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 issued temporary waivers and new rules to help the American health care system address the increased need for health care services caused by COVID-19. Among the waivers, CMS is allowing hospitals to set up services in alternative sites to accommodate increased patient census. Hospitals may be allowed to use ASCs, inpatient rehab hospitals, hotels and dormitories for non-COVID-19 patients or patients not requiring critical inpatient services. Hospitals are also being encouraged to increase staffing, allowing hospitals to increase staff through hiring of local and non-local providers/practitioners as long as they are appropriately licensed in the same state as the hospital or another state. However, even though CMS has created flexibility for rendering services during this pandemic, use of alternative “hospital” sites and expansion of hiring staff must comport with a state’s emergency preparedness or pandemic response plan. read more
The issue of scope of practice is front and center in Florida right now with the expansion of what nurse practitioners (and nurse midwives) are legally permitted to do. The newly enacted 464.0123 allows for qualified APRNs (there is specific criteria) to practice independent of a supervising physician in the following areas of medicine–primary care, family medicine, general pediatrics, and general internal medicine.
Even more, assuming they meet the membership criteria for admission to a healthcare facility medical staff, they may admit patients, manage patient care, and discharge patients. One of the only preserved connections with a physician established by the law is if the APRN practices at a healthcare facility, a transfer agreement including a physician is required. Additionally, the new law establishes a Council On Advanced Practice Registered Nurse Autonomous Practice, two members of which are appointed by the Board of Medicine and an additional two appointed by the Board of Osteopathic Medicine. read more
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
The Office of Civil Rights within the U.S. Department of Health and Human Services recently imposed $2,154,000 in civil money penalties against Jackson Health System in Miami, Florida for multiple violations of HIPAA. The majority of the penalties were due to violations of the HIPAA Security and Breach Notification Rules, rather than for the actual breaches of confidentiality. This action by the government underscores the importance of complying with all of HIPAA, and not just the requirements to safeguard Protected Health Information. read more
With the legalization of medical marijuana, I could not help but think, could a medical marijuana practice be the next “pill mill” and how could that be possible with the strict requirements set forth in Section 381.986, Florida Statutes. Turns out, only a handful of physicians are prescribing the majority of medical marijuana. While this may at first blush indicate a problem, keep in mind that marijuana, even medical marijuana is still outlawed under federal law and many physicians are not willing to risk a DEA license or possibly a state license to become a physician that certifies a patient for using medical marijuana. If a physician does become a qualified physician and issues medical marijuana certifications, certain practices and behaviors should be avoided.
A Practice with Similarities to a Pill Mill
In May 2019, Department of Health filed an administrative complaint against a “qualified physician” for basically over-certifying the use of medical marijuana. Pursuant to Section 381.986, there are only 13 medical conditions for which medical marijuana may be recommended. Of those 13 medical conditions, one is a bit of a “catch-all” as it is for medical conditions of the same kind or class as or comparable to a list of ten specific conditions, i.e., cancer, epilepsy, glaucoma, positive status for HIV, AIDS, PTSD, ALS, Crohn’s disease, Parkinson’s disease, and MS. This is where the physician ran into a problem. read more
On November 15, 2019 Centers for Medicare and Medicaid Services (CMS) issued a final rule requiring hospitals to publicly disclose “standard charges, including payer-specific negotiated rates for items and services. Hospitals will be required to comply by January 1, 2021. The proposed rule is subject to 60 days of comment.
The final rule requires hospitals to make public in a machine-readable file online all standard charges (including gross charges, discounted cash prices, payer-specific negotiated charges) for all hospital items and services. It requires hospitals to de-identify minimum and maximum negotiated charges for at least 300 “shoppable” services. 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