New 2019 Legislation

Colorado Medical Board

Mental Health Boards

State Board of Pharmacy

All Prescribers

 

 

 

Colorado Medical Board

HB19-1028 Medical Marijuana Condition Autism

On April 2, 2019, Governor Jared Polis signed HB19-1028 Medical Marijuana Condition Autism. The new law allows a patient with an autism spectrum disorder (ASD) to use medical marijuana and went into effect immediately upon the Governor's signature. The new law creates the same rights, limitations, affirmative defense, and exceptions from criminal laws for these conditions as the constitutional right to use medical marijuana for other debilitating conditions. ASD must be diagnosed by a primary care physician, a physician with experience in ASD, or licensed mental health provider acting within their scope of practice in order to qualify as a disabling medical condition.

Under current law, to be added to the medical marijuana registry, a child under the age of 18 must have been diagnosed with a disabling medical condition by two physicians, one of whom must be a board-certified pediatrician, family physician, or a child and adolescent psychiatrist who attests that he or she is part of the patient's primary care team. The new law removes the requirement on specific physicians, aligning it with the constitutional requirement that two physicians diagnose the patient as having a disabling medical condition. If the recommending physician is not the patient's primary care physician, the recommending physician must review the records of a diagnosing physician or a licensed mental health provider acting within their scope of practice. In addition, the new law encourages the State Board of Health in the Colorado Department of Public Health and Environment (CDPHE) to prioritize medical marijuana health research grants for studies to gather objective scientific research regarding the efficacy and the safety of administering medical marijuana for ovarian cancer, dementia, and pediatric conditions, including but not limited to ASD, and other conditions the State Board deems suitable.

 

HB19-1095 Physician Assistants Supervision and Liability

On June 3, 2019, Governor Jared Polis signed HB19-1095 Physician Assistants Supervision and Liability. The new law modifies supervision requirements for physician assistants and goes into effect August 2, 2019. It also modifies physician assistant representation on the Colorado Medical Board and its licensing panel.

Supervision requirements

  • Less than three years - Under current law, physician assistants are continually supervised by a supervising physician. For physician assistants who have practiced less than three years, the bill requires at least 160 hours of supervision by a supervising physician, of which 40 hours must be completed by the primary supervising physician. After 160 supervised hours, the supervising physician must complete an initial performance assessment, complete a supervisory plan, and remain available to the physician assistant at all times while the physician assistant is working.
  • Changing practice - For a physician assistant who has practiced for at least 12 months and is making a substantive change in his or her practice area, the first 80 working hours must be supervised by a supervising physician who works at the same location, with 20 hours of supervision from the primary supervising physician. The supervising physician must then remain available to the physician assistant during all working hours and complete a performance assessment after 6 and 12 months of work.
  • After three years - For a physician assistant who has practiced in the state for three years or more, the scope of supervision is determined by a practice agreement between the primary supervising physician and the physician assistant. In addition, after 3 years, a physician assistant may be liable for damages resulting from negligence, unless the damages occur as a result of a direct order from a supervising physician. A physician assistant who may be liable for damages must maintain at least $1.0 million per claim in liability insurance and $3.0 million for all claims.
  • Supervision limit changed - Under current law, a physician can supervise up to four physician assistants at any one time. The new law increases this limit to eight, if the physician agrees to assume the responsibility of more than four physician assistants.

In addition, the new law increases the number of physician assistants on the Colorado Medical Board, from one to two, and adds one physician assistant to the licensing panel of the Colorado Medical Board.

 

SB19-013 Medical Marijuana Condition Opiates Prescribed

On May 23, 2019, Governor Jared Polis signed SB19-013 Medical Marijuana Condition Opiates Prescribed, which goes into effect August 2, 2019. The new law creates a statutory right to use medical marijuana for a patient with a condition for which a physician could prescribe an opiate for pain. The law creates the same rights, limitations, affirmative defense, and exceptions from criminal laws for these conditions as the constitutional right to use medical marijuana for other debilitating conditions. Under current law, to be added to the medical marijuana registry, a child under the age of 18 must have been diagnosed with a disabling medical condition by two physicians, one of whom must be a board-certified pediatrician, family physician, or a child and adolescent psychiatrist who attests that he or she is part of the patient's primary care team.

The new law removes the requirement on specific specialty physicians, aligning it with the constitutional requirement that two physicians diagnose the patient as having a disabling medical condition. If the recommending physician is not the patient's primary care physician, the recommending physician must review the records of a diagnosing physician or a licensed mental health provider acting within their scope of practice. To conform with current law, the bill clarifies that a patient with a disabling medical condition who is under the age of 18 must only use medical marijuana in a non-smokeable form when at the student's school, on a school bus, or at a school-sponsored event.

 

SB19-052 Emergency Medical Service Provider Scope of Practice

On May 16, 2019, Governor Jared Polis signed SB19-052 Emergency Medical Service Provider Scope of Practice. The new law is effective August 2, 2019, and expands an emergency medical service (EMS) provider's scope of practice to practice in a clinical setting under the medical supervision of a physician, physician assistant, advanced practice nurse, or registered nurse. The State Board of Health in the Department of Public Health and Environment must promulgate conforming rules. Each clinical setting at which an EMS provider practices must establish operating policies and procedures to ensure that EMS providers perform tasks and procedures within their scope of practice.

 

SB19-073 Statewide System of Medical Directives

On May 16, 2019, Governor Jared Polis signed SB19-073 Statewide System of Medical Directives. The new law goes into effect on August 2, 2019, and creates a statewide electronic system of medical directives that allows qualified individuals to upload and access these documents. The individual whose medical treatment is subject to the advanced medical directive, or the individual‚Äôs surrogate decision-maker, is responsible for ensuring the information uploaded to the system is current and accurate. No emergency personnel, health care provider, health care facility, or any other person is civilly or criminally liable for actions that comply with a legally executed advance medical directive that is accessed from the system, unless the person or entity has knowledge of an advance health care directive that is executed after the date of the advance health care directive that is uploaded to the system. The Colorado Department of Public Health and Environment will promulgate rules and contract with one or more health information organization networks for the creation, administration, and maintenance of the system.

 

SB19-079 Electronic Prescribing of Controlled Substances

On April 8, 2019, Governor Jared Polis signed SB19-079 Electronic Prescribing of Controlled Substances. This law requires that all podiatrists, dentists, physicians, physician assistants, advanced practice nurses, and optometrists that prescribe a schedule II, III, or IV controlled substance do so electronically, with certain exceptions. The law does not require pharmacists to verify the applicability of an exception to electronic prescribing and pharmacists may dispense the controlled substance pursuant to an order that is written, oral, or facsimile-transmitted that is valid and consistent with current law. For most prescribers, the requirement begins July 1, 2021. For dentists and prescribers who work in a solo practice, or in a rural area, the requirement begins July 1, 2023.

 

SB19-193 Sunset Continue Colorado Medical Practice Act

On May 31, 2019, Governor Jared Polis signed SB19-193 Sunset Continue Colorado Medical Practice Act. The new law goes into effect on July 1, 2019, and continues the Colorado Medical Board in the Department of Regulatory Agencies until September 1, 2026. It also implements the following recommendations from the Sunset Review:

  • Eliminates the 60-day limit on a physician pro-bono license.
  • Removes the requirement for the Board to send a letter of admonition through certified mail.
  • Adds ‚Äúresorting to fraud in order to obtain a license‚Äù as unprofessional conduct for an anesthesiologist assistant.
  • Allows the Colorado Medical Board to suspend a medical license if the licensee has been formally charged with a crime, and the Board finds the crime is a continuing threat to patient safety.

The Colorado Medical Board's new sunset date is September 1,2026.

 

SB19-201 Open Discussions About Adverse Health Care Incidents

On May 6, 2019, Governor Jared Polis signed SB 19-201 Open Discussions About Adverse Health Care Incidents. This new law creates the "Colorado Candor Act‚ and establishes a process for the communication between a patient and a healthcare provider or health facility after an adverse health care incident. Under the new law, if an adverse health care incident occurs, a health care provider involved with the incident, either individually or jointly with the facility involved, may request that the patient enter into an open discussion concerning the incident. The request must include certain components listed in the law.

If an offer of compensation is made, the new law requires certain processes for payment and financial resolution to be followed. If a health care provider or health facility determines that no offer of compensation is warranted, the health care provider or health facility shall orally communicate that decision with the patient.

A health care provider or facility may provide de-identified information about an adverse health care incident to any patient safety centered nonprofit organization.

 

SB19-218 Sunset Medical Marijuana Program

On May 29, 2019, Governor Jared Polis signed SB19-218 Sunset Medical Marijuana Program. This bill extends the Medical Marijuana Program in the Department of Public Health and Environment (CDPHE) until September 1, 2028, implements recommendations from the Department of Regulatory Agencies sunset review, and makes a number of other changes. Specifically, the bill:

  • Clarifies that if the patient is a minor, the physician must consult with the patient and the patient's parents and clarifies that a parent can serve as a primary caregiver for a child with a disabling medical condition.
  • Specifies that doctor-patient consultations include explaining the possible risks and benefits of the use of medical marijuana
  • Clarifies that caregivers for patients with debilitating medical conditions are extended the same confidentiality protections as caregivers for patients with disabling medical conditions.
  • Clarifies that medical marijuana registry cards are subject to revocation if a patient is convicted of a drug crime.
  • Specifies that only a physician can make a medical marijuana recommendation, except for recommendations for patients with disabling medical conditions, which may be made by a physician, dentist, or advanced practice practitioner with prescriptive authority who holds a license in good standing and who is acting within his or her scope of practice.
  • Directs CDPHE to promulgate rules related to the length of time that a medical marijuana registry card is valid.
  • Requires financial disclosures from members of the Retail Marijuana Public Health Advisory Committee and expands the expertise that must be represented on the committee.
  • Allows CDPHE to inquire about collecting Colorado-specific data from the All-Payer Claims Database, hospital discharge data, and available peer-reviewed research studies.

 

SB19-224 Sunset Regulated Marijuana

On May 28, 2019, Governor Jared Polis signed SB19-224 Sunset Regulated Marijuana. The new law, effective at various points beginning on August 2, 2019, continues the regulation of medical and retail marijuana until September 1, 2028, incorporates recommendations from the sunset reviews for the Colorado Medical Marijuana Code and the Colorado Retail Marijuana Code, and makes other changes. Changes include integrating the two codes into one code entitled the Colorado Marijuana Code. Other changes affect licensing, enforcement, medical marijuana specifically, and industrial hemp as shown below.

The new law makes the following changes to marijuana licensing:

  • Creates new ownership types and updates definitions and various requirements of direct beneficial interest owner, indirect beneficial interest owner, and permitted economic interest.
  • Streamlines the license renewal process.
  • Merges the research and development license and research and development cultivation licenses.
  • Creates two accelerator licenses and endorsements, and related requirements and limits.
  • Requires the Marijuana Enforcement Division (MED) to track information on license disqualifications based on criminal history.
  • Permits a person to hold a license from both the MED and Limited Gaming Divisions.
  • Makes certain confidential information available to the public on an aggregated and de-identified basis.
  • Requires certain licensees to post signage about the risks of marijuana use while pregnant or breastfeeding.
  • Establishes a permit to allow a cultivation licensee to operate at two locations temporarily while changing locations, with certain restrictions.
  • Allows retail marijuana stores to offer bonuses to employees.
  • Specifies marijuana employee labor rights and designations.
  • Specifies requirements about delivery of marijuana, and the issuance of marijuana delivery permits.
  • Requires notification to applicants that having a license or working in the marijuana industry may have adverse federal immigration consequences.
  • Allows, under some circumstances, publicly traded corporations to hold an interest in marijuana businesses.
  • Limits redundant testing requirements.
  • Requires, for the purpose of regulation and testing, treating metered-dose inhalers the same as vaporized delivery devices.
  • Requires the MED to establish conditions under which a licensee can recycle cannabis waste.
  • Aligns medical and retail labeling requirements.
  • Allows manufacturing facilities to manufacture products using ingredients from more than five sources.
  • Removes the prohibition against issuing a license for a medical marijuana business to a physician who makes patient recommendations.
  • Directs the state licensing authority to convene a workgroup to advise on various rule-making processes.
  • Reduces the amount of time after a felony conviction or drug felony conviction for a person to be eligible to apply for licensure.

The new law makes the following changes to the enforcement function of the MED:

  • Defines "open" and "public" consumption and allows local governments to authorize exceptions for certain consumption locations or circumstances.
  • Authorizes the MED to seek injunctive relief and investigatory subpoenas from district courts as necessary to enforce the codes against licensees and unlicensed individuals.
  • Authorizes discipline for not accurately satisfying reporting, disclosure, or registration requirements.
  • Specifies that info or records related to a medical marijuana patient constitute medical data.
  • Harmonizes the unlawful acts between the two codes.
  • Makes it unlawful to knowingly adulterate or alter samples to circumvent testing results.

Several changes affect only medical marijuana. These include:

  • Requiring the MED to adopt equivalency standards for medical marijuana products and concentrate by July 1, 2020.
  • Limiting the amount of medical marijuana that can be sold, except if certain circumstances apply.
  • Specifying requirements for medical research and pesticide manufacturers to obtain medical marijuana.
  • Limiting the source of marijuana seeds or immature plants by medical cultivators to certain specified sources.
  • Repealing the requirement that a medical marijuana patient show a certified mail receipt as proof of a registry application submission.
  • Expanding the applicability of the Colorado Food and Drug Act to medical marijuana, while repealing the requirement to label medical marijuana with a list of all chemical additives used in cultivation and production.

Two changes address industrial hemp products. These include:

  • Allowing retail marijuana stores to sell industrial hemp consumable products, and providing related definitions.
  • Requiring industrial hemp to be tested prior to being manufactured into regulated marijuana products.

 

SB19-227 Harm Reduction Substance Use Disorders

On May 23, 2019, Governor Jared Polis signed SB19-227 Harm Reduction Substance Use Disorders. The new law creates and expands certain substance use disorder treatment programs. Among other provisions, the new law:

  • creates an opiate antagonist bulk purchase program,
  • expands the list of individuals and organizations to whom a physician and advanced practice nurse may prescribe or dispense an opiate antagonist,
  • requires opioid antagonists to be made available alongside publicly funded defibrillators,
  • allows opiate antagonists to be administered by school staff, and
  • expands the medication take-back program to include syringes.

 

SB19-228 Substance Use Disorders Prevention

On May 23, 2019, Governor Jared Polis signed SB19-228 Substance Use Disorders Prevention.

The law went into effect immediately upon the Governor's signature. The law requires the Colorado Medical Board, State Board of Nursing, Colorado Dental Board, State Board of Optometry, Colorado Podiatry Board, and the State Board of Veterinary Medicine to adopt rules on substance use disorder training for prescribers. The rules must require certain health care providers, as a condition of license renewal, reactivation or reinstatement on or after October 1, 2019, to complete up to four credit hours of training per licensing cycle related to:

  • Best practices for opioid prescribing, according to the most recent version of the Division‚Äôs Guidelines for Prescribing and Dispensing Opioids,
  • Recognition of substance use disorders,
  • Referral of patients with substance use disorders for treatment, and,
  • Use of the Electronic Prescription Drug Monitoring Program.

The new requirements apply to podiatrists, physicians, physician assistants, dentists, advanced practice nurses with prescriptive authority, optometrists, and veterinarians, except that each Board’s rules must exempt from the training requirements any health care provider who:

  • Maintains a national board certification that requires equivalent substance use prevention training, or
  • Attests to the appropriate board that the health care provider does not prescribe opioids.

In addition to the substance abuse prevention training requirements, the new law includes the following provisions:

  • Restricts a physician, physician assistant, or advanced practice nurse from accepting any direct or indirect benefits for prescribing a specific medication,
  • Allows pharmacies to charge enhanced dispensing fees if they provide counseling concerning the risks of opioids to patients who have not previously received opioid prescriptions,
  • Allows medical examiners and coroners to access the Prescription Drug Monitoring Program (PDMP) under specified circumstances,
  • Requires opioid prescriptions for outpatient use to bear a warning label, and,
  • Provides funding for the implementation of several programs for the prevention of opioid and other substance use disorders in the Department of Human Services (DHS), the Department of Public Health and Environment (CDPHE) and local public health agencies (LPHAs), and the University of Colorado.

 

 

 

Mental Health Boards

HB19-1044 Advance Behavioral Health Orders Treatment

On March 28, 2019, Governor Jared Polis signed HB19-1044 Advance Behavioral Health Orders Treatment. The new law, effective August 2, 2019, allows an adult, 18 years of age or older, to establish a behavioral health order for scope of treatment (behavioral health orders) that communicates his or her behavioral health history, decisions, and preferences in the event that he or she later lacks decisional capacity to provide informed consent to, withdrawal from, or refuse behavioral health treatment. The law also: aligns the new process for behavioral health orders with current advance medical orders for scope of treatment, lists the requirements for behavioral health orders, details the duties and immunities for medical personnel treating an adult with a behavioral health order, details how a behavioral health order form may be executed, amended, or revoked, and specifies that executing or failing to execute a behavioral health order does not affect any health insurance contract, life insurance contract, or annuity.

 

HB19-1120 Youth Mental Health Education &, Suicide Prevention

On May 16, 2019, Governor Jared Polis signed HB19-1120 Youth Mental Health Education &, Suicide Prevention. The new law, which took effect upon signature, permits a licensed or registered mental health professional to provide psychotherapy services to a minor who is between the ages of twelve and fourteen years old, at the minor's request, with or without consent of the minor's legal guardian, if the mental health professional determines that psychotherapy services are clinically indicated and necessary to the minor‚Äôs well-being. The mental health professional may advise the minor's legal guardian of services provided with the consent of the minor or a court in specific circumstances, unless notifying the legal guardian would be inappropriate or detrimental to the minor's care and treatment. The mental health professional may notify the legal guardian, without the minor's consent, if their professional opinion the minor is unable to manage their own care or treatment. The law includes documentation requirements and specifies that psychotherapy services must be provided in a culturally appropriate manner. The law also specifies that treatment without parental consent does not apply to inpatient treatment and that current law concerning liability and duty to warn for mental health professionals applies when a minor communicates a threat or intent to harm themselves or others.

The new law also requires the Colorado Department of Education (CDE) to - by July 1, 2010 - create and maintain a resource bank of program materials and curricula pertaining to mental health that is available to elementary and secondary schools in the state free of charge, in both English and Spanish. Upon request, CDE must provide technical assistance schools and others in designing age-appropriate curricula pertaining to mental health. The law also requires the Colorado State Board of Education to adopt standards that identify the knowledge and skills that an elementary through secondary education student should acquire related to mental health, including suicide prevention.

 

HB19-1129 Prohibit Conversion Therapy for a Minor

On May 31, 2019, Governor Jared Polis signed HB19-1129 Prohibit Conversion Therapy for a Minor. The new law goes into effect on August 2, 2019, and prohibits a licensed physician specializing in psychiatry or a licensed, certified, or registered mental health care provider from engaging in conversion therapy with a patient under 18 years of age. Any licensee who engages in these practices is subject to disciplinary action by the appropriate mental health licensing board or the Colorado Medical Board, respectively.

 

HB19-1197 Protect Caseworkers\' Personal Information on the Internet

On April 11, 2019, Governor Jared Polis signed HB19-1197 Protect Caseworkers’ Personal Information on the Internet. The new law, effective upon signature, makes it illegal for a person to post on the internet the personal information of caseworkers or their immediate family members if the dissemination of personal information poses an imminent and serious threat. A caseworker is defined as a state or county employee, including a county attorney, who is engaged in investigating or taking legal action regarding allegations of child abuse or neglect. Any violation of this section is a class 1 misdemeanor. In addition, the caseworker may submit a written request to a state or local government official to remove records that the official makes available on the internet if the public availability of this information poses an imminent and serious threat to the caseworker or their immediate family members.

 

SB19-1017 Kindergarten through Fifth Grade Social and Emotional Health Act

On March 10, 2019, Governor Jared Polis signed SB19-1017 Kindergarten through Fifth Grade Social and Emotional Health Act. The new law creates the K-5 Social and Emotional Health Pilot Program in the Colorado Department of Education (CDE), which will begin in the 2020-21 school year and continues for three years. The program places additional school mental health professionals in up to 10 pilot elementary or K5 schools that have high poverty and high needs students, with the intent of reducing social, emotional, and behavioral issues, adverse childhood experiences, disciplinary referrals, delinquency, truancy, and incidences of self-harm. A school mental health professional means a school counselor, a school psychologist, or a school social worker, each of which are further defined in the new law. Each school mental health professional must provide students with the services authorized under their professional special services license and specific endorsement, including functional behavior assessments, development of behavior intervention plans, and arranging for students to receive additional services from mental health professionals outside the school. Services may be provided to the student's family and household. The new law also lays out the pilot program implementation schedule and various pilot program requirements.

 

 

 

State Board of Pharmacy

HB19-1077 Pharmacist Dispense Drug Without Prescription in Emergency

On March 21, 2019, Governor Jared Polis signed HB19-1077 Pharmacist Dispense Drug Without Prescription in Emergency. The new law went into effect immediately upon signature and allows pharmacists to dispense to a patient an emergency supply of a chronic maintenance drug without a current valid prescription if the following conditions exist:

  • the pharmacist has made every reasonable attempt to obtain an authorization for a refill,
  • the pharmacist has a record of the prescription or has been presented proof of a recent prescription or, in the pharmacist's professional judgment, refusal to dispense the drug would endanger the patient's health,
  • the amount dispensed does not exceed the most recent prescription or the standard quantity of the drug,
  • the pharmacist has not dispensed an emergency supply of the chronic maintenance drug to the same patient in the previous 12 months, and
  • the prescriber has not indicated that no emergency refills are authorized.

A chronic maintenance drug is defined as one prescribed to a patient to take on a recurring basis or is used as a lifesaving rescue drug for a chronic condition, but is not an opioid or controlled substance that is prohibited from being dispensed without a prescription under federal law. In accordance with Section 12-280-122.5, Colorado Revised Statutes, the State Board of Pharmacy has adopted rules, in consultation with the Colorado Medical Board and the State Board of Nursing, to establish standard procedures for pharmacists. In addition, the pharmacist, pharmacist's employer, or the original prescriber is not civilly liable for an act or omission in connection with the dispensing of a chronic maintenance drug unless there is negligence, recklessness, or willful or wanton misconduct.

 

HB19-1109 Convalescent Centers as Pharmacies

On March 7, 2019, Governor Jared Polis signed HB19-1109 Convalescent Centers as Pharmacies. The new law is effective August 2, 2019 and it allows a licensed convalescent center or hospice to register as an Other Outlet with the Board of Pharmacy in order to procure, store, order, dispense, and administer prescription medications.

 

HB19-1131 Prescription Drug Cost Education

On May 16, 2019, Governor Jared Polis signed HB19-1131 Prescription Drug Cost Education. The new law is effective August 2, 2019. The new law requires a drug wholesaler or manufacturer (or agent/employee thereof) who is engaged in prescription drug marketing to provide the wholesale acquisition cost of a prescription drug to a prescriber with whom drug-related information is shared, as well as information on other prescription drugs in the same therapeutic class.

 

HB19-1242 Regulate Pharmacy Technicians

On June 3, 2019, Governor Jared Polis signed HB19-1242 Regulate Pharmacy Technicians. This new law goes into effect on October 1, 2019, and requires pharmacy technicians practicing in Colorado on or after March 30, 2020, to obtain a certification or provisional certification from the State Board of Pharmacy (Board). An applicant for certification by the Board must pass a criminal history record check and provide proof of certification by a board-approved, nationally-recognized organization that certifies pharmacy technicians. To allow time to meet the requirements, the Board may grant a one-time provisional certification of up to 18 months to an applicant who has not satisfied certain requirements for certification. The provisional certification may be extended due to hardships. Pharmacy technicians also must meet continuing education requirements before renewing a certification. The new law states that any pharmacy technician on duty must be certified or have a provisional certification. Finally, the law includes a sunset date of September 1, 2021.

 

SB19-005 Importation of Prescription Drugs From Canada

On May 16, 2019, Governor Jared Polis signed SB19-005 Importation of Prescription Drugs From Canada. The new state law creates the Canadian Prescription Drug Importation Program in the Department of Healthcare Policy and Financing (HCPF) and goes into effect on August 2, 2019. By September 1, 2020, HCPF must submit a request for federal approval of the program. If the program is approved, HCPF is required to begin operating the program no later than six months after receiving federal approval.

Vendor requirements:

HCPF is required to contract with one or more vendors when the program receives federal approval, vendor selection is exempt from the state procurement process for the first three years. Vendors, in consultation with HCPF and other vendors, must annually establish a wholesale prescription drug importation list that identifies the prescription drugs that have the highest potential for cost savings to the state. HCPF is required to ensure these lists meet program requirements every three months.

Vendors must identify Canadian suppliers, verify the supplier meets all legal and program requirements, and contract with or facilitate contracts with suppliers to import prescription drugs under the program. Vendors must follow specific requirements related to:

  • developing and administering distribution programs,
  • assisting HCPF with annual reporting,
  • ensuring safety and quality of imported drugs through requirements for testing and certification,
  • laboratory and documentation standards,
  • financial reporting,
  • surety bonds,
  • required participation in applicable legal actions, and
  • payments.

Eligible drugs, importers, and suppliers:

A vendor may import a prescription drug from a Canadian supplier if the drug meets U.S. standards related to the drug's safety, effectiveness, misbranding, and adulteration, importing the drug would not violate federal patent laws, and importing the drug is expected to generate cost savings. Eligible importers include the following:

  • licensed Colorado pharmacists,
  • pharmacists or wholesalers dispensing to Medicaid recipients,
  • pharmacists or wholesalers dispensing to inmates in the custody of the Department of Corrections, and,
  • wholesalers approved by HCPF.

An eligible Canadian supplier may only export prescription drugs into Colorado if the supplier is in full compliance with Canadian law and submits proof of a registered agent in the U.S. Canadian suppliers and eligible importers participating under the program must comply with the tracking and tracing requirements of federal pharmaceutical distribution supply chain law, and may not distribute, dispense, or sell prescription drugs imported under the program outside of Colorado. In addition, both entities are required to submit certain information to the vendor related to drug type, quantity, point of origin and destination, price, and shipping information as applicable.

HCPF must immediately suspend the importation of specific drugs or the importation of drugs by specific eligible importers if it discovers that any drug or activity is in violation of any federal or state law or regulation. HCPF may revoke the suspension if, after conducting an investigation, it determines that the public is adequately protected from counterfeit or unsafe drugs being imported into this state.

Designated wholesaler:

HCPF must designate an office or division that must be a licensed pharmaceutical wholesaler or that must contract with a licensed pharmaceutical wholesaler to:

  • set a maximum profit margin,
  • exclude generic products if their importation would violate U.S. patent law,
  • comply with federal laws regarding pharmaceutical distribution supply chains, and
  • determine a method for covering the administrative costs of the program, which may include a fee imposed on each prescription drug sold through the program, as long as the fee amount does not significantly reduce consumer savings.

Reporting:

HCPF is required to report on program operations to the Governor and the General Assembly by December 1 of each year starting in 2021. The report must include information about participants, prescription drugs imported and dispensed, methodology, and estimated cost saving.

 

SB19-079 Electronic Prescribing of Controlled Substances

On April 8, 2019, Governor Jared Polis signed SB19-079 Electronic Prescribing of Controlled Substances. This law requires that all podiatrists, dentists, physicians, physician assistants, advanced practice nurses, and optometrists that prescribe a schedule II, III, or IV controlled substance do so electronically, with certain exceptions. The law does not require pharmacists to verify the applicability of an exception to electronic prescribing and pharmacists may dispense the controlled substance pursuant to an order that is written, oral, or facsimile-transmitted that is valid and consistent with current law. For most prescribers, the requirement begins July 1, 2021. For dentists and prescribers who work in a solo practice, or in a rural area, the requirement begins July 1, 2023.

 

SB19-081 Repeal of the Cancer Drug Repository Act

On March 15, 2019, Governor Jared Polis signed SB19-081 Repeal of the Colorado Cancer Drug Repository Act. The legislation repeals a section of statute that established a state cancer drug repository program. There is a broader drug repository program for all types of unused medication in state law, making this limited provision obsolete.

 

SB19-201 Open Discussions About Adverse Health Care Incidents

On May 6, 2019, Governor Jared Polis signed SB 19-201 Open Discussions About Adverse Health Care Incidents. This new law creates the "Colorado Candor Act” and establishes a process for the communication between a patient and a healthcare provider or health facility after an adverse health care incident. Under the new law, if an adverse health care incident occurs, a health care provider involved with the incident, either individually or jointly with the facility involved, may request that the patient enter into an open discussion concerning the incident. The request must include certain components listed in the law.

If an offer of compensation is made, the new law requires certain processes for payment and financial resolution to be followed. If a health care provider or health facility determines that no offer of compensation is warranted, the health care provider or health facility shall orally communicate that decision with the patient.

A health care provider or facility may provide de-identified information about an adverse health care incident to any patient safety centered nonprofit organization.

 

SB19-228 Substance Use Disorders Prevention

On May 23, 2019, Governor Jared Polis signed SB19-228 Substance Use Disorders Prevention.

The law went into effect immediately upon the Governor's signature. The law requires the Colorado Medical Board, State Board of Nursing, Colorado Dental Board, State Board of Optometry, Colorado Podiatry Board, and the State Board of Veterinary Medicine to adopt rules on substance use disorder training for prescribers. The rules must require certain health care providers, as a condition of license renewal, reactivation or reinstatement on or after October 1, 2019, to complete up to four credit hours of training per licensing cycle related to:

  • Best practices for opioid prescribing, according to the most recent version of the Division‚Äôs Guidelines for Prescribing and Dispensing Opioids,
  • Recognition of substance use disorders,
  • Referral of patients with substance use disorders for treatment, and,
  • Use of the Electronic Prescription Drug Monitoring Program.

The new requirements apply to podiatrists, physicians, physician assistants, dentists, advanced practice nurses with prescriptive authority, optometrists, and veterinarians, except that each Board's rules must exempt from the training requirements any health care provider who:

  • Maintains a national board certification that requires equivalent substance use prevention training, or
  • Attests to the appropriate board that the health care provider does not prescribe opioids.

In addition to the substance abuse prevention training requirements, the new law includes the following provisions:

  • Restricts a physician, physician assistant, or advanced practice nurse from accepting any direct or indirect benefits for prescribing a specific medication,
  • Allows pharmacies to charge enhanced dispensing fees if they provide counseling concerning the risks of opioids to patients who have not previously received opioid prescriptions,
  • Allows medical examiners and coroners to access the Prescription Drug Monitoring Program (PDMP) under specified circumstances,
  • Requires opioid prescriptions for outpatient use to bear a warning label, and,
  • Provides funding for the implementation of several programs for the prevention of opioid and other substance use disorders in the Department of Human Services (DHS), the Department of Public Health and Environment (CDPHE) and local public health agencies (LPHAs), and the University of Colorado.

 

 

 

All Prescribers

SB19-079 Electronic Prescribing of Controlled Substances

On April 8, 2019, Governor Jared Polis signed SB19-079 Electronic Prescribing of Controlled Substances. This law requires that all podiatrists, dentists, physicians, physician assistants, advanced practice nurses, and optometrists that prescribe a schedule II, III, or IV controlled substance do so electronically, with certain exceptions. The law does not require pharmacists to verify the applicability of an exception to electronic prescribing and pharmacists may dispense the controlled substance pursuant to an order that is written, oral, or facsimile-transmitted that is valid and consistent with current law. For most prescribers, the requirement begins July 1, 2021. For dentists and prescribers who work in a solo practice, or in a rural area, the requirement begins July 1, 2023.

 

SB19-218 Sunset Medical Marijuana Program

On May 29, 2019, Governor Jared Polis signed SB19-218 Sunset Medical Marijuana Program. This bill extends the Medical Marijuana Program in the Department of Public Health and Environment (CDPHE) until September 1, 2028, implements recommendations from the Department of Regulatory Agencies sunset review, and makes a number of other changes. Specifically, the bill:

  • Clarifies that if the patient is a minor, the physician must consult with the patient and the patient's parents and clarifies that a parent can serve as a primary caregiver for a child with a disabling medical condition.
  • Specifies that doctor-patient consultations include explaining the possible risks and benefits of the use of medical marijuana
  • Clarifies that caregivers for patients with debilitating medical conditions are extended the same confidentiality protections as caregivers for patients with disabling medical conditions.
  • Clarifies that medical marijuana registry cards are subject to revocation if a patient is convicted of a drug crime.
  • Specifies that only a physician can make a medical marijuana recommendation, except for recommendations for patients with disabling medical conditions, which may be made by a physician, dentist, or advanced practice practitioner with prescriptive authority who holds a license in good standing and who is acting within his or her scope of practice.
  • Directs CDPHE to promulgate rules related to the length of time that a medical marijuana registry card is valid.
  • Requires financial disclosures from members of the Retail Marijuana Public Health Advisory Committee and expands the expertise that must be represented on the committee.
  • Allows CDPHE to inquire about collecting Colorado-specific data from the All-Payer Claims Database, hospital discharge data, and available peer-reviewed research studies.

 

SB19-228 Substance Use Disorders Prevention

On May 23, 2019, Governor Jared Polis signed SB19-228 Substance Use Disorders Prevention.

The law went into effect immediately upon the Governor's signature. The law requires the Colorado Medical Board, State Board of Nursing, Colorado Dental Board, State Board of Optometry, Colorado Podiatry Board, and the State Board of Veterinary Medicine to adopt rules on substance use disorder training for prescribers. The rules must require certain health care providers, as a condition of license renewal, reactivation or reinstatement on or after October 1, 2019, to complete up to four credit hours of training per licensing cycle related to:

  • Best practices for opioid prescribing, according to the most recent version of the Division‚Äôs Guidelines for Prescribing and Dispensing Opioids,
  • Recognition of substance use disorders,
  • Referral of patients with substance use disorders for treatment, and,
  • Use of the Electronic Prescription Drug Monitoring Program.

The new requirements apply to podiatrists, physicians, physician assistants, dentists, advanced practice nurses with prescriptive authority, optometrists, and veterinarians, except that each Board’s rules must exempt from the training requirements any health care provider who:

  • Maintains a national board certification that requires equivalent substance use prevention training, or
  • Attests to the appropriate board that the health care provider does not prescribe opioids.

In addition to the substance abuse prevention training requirements, the new law includes the following provisions:

  • Restricts a physician, physician assistant, or advanced practice nurse from accepting any direct or indirect benefits for prescribing a specific medication,
  • Allows pharmacies to charge enhanced dispensing fees if they provide counseling concerning the risks of opioids to patients who have not previously received opioid prescriptions,
  • Allows medical examiners and coroners to access the Prescription Drug Monitoring Program (PDMP) under specified circumstances,
  • Requires opioid prescriptions for outpatient use to bear a warning label, and,
  • Provides funding for the implementation of several programs for the prevention of opioid and other substance use disorders in the Department of Human Services (DHS), the Department of Public Health and Environment (CDPHE) and local public health agencies (LPHAs), and the University of Colorado.