Healthcare Law Blog

Updates and Modernization of Kentucky's Assisted Living Legal Framework

Since 2022, Kentucky's assisted living community regulations have undergone significant updates. The recent updates to Kentucky’s assisted living community laws and regulations enhance resident safety and improve the communities that support them. Although Senate Bill (SB) 11 passed in 2022, as is often the case with complex regulatory frameworks, the applicable regulations were promulgated and enacted well into the end of 2023. More >

Recent Supreme Court Decisions and the Impact on Reproductive Rights

Recent United States Supreme Court decisions have delivered small temporary wins for reproductive rights. A unanimous Supreme Court rejected a challenge to the FDA’s rule for prescribing and dispensing abortion pills. On June 13, 2024, a unanimous court decided in Food and Drug Administration v Alliance for Hippocratic Medicine that the anti-abortion doctors and medical groups that challenged the expansion of access to mifepristone, one of the two drugs used in medical abortions, lacked standing. Justice Brett Kavanaugh, writing for the court, acknowledged the challengers’ “sincere legal, moral, ideological, and policy objections” to elective abortion and to the FDA’s changes to the conditions on the use of mifepristone. However, the challengers to the FDA regulation failed to show how they had been harmed, as they do not themselves prescribe the medication. The court further found that merely objecting to abortion and to the FDA’s policies are not enough to establish standing and bring a case to federal court. The challengers contended that having to treat patients who suffered complications from using the drug is a harm to them and similarly convicted providers in other respects, such as diverting resources, increasing the likelihood of lawsuits, and increasing insurance costs. Justice Kavanaugh continued to describe the speculative nature of the challengers’ attempt to establish standing. If the challengers could sue with this theory, it could open a dangerous door to challenge “almost any policy affecting public health.” More >

DEA Proposes New Tele-Prescribing Rules for End of COVID-19 State of Emergency

At the end of January, the Biden Administration announced that May 11, 2023, would mark the end of the federal public health emergency (PHE) declarations that have been in place for the last three years. For healthcare providers, this means change is on the horizon, especially where telemedicine is concerned. In response to the impending end of emergency telehealth provisions, the Drug Enforcement Agency (DEA) has proposed a permanent rule regarding the prescription of controlled medications via telemedicine in order to extend COVID-era accommodations. The public will be able to comment for 30 days on the proposed rules. A summary of the rules can be found here: Proposed Telemedicine Rules Summary. More >

OIG, in a Departure, Approves Hospital Provision of Nurse Practitioner Services

Traditionally, the Office of the Inspector General for the U.S. Department of Health and Human Services (“OIG”) would take a hard stance on any arrangements that might involve some form of remuneration from a hospital to a referring physician, but the winds of change may be blowing. In Advisory Opinion 22-20, published in December of 2022, the OIG has given a green light, albeit in a limited context, to an arrangement in which a hospital may have its employee nurse practitioners perform some services traditionally performed by the patients’ primary care physicians. This is a small step in the direction of a more flexible OIG stance on the federal Anti-Kickback Statute (“AKS”), but it doesn’t completely sidestep risks. More >

Fine Lines in Medical Spa Regulations

Medical spas (also known as ‘medspas,’ ‘medispas,’ or ‘esthetic salons’) combine advanced medical esthetic services that would have previously only been found at plastic surgery clinics or dermatologists’ offices (such as Botox injections, laser hair removal, chemical peels, injectable fillers, and acne treatments) with those found in a traditional day spa. Often, these procedures require the supervision of a licensed physician or nurse practitioner, creating a unique regulatory issue. As medspas have generated billions in revenue annually across the country and involve several types of healthcare and cosmetology professionals, it is critical for healthcare professionals offering services at a medspa to understand their specific obligations to maintain compliance with the law and prioritize patient safety. More >

Malnutrition Diagnosis Codes: The Compliance Danger You’re Not Taking Seriously Enough

It may seem like hair-splitting, but including the wrong diagnostic codes for malnutrition on hospital inpatient claims – using codes for severe malnutrition in place of other forms of malnutrition – is a costly mistake. The estimated overpayment as a result of these coding errors is a reported $1 billion. Because the payment error rate was so high at a colossal 31%, Medicare-Severity Diagnosis Related Group ("MS-DRG") applicable entities must take note and prepare for a marked increase in Department of Health and Human Services Office of Inspector General ("OIG") audits for these coding practices. The Centers for Medicare & Medicaid Services ("CMS") also plans to implement review practices for malnutrition coding on a sample of inpatient claims. The increased payer audits will result in severe financial damage for hospitals and other MS-DRG applicable entities if they do not mitigate coding and documentation risks. More >

Companies—It May Be Time to Reevaluate Your Corporate Compliance Program

In April 2019, the United States Department of Justice (“DOJ”), Criminal Division, issued a guidance document entitled “Evaluation of Corporate Compliance Programs.”[1] This guidance updates standards the DOJ utilizes to investigate, charge, and negotiate criminal charges related to corporate crimes.[2] Although the DOJ recognizes that each company has its own set of unique risks, its investigations often include three common questions in assessing the effectiveness of a company’s corporate compliance program. More >

A Physician’s Guide to Employment Contracts with Hospitals and Health Systems

As hospitals and health systems continue moves toward clinical integration, more physicians are being employed by hospitals and health systems rather than practicing medicine in their own private practices.  The trend toward direct hospital employment of physicians accelerated after 2012 and it appears that the trend will continue as both hospitals and physicians navigate regulatory, reimbursement, and operational challenges in the future.  When considering employment by a hospital or health system, physicians should be mindful of various provisions that are often contained in physician employment agreements and how these provisions may impact the physician’s professional practice and personal life.  Here are important issues to consider when evaluating whether to enter into an employment agreement with a hospital or health system.  More >

A New Opportunity: Centers for Medicare and Medicaid Services Recognizes the Full Potential of Ambulance Crews and Services

In mid-February 2019, the Centers for Medicare and Medicaid Services (“CMS”), Innovation Center and the Department for Health and Human Services (“HHS”) announced a ground-breaking payment and medical services initiative for ambulance providers called “Emergency Triage, Treat and Transport” (the “ET3”). This new model is the first step in allowing providers of Emergency Medical Services to finally “take off the gloves” to fully utilize both their medical skills and unique patient knowledge to implement a more efficient and effective care model. More >

Compliance is Crucial

This article appeared in the December edition of MD-UPDATE, available at  http://www.md-update.com/wp-content/uploads/2018/12/MD-Update-Issue-118/#?page=8

In the current legal enforcement environment, it is crucial that healthcare providers prioritize compliance initiatives and programs in order to avoid illegal practices that may result in large financial penalties and both criminal and civil liability.   More >