Concierge medicine has been around for over two decades but has recently exploded in popularity. Overwhelmed with high patient volume, high administrative costs, and low reimbursement rates from third party payors, primary care physicians are turning to the concierge model to provide better care to their patients without risking loss of income. The concierge model’s fee structure allows physicians to reduce their patient volume and in turn allows them to spend more time on patient care and less time on the administrative and billing tasks associated with the traditional model. However, as with anything in the heavily regulated health care industry, concierge medicine faces regulatory issues and compliance concerns.
This field guide is a four-part series and will cover the issues and concerns associated with concierge medicine physicians must navigate to set up a compliant model:
- Part 1 – The Why
- Part 2 – The What
- Part 3 – The Insurance Issue
- Part 4 – Other Compliance Concerns
Other Compliance Concerns
As health care is heavily regulated, the regulatory framework can be complex with many of the laws and regulations being broad in scope and subject to differing interpretations. In Part 3 we discussed a significant regulatory hurdle faced by concierge medicine practices who get reimbursed by insurance (i.e. commercial payors and Medicare). However, there are other potential compliance concerns that all concierge practices may face on both state and federal levels.
Medical Board Licensing
State licensing regulations vary from state to state and are designed to protect the public by ensuring that health care professionals meet certain standards of competence, ethics, and accountability. These regulations detail the requirements for obtaining and maintaining professional licensure in the state. They also define the scope of practice for the licensee. There are several unique aspects of concierge medicine that practices need to be aware of when it comes to state licensing regulations.
For example, establishing a strong physician-patient relationship is a key component of concierge medicine and why many patients choose to be a member of a concierge medicine practice. However, state licensing regulations may have specific requirements for initiating, maintaining, and terminating such relationships. Practices should establish clear documentation processes to demonstrate compliance with these requirements and develop comprehensive consent forms and policies that align with state regulations.
Telemedicine
Additionally, many concierge medicine practices leverage telemedicine to provide convenient care to patients remotely. However, telemedicine regulations can vary by state, requiring providers to comply with specific licensing, credentialing, and patient consent requirements specific to telemedicine.
Membership Fee
Another unique aspect of concierge medicine is the membership fee. Practices need to be clear in their membership agreement on what services are covered by the fee and the cancellation process. Complaints of improper billing or billing for medically unnecessary services can lead to medical board investigations and possible disciplinary actions. These cases can sometimes also open inquiries into the physician’s medical treatment of the patient and the sufficiency of the medical record documentation.
Due to these unique aspects of concierge medicine, physicians must ensure they meet the standard set forth by their licensing board. Failure to comply with state licensing regulations can result in penalties, legal consequences, and damage to professional reputation.
Corporate Practice of Medicine (“CPOM”)
CPOM refers to state specific laws and regulations that prohibit corporations or non-physician entities from practicing medicine or employing physicians directly. These laws aim to preserve the integrity of the physician-patient relationship and prevent interference from non-medical entities in medical decision-making. While state laws vary, many CPOM states limit the management and control of a medical practice by non-physicians in addition to restrictions that prohibit non-physicians from employing or contracting with physicians to provide medical services to a non-physician owned business entity. For a more comprehensive view into the corporate practice of medicine, see our Corporate Practice of Medicine Field Guide.
For concierge medicine practices operating within a CPOM state, the ownership and control structure must still be developed to comply with CPOM regulations. The underlying principles involving physician ownership and control of medical decision-making are not affected or altered by a concierge medical practice’s unique operational structure. Therefore, the level of involvement and responsibilities of non-physician owned entities such as management services organizations (MSOs) do not change. For a more in depth discussion of the functionality of the MSO model as a means to navigate CPOM, please see our MSO Field Guide: Part 2 (CPOM Uses).
Stark Law
The Physician Self-Referral Act, commonly known as the Stark law, prohibits physicians from referring Medicare and Medicaid patients for designated health services (“DHS”) to entities with which they have a financial relationship, unless an exception applies. DHS includes services such as clinical laboratory tests, physical therapy, and radiology. The law aims to prevent financial incentives from influencing medical decision-making, ensuring the provision of medically necessary services.
For concierge medical practices choosing to continue servicing Medicare patients, referrals of such patients for DHS can potentially trigger Stark and therefore, it is crucial for practices to analyze their structure to avoid non-compliance with Stark.
Federal Anti-Kickback Statute
The Federal Anti-Kickback Statute makes it illegal to offer, pay, solicit, or receive remuneration in exchange for referrals of patients for services covered by federal health care programs, such as Medicare, Medicaid and Tricare. The statute broadly prohibits any arrangement that involves remuneration and is intended to induce referrals or generate business. While Stark focuses on the physician financial relationships, the Anti-Kickback Statute has a broader focus of involving all financial relationships. Additionally, many states have state anti-kickback laws that are broader and apply to services covered by all sources of payments, even cash.
Once again, concierge medicine practices must carefully evaluate their structure and other arrangements to ensure successful navigation around federal and state anti-kickback laws.
HIPAA
The Health Insurance Portability and Accountability Act (“HIPAA”) establishes standards for safeguarding electronic protected health information (“ePHI”) and sets guidelines for health care providers to protect the privacy and security of individuals’ health information. Through their electronic health records systems, concierge medicine practices maintain vast amounts of sensitive patient information and face the threats of unauthorized access, data breaches, or inadvertent disclosures. Because of this, concierge health care providers must be cognizant of HIPAA’s rules and regulations.
Therefore, concierge medicine practices should evaluate their policies and procedures for the handling of confidential patient information and ensure they are in line with all applicable rules and standards.
Learn More About Concierge Medicine with ByrdAdatto
Over the past three parts of this field guide, we have hopefully provided you helpful information on the various aspects of concierge medicine. If you have any questions or would like to learn more about concierge medicine, please contact us at info@byrdadatto.com.
