According to the American Board of Physician Specialties, integrative cardiology “applies the tenets of integrative medicine to pick the most appropriate treatments for a person’s individual health benefits and disease risks.” Integrative cardiology uses “conventional therapies such as percutaneous coronary interventions and pharmacotherapy when necessary, while including the less conventional treatments such as mind-body medicine, acupuncture, nutrition, exercise and spirituality.” Integrative cardiology focuses on prevention and healing by using less costly and less risky treatments.
Standard cardiology is good at treating acute cardiac problems such as heart failure and myocardial infarctions. Stents and other related procedures do save many lives after the damage to the heart has been done.
The US Centers for Disease Control and Prevention states that lifestyle choices could prevent about 80% of premature heart attacks and strokes. The American Heart Association and the American College of Cardiology and conventional cardiology have many “well researched and evidence-proven lifestyle guidelines in place.” Unfortunately, according to an article published by the American Board of Physician Specialties, many cardiologists are not properly trained on the preventive and healing side of heart healthcare.
While cardiologists generally agree that nutrition is essential to preventing and treating atherosclerosis, surveys show that cardiologists aren’t that skilled in how nutrition works. A survey of 930 cardiologists who were asked about nutrition training found that:
- 90% received little or no training during fellowship
- 59% had little or none during residency
- One-third little or none during medical school
- Only 8% described themselves as experts in nutrition
- Most cardiologists believed that they need to provide recommendations to their patients.
According to Integrative Cardiology of Long Island (New York), integrative cardiology combines traditional medical treatments with functional medicine. “It incorporates advances in pharmacogenomics, nutrigenomics, metabolic, nutritional, and exercise approaches in addition to pharmacological treatments, cardiac procedures and interventions. “
According to the Institute for Functional Medicine, “the Functional Medicine model is an individualized, patient-centered, science-based approach that empowers patients and practitioners to work together to address the underlying causes of disease and promote optimal wellness. Functional medicine relies on a detailed understanding of each patient’s genetic, biochemical, and lifestyle factors and leverages that data to direct personalized treatment plans that lead to improved patient outcomes.”
What types of services do integrative cardiologists provide?
In addition to standard cardiac care, integrative cardiology, according to Scripps Clinic Medical Group, includes:
- Acupuncture
- Biofeedback
- Healing touch
- Nutrition consultation
- Mindfulness-based stress reduction
- Vegan cooking classes
- Advanced cardiac rehabilitation, using a state-of-the-art fitness gym and swimming pool
- Lifestyle intervention classes
- Yoga
- Tai chi
- Sound healing
- Parkinson’s boxing
- Sound bath for cancer care
- Massage
- Early detection center with CT/PET/Nuclear/echo/stress imaging
- Trigger point injections
Other integrative care may vary depending on the cardiology practice.
Compliance issues for integrative cardiology?
Cardiologists who work with acupuncturists, nutritionists, meditation practitioners, spiritual advisers, and other care providers need to review their relationships with an experienced healthcare lawyer. The non-physician practitioners need to review their relationships also. There are many different laws involving relationships between physicians and non-physicians that can affect a cardiologist’s license to practice, patient privacy issues, and the ways that referrals between patients are made.
State licensing requirements
Cardiologists in California are licensed by the Medical Board of California. Many of the other healthcare providers that are part of an integrative cardiology practice may also require a license. To obtain a license, the practitioner must meet specific educational requirements and comply with other criteria. Each state has its own set of licensing requirements.
Cardiology practitioners and other healthcare practitioners need to understand:
- What practices require licensing.
- When a practitioner could be charged with practicing medicine without a license.
- What the supervision requirements are for cardiologists when cardiologists work with other licensed healthcare professionals.
- What the supervision requirements are for cardiologists when cardiologists work with non-licensed healthcare professionals.
A skilled healthcare professional advises cardiologists and other integrative cardiology practices about what state laws apply to their practice, what medical boards regulate their practice, what other rules apply, and what exceptions may apply.
Generally, a practitioner in an integrative cardiology practice cannot make a diagnosis or order treatments for any disease, injury, physical, or mental condition – and cannot recommend any products to treat any disease or disorder. Even order imaging tests or lab tests (or reviewing the results) could be considered the illegal practice of medicine.
For example, the California Board of Acupuncture regulates “the practice of Asian medicine through acupuncture in California and is the sole issuer of acupuncture licenses in the state.”
Integrative cardiology and the Health Insurance Portability and Accountability Act (HIPAA)
HIPAA regulates how patient health information in electronic form is disclosed. The law applies to healthcare providers, health insurance companies, Medicare, Medicaid, long-term care insurers, and other entities. The law specifically states that healthcare providers include people “who electronically transmit health information in connection with certain transactions. These transactions include claims, benefit eligibility inquiries, referral authorization requests.”
There is a lot of sharing of patient information in an integrative cardiology practice. Whether a practitioner such as a nutritionist or a yoga instructor is bound by HIPAA depends on how the healthcare provider bills the client/patient. Some integrative healthcare practitioners do not bill insurance carriers or third parties such as Medicare because their services are not covered.
Each type of integrative cardiology practice (acupuncture, nutrition, yoga, etc.) is different. An experienced healthcare lawyer will review whether a practice must meet HIPAA requirements and whether any exceptions apply. Often, there are practical solutions.
The corporate practice of medicine and integrative cardiology
California, along with most other states, is concerned that physicians place the healthcare of their patients first. For this reason, California law forbids corporations and related businesses from conducting the practice of medicine. Corporate officials should not be able to tell physicians how to treat their patients – that the physicians should/shouldn’t do something for a patient because that something might affect the corporation’s profits. The law is called the Moscone-Knox Professional Corporation Act.
The Moscone-Knox Professional Corporation Act states that only physicians who are licensed in the state of California can own a medical practice. Non-physicians (such as many of the healthcare providers an integrative cardiology practice works with) cannot own a medical practice. There is an exception. Non-physicians can own a minority interest in the medical practice – but the majority owners must be state-licensed doctors. Skilled California healthcare lawyers explain which providers in an integrative cardiology practice can have an ownership interest and under what conditions.
The corporate practice of medicine discussion with your healthcare lawyer should also review when a doctor can act as a medical director of the corporation and when doctors can’t.
The lawyer will also review what acts may constitute the unauthorized practice of medicine. Generally, non-physicians cannot make a medical diagnosis, prescribe medications or treatments, or provide other regulated healthcare advice. The attorney will review the laws that govern the practice of medicine and the medical boards that regulate each practice type. For example, California has specific Laws and Regulations Relating to the Practice of Acupuncture.
WHAT PHYSICIANS NEED TO KNOW ABOUT THE CORPORATE PRACTICE OF MEDICINE
Most states prohibit the corporate practice of medicine but allow for professional medical corporations. The hiring of doctors by hospitals is mostly illegal in California.
Referrals and financial relationships between integrative cardiology practices
Cardiology practices need to be very careful about the working relationships they with other integrative health practices. There are federal laws that regulate referrals between healthcare practices and businesses. The first federal law is a civil law – called Stark Law. The second federal law is a criminal law – called the Anti-Kickback Statute (AKS). Violations of these laws can result in financial damages and penalties, the loss of license to practice, and other consequences. Violations of the AKS can result in imprisonment.
Stark Law. Stark law prohibits cardiologists (who bill Medicare or Medicaid) from referring Medicare and Medicaid patients to designated health services (called ancillary services) in which the cardiologist (or a member of the doctor’s family) has a financial interest. The law was enacted to sure that doctors work for what is in the best interest of the patient – and not their own financial wealth.
Stark Law means the cardiologists need to review when the law applies and the consequences for noncompliance with an experienced healthcare lawyer. Any integrative cardiology practice should also review Stark Law before beginning any type of referral arrangement.
Stark Law does have some exceptions which can help the various individual practices as part of an integrated cardiology team. The core exception focuses on ensuring patient care is the priority. Referrals may qualify for an exception if the referral is based on merit and not on the value or volume of the referrals. Referral arrangements should be based on fair market value and the commercial and medical reasonableness of the referral. Stark Law exceptions include:
- Leasing office space
- Renting medical equipment
- Bona-fide employment relationships
- Physician recruitment
- Personal service arrangements
- Other statutory exceptions
The Anti-Kickback Statute (AKS). This federal law prohibits any inducement to obtain a referral. Examples of inducement include cash, medical directorships, vacations, meals, and other benefits that are given to induce the referral. The AKS applies to claims for payment submitted to federal agencies such as Medicare, Medicaid, and TRICARE. All participants to the illegal referral arrangement, the person/entity giving or receiving the inducement, can be charged.
Similar (but not identical) to Stark Law, AKS has “safe harbors” that can justify a financial relationship between a cardiologist and an integrative health service.
Your healthcare lawyer will review Stark Law, the AKS, and any state self-referral laws that may apply to an integrated cardiology practice. Many violations of Stark Law or the AKS are brought through the False Claims Act. For a review of self-referral laws, please see our article titled Quick Summary of Federal “Stark” Self-Referral & Anti-Kickback Law and California Self-Referral and Fee-Splitting Prohibitions.
STARK LAW EXCEPTIONS THAT MIGHT APPLY TO YOU
In today’s video, we discuss some exceptions to Stark Law, which deals with improper referrals by physicians and healthcare practitioners.
RECENT STARK LAW AND ANTI-KICKBACK STATUTE CASES
Medical providers must abide by Stark Law and the AKS. Referrals must be based on what is best for the patient. If profit is the driver, the providers will often pay a substantial settlement or […]
Additional integrative cardiology compliance issues
Cardiologists and the related integrated healthcare practices should also review with a seasoned healthcare lawyer:
- The informed consent requirements for procedures.
- How the FDA regulates drugs, medical devices, cosmetics, dietary supplements, and other products.
- How the FTC regulates the marketing and branding of your integrative cardiology practice.
- The various California laws including the California Labor Code.
Integrative cardiology practices provide a team of services for patients with heart problems or patients who want to keep their hearts as healthy as possible. The cardiology doctors and the rest of the team need to understand what federal and state laws regulate their practice. The practitioners need to understand what types of business relationships are permissible, when medical care may be unauthorized, the privacy rights of their patients, and many other healthcare compliance issues. Noncompliance can have severe consequences.
Cardiologists, nutritionists, dieticians, and all participants in an integrated cardiology practice should contact Cohen Healthcare Law Group, PC to discuss HIPAA, Stark Law, the AKS, and other laws that regulate their medical practices. Our experienced healthcare attorneys help healthcare providers understand and address their compliance requirements.
Contact our healthcare law and FDA attorneys for legal advice relevant to your healthcare venture.
