Latest Developments in Medical Law
With changes in healthcare policies coming so rapidly, it is often difficult to keep up with the latest updates. In this section, we will explore some of these new laws and regulations and how they may affect your practice. The past year brought a number of notable legal changes affecting the medical and dental community. New laws and regulations have reshaped the requirements for medical professionals across the country in what is becoming a fast-paced environment. The transition to the new healthcare law system brings new privacy rules and regulations. There is an expectation that the government is aiming to strengthen protections for patient data privacy by putting more controls on what information can be shared amongst providers. Lawmakers have increased penalties for violations under HIPAA. However, the fee increases and mandatory jail sentences have made it easier for private-sector healthcare organizations to handle compliance issues internally leading to fear that new violations are not being widely reported. The new privacy laws have also added additional protections for minors who are the victims of a crime. The new updated laws also affects physician compensation. The new law allows healthcare organizations to recruit physicians with hefty bonuses in hopes of lowering the national physician shortage . The law would allow organizations to cover relocation expenses, travel, and physician recruitment expenses. These new laws will make it a lot cheaper and easier for healthcare organizations to attract top talent. The recent change in medical law can also bring new patient and healthcare ratios saving lives. California had already set the standard and last year saw an increase in healthcare ratios from 4:1 to 10:1 for more stable patient care. This change is thought to have saved thousands of lives. Doctors are also seeing increased overtime limits and longer work hours. The U.S. Supreme Court lifted a stay on a lower court decision requiring doctors working in hospital emergency rooms for HCA Health could join wage and hour class actions. Private hospital and emergency room doctors in California might now receive overtime pay and are no longer classified as independent contractors. The changes in both medical law and compensation may affect physician overtime laws and liability laws. The new law states that organizations can no longer take hours away from physicians who earn hourly based on their commission. New protections allow compensation plans to offer hourly physicians bonuses that also include benefits. These benefits cover the cost of professional liability insurance, which is often required by employers.
New Regulations for Dentistry Practice
The Department of Public Health ("DPH") and the Executive Office of Elder Affairs ("EOEA") implemented several changes regarding the delegation of certain services to dental hygienists.
Licensure
The regulations state that DPH may grant dental hygienists licenses to practice under an Expanded Practice Permit if they have completed a course in "practice in public health settings." The permit allows the dentist to assign specified procedures, including the administration of local anesthetic, to be carried out by the dental hygienist for dental patients who are:
Additionally, the regulations also set forth requirements including written evidence, such as a contract, that the dental hygienist has:
The dentist must also abide by the following regulations:
Direct Access
DPH expanded the list of procedures that a dental hygienist may perform under "direct access" or on-site without the authorization, or "standing orders," of a dentist. Examples include prophylaxis, fluoride treatment, patient education, biofilm removal and application of desensitizing agents. DPH also issued revised "Policies & Procedures" to ensure the safe and efficient provision of dental hygienist procedures.
Telehealth Services
The EOEA issued new regulations under the Elder Telehealth Act which allow dental hygienists to deliver direct dental services under a dentist’s order, and subject to DPH and DPH regulations, through telehealth technology to patients who live in underserved areas of the Commonwealth, including remote or isolated locales.
Legality of Telemedicine
One topic that patients are always shocked to learn about is the complicated web of rules governing the practice of telemedicine delivered across state lines. The recent legal developments in the regulation of telehealth will have a substantial impact on the practice and delivery of telehealth and telemedicine in Michigan and surrounding states. The new Caroline P. Arnaudo MD Law, passed this past November and effective April 2023, will allow Michigan physicians, physician assistants, and nurse practitioners to treat patients by way of remote health care service delivery without first having an established relationship with the patient (meaning a traditional in-person visit) as long as the practitioner establishes a good-faith expectations and belief that the new law allows.
The law, which takes effect next year sets up a new special telehealth limited medical license issued by the Board of Medicine, but so far includes only physicians. The law also instructs the Board of Medicine to create a task force to study and report on whether the law should be expanded to include physician assistants and nurse practitioners. There are many unanswered questions about how the law will be implemented and what licensure will require.
Two other states, Maryland and Oklahoma have also taken steps to implement similar laws allowing liberty of practice across state lines. In addition to state-wide telehealth laws, it is important to be mindful of the federal regulations that govern the practice of telemedicine, especially for practitioners that provide Medicare services or prescribe controlled substances.
The Substance Abuse and Mental Health Services Administration published its first ever guidance under the Ryan Haight Act of 2008 detailing when or if physicians can prescribe controlled substances by way of telemedicine with federal support. The guidance includes a host of changes to federal law allowing doctors greater flexibility in the way they can treat opioid use disorder by prescribing medications to opioid use disorder by telemedicine.
Although federal law will still require patients to meet in-person at least once a year and get a full clinical evaluation, these modest changes from the federal government provide opportunities for health care providers and patients to access treatment earlier and more easily.
Patient Privacy / Data Laws
Recent legal updates have focused on stricter data protection mandates in an increasingly digital and connected world. The Health Insurance Portability and Accountability Act, with its Health Information Technology for Economic and Clinical Health Act ("HITECH") rules, regulates the storage and transmission of electronic protected health information ("PHI"). Its states’ counterparts, such as California’s Confidentiality of Medical Information Act , have specific provider-centric language that limit their application to persons or facilities "providing health care." Newer statutes have provided broader definitions and new conditions for personal data that address vendor relationships (e.g., the General Data Protection Regulation). Expect further changes in 2023 as established laws seek to affirmatively address data breaches affecting U.S. citizens, patients, or entities.
Connected equipment was adopted at first for a more efficient patient experience. The law has only recently caught up. Medical device makers will need to be aware of these shifting requirements and carefully examine even the most protective vendor agreements.
Malpractice Trends
Trends in Malpractice Litigation: As new laws emerge from the halls of power, so too do fresh cases and new legal precedents regarding specific legal issues. When the law in question is a statute, it is more straightforward to examine its impact on the current litigation surrounding it. However, when it is case law, it requires vigilance and awareness as new developments are constantly occurring.
Trending in 2023 are cases concerning the statute of limitations in regard to medical malpractice. From long-awaited decisions to new rulings on pending motions, it is important for physicians and dentists to stay on top of their legal situation when being pursued for alleged malpractice. Notably, this year saw a major decision by the New Jersey Supreme Court concerning the two-year statute of limitations for medical malpractice.
While previous decisions held that when the relevant injury was found sufficiently beyond the scope of the malpractice as to constitute a new injury and cause the statute of limitations to re-start, it was not clear whether a new injury that was too remote as to be considered malpractice instead would also count. In April of 2022, the court held that such an event would not restart the statute of limitations, but would instead relate back to the originally alleged malpractice.
This significantly affects the litigants currently in the process of a medical malpractice case, as the court declined to create a bright-line rule, and held that a slow deterioration of health in the context of one malpractice statute did not restart the statute of limitations for a later malpractice instance in the case. This unfortunately means that defendants being pursued for medical malpractice must be prepared to dig in for the long haul, especially when the injuries being cited are still in their relatively early stages.
As the legislative session is ongoing, there are several bills making their way through the legislature that will conceivably impact medical malpractice. These include proposed increases to the statute of limitations from two years to three and legal action to allow for discovery-rule applicability in certain sexual assault instances. We will be updating these portions of the article periodically as new laws and bills make significant strides through their legislative processes.
Foresight in Future Legal Matters
The rapid evolution of healthcare laws and regulations makes it necessary for providers to take proactive measures now to help prepare for the potential legal challenges of tomorrow. By implementing a robust compliance program, evaluating changing levels of medical necessity in an era of value-based care, and managing their legal risk in context of changing reimbursement models, providers can better position themselves to weather the changes to come.
New regulations mean new ways of doing business, and as such, healthcare providers must be prepared for the realities of an often unregulated digital marketplace. While telemedicine has existed for some time now, COVID-19 has dictated that is must grow at a pace never seen before, and the regulatory bodies have been flexible to allow for such an unprecedented growth opportunity. However, changing regulations require more than simply checking all the boxes of the CHiME Telehealth Operating System ModelTM; proactive compliance with the laws across the healthcare ecosystem is essential, and the healthcare industry even has its own version of HIPAA, the Confidentiality of Substance Abuse Treatment Records at 42 CFR Part 2, which must be considered in the privacy analysis of telehealth. Further, in the post-market place, historically applicable fraud and abuse prohibitions remain in effect, and digital marketers must ensure that they are compliant with all of these requirements, including anti-kickback and Stark regulations.
In the realm of medical necessity, the question confronting providers will be whether the restrictions on medical necessity will continue to loosen over the next several years or return to more strict criteria as payers push for decreased expenditures . Either way, the providers in the healthcare system must begin to consider how to best demonstrate medical necessity in order to avoid denials in a value-based environment. Medical necessity is defined and measured by accepted standards of care in each specialty and can be affected by guidelines created by governmental entities as well as private payers. Medical necessity encompasses both the conditions and the frequency with which conditions are treated without having to customize treatment for each individual patient. Commercial payers issue medical necessity criteria that providers must comply with in order to receive payment. As the healthcare industry moves from volume to value, understanding how medical necessity is determined and changing, and how to document and demonstrate medical necessity in a changing clinical landscape, will help providers optimizing their business practices and financial outcomes as they navigate this difficult time.
To contend with these changes in the legal landscape, networks and other providers can build a multi-faceted compliance program to address these risks and to monitor compliance with the changing laws. A strong compliance program requires more than just a handbook filled with general guidance on the expectations of the network and trimming the low performers. A tailored compliance program that accommodates a provider’s particular and unique risks as well as its size can be a powerful weapon in the network’s compliance arsenal. The foundation of such compliance program can be used to mitigate risk and prevent litigation for future healthcare disputes.