New 2019 Legislation
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.
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 and requires certain health care providers with prescriptive authority to complete substance use disorder training as part of the continuing education requirement for professional license renewal on or after October 1, 2019. The new requirements apply to podiatrists, physicians, physician assistants, dentists, advanced practice nurses, optometrists, and veterinarians, and prescribers must be able to demonstrate competency regarding:
- Best practices for opioid prescribing, according to the most recent version of the Division's 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 law exempts any provider from the continuing education requirements who meets the following criteria:
- 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 continuing education 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.
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 the 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.
On March 21, 2019, Governor Jared Polis signedHB19-1077 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 12-280-125.5, 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.
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 enters 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.
On March 15, 2019, Governor Jared Polis signed SB19-081 Repeal of the "Colorado Cancer Drug Repository Act." The legislation repeals a section of the 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.