Health law is the federal, state, and local law, rules, regulations and other jurisprudence among providers, payers and vendors to the healthcare industry and its patient and delivery of health care services; all with an emphasis on operations, regulatory and transactional legal issues.
Genetic tests are valuable because they can provide important information to patients and their medical providers regarding diagnoses, treatment, and disease prevention. However, the rapid growth in the number of tests ordered, especially in light of the telemedicine expansion during the pandemic, has invited well-earned scrutiny to the industry.
Make no mistake: genetic testing is heavily regulated (and enforced). The Federal Anti-Kickback Statute, Eliminating Kickbacks in Recovery Act, and Commercial Insurance Fraud Law have all been used to prosecute unscrupulous marketers, call centers, and telemedicine providers in the last few months. Kickbacks in exchange for genetic specimens are just as illegal as kickbacks for patients. Three months ago, a Florida man was sentenced to 10 years in prison for conspiracy to commit health care fraud. His actions resulted in the submission of approximately $3.3 million in fraudulent claims to Medicare for genetic testing. read more
Wanna know how often we’re asked whether the laws re healthcare marketing are really enforced? How often we hear “Everyone is doing it.” “Surely they [regulators] understand that every healthcare business has to market its services and item,” we’re told. And when we start to educate people re the state and federal laws that pertain to marketing healthcare items and services (INCLUDING those for which payment isn’t made by a state or federal healthcare program), their impatience and intolerance is palpable.
Take a look at the latest report from the Department of Justice guilty plea from someone who marketed the services of a genetic testing lab. He admitted being guilty of receiving over $300K in kickback money (presumably in the form of marketing fees) and now faces (1) a $250K fine, (2) returning all the money he received, and (3) five years in prison!
Marketing any healthcare service or item is at the tip of the sword in terms of regulatory investigation and enforcement. It’s that simple. And so when your lawyers drag you through laws like the Anti-Kickback Statute, the Florida Patient Brokering Act, the federal health insurance fraud law, the bona fide employee exception, the personal services arrangement and management contract safe harbor and EKRA, thank them! And expect nothing less. If you do ANYTHING at all in the neighborhood of marketing a healthcare item or services, the first place to start is: meet with a very experienced healthcare lawyer who is not learning on your dime. And have them take a couple hours to educate you about the laws, the options and the risks of each one. And once you’ve done that, ask them what more you can do to reduce your risk, for instance— read more
Since the beginning of the COVID pandemic many healthcare businesses are exploring various ways to increase their referrals, and although exchanging fees and gifts in return for referrals may sound like an easy way to obtain additional business, there are state and federal laws that strictly prohibit such activities that are discussed in greater detail below.
Two of the most important laws that all physical therapists should be aware of are the Anti-Kickback Statute and the Stark Law which are used to ensure that medical decisions are not made based on financial incentives. However, each of the laws do have distinctions that you need to be aware of. read more
As the country reopens in light of COVID-19 many patients are beginning to feel safe to return to practices for services. In an effort to generate additional business to make up for lost revenue many practices have turned to internet-based marketing programs, such as Groupon to help attract new patients. Such sites provide a platform for discounted services, in exchange for a fee to refer patients to those businesses. While every state and business is different, chiropractors need to be aware of the implications of working with such sites while accepting federal health care insurance reimbursements, and the marketing requirements that still must be adhered to that often go overlooked.
When a discount is offered, Groupon customers (in this case, chiropractic patients) pay fees directly to Groupon. The chiropractor is then paid a percentage of the fees collected. Such marketing might affect Federal laws, for patients covered by federal insurance programs. The federal anti-kickback statute (AKS) prohibits any person from knowingly and willfully offering or paying cash to any person to induce the person to refer a patient for services for which payment may be made under a federal healthcare program. While some safe harbors exist, none specifically fit in a case like this. read more
As an Acupuncturist in a private, solo-practice or group practice, proper start-up is key. Understanding how to set up your business properly with the State and IRS, developing a business plan, and understanding all requirements will help eliminate obstacles that will slow your growth.
When working with new acupuncture businesses, consider the following:
1. Corporate Structure
a. A company is considered a legal entity and recognized by both the IRS and the State. Depending on the number of owners and type of business, different options exist regarding entity type. Specifically, most healthcare professionals choose a limited liability company, corporation or a professional association. Once you choose the appropriate type of entity, you’ll want to meet with your CPA to discuss taxation of the entity and how that affects the owners personally.
2. Obtaining an EIN/TID
a. Before you can open a business bank account, or even do business in your city, you will need to obtain an Employer Identification Number or Tax ID for your business. Properly applying will save you time down the road with IRS tax issues.
In a recent article, I touched on some of the reasons to consider trademark registration and what is required. Many people hear trademarks and might think only of the Federal registration through the United States Patent and Trademark Office (USPTO). Florida, however, also offers state level registration for marks that likely won’t qualify at the Federal level.
Trademark registration grants an intellectual property rights that help its owner protect a brand’s mark, logo, name or any other way that it conveys intangible property.
Trademark protection is available under both Federal and State law. Federal trademark protection allows the brand owner to protect their trademark in interstate commerce, while Florida registration allows trademark protection for marks only in the state of Florida. Florida law does share a lot of the same concepts and requirements of the Federal trademark requirements, however is limited only to protection in the State of Florida. Florida trademarks are less expensive and easier to obtain than Federal trademarks, but are superseded by a Federal trademark registration. read more
Investing in a healthcare related business involves significant time and money. Building a brand takes even more and is extremely important in today’s society. Having the ability to build a recognizable brand, scale, and potentially sell, is the goal of many healthcare business entrepreneurs. With the ever-booming impact of social media, online advertising, and online reviews, healthcare businesses seek to engage at a higher degree than ever before to attract new patients, retain current patients, and establish themselves as experts in their respective fields.
Building a brand is part of it, while protecting that brand is far more important. A well-recognized word or logo can be worth everything to your business. Obtaining ownership and protection over a name or mark is a fairly simply task with significant rewards. Trademarks are the names, slogans, tag lines, and/or logos that identify and represent your business, its services, and mission to the public, and are the foundation for the business’s overall branding and marketing. Trademarks can also be used to protect your business in a specific area or a specific area of expertise. If you do not protect your brand, a competitor could use it (or something similar, which could confuse the public and your patients and therefore potentially draw business away from your brand. read more
This section is a contract between you and the users of your website regarding what they can expect from the website and how they will act while on the website. You can use this section to protect you and your business from a variety of potential disasters including (but not limited to): limitless liability and intellectual property infringement.
You can use this section to limit any liability that you might create by having a website. For instance, if you give some medical advice (i.e., “Lowering your cholesterol reduces your risk for a heart attack.”), you can use your Terms and Conditions to limit a user’s reliance on that advice without additional medical intervention (“We are not your treating physician—if you have questions about your cholesterol levels, contact your physician.”).
You can also use this section to inform your users about any intellectual property protections that you might have. If your technology or services have pending or protected status, you’ll need to make your users aware of this information.
Finally, this section should establish the laws under which your website agrees to be governed. Even if the internet knows no boundaries, your website should establish its own. If your business is located in Florida, you can choose to be bound by Florida and Federal laws. It could limit any potential exposure in other states or nations.
The Children’s Online Privacy Protection Act (COPPA) protects minors under the age of 13 from having personal information collected without parental consent. How can a website operator be expected to know whether a user is 13 or under? If you plan on collecting any information from your uses, your Terms and Conditions should have a section prohibiting anyone under age 13 from accessing and using your site. It’s a simple fix that can potentially save you huge penalties.