, in any regulatory matter, and especially those where a client’s business practices may be exposed to the bright lights of a courtroom, counsel must carry a sophisticated understanding of its client’s business, including applicable statutes, regulations, guidance documents, and industrywide best practices. We pride ourselves for taking the time to understand how each of our clients operate and how they are regulated. Second, in any matter involving complex litigation, counsel must be familiar with state and federal rules of civil procedure, as well as the local rules governing litigation in individual courts, and our decades of litigation experience gives us that knowledge. Third, many complex disputes against the government carry overtones of criminal liability, and we have extensive experience representing clients in grand jury investigations and white collar criminal prosecutions which allows us to recognize when a regulatory dispute has turned criminal. Fourth, litigating against the government requires a deep understanding of the varieties of deference courts are required to give to regulatory agencies, which may vary depending upon the precise nature of the dispute and the manner by which the agency has chosen to regulate in any given industry. Finally, counsel must understand the limited subject matter jurisdiction afforded to federal district courts, as well as the limited jurisdiction often afforded to federal agencies by Congress. We routinely address these issues in our practice, and are well situated to argue them in court when litigation is our client’s only option.

FIDJ is highly experienced in litigating against the government in a variety of forums, and we pursue each case with the singular goal of maximizing the rights of our clients. To contact one of our experienced government agency litigation attorneys, contact us at (305) 350-5690 or contact@fidjlaw.com for a free consultation