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.
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
On October 6, 2020, the Unites States Attorney’s Office of the Western District of Louisiana announced that George M “Trey” Fluitt III of Monroe, Louisiana was indicted. The federal grand jury indicted the lab owner for paying bribes and kickbacks in violation of the Anti-Kickback Statute, resulting in improper Medicare billing of approximately $117 million. Fluitt was the owner and operator of Specialty Drug Testing, LLC and is alleged to have solicited paid kickbacks and bribes in return for patient DNA specimens and physicians’ orders for cancer genetic and pharmacogenetic testing. Medicare allegedly paid Specialty Drug Testing, LLC $28,726,299 as a result of the fraudulent claims. If convicted, the defendant faces up to five years in prison for each count of conspiracy to defraud a healthcare program. Fluitt also faces 10 years in prison for illegal kickbacks, a $250,00 fine, forfeiture and restitution.
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
Has your attorney ever told you to do your best to comply with certain safe harbors to the Federal Anti-Kickback Statute, and you’ll be likely to survive scrutiny under the Florida Patient Brokering Act (the PBA)? If you’ve heard that, it’s time to re-examine that relationship. In the last month, the Patient Brokering Act has been amended, and then interpreted by a court of law in a way that affects all healthcare providers.
The Patient Brokering Act has been used in recent years to prosecute abuses in the addiction treatment industry. Other healthcare providers subject to the act have largely been uninvolved in these prosecutions. However, the PBA has been remolded 4 times in the past 5 years as a means to tailor it to allow for prosecutions of bad actors in healthcare, including addiction treatment. One item should be made clear: the PBA applies to any facility at all that is licensed by the Agency for Healthcare Administration (AHCA) or practitioner licensed by the Department of Health (DOH), including physicians, surgery centers, home health agencies, skilled nursing facilities, hospitals, DME providers, diagnostic imaging facilities, clinical laboratories, pharmacies and many other. During the legislative process, barely any healthcare industry representatives (from any provider group) showed up to any legislative workshops or produced counterbalancing input or language proposals that reflected a broader perspective. read more
Over the past several months, the Centers for Medicare & Medicaid Services (CMS) has taken a number of steps that show an awareness of the regulatory burden placed upon participants in the government’s health care programs, and even some willingness to consider reducing those burdens. While it remains to be seen whether the recent proposals will have measurable results, the following actions can still be viewed with guarded optimism.
Proposed Changes to Medicare
In July, 2018, CMS proposed significant changes to Medicare, to be included in rules that take effect in 2019. These changes cover physician fee schedules, streamlining Evaluation & Management (E&M) billing, advancing “virtual care,” decreasing drug costs, revising the MIPS program and establishing the MAQI demonstration project. The agency also asked for comments on price transparency issues. read more
Healthcare marketing arrangements that violate the Anti-Kickback Statute (AKS) can lead to serious financial and criminal consequences. Understanding the types of marketing arrangements that courts have found to be in violation of the statute and the potential implications are critical for marketers to know in order to operate in the healthcare industry.
Under the AKS, it is a criminal offense to knowingly and willfully offer, pay, solicit, or receive any remuneration to induce referrals of items or services reimbursable by the Federal health care programs. Where remuneration is paid purposefully to induce referrals of items or services paid for by a Federal health care program, the AKS is violated. By its terms, the AKS ascribes criminal liability to parties on both sides of an impermissible transaction. An example of a highly scrutinized arrangement involves percentage compensation. For regulators, percentage compensation arrangements provide financial incentives that may encourage overutilization and increase program costs.
One healthcare employer’s compensation arrangement with its employees just got much needed support from the 11th Circuit Court of Appeals. The employer there, which provided AIDS patients certain healthcare related services, paid its employees a bonus of $100 per patient. The case was brought on the argument that the compensation arrangement constituted an illegal kickback under the federal Anti- Kickback Statute. The court, however, disagreed because the employees who received the bonuses were “bona fide employees.”
The court’s focus on the plain language of the safe harbor for bona fide employees was refreshingly clear, notably that “any amount paid by an employer to an employee (who has a bona fide employment relationship with such an employer) for employment in the furnishing or any item or service.” Essentially, any amount paid by an employer to a bona fide employee is not considered to be “remuneration” under the Anti-Kickback Statute. read more
A recent ruling by a state trial court handling the Palm Beach County Sober Home Task Force prosecutions against providers of addiction treatment and sober home services is creating lots of confusion and alarm around the state and could have very far reaching consequences for the entire healthcare industry well beyond addiction treatment.
The issue presented by the prosecution focuses on whether a person charged with violating the state’s Patient Brokering Act (PBA) can be found guilty even if he/she didn’t know what he was doing was unlawful. The PBA broadly prohibits paying someone for patient referrals, very much like the federal Anti-Kickback statute. If allowed, the client would have gotten legal advice, paid for it, followed it, and still not be able to show a judge or jury that, despite all their best efforts, they simply followed the law as instructed.
Can a healthcare facility or provider be guilty of violating a criminal law [the PBA] if they’d gotten legal advice and followed it? Traditionally, the answer would be a clear “no.” The argument against the State’s position would be something like “How can someone intend to violate a criminal law if they got legal advice regarding how to comply with it and then followed that advice?” The argument of the state might look something like “We don’t even think the judge or jury ought to be able to hear that the person got legal advice and followed it.” The court punted the issue to the appellate court. read more
Florida’s Agency for Health Care Administration (“AHCA”) is the state’s chief health policy and planning organization. AHCA is also responsible for the state’s Medicaid program. One of the agency’s latest targets are behavioral analysis providers who treat children with autism. Recently, AHCA imposed a temporary six-month moratorium on enrollment of new providers due to newly discovered fraud and abuse. AHCA states that the temporary moratorium will allow the agency the time to complete a full assessment of the current provider population. In other words, all behavioral analysis providers will experience heightened scrutiny in the coming months if not already. This can include in-person interviews and requests for records. Given this increased regulatory action, it is important for behavioral analysis business owners to be aware of the audit process and to prepare for likely future reviews.
Here are a few of the notable findings cited by AHCA regarding the identified fraud and abuse: read more