Knox And Stark Law: Acupuncturists' Legal Obligations And Limits

Acupuncturists and other practitioners of integrative medicine need to be aware of the legal issues surrounding their profession. Integrative medicine, also known as complementary or alternative medicine, is often used alongside traditional medicine to supplement standard care. While integrative medicine providers usually operate independently from hospitals and medical practices, physicians may recommend certain patients – such as those who have received a hip replacement – to an acupuncturist for pain management. This blurs the lines between the two practices and can lead to legal issues. Acupuncturists and integrative practitioners must understand the laws surrounding the unauthorised practice of medicine, Medicare and Medicare coding requirements, FDA laws and regulations, and state licensing requirements. They must also be aware of the Health Insurance Portability and Accountability Act (HIPAA) and whether they need to comply with it. This is a complex issue, as there is currently no clear-cut answer. In addition, acupuncturists should be aware of the Knox-Keene Act, which contains additional prohibitions applicable to health plans.

Acupuncturists and Stark Law compliance with Medicare and Medicaid

Acupuncturists, like all healthcare providers, must comply with various laws and regulations to ensure patient safety and well-being. One important area of compliance is Stark Law, which pertains to physician self-referrals for Medicare and Medicaid patients.

Stark Law, named after US Congressman Pete Stark, prohibits physicians from referring patients on Medicare or Medicaid to entities for designated health services (DHS) if the physician or their immediate family has a financial relationship with that entity. This includes ownership, investment interest, or compensation arrangements. Acupuncturists should be aware of this law as it applies to all physicians who treat Medicare or Medicaid patients, and violations can result in significant penalties, including civil penalties of up to $15,000 per service and exclusion from the Medicare program.

It's important to note that there are exceptions to Stark Law, including physician services, in-office ancillary services, and rental of office space and equipment. However, to avoid violations, contracts between physicians and hospitals must fit within seven safe harbors, including duration, being in writing, specifying aggregate payment, and more.

In addition to Stark Law, acupuncturists should also be aware of the Anti-Kickback Statute (AKS), a criminal law that forbids inducements to obtain referrals from physicians. AKS applies to any claim submitted to the federal government for payment, including Medicare and Medicaid, and carries both civil and criminal penalties.

Furthermore, acupuncturists must comply with state licensing requirements and understand the scope of their practice, as they cannot make diagnoses or recommend treatments for any disease or disorder. They should also be cautious when ordering or reviewing lab results, as this could be considered the practice of medicine.

Another area of compliance for acupuncturists is the Health Insurance Portability and Accountability Act (HIPAA), which regulates the disclosure of personal health information by covered entities, including healthcare providers and Medicare and Medicaid. While there is no clear-cut answer, acupuncturists are generally considered health providers and should comply with HIPAA when they submit electronic health records.

Lastly, acupuncturists should understand the corporate practice of medicine laws, such as the Moscone-Knox Professional Corporation Act, which prohibits corporations or business entities from conducting the practice of medicine. This law ensures that physicians make decisions based on the patient's needs rather than financial interests.

In conclusion, acupuncturists must comply with various laws and regulations, including Stark Law, AKS, state licensing requirements, HIPAA, and corporate practice of medicine laws, to ensure legal and ethical provision of their services. Seeking legal counsel from experienced healthcare lawyers is advisable to navigate the complex landscape of compliance issues.

Acupuncturists and fee-splitting

At its core, fee-splitting refers to the practice of hiring another acupuncturist or healthcare practitioner as an independent contractor and giving them a "cut" of patient revenues. This scenario can give rise to concerns about self-referral, kickbacks, and fee-splitting, particularly when Medicare or Medicaid reimbursement is involved. In such cases, a Stark and federal anti-kickback law analysis would be necessary.

However, when Medicare or Medicaid is not involved, the focus shifts to state law. For example, in California, several provisions of state law address self-referral, kickbacks, and fee-splitting. The California Business & Professions Code 650 ("B&P 650") is a key statute that prohibits kickbacks and fee-splitting. It states that offering, delivering, receiving, or accepting any form of compensation as an inducement for referring patients is unlawful. This provision applies to licensed healthcare practitioners, including acupuncturists.

Other states, such as New York, have their own set of rules and regulations regarding fee-splitting. New York has a strong corporate practice of medicine prohibition, which means laypersons cannot hire physicians. Additionally, New York has specific rules addressing self-referral, kickbacks, and fee-splitting, such as the New York State Education Law, Section 6509-a, and Rule 29b-1 of the Rules of the Board of Regents. These rules include prohibitions on exploiting patients for financial gain and directly or indirectly offering or receiving fees for referrals.

To ensure compliance, acupuncturists must carefully review the laws and regulations in their respective states. Consulting with a knowledgeable healthcare lawyer is essential, as they can provide guidance on interpreting and applying the relevant rules to their specific circumstances. By understanding the legal landscape, acupuncturists can structure their practices and compensation arrangements in a way that avoids potential violations and enforcement actions.

Acupuncturists and anti-kickback laws

Acupuncturists and other integrative medicine practitioners need to be aware of the legal issues surrounding their profession, including compliance with relevant laws and regulations. One important area to consider is anti-kickback laws, which aim to prevent healthcare providers from receiving or offering kickbacks in exchange for patient referrals. Both federal and state anti-kickback laws exist, and acupuncturists should understand how these laws apply to their practice.

Federal Anti-Kickback Laws

The Federal Anti-Kickback Statute (AKS) is a criminal law that prohibits offering, accepting, or paying kickbacks to generate healthcare business. This includes referrals made by physicians for items or services paid for by health insurance, such as drugs, tests, equipment, specialists, and hospital services. AKS is a felony offence, with penalties including fines of up to $100,000 and up to 10 years in jail. It is important to note that AKS applies to both sides of the transaction, including the person or entity providing the inducement and the one receiving it.

State Anti-Kickback Laws

In addition to federal laws, individual states have their own anti-kickback statutes. For example, California has several provisions that address self-referral, kickbacks, and fee-splitting, such as California Business & Professions Code 650 (B&P 650). B&P 650 prohibits licensed healthcare practitioners, including acupuncturists, from receiving or offering rebates, commissions, or other forms of compensation as an inducement for referring patients. Other states have similar laws, such as Alabama's "Kickbacks, Bribes, etc." statute (Ala. Code § 22-1-11(b)-(c)) and Arizona's "Consideration for Referral of Patient" law (Ariz. Rev. Stat. Ann. 13-3713(A)).

Safe Harbors and Exceptions

It is worth noting that both federal and state anti-kickback laws provide safe harbors and exceptions to protect certain payment and business practices that could otherwise be considered violations. For example, the AKS includes safe harbors for bona fide employment, personal services and management contracts, discounts and rebates, and space rental arrangements. These safe harbors have specific requirements that must be met to qualify. Additionally, there are exceptions to Stark Law, such as leasing office space, renting medical equipment, and bona fide employment relationships.

Compliance and Regulatory Scrutiny

Acupuncturists should seek legal counsel to ensure their practices are in compliance with anti-kickback laws and other relevant regulations. Regulatory authorities are increasingly scrutinizing arrangements that raise red flags for fee-splitting and kickbacks. Violations of these laws can result in significant penalties, including criminal charges, civil monetary penalties, and exclusion from participation in federal healthcare programs. Therefore, it is crucial for acupuncturists to understand their legal obligations and structure their practices accordingly.

Acupuncturists and HIPAA compliance

Acupuncturists, like all healthcare providers, need to ensure that their websites are HIPAA-compliant. The Health Insurance Portability and Accountability Act (HIPAA) is a US federal statute that regulates the disclosure of personal health information in electronic form. It requires covered entities, including healthcare providers, to protect the privacy of patients' protected health information (PHI). PHI includes individually identifiable health information transmitted or maintained in any form, including electronic media and hard copies.

While it may seem that a website is just a digital business card, it collects user data, including the names, phone numbers, and email addresses of current and potential patients, which are all considered PHI. As such, acupuncture practice websites must be HIPAA-compliant to securely handle this sensitive information. This extends beyond the website itself to include any contact forms, online schedulers, chatbots, blog subscriptions, or lead forms that collect user data.

In addition to website compliance, acupuncturists should also be aware of other legal issues. For example, the Stark Law and Anti-Kickback Statute govern referral arrangements between medical practices and integrative medicine providers. The Stark Law prohibits physicians from referring Medicare or Medicaid patients to designated health services if the physician or their family member has a financial interest in that entity. The Anti-Kickback Statute, on the other hand, forbids inducements, such as cash or vacations, offered to obtain referrals from physicians.

To ensure compliance with HIPAA and other relevant laws, acupuncturists should consult with a healthcare lawyer who can provide guidance on state licensing requirements, Medicare and Medicaid coding requirements, FDA laws and regulations, and other legal considerations specific to their practice.

Acupuncturists and state licensing requirements

Acupuncturists are required to have some form of license in 47 states and the District of Columbia. However, the requirements for these licenses are not the same across all states. In some states, you will need to take a series of exams, while in others, you will need to maintain a national certification alongside your state license. Some states only require you to submit proof of your education to the state board.

Regardless of the state, having a license is incredibly important. It allows you to practice and work in certain facilities, and you will need a license to accept insurance payments at your clinic. Even if you live in a state where a license is not required, earning a national certification can boost your career, as it demonstrates your knowledge and professional dedication to clients.

State Licensing and Certification Requirements

Education

Acupuncturists need at least a master's degree to practice. While this is not explicitly stated by states that don't require licensure, it is still considered best practice.

Examinations

Beyond your degree, you will typically need to take exams to prove your knowledge. Usually, you will need to take exams from the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM). However, there are some states that do not require NCCAOM exams:

• Alabama: Medical doctors, osteopaths, chiropractors, and physician assistants can perform acupuncture without additional training.
• Oklahoma: Acupuncture is considered within a medical doctor's scope of practice. Chiropractors are also permitted to practice acupuncture.
• Mississippi: Medical doctors, osteopaths, and chiropractors are able to practice acupuncture with additional training, testing, or certification.

The exams you will need to take will depend on your state. NCCAOM offers four:

• Acupuncture with Point Location
• Foundations of Oriental Medicine
• Chinese Herbology
• Biomedicine

To earn licensure in all states that require NCCAOM certification, you will need to take the Acupuncture with Point Location and Foundations of Oriental Medicine exams. Some states also require that you take the Chinese Herbology exam, especially if you want to practice herbs.

Even if your state doesn't require NCCAOM certification, you will still need to take NCCAOM exams in all states except Alabama, Mississippi, and Oklahoma. This often includes at least the Acupuncture and Biomedicine exams.

Accreditation

To take an NCCAOM exam, you will need to have graduated from a school accredited by the Accreditation Commission for Acupuncture and Herbal Medicine (ACAOM). You will need to submit proof of your education, along with proof of completing a course in Clean Needle Technique (CNT), to NCCAOM. Once your application is approved, you can take the exams required by your state.

State Board Submission

After passing the required exams, you can submit your results to your state board and become eligible for licensure. In some states, you will need to renew your license every few years, which may include providing proof of a current NCCAOM certification or completing state-approved continuing education hours.

Frequently asked questions