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.
CMS has rolled out a telehealth/telemedicine tool kit to assist medical professionals with health care delivery during the current COVID-19 public health emergency.
The toolkit contains information and links concerning:
1135 Waivers – allows the Secretary of HHS to temporarily waive or modify certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements to ensure sufficient health care services and items are available to meet the needs of individuals enrolled in Social Security Act programs during the emergency and that providers who provide services in good faith can be reimbursed and exempted from sanctions (provided there is no determination of fraud and abuse). 1135 waiver or modifications include:
Conditions of participation and other certification requirements;
Program participation and similar requirements;
State licensing requirements where services are rendered as long as the provider has equivalent licensing in another State (for Medicare, Medicaid, CHIP reimbursement only; State licensing still controls whether a non-Federal provider may provide services in a state he/she is not licensed in);
EMTALA sanctions for redirection for medical screening, as long as redirection is not the result of discrimination on the basis of a patient’s source of payment or ability to pay;
Stark self-referral sanctions;
Adjustment (not waiver) to performance deadlines and timetables;
Limitations on payment to permit Medicare enrollees to use out of network providers in an emergency situation.
Those in the practice of dentistry today have many options when it comes to building a practice. Should you work for an employer? Build your own? What about buy a practice? More and more, we see young dentists wishing to avoid private equity and buying out a retiring dentist’s practice. The amount of regulation imposed upon those entering into the dental practice arena can be staggering. Further, buying a dental practice requires many considerations that are unique to other areas of business. Understanding the purchase process will help protect your investment and could keep you from experiencing any unnecessary liability.
First, organize a team of specialized dental experts, such as a dental CPA, Professional Practice Lender, dental law attorney, and a practice consultant. Having a team of professionals guide you through all aspects of the deal will keep you on track, avoid potential issues, accomplish specific task items, and properly comply with any legal considerations. read more
On February 4, 2020, the Department of Justice announced a $1.5 million settlement with Southeastern Retina Associates, a 17 physician practice, with offices in Tennessee, Georgia and Virginia. The sole basis of the claim was the alleged misuse of the Modifier 25 billing code and charging for exams at higher levels than warranted. The claim was initiated by a whistleblower, who will receive $270,000 from the settlement.
Use and potential abuse of Modifier 25 is obviously not unique to retina surgeons. In fact, the modifier can be very beneficial to providers, since it allows for payment for those patient visits when the care provided exceeds the scope of the scheduled appointment. However, given the potential for abuse and the many watchful eyes of the government (the Southeastern Retina case was investigated by the U.S. Attorney’s Office, the HHS Office of Inspector General, the U.S. Office of Personnel Management, the FBI, and the Tennessee Attorney General’s Office) and wannabe whistleblowers, a periodic review of a provider’s billing practices is always a good idea. read more
With phenomenal growth and expansion in the Hemp Industry comes trials, tribulations, the FDA, and consumer complaints! Let’s take a look at what’s going on that might have an adverse impact on your burgeoning business or foray into Hemp a/k/a CBD.
The FDA sent letters to 15 CBD business companies in late November 2019, warning and admonishing these companies that their CBD products were being promoted to treat disease or for having certain therapeutic properties. Specifically, the FDA reviewed these companies’ websites, social media pages, marketing material, etc., finding that the companies promoted products containing cannabidiol or CBD in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Further, the FDA stated that the companies’ CBD products are unapproved new drugs sold in violation of the FD&C Act, and were misbranded under the FD&C Act. The FDA letters did not just target products sold for human use and consumption, but also targeted CBD products sold for use on pets, stating that “the products are unapproved new animal drugs that are unsafe under the FD&C Act and adulterated products under the FD&C Act. 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.
I am a successful physician who works for a thriving practice that is affiliated with a local hospital or Ambulatory Surgical Center (“ASC”). The hospital/ASC was so impressed with my professionalism and skills that they retained me to perform certain additional duties and services for them. Of course, they are paying me for my time and services. This is great, I love my work, I am generating two sources of respectable income – all is good.
Not so fast!
As can sometimes be the case, all is good while there is smooth sailing and while the money is coming in. However, once there is a bump in the road, a hiccup in a procedure, or a third party employee files a complaint with the Equal Employment Opportunity Commission (“EEOC”); the Florida Commission on Human Relations (“FCHR”); Department of Labor (“DOL”) or any federal or state agency complaining about some alleged incident in their workplace. Their filing of a lawsuit can be against you individually, against your practice or against the hospital/ASC. Not to mention, a lawsuit can be filed by a patient or third party against the practice or the hospital/ASC. Then what? read more
A Final Rule recently issued by CMS will require Medicare, Medicaid, and CHIP (Children’s Health Insurance Program) providers and suppliers to disclose current and previous affiliations (direct or indirect) with a provider or supplier that: (1) has uncollected debt; (2) has been or is excluded by the OIG (Office of Inspector General) from Medicare, Medicaid or CHIP, or (3) has had its billing privileges with either of these three programs denied or revoked. Such provider affiliations may lead to enrollment being denied if it poses a risk to fraud, waste or abuse. read more
In Florida, a licensed physician can provide supervision of healthcare providers that are not physicians under certain circumstances. Understanding who a physician can cover and under what circumstances can help protect your license and avoid receiving a complaint by the Florida Department of Health.
In every case, when a physician agrees to supervise another provider, Florida law requires certain documentation and notice to be filed. read more
Employers are approaching us in increasing numbers regarding their obligations toward employees battling substance abuse. Two federal laws primarily govern the space, the Americans with Disabilities Act and the Family and Medical Leave Act. Note that state laws may be more restrictive, so we encourage our clients to reach out to local attorneys to determine if additional legal protections are available to employees in their state.
The Americans with Disabilities Act (ADA) covers businesses with 15 or more employees to protects workers from discrimination based on a qualifying disability or a perceived disability, which is defined to include alcoholism and illegal drug use. However, to be eligible, the ADA protects only workers who either (i) have successfully been rehabilitated and are no longer using illegal drugs or misusing alcohol; or (ii) are currently participating in a rehabilitation program and are no longer using illegal drugs or misusing alcohol. Importantly, the ADA does not protect any employee who is presently battling alcoholism and illegal drug use and is not participating in a treatment program. An employee in the throes of substance abuse who is not actively seeking treatment is not protected by the ADA. read more
In a decision expected to cause waves through the rapidly-expanding regenerative medicine industry, a U.S. District Court Judge ruled on June 3rd that the U.S. Food and Drug Administration (FDA) is entitled to an injunction in a lawsuit filed against U.S. Stem Cell Clinic, LLC (US Stem Cell) based in Sunrise, Florida. In her decision, U.S. District Court Judge Ursula Ungaro agreed that the FDA has the authority to regulate the popular stem cell procedure known as stromal vascular fraction (SVF) – administering processed stem cells derived from adipose tissue (i.e. fat tissue) – and that US Stem Cell is not exempt from regulation.
To recap, in May 2018, the U.S. Department of Justice (DOJ) filed complaints against US Stem Cell and a California stem cell clinic seeking permanent injunctions to prevent the marketing and administration of the SVF procedures without FDA approval. Prior to the filing of these actions, both companies received warning letters from the FDA. The letters also addressed the results of inspections and the need to resolve significant deviations from manufacturing practice requirements. read more