The Stark Law, or Stark Act, is also known as the Physician Self-Referral Law. It prohibits physicians from making referrals to entities for designated health services reimbursed by Medicare if the physician has a financial relationship with the entity. The law does not apply to nurse practitioners or other advanced practice nurses. Nurse practitioners in Tennessee are authorised to prescribe and/or issue controlled substances listed in Schedules II, III, IV, and V of title 39, chapter 17, part 4, upon joint adoption of physician collaboration rules concerning controlled substances.
Characteristics | Values |
---|---|
Does the Stark Law apply to nurse practitioners? | No |
Does the Stark Law apply to physician assistants? | No |
Does the Stark Law apply to other advanced practice nurses? | No |
What You'll Learn
Prescribing controlled substances
In Tennessee, certified nurse practitioners are allowed to prescribe controlled substances. They must first obtain a certificate of fitness from the State Board of Nursing and have their physician collaboration rules adopted.
Nurse practitioners are allowed to prescribe controlled substances listed in Schedules II, III, IV, and V. However, Schedules II, III, and IV controlled substances may only be prescribed after consultation with a licensed physician. Furthermore, a nurse practitioner may only prescribe or issue a Schedule II or III opioid listed on the formulary for a maximum of a non-refillable, 30-day course of treatment unless specifically approved after consultation with the collaborating physician.
Additionally, prescriptions must be written on a pre-printed prescription pad bearing the name, address, and telephone number of the collaborating physician and the nurse practitioner. The prescription must be signed by the nurse practitioner and include the name and strength of the drug, the quantity, instructions for use, and the date.
Nurse practitioners are also required to maintain a copy of the protocol they are using and make it available upon request by the Board of Nursing or the Board of Medical Examiners.
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Prescribing buprenorphine
In Tennessee, nurse practitioners are allowed to prescribe buprenorphine products under certain conditions. To do so, they must hold a federal DEA waiver and meet specific requirements. Here are the key points regarding nurse practitioners' authority to prescribe buprenorphine in Tennessee:
- Nurse practitioners in Tennessee are authorized to prescribe buprenorphine products if they possess a federal DEA waiver.
- To obtain a DEA waiver, nurse practitioners must complete specific training and meet certain qualifications, as outlined by the Drug Enforcement Administration (DEA).
- In addition to the DEA waiver, nurse practitioners must also obtain a certificate of fitness from the State Board of Nursing.
- The State Board of Nursing issues the certificate of fitness to nurse practitioners who meet the necessary qualifications, competencies, training, education, and experience to prescribe medications.
- When prescribing buprenorphine, nurse practitioners must collaborate with a licensed physician. This collaboration does not require the constant physical presence of the supervising physician, but they must be available for consultation at all times.
- Nurse practitioners can prescribe buprenorphine for substance use disorders and pain management.
- Buprenorphine prescriptions by nurse practitioners are subject to certain limitations and conditions specified by Tennessee law and regulations.
- Prior authorization requirements for prescribing buprenorphine may depend on the patient's insurance coverage, with state Medicaid or private insurance companies having discretion over these requirements.
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Prescribing hormonal contraceptives
In Tennessee, hormonal contraceptives are defined as self-administered drugs or transdermal patches applied to the skin of a patient, either by the patient or a practitioner, that release a combination of hormones approved by the FDA to prevent pregnancy.
Pharmacists in Tennessee are authorised to provide hormonal contraceptives to individuals who are 18 years of age or older, or under 18 if they are an emancipated minor. To do so, they must complete a training program, provide the patient with a self-screening risk assessment tool, and advise the patient to consult a primary or women's healthcare practitioner.
Nurse practitioners in Tennessee are authorised to prescribe and/or issue controlled substances (including hormonal contraceptives) listed in Schedules II, III, IV, and V. However, they must first obtain a certificate of fitness from the State Board of Nursing and adopt physician supervisory rules. For Schedules II, III, and IV controlled substances, prescriptions must be specifically authorised by the formulary or expressly approved after consultation with the collaborating physician.
In 2019, the Tennessee Board of Pharmacy revised Rule 1140-15, authorising pharmacists to prescribe and dispense hormonal contraceptives in specific circumstances.
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Prescribing requirements
In Tennessee, a nurse practitioner (NP) must obtain a certificate of fitness from the State Board of Nursing and have a collaborative practice agreement with a physician to prescribe medications. This includes controlled substances listed in Schedules II-V. However, for Schedules II-IV, the NP must first consult with the collaborating physician. The NP must also file a notice with the board, including the NP's name, the name of the collaborating physician, and a copy of the formulary describing the categories of legend drugs to be prescribed.
The prescription must be written on a preprinted prescription pad bearing the name, address, and telephone number of both the NP and the collaborating physician. The prescription must include the name and strength of the drug, the quantity, instructions for use, and the date it was issued. It must be signed by the NP and be legible to the pharmacist who fills it. Verbal prescriptions are also permitted.
Additionally, the NP must maintain a copy of the protocol they are using and make it available upon request by the Board of Nursing or the Board of Medical Examiners.
NPs providing services at a site remote from their collaborating physician's practice site may arrange for the required personal review of their charts by the collaborating physician either via HIPAA-compliant electronic means or in person. They may also arrange for up to ten of the required annual remote site visits by a collaborating physician via HIPAA-compliant electronic means. All other required site visits must take place in person.
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Prescribing authority
In Tennessee, a nurse practitioner (NP) can prescribe medication, including controlled substances, but only after receiving a certificate of fitness from the State Board of Nursing and the adoption of physician supervisory rules.
To obtain a certificate of fitness, a nurse practitioner must meet the qualifications, competencies, training, education, and experience to prepare them to write and sign prescriptions and/or issue drugs. This includes having a master's degree in a nursing clinical specialty area with preparation in specialized practitioner skills, including three-quarter hours of pharmacology instruction or its equivalent.
Once a nurse practitioner has been issued a certificate of fitness, they must file a notice with the board, containing the name of the licensed physician they are collaborating with, who has control and responsibility for the prescriptive services rendered by the nurse practitioner. The notice must also include a copy of the formulary describing the categories of legend drugs to be prescribed and/or issued by the nurse practitioner.
Nurse practitioners with a certificate of fitness are authorized to prescribe and/or issue controlled substances listed in Schedules II, III, IV, and V. However, they cannot prescribe Schedules II, III, and IV controlled substances unless the prescription is specifically authorized by the formulary or expressly approved after consultation with the collaborating physician before the initial issuance of the prescription or dispensing of the medication.
A nurse practitioner can only prescribe or issue a Schedule II or III opioid listed on the formulary for a maximum of a non-refillable, thirty-day course of treatment unless specifically approved after consultation with the collaborating physician before the initial issuance of the prescription or dispensing of the medication. This limitation does not apply to prescriptions issued in a hospital, a nursing home licensed under Tennessee law, or inpatient facilities licensed under Tennessee law.
Any prescription written and signed or drug issued by a nurse practitioner under collaboration with and the control of a collaborating physician is deemed to be that of the nurse practitioner. Every prescription issued by a nurse practitioner must be entered into the medical records of the patient and written on a preprinted prescription pad bearing the name, address, and telephone number of the collaborating physician and the nurse practitioner, and the nurse practitioner must sign each prescription.
Nurse practitioners are also authorized to issue verbal prescription orders.
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Frequently asked questions
The Stark Law is a strict liability statute that prohibits a physician from making a referral to an entity for designated health services that are reimbursable by Medicare if the physician has a financial relationship with the entity.
No, the Stark Law only applies to physicians.
The name comes from a United States Congressman named Peter Stark, who represented districts in California between 1972 and 2012.
Firstly, there is a prohibition on seeking payment for services that violate the Stark Law. Secondly, the Stark Law requires any amounts paid (patient deductibles and coinsurance, reimbursement from Federal health care programs) to be refunded. Finally, the government may penalize organizations $15,000 per claim and treble damages.
Exceptions to the Stark Law are divided into various categories and, for the most part, may only be utilized in that category. For example, certain exceptions only apply to investments or ownership by a physician, while others only apply to compensation arrangements with physicians.