In my last couple of articles, I’ve focused on the controls necessary to safely operate a pharmacy and dispense appropriate prescribed medications, including controlled substances. And those of you who heed that kind of advice are likely to avoid the unwanted attention of law enforcement. However, for those who continue to think they can operate with impunity, heads’ up: the war against opioids in the U.S. is ongoing and enforcement activities are not slowing down. Below is an article about this recent case out of Texas and some lessons we can all take away from what was reported.
In this most recent case, a federal jury in Texas convicted a Texas pharmacy owner (Carr) on March 7 of one count of conspiracy to unlawfully distribute and dispense controlled substances, four counts of unlawfully distributing and dispensing controlled substances, one count of conspiracy to launder money, and two counts of engaging in transactions in property obtained from the illicit activity. Carr now faces up to 140 years in prison, among other consequences.
Developing a Personal Caregiver Handbook that spells out expectations and accountabilities of both the resident hiring the caregiver as well as the caregiver is one of the best defenses to issues of liability that may arise. But where do you start in building out the Handbook? Here are some key considerations as well as areas that should be covered in the Handbook:
Prior to Developing Handbook
Because the CCC’s relationship with its residents is governed by each resident’s agreement and any move-in documents that accompanied that agreement, it is important first to review those documents to determine if there are any barriers to implementation. Because each resident contract might be different, this process might require review of all versions in effect for any current residents.
Assuming the resident contracts do not require any additional steps before rolling out such a program, the CCC can move to the drafting of the Personal Caregiver Handbook.
Providing a high-quality and safe environment and care for vulnerable seniors is a top priority for continuing care communities (CCCs). Senior communities that provide a full continuum for seniors aging in place (including independent living, assisted living, skilled nursing, and memory care) often focus their safety concerns and resources on the licensed areas of the community, where falls and skin breakdown are the subject of lawsuits. Sometimes overlooked are the risks that arise when independent living residents bring their own personal caregivers into the community to support their needs.
Growing Use of Personal Caregivers
More and more seniors are finding safety and security in CCCs throughout the country. And, as they age in place, maintaining that independence often involves the use of personal caregivers who come into the CCCs and create additional risks. Each time a personal caregiver is allowed admittance to the CCC, real risk is created- and that risk can lead to legal liability, including:
Injury to other residents
Injury to the resident that hired the caregiver
Injury to the caregiver caused by other residents
Slip, trip and fall (or other general liability claims) by the caregiver against the CCC
Theft/damage to property
But there are a few basic steps that a CCC can do to reduce those risks, while still allowing residents their independence. Here are some simple considerations:
The U.S. Attorney arrested 13 people in a $100 Million healthcare fraud scheme in NY and NJ involving automobile insurance claims. Some of the facts alleged include—
Bribed 911 operators and hospital employees for confidential information of insured drivers
Unnecessary and painful medical procedures
A non-physician owning medical clinics
Paying hundreds of thousand of dollars to “runners” who used the money to bribe people
Healthcare businesses that largely serve people injured in motor vehicle accidents remain a top tier focus for law enforcement and special investigative units (SIUs) of insurers. But so do many other providers in the healthcare sector, such as pharmacies, durable medical equipment (DME) providers, addiction treatment providers and labs. Payer and governmental presumption is often that financial motives are driving clinical behavior, NOT documented medical necessity. Hence the need for active compliance plans and policies and procedures that don’t sit on a shelf, but rather are woven into daily business and clinical operations. Nothing less than the right contracts, the right compliance plan and the right business culture will establish and maintain a sustainable healthcare business!
Telemedicine pharmacy arrangements continue to be of significant interest to fraud enforcement. A 2018 case in which four individuals and seven companies were indicted ended in a month-long jury trial of one of the individuals, a Florida pharmacy owner. The federal jury trial in the billion-dollar telehealth pharmacy fraud scheme resulted in conviction on 22 counts of mail fraud, conspiracy to commit health care fraud and introduction of misbranded drugs into interstate commerce. Sentencing in the case is set for May of 2022. Other co-conspirators entered plea agreements along the way, pleading guilty to various charges including felony conspiracy to commit health care fraud, felony misbranding, conspiracy to commit wire fraud, and fraudulent telemarketing of dietary supplements, skin creams and testosterone. Many of these are still awaiting sentencing, also expected to be scheduled sometime in 2022.
The scheme involved several individuals, compounding pharmacies and telemarketers engaged in a conspiracy to commit health care fraud, mail fraud and introducing misbranded drugs into interstate commerce. Peter Bolos, along with two other co-conspirators, owned and operated Synergy Pharmacy in Palm Harbor, Florida. Working with HealthRight, a telemarketer, the co-conspirators generated prescriptions for drugs such as pain creams, scar creams, and vitamins. Using the HealthRight telemarketing platform, they would call consumers and deceive them into providing their personal insurance information and accept the drugs. HealthRight then communicated the prescription requests to physicians who authorized the prescriptions without ever interacting with the patients, and paid those physicians for issuance of the prescriptions. Through this scheme, the co-conspirators were able to solicitate insurance coverage information from consumers across the county for prescription pain creams, fraudulently obtain prescriptions, mark up the prices of the drugs and bill private insurance carriers.
Enforcement against medical device companies is not new and yet, these companies continue to engage in schemes that land them in hot water. Frequently the same schemes are repeated over and over- some form of payment by the device company to a physician who selects/recommends the device to patients. In some cases, the payment is in the form of an honorarium for speaking engagements. In others, the payment is an all-expense paid travel to attend device company-sponsored “CME” in exotic locations or consulting fees for assisting in the evaluation and design of the device.
Announced yesterday by the U.S. Department of Justice (DOJ), is the settlement of allegations against Florida-based Arthrex Inc., a medical device company that specializes in orthopedic products. Under the settlement agreement, Arthrex will pay $16 million for allegedly paying kickbacks to an orthopedic surgeon (Dr. Peter Millett) in Colorado. The “payment” in this case was structured as royalty payments purportedly to compensate the orthopedic surgeon for his “contributions” to the development of two of Arthrex’s products when in fact the “payment” was intended to induce the surgeon’s recommendation/selection of the Arthrex products. By offering the payments to the surgeon with the intent to induce purchase of Arthrex’ products which were then billed to Medicare, Arthrex violated the Anti-Kickback Statute (AKS) as well as the False Claims Act.
The field of regenerative medicine is ever expanding and evolving. As more viable options become available to patients, it’s important to stay abreast of regulation surrounding many of these applications.
In late 2019, the Food and Drug Administration (FDA) began informing the public of multiple reports of serious adverse events experienced by patients who were “treated” with non-FDA approved products marketed as containing exosomes. As a general matter, exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products under the Public Health Service Act and the Federal Food Drug and Cosmetic Act and are subject to premarket review and approval requirements. At the time of the 2019 warning, there were no FDA-approved exosome products and the FDA since then has not put out any new guidance.
There has been a lot of confusion lately as to whether Paramedics can administer IVs at doctors’ offices, clinics or MedSpas. While these professionals are trained to administer IVs during emergency transport, they are not allowed to administer IVs in most other situations.
The statutes and rules pertaining to paramedics and scope of practice fall under Chapter 401, Medical Telecommunications and Transportation, Florida Statutes, and Chapter 64J-1, Emergency Medical Services, Florida Administrative Code.
Based on definitions and the text of the statutes and rules, although a paramedic is trained to administer IVs, they can only do so during the course of emergency services and transportation and at public health care programs. Further, a paramedic’s services must be rendered under a medical director’s supervision, as the term medical director is defined under Section 401.23, Florida Statues. Under this statute, a medical director “is a physician employed or contracted by a “licensee” and who provides medical supervision, including appropriate quality assurance but not including administrative and managerial functions, for daily operations and training pursuant to this part.” Section 401.23(15). Pursuant to statutes, a “licensee” means any basic life support service, advanced life support service, or air ambulance service licensed pursuant to this part.” Section 401.023(13).
Hormone replacement therapy (HRT) and other similar “body hacking” treatments have expanded significantly over the years. With more and more people choosing alternative treatments to common ailments, these practices have experienced explosive growth in response to the demand. But what does it take to open one of these businesses and how risky can it be?
Understanding the Regulations
Healthcare businesses, especially in Florida, are heavily regulated. Even as a typically cash-only business, owners must stay aware of the ever-changing regulations. First, Florida and Federal anti-kickback laws affect cash-only businesses in regard to patient referrals. They also apply to laboratory referrals. Florida law has additional regulations against physician ownership in certain entities. In this case, ownership in an HRT business and a lab or pharmacy that you refer to could put you in violation of a number of Florida and Federal laws. While many HRT businesses offer other treatments that are not just hormones, the big draw is hormones, which are considered controlled substances. Prescribing controlled substances requires certain patient evaluation standards, prescribing standards, and pharmacy standards.
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 businesses choose a limited liability company, corporation or a professional association, depending on the type of owner. 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. Equally as important as choosing the right entity is ensuring that all corporate documents are appropriately buttoned up and protecting the owners.
As a business owner, you’ll need additional business, state, county, and city government licensure to do business. Florida has many counties, each with different rules. You may need local tax licenses depending upon your offerings and services as well. In addition to business licenses, you will need to either maintain a Florida medical license or contract a physician to treat patients.
Starting a successful practice begins months before with business planning. Develop a business plan for financing purposes, gather information regarding day-to-day operations, explore different financing options, develop a practice culture, assess bringing on any partners, and other practice considerations. You will also want to ensure that all of your patient and staffing policies are well thought out and comprehensive.
Trademarks and Branding
People recognize businesses by their logos, name, service, or specialists. Protecting your brand is just as important as building your business. Utilizing Federal or State trademark protections is just one method of building and creating your brand. This is at least a six (6) month process, so the earlier you evaluate your intellectual property, the better.
Once you’ve built the foundations of your new practice, protecting its assets should be high on your priority list.
In a high-earning business, you want to take all the necessary steps to ensure your business looks like and functions as an entity separate from yourself individually. With partners, the right agreements and actions will ensure that the company is treated as a legitimate entity.
While these are some of the biggest considerations, there are many more to opening and operating a successful HRT business.
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.