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.
Almost two years after “Operation Brace Yourself” regarding purported telemedicine and orthotic bracing fraud made national headlines, on February 4, 2021 the Department of Justice Announced that a major player in that fraud – Florida businesswoman Kelly Wolfe – recently pled guilty to criminal health care and tax fraud charges.
Operation Brace Yourself was a 2019 crackdown on the illegal use of telemarketing and telemedicine to generate fraudulent claims for DME orders, whose reach spanned continents and ultimate implications defrauded taxpayers out of billions of dollars.
According to the Department of Justice Press Release and Settlement Agreement, Mr. Wolfe was seemingly a significant mastermind in establishing hundreds of DME companies that went on to defraud US taxpayers and Medicare beneficiaries.
Here are some highlights of the recently signed Settlement Agreement between the United States DOJ, Kelly Wolfe and her company Regency, Inc. 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
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.
COVID-19 has affected all aspects of everyday life and healthcare rules and regulations are no exception. All areas of healthcare have been impacted, including the patient’s financial responsibility for healthcare services in the form of co-insurance, copays and deductibles. The waiver of a patient’s financial responsibility for healthcare services is regulated by federal and state law. The waiver of co-pays, co-insurance and deductibles has been deemed a violation of the federal Anti-Kickback statue. A provider who routinely waives the patient’s financial obligation may be violating the participating provider agreement with commercial carriers, state law and federal law with respect to Medicare beneficiaries. Waiving patient fees is seen as an inducement to the patient to prefer one provider over another for financial reasons. However, The Centers for Medicare and Medicaid Services (CMS) and commercial carriers have been authorized by the federal government to waive patient financial responsibility during the pandemic in order to encourage the public to get treated for COVID-19 and non-COVID medical conditions without fear of a hefty bill.
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
Out of network physician owned specialty hospitals are unique in that there are less stringent legal requirements on the facility, but patient care obligations remain the same. This means that patient care must be prioritized over profits and all actions taken by the hospital and any physician investor must showcase that order of priority.
Given the amount of scrutiny placed in physician owned specialty hospitals in the past two decades, these facilities are well served to identify and implement a process to remedy compliance concerns. Even when a facility does not submit claims to any Federal health insurance provider and is out of network with all commercial insurance companies, it is still required to follow the laws of the state where it is located.
The best plan for surviving scrutiny in such situations is to have a plan. Proactively seek out applicable laws and regulations, and determine how your hospital will abide by them. Compliance can be tailored to fit your facility.
Overutilization and Self-Referrals
A physician who shares ownership in a hospital may have a financial incentive to refer patients for services if he or she receives a percentage of the revenue generated. Laws including the Federal Stark Law and Anti-Kickback Statute were promulgated to combat unnecessary referrals. A 2003 study by the Department of Health and Human Services concluded that physician-investor referrals to hospitals in which they have an investment interest are similar to those physicians without investment interests. Nevertheless, the fear of overutilization and unnecessary self referral remains at the forefront of the regulators’ minds at both the State and Federal level. read more
The Florida Healthcare Law Firm is hosting a free webinar for physicians on appropriate third party relationships. With shrinking reimbursement rates, physicians are increasingly turning to alternative methods and innovative physician relationships to increase revenue. However, not every opportunity is compliant with Federal and State kickback laws, which are designed to prevent overutilization of services.
This course aims to help attendees recognize and advise physicians about relationships designed to compensate for more than just patient care, including, but not limited to:
It will use recent trends in the market to reinforce its objectives. This free webinar is for physicians and healthcare providers full of valuable information.All you have to do is register here, put it on your calendar and then click on the link emailed to you on March 25th!
Physician relationships of any kind should be approached carefully by a highly qualified healthcare attorney. Nearly every aspect of healthcare is governed by a complex array of regulations and remaining compliant when drafting a contractual relationship of any kind is no easy task.
HHS found that a home health agency incorrectly billed Medicare and did not comply with Medicare Billing requirements for beneficiaries that were not homebound and for others that did not require skilled services at all.
In August and September 2018, physicians and the owner of a home health agency were each sentenced on multiple counts of conspiracy and healthcare fraud and ordered to pay $6.5 million in restitution. One physician was sentenced to 132 months in prison following trial. A physician who pled guilty was sentenced to 27 months in prison following a guilty plea. The home health agency owner was sentenced to 42 months in prison. The defendants paid and received kickbacks in exchange for patients and billed Medicare more than $8.9 million for services that were medically unnecessary, never provided, and/or not otherwise reimbursable. Additionally, certain defendants provided prescriptions for opioid medications to induce patient participation in the scheme.
In September 2018, the co-owner and administrator of a home health agency was sentenced to 24 months in prison, ordered to pay over $2.2 million in restitution, and ordered to forfeit over $1.1 million. The co-owners participated in a home healthcare fraud conspiracy that resulted in Medicare paying at least $2.2 million on false and fraudulent claims. The owners and their co-conspirators paid kickbacks to doctors and patient recruiters in exchange for patient referrals, billed Medicare for services that were medically unnecessary, and caused patient files to be falsified to justify the fraudulent billing.
Back in February 2018, the owner of more than twenty home health agencies was sentenced to 240 months in prison and ordered to pay $66.4 million in restitution, jointly and severally with his co-defendants, after pleading guilty to one count of conspiracy to commit health care fraud and wire fraud. A patient recruiter for the home health agencies, who also owned a medical clinic and two home health agencies of her own, was sentenced to 180 months in prison. Another patient recruiter, who also was the owner of two home health agencies, was sentenced to 115 months in prison. These conspirators paid illegal bribes and kickbacks to patient recruiters in return for the referral of Medicare beneficiaries many of whom did not need or qualify for home health services. Medicare paid approximately $66 million on those claims.
Illegal kickbacks in exchange for referrals of Medicare beneficiaries, lack of medical necessity for home health services, failing to meet the guidelines, fraudulent billing, billing for services beneficiaries did not receive and fraudulent documentation continues to plague the home healthcare industry.
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