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Obtaining Patient Consent

Client Alert

Patients have autonomy to choose what can and cannot be done to their bodies. Therefore, informed consent is required before any treatments or procedures commence. This is a stark contrast to the previously recognized paternalistic approach, which relies solely on the decision-making of the provider.

However, in order for patients to really choose whether or not to submit themselves to a particular healthcare service, they must actually understand what the service is. Therefore, patient consent should help the patient understand the risks and benefits, as well as any alternative treatment options.

Obtaining Consent

Merely having a patient sign an informed consent is not enough for a patient to consent. Rather, providers should have an active dialogue with patients, which starts with explaining a diagnosis, the proposed treatment including its benefits and risks, and any alternative treatment options and their benefits and risks. Providers should allow patients to ask any clarifying questions they may have. Only after this dialogue can a signed consent be obtained.

While some states recognize verbal consents as valid, others require that patients sign an authorization form to show that consent was actually obtained.

Capacity to Consent

Even if a provider engages in a dialogue with a patient clearly laying out the patient’s diagnosis, treatment options, and benefits and risks, some patients still cannot consent due to lack of capacity. If a patient cannot understand or appreciate the benefits, risks, and alternatives, or cannot demonstrate reasoning in their decision-making, the patient likely does not have capacity to give a valid informed consent. One way to determine whether a patient has capacity is to have the patient restate in their own words what they understood about the dialogue with their provider.

Further, while minor patients may seem to have capacity, they are incapable of providing informed consent (although there are some exceptions in states where the minor is emancipated or is being treated for specific illnesses, such as sexually transmitted diseases). Therefore, consent to treat minors will generally require a parent or guardian’s signature. 

Penalties

Failure to adequately obtain informed consent may result in consequences, including but not limited to medical malpractice lawsuits, loss of hospital privileges, or removal from preferred provider lists.

If you have any questions regarding patient consent in general, or whether your current process for obtaining informed consent is compliant with applicable state and/or federal law, please don’t hesitate to contact BMD Health Law Group Member Jeana M. Singleton at jmsingleton@bmdllc.com or 330-253-2001, or BMD Attorney Rachel Stermer at rcstermer@bmdllc.com or 330-253-2019.  


“I’m Out Of Here!” Now What?

We all know that the healthcare industry is experiencing a wave of integration. This trend has been evident for many years. Fewer physicians are willing to assume the legal, financial and other business risks associated with owning their own practices. More and more physicians, including anesthesiologists, are becoming employed by large physician groups, health systems and national providers. This shift necessarily involves not only entry into new employment arrangements but also the termination of existing relationships. And those terminations are often governed by written employment agreements, state and federal healthcare laws and employer benefit plans and other policies and procedures. Before pursuing their next opportunity, physicians should pause for a moment and first attend to the arrangement that they are leaving. Departing physicians need to understand their legal rights and obligations when leaving their current employment relationships in order to avoid unintended consequences and detrimental missteps along the way. Here are a few words of practical advice for physicians contemplating an exit from their current employment arrangements.

Investment Training for the Second and Third Generations

Consider this scenario. Mom and Dad started the business from the ground up. Over the decades it has expanded into a money-making machine. They are able to sell the business and it results in a multimillion-dollar payday for their labors. The excess money has allowed Mom and Dad to invest with various financial advising firms, several fund management groups, and directly with new startups and joint ventures. Their experience has made them savvy investors, with a detailed understanding of how much to invest, when, and where. They cannot justify formation of a full family office with dedicated investors to manage the funds, but Mom and Dad have set up a trust fund for the children to allow these investments to continue to grow over the years. Eventually, Mom and Dad pass. Their children enjoy the fruits of their labors, and, by the time the grandchildren are adults, Mom and Dad's savvy investments are gone.

Provider Relief Funds – Continued Confusion Regarding Reporting Requirements and Lost Revenues

In Fall 2020, HHS issued multiple rounds of guidance and FAQs regarding the reporting requirements for the Provider Relief Funds, the most recently published notice being November 2, 2020 and December 11, 2020. Specifically, the reporting portal for the use of the funds in 2020 was scheduled to open on January 15, 2021. Although there was much speculation as to whether this would occur. And, as of the date of this article, the portal was not opened.

Ohio S.B. 310 Loosens Practice Barrier for Advanced Practice Providers

S.B. 310, signed by Ohio Governor DeWine and effective from December 29, 2020 until May 1, 2021, provides flexibility regarding the regulatorily mandated supervision and collaboration agreements for physician assistants, certified nurse-midwives, clinical nurse specialists and certified nurse practitioners working in a hospital or other health care facility. Originally drafted as a bill to distribute federal COVID funding to local subdivisions, the healthcare related provisions were added to help relieve some of the stresses hospitals and other healthcare facilities are facing during the COVID-19 pandemic.

HHS Issues Opinion Regarding Illegal Attempts by Drug Manufacturers to Deny 340B Discounts under Contract Pharmacy Arrangements

The federal 340B discount drug program is a safety net for many federally qualified health centers, disproportionate share hospitals, and other covered entities. This program allows these providers to obtain discount pricing on drugs which in turn allows the providers to better serve their patient populations and provide their patients with access to vital health care services. Over the years, the 340B program has undergone intense scrutiny, particularly by drug manufacturers who are required by federal law to provide the discounted pricing.