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ADVISORY CONCERNING ELECTRONIC CIGARETTES, THE PRACTICE OF “VAPING,” “JUULING” AND USE OF OTHER ELECTRONIC NICOTINE DELIVERY SYSTEMS OR ENDS

Board of Pharmacy

Legislative Update - 2019

Public Chapter 61

This act states that an entity responsible for an AED program is immune from civil liability for personal injury caused by maintenance or use of an AED if such conduct does not rise to the level of willful or wanton misconduct or gross negligence.

This act took effect on March 28, 2019.

Public Chapter 87

This act redefines hemp in 43-27-101 to mirror the federal Hemp Farming Act of 2018. The act excludes hemp and any nonnarcotic substance approved by the FDA that can lawfully be sold over the counter without a prescription from a schedule. A license from the Department of Agriculture is required in order to produce hemp. The Commissioner of Agriculture shall promulgate rules within 120 days of this bill becoming law.

This act took effect April 4, 2019.

Public Chapter 117

This act adds a definition of “alternative treatments” to 63-1-164 pertaining to the restrictions and limitations on treating patients with opioids.

This act took effect April 9, 2019.

Public Chapter 124

This act makes a variety of small changes and additions to the TN Together opioid initiative put in place in 2018.  One addition is allowing access to CSMD data to a healthcare practitioner under review by a quality improvement committee (QIC), as well as to the QIC, if the information is furnished by a healthcare practitioner who is the subject of the review by the QIC. 

The requirement for e-prescribing of all schedule II substances by January 1, 2020 has been delayed to January 1, 2021 and is modified to require all schedule II through V prescriptions to be e-prescribed except under certain circumstances.  The law also requires all pharmacy dispensing software vendors operating in the state to update their systems to allow for partial filling of controlled substances.

Definitions are given by this act to the terms palliative care, severe burn and major physical trauma.  Along with its new definition, palliative care has now joined severe burn and major physical trauma as an exception to the opioid dosage limits otherwise required under TN Together. 

An unintended consequence of last year’s Public Chapter 1039 was on cough syrup.  This act establishes that the law does not apply to opioids approved by the FDA to treat upper respiratory symptoms or cough, but limits such cough syrup to a 14 day supply.

Also changed from last year’s act is the requirement to partial fill.  Partial filling of opioids is now permissive.

Finally, the opioid limits under have been simplified from the previous year’s act.  The twenty day supply and morphine milligram equivalent limit has been eliminated.  Three day and ten day requirements remain the same.  Instances such as more than minimally invasive surgery, which previously fell under the twenty day provision, now can be treated under the limits of the thirty day category.

This act took effect on April 9, 2019.            

Public Chapter 144

This act amends the Prevention of Youth Access to Tobacco and Vapor Products Act by limiting the places in which one may use vapor products.  The act defines vapor products and prohibits the use of such products in a number of locations including child care centers, group care homes, healthcare facilities (excluding nursing homes), residential treatment facilities, school grounds, and several other areas.  Several locations have specific exceptions set forth in the statute.

This act took effect on April 17, 2019.

Public Chapter 195

The majority of this act pertains to boards governed by the Department of Commerce and Insurance.  One small section applies to the health related boards. Currently, the health related boards have an expedited licensure process for military members and their spouses.  Previously, a spouse of an active military member had to leave active employment to be eligible for this expedited process.  This act removes that requirement.  This section applies to all health related boards.  The Commissioner of Health is permitted to promulgate rules, but rules are not needed to implement the act.

This act takes effect July 1, 2019.

Public Chapter 229

This act allows healthcare professionals to accept goods or services as payment in direct exchange of barter for healthcare services. Bartering is only permissible if the patient to whom services are provided is not covered by health insurance. All barters accepted by a healthcare professional must be submitted to the IRS annually. This act does not apply to healthcare services provided at a pain management clinic.

This act took effect April 30, 2019.

Public Chapter 243

This act mandates that an agency that requires a person applying for a license to engage in an occupation, trade, or profession in this state to take an examination must provide appropriate accommodations in accordance with the Americans with Disabilities Act (ADA). Any state agency that administers a required examination for licensure (except for examinations required by federal law) shall promulgate rules in regard to eligibility criteria. This legislation was introduced to assist individuals with dyslexia.

 This act took effect May 2, 2019 for the purpose of promulgating rules, and for all other purposes, takes effect July 1, 2020.

Public Chapter 255

The act permits a medical professional who has a current license to practice from another state, commonwealth territory, or the District of Columbia is exempt from the licensure requirements of such boards if: (1) the medical professional is a member of the armed forces; and (2) the medical professional is engaged in the practice of the medical profession listed in 68-1-101 through a partnership with the Federal Innovative Readiness Training. The respective health boards may promulgate rules for implementation.

This act took effect April 18, 2019 for the purpose of promulgating rules, and for all other purposes, takes effect July 1, 2019.

Public Chapter 264

This act permits the attorney general, reporter, and personnel to access confidential data from the Controlled Substance Monitoring Database upon request for the purposes of investigation or litigation of a civil action. Release of this information to other parties must be accompanied by an appropriate protective order. This bill was brought by the Office of the Attorney General.

This act took effect April 30, 2019.

Public Chapter 319

This act expands the practice of dental hygiene to include prescriptive authority limited to fluoride agents, topical oral anesthetic agents, and non-systemic oral antimicrobials provided that it is not a controlled substance under state and federal laws and it does not require a license by the federal drug enforcement agency. A dental hygienist’s prescriptive authority must be exercised under the general supervision of a licensed dentist, pursuant to board rules, and in compliance with all applicable law concerning prescription packaging, labeling, and record keeping requirements. A prescription written by a dental hygienist must be reviewed by a dentist within thirty days. The board shall promulgate rules to implement this act.

This act took effect May 8, 2019 for the purpose of promulgating rules. For all other purposes, this act will take effect on July 1, 2020.

Public Chapter 327

This act requires the Commissioner of Health, by January 1, 2020, to study instances when co-prescribing of naloxone with an opioid is beneficial and publish the results to each prescribing board and to the board of pharmacy.  The findings shall be included in the chronic pain guidelines adopted by the Chronic Pain Guidelines Committee.

This act took effect May 8, 2019.

Public Chapter 447

This act permits law enforcement agencies to subpoena materials and documents pertaining to an investigation conducted by the Department of Health prior to formal disciplinary charges being filed against the provider. This bill was brought by the Tennessee Bureau of Investigation.

This act went into effect May 22, 2019.

 

Legislative Update - 2018

 

Public Chapter 82

This act prohibits the sale of products containing dextromethorphan to persons less than 18 years of age.

Public Chapter 293

This act allows the Board of Pharmacy to regulate and license third party logistics providers with regard to controlled substances. 

Senate Bill 98/House Bill 87

This act allows would allow the Commissioner of Health or his designee to have electronic access to medical records in order to facilitate investigations when responding to an immediate threat to public health. Today the Commissioner of Health or his designee already has this authority but must go to the facility to review the medical records.

Public Chapter 94

This act defines “abuse” and “neglect” for purposes of placing a person on the registry of persons who have abused, neglected, or misappropriated the property of vulnerable individuals specifically within the statutes that govern the Dept. of Health. It does not impact the definitions within the statutes that govern the Dept. of Intellectual and Developmental Disabilities nor the Dept. of Human Services.  It also increases the time within which placement on the registry may be appealed from 30 to 60 days.

Public Chapter 59

This act changes the limits and the identification requirements for products that may be sold containing ephedrine or pseudophedrine. This applies to their salts, isomers and salts of isomers as well.

Public Chapter 26

This legislation deletes the Intractable Pain Act.  This becomes effective on July 1, 2015.

Public Chapter 352

This legislation would decriminalize the possession of cannabis oil as long as all of the following are met:

The oil contains less than 0.9% of THC and is labeled as such by the manufacturer
The person in possession retains proof of the legal order or recommendation from the issuing state
The person in possession retains proof that the person or person’s family member has been diagnosed with intractable seizures or epilepsy by a physician licensed to practice in TN

This legislation does not allow a physician in TN to prescribe, order or recommend the oil. 

This act became effective on April 16, 2015.

Public Chapter 40

This act allows pharmacies to participate in pharmacy drug disposal programs. This act will require rulemaking form the board.

Public Chapter 502

This act allows the Joint Government Operations Committee (the legislative committee that reviews all rules) to stay a rule up to 75 days instead of 60 days.  Present law authorizes the Joint Government Operations Committee to consider the following factors when reviewing rules: authority, clarity, consistency, justification, necessity and reference. This act adds arbitrariness and capriciousness as two new considerations.

Public Chapter 376

This creates the “Tennessee Right to Try Act.” It authorizes eligible patients to utilize investigational drugs, biological products or devices that have completed phase 1 of a clinical trial, but has not yet been approved for general us by the FDA. The clinical trial must be documented by the National Institutes of Health.  An eligible patient is:

someone with an advanced illness that is attested to by the patient’s treating physician and confirmed by a second physician
has considered all other FDA-approved treatment options
has received a recommendation from the patient’s physician for an investigational drug, biological product, or device
has given written, informed consent for the use of an investigational drug, biological product, or device
has documentation from such physician that the patient meets all the aforementioned requirements.

All expenses related to the use of investigational treatment will be borne by the patient.  Manufacturers are authorized to make investigational products available to patients with or without compensation.  This bill specifically prohibits Medicare or any licensing board from taking any adverse action against a licensee based solely on a recommendation for treatment with an investigational product and holds manufacturers and providers harmless if operating in good faith.  This act takes effect on July 1, 2015.

Public Chapter 396

This creates the “Addiction Treatment Act of 2015.”  It prevents certain criminal drug charges from being filed against an individual who is experiencing a drug overdose or is in the company of an individual who is experiencing a drug overdose and seeks or is the subject of a request for medical assistance.  Any such person is immune to penalties for a violation of a permanent or temporary protective order or restraining order or sanctions for a violation of a condition of pretrial release, condition of probation, or condition of parole based on a drug violation.  This immunity does not provide protection against seizure of any evidence or contraband, limit the admissibility of any evidence in connection with the investigation or prosecution of a crime for an individual who doesn’t qualify for the aforementioned exemptions, or limit the authority of a law enforcement officer to detain or take into custody a person in the course of an investigation or to effectuate an arrest for any offense not immune by the aforementioned exemptions.  This immunity only applies to the person’s first such drug overdose.

This bill further mandates that only M.D.’s or D.O.’s are permitted to prescribe buprenorphine for opioid dependence and it may only be prescribed for uses recognized by the FDA unless the patient has a documented opiate addiction, receives treatment from a DEA registered addiction treatment practice, and is counted as one of the total allowable number of patients the provider is allowed to treat.  Only pregnant women, nursing mothers, or patients with a hypersensitivity to naloxone may be prescribed buprenorphine mono.  These provisions do not apply to perioperative surgery or ventilator sedation performed in a licensed facility, or to inpatients and outpatients of a hospital.

The BME and the BOE are required to promulgate rules establishing requirements for licensees to qualify as addiction specialists. 

This act takes effect on July 1, 2015.

Public Chapter 268

This act makes disclosures of protected healthcare information permissible in medical malpractice lawsuits and became effective on April 24, 2015.

Public Chapter 371

This act defines biological product and interchangeable biological product and allows their use under all circumstances unless:

  •     An adverse reaction has previously taken place
  • The interchangeable has been previously deemed ineffective
  • Any other clinically based prescriber determined need or the interchangeable biologic is not available

When prescriber determines biological is medically necessary he/she must:  

  • Place these instructions on the prescription showing intent in writing
  • If orally the prescriber must alert the pharmacist
  • An electronic communication between prescriber and pharmacist that only the biological product be communicated

When a biologic is issued a pharmacist must:

  • Notify the patient of the substitution on the prescription label
  • Communication within 5 days to the prescriber by:
    • Add it to the interoperable electronic medical records system
    • Communication can be set forth in collaborative pharmacy agreement
    • That this communication only applies to the original communication and not the refill
  • Maintain a record of the biologic dispensed

This does not apply if the product if the product is:

  • Is directly dispensed to the patient
  • Is dispensed in a nursing home or assisted living facility
  • Vaccines

The board of pharmacy shall maintain a link on its website to the current list of all biological products determined by the FDA to be interchangeable.

Public Chapter 261

The act provides for the practice of telehealth. It outlines the following:

Defines a healthcare provider
Establishes a provider-patient relationship by mutual consent and mutual communication
Specifies that telehealth does not create a new standard care
Prohibits any board from creating a more restrictive standard of professional practice for telehealth service
Allows a physician to prescribe by means of telemedicine and follow all prescribing applicable statutes such as checking the Controlled Substance Monitoring Database; however, pain management clinics are not permitted

There is no separate telehealth license required by the Bd of Medical Examiners.

Public Chapter 476

Currently, the top 50 prescribers of controlled substances in the state are annually identified and sent a letter notifying them of their inclusion on this list and asked to respond with a justification for their prescribing patterns.  This legislation expands on this list and requires the top 10 prescribers from all of the combined counties having populations of fewer than 50,000 to also be on this annual list.

Separate from this provision, the bill also specifies that a provider of home medical equipment or services that provides its own company-branded insulin pumps and related supplies does not have to have a physical place of business in the state if the provider maintains an employee presence in the state, is accredited by the Joint Commission on Accreditation of Healthcare Organizations and maintains a 24-7 service telephone number.

This act took effect on April 22, 2015.

Public Chapter 611

This law requires an agency holding a public hearing as part of its rulemaking process, to make copies of the rule available in “redline form” to people attending the hearing.

This takes effect July 1, 2018.

Public Chapter 615

This act allows pharmacists in Tennessee to dispense a prescription without proper authorization or valid prescription to a patient from another state who was displaced by a disaster.  This must be done in good faith and the prescription information may be obtained from a prescription label, verbal order, or any other means determined to be legitimate in the professional judgment of the pharmacist.  The prescription may be for the number of dosages necessary to allow the patient to secure a valid prescription but no more than a 20 day supply.

This act takes effect on July 1, 2018.

Public Chapter 638

This chapter prohibits healthcare prescribers and their employees, agents, or independent contractors from in-person solicitation, telemarketing, or telephonic solicitation of victims within 30 days of an accident or disaster for the
purpose of marketing services of the healing arts related to the accident or disaster.  There are specific exceptions
laid out in the chapter.

This act takes effect July 1, 2018.

Public Chapter 675

This act requires the department of health to accept allegations of opioid abuse or diversion and for the department to publicize a means of reporting allegations. 

Any entity that prescribes, dispenses, OR handles opioids is required to provide information to employees about reporting suspected opioid abuse/diversion.  That notice is to either be provided individually to the employee in writing and documented by the employer OR by posting a sign in a conspicuous, non-public area of minimum height and width
stating: “NOTICE: PLEASE REPORT ANY SUSPECTED ABUSE OR DIVERSION OF OPIOIDS, OR ANY OTHER IMPROPER BEHAVIOR WITH RESPECT TO OPIOIDS, TO THE DEPARTMENT OF HEALTH'S COMPLAINT INTAKE LINE: 800-852-2187.”

Whistleblower protections are also established.  An individual who makes a report in good faith may not be terminated or suffer adverse licensure action solely based on the report.  The individual also is immune from any civil liability related to a good faith report. 

This act takes effect January 1, 2019.

Public Chapter 744

This statute allows a licensing entity the discretion to not suspend/deny/revoke a license in cases where the licensee has defaulted or become delinquent on student loans IF a medical hardship significantly contributed to the default or delinquency.

This act took effect January 1, 2019.

Public Chapter 745 and Public Chapter 793

These public chapters work together to create and implement the “Fresh Start Act.”  Licensing authorities are prohibited from denying an application or renewal for a license/certificate/registration due to a prior criminal conviction that does not directly relate to the applicable occupation.  Lays out the requirements on the licensing authorities as well as the exceptions to the law (ex: rebuttable presumption regarding A and B level felonies). 

These acts take effect July 1, 2018.

Public Chapter 754

This chapter prevents any board, commission, committee, etc. created by statute from promulgating rules, issuing statements, or issuing intra-agency memoranda that infringe on an entity member’s freedom of speech. 

Freedom of speech includes, but is not limited to, a member’s freedom to express an opinion concerning any matter relating to that governmental entity, excluding matters deemed to be confidential under TCA 10-7-504.

Violations as determined by a joint evaluation committee may result in recommendations to the general assembly concerning the entity’s sunset status, rulemaking authority and funding.

This act took effect April 18, 2018.

Public Chapter 883

This act lays the framework for e-prescribing practices in the state and the exceptions from electronic prescriptions. Requires that all Schedule II prescriptions be e-prescribed by January 1, 2020 except under certain circumstances.  Any health-related board under TCA 68-1-101(a)(8) that is affected by this act shall report to the general assembly by January 1, 2019 on issues related to the implementation of this section.  The commissioner of health is authorized to promulgate rules to effectuate the purposes of this act. 

This act took effect May 3, 2018 for rule purposes.

The act takes effect January 1, 2019 for all other purposes.

Public Chapter 893

This chapter allows for pharmaceutical manufacturers or their representatives to engage in truthful promotion of off-label uses.  The act also prohibits action against pharmaceutical manufacturer’s, pharmaceutical representative’s, healthcare institution’s or physician’s license solely for such activity.

This act takes effect July 1, 2018

Public Chapter 901

This act requires that prior to prescribing more than a three day supply of an opioid or an opioid dosage that exceeds at total of 180 MME to a woman of childbearing age (15-44yo), a prescriber must do the following:

  1. Advise of risks associated with opioid use during pregnancy;
  2. Counsel patient on effective forms of birth control; and
  3. Offer information on availability of free or reduced cost birth control  

Doesn’t apply if previously informed by prescriber in previous three months or prescriber reasonably believes patient is incapable of becoming pregnant.  Requirements may be met with a patient under 18 years of age by informing parent of the patient. 

The Department of Health is to publish guidance to assist prescribers in complying with this act.

This act takes effect July 1, 2018.

Public Chapter 929

This act redefines policy and rule and requires each agency to submit a list of all policies, with certain exceptions, that have been adopted or changed in the previous year to the chairs of the government operations committees on July 1
of each year.  The submission shall include a summary of the policy and the justification for adopting a policy
instead of a rule.

This act also prohibits any policy or rule by any agency that infringes upon an agency member’s freedom of speech. 

Finally, this act establishes that an agency’s appointing authority shall have the sole power to remove a member from a board, committee, etc.

This act takes effect July 1, 2018 and applies to policies adopted on or after that date.

Public Chapter 954

This legislation requires the initial licensure fee for low-income persons to be waived.  Low income individuals per the
statute are defined as persons who are enrolled in a state or federal public assistance program including but not limited to TANF, Medicaid, and SNAP.  All licensing authorities are required to promulgate rules to effectuate the purposes of this act. 

This act takes effect January 1, 2019.

Public Chapter 978

This act makes a number of revisions to opioid treatment regulations.  The definition of “nonresidential office-based opiate treatment facility” (OBOT) has been changed to encompass more facilities.

The commissioner of mental health is required to revise the rules of OBOTs to be consistent with state and federal law for such facilities to establish certain new protocols. Rules regarding OBOTs are to be reviewed each even-numbered year and the department of mental health and substance abuse services shall submit the rules for OBOTs to each health related board that licenses any practitioner authorized by the state to prescribe products for treatment of an opioid use disorder.  Each board is required to enforce the rules.  Each board is required to post the rules on the board’s website. Violation of a rule is grounds for disciplinary action by the board.

The act also makes revisions to the licensing fees of OBOTs.

The act requires revision of the buprenorphine treatment guidelines.

The legislation also requires (subject to 42 CFR part 2) that dispensing of buprenorphine be subject to the Controlled Substance Monitoring Database (CSMD) requirements.

The act prohibits dispensing of buprenorphine except by certain individuals/facilities and requires pharmacies/distributors to report to the department of health (TDH) the quantities of buprenorphine that are delivered to OBOTs in the state.

The act also makes revisions to the high-volume prescriber list compiled by TDH.

The act requires the comptroller to complete a study of statistically abnormal prescribing patterns.  After the study,
TDH shall identify prescribers and shall inquire with the boards of action taken against the prescribers and the board is required to respond within 30 days.  Each board is required to report the total number of prescribers disciplined each year, as well as other information.  TDH shall report a summary of the data and of the disciplinary actions to the chairs of the health committees.

The act also comprises a task force to create minimum disciplinary actions for prescribing practices that are a significant deviation from sound medical judgment.  The board of medical examiners, osteopathic examination, dentistry, podiatric medical examiners, optometry, nursing and medical examiner’s committee on physician assistants shall select one member each for the task force before September 1, 2018. 

This act took effect for rulemaking on May 21, 2018 and takes effect July 1, 2018 for all other purposes.

Public Chapter 1007

This act allows for a prescription for a controlled substance to be partial filled if requested by the patient or the practitioner who wrote the prescription AND the total quantity dispensed through partial fills does not exceed the total
quantity prescribed for the original prescription.  The act lays out the requirements on the pharmacists and gives details regarding payments.

This act takes effect January 1, 2019.

Public Chapter 1015

This legislation lays out the specific requirements of hospitals to notify law enforcement of involuntary commitments as well as the possible penalties for failure to comply.  Inspections of hospitals by the department of mental health and the department of health shall include a determination of the hospital’s compliance with the reporting requirements of this act.   

The act also allows a pharmacist the right to provide information to an insured regarding the amount of the insured’s cost share for a prescription drug.  Neither a pharmacy nor a pharmacist shall be penalized by a pharmacy benefits manager for discussing such information or selling a lower priced drug if one is available. 

This act takes effect July 1, 2018.

Public Chapter 1021

This act allows for appeals of contested case hearings to be in the chancery court nearest the residence of the person contesting the agency action or at that person’s discretion, in the chancery court nearest the place the action arose,
or in the chancery court of Davidson County.  Petitions seeking review must be filed within 60 days after entry of the
agency’s final order. 

This act takes effect July 1, 2018.

Public Chapter 1029

This act requires the board of pharmacy to promulgate rules regarding the board’s oversight of facilities that manufacture, warehouse, and distribute medical devices.  Rulemaking shall begin no later than September 1, 2018.  The rulemaking process shall include the formation of an advisory committee composed of medical device industry representatives and a representative of the department of economic and community development. Rules promulgated shall be reviewed every three years for purposes of reviewing advancements of new medical device technologies.

This act takes effect July 1, 2018.

Public Chapter 1039

This legislation places limits and requirements on the amount of opioids prescribed and dispensed.  It limits opioid prescriptions to up to a three day supply with a total of 180 MME (morphine milligram equivalents) for those three
days.  This limitation is subject to a number of exceptions under certain circumstances.  These exceptions include up to a ten day supply with a total of 500 MME, up to a twenty day supply with a total of 850 MME for a procedure that is more than minimally invasive, and up to a thirty day supply with a total of 1200 MME when other reasonable and appropriate non-opioid treatments have been attempted and failed and the risk of adverse effects from the pain exceeds the risk of the patient developing an addiction or overdose.  Prescribing under these exceptions requires the prescriber to check the controlled substance monitoring database, personally conduct a physical exam of the patient, consider non-opioid alternatives, obtain informed consent including counseling about neonatal abstinence syndrome and contraception for women of childbearing age, and document the ICD-10 code for the patient’s primary disease (as well as the term “medical necessity” on thirty day prescriptions).  These ten, twenty, and thirty day opioid prescriptions will only be filled by dispensers in an amount that is half of the full prescription at a time, requiring patients and pharmacists to consider
whether the patient requires the full amount prescribed.  There are still further exceptions for those patients undergoing active or palliative cancer treatment, receiving hospice care, diagnosed with sickle cell disease, administered to in a hospital, being treated by a pain management specialist or collaborating provider in a pain management clinic, who have received ninety days or more in the year prior to April 2018 or subsequently do so under one of the exceptions, receiving treatment for medication-assisted treatment, or suffering severe burns or major physical trauma. 

This act took effect for rule purposes on May 21, 2018, and for all other purposes shall take effect July 1, 2018.

Public Chapter 1040

This act revises various provisions of the law regarding controlled substances and their analogues and derivatives, including updating identifications of drugs categorized in Schedules I - V.  The act also creates an offense for the sale or offer to sell Kratom, unless it is labeled and in its natural form.  It is also an offense to distribute, sell, or offer for sale, kratom to a person under 21 years of age.  It is also an offense to purchase or possess kratom if under 21 years of age.  

This act takes effect July 1, 2018.