Bill Tracker

The League supports the objective of greater regulation and monitoring of the sale and use of nicotine products by licensing retailers and by controls on locations of new retailers away from schools.  The high rate (27%, Legislative Council memo June 2019) of nicotine vaping by high school students is of great public health concern because of the addiction capacity of nicotine.

However, raising the age limit for sales from 18 years to 21 years seems inconsistent with our position that 18 year-olds are mature enough to vote in state and national elections. 

We support restrictions on nicotine product advertising directed to young students and on direct-to-consumer online sales.

Update 3/6

The bill has Passed the House with a significant floor amendment that instructs the CDPHE, in collaboration with the state boards of pharmacy, medicine and nursing, to develop statewide drug therapy protocols within 6 months for pharmacists to prescribe and dispense HIV prevention drugs.  The protocols should consider physician referrals, lab testing, patient referrals and counseling, and follow-up care and counseling.

In the interim, the Department shall implement a standing order for post-exposure prophylaxis (high risk exposure) so that pharmacists may prescribe and dispense the recommended drugs.  A standing order means a prescription that is not specific to and does not identify a particular patient. 

(2/17) The bill has advanced to the House COW after amendments and an appropriation.

Instead of detailing the new functions and services that a pharmacist will provide under this bill, the amended bill simply specifies that the qualified pharmacist will hold a license, be engaged in the practice of pharmacy, have a Pharm. D degree or equivalent, have liability insurance, and be trained in the specific protocol for prescribing and dispensing PrEP and PEP as designed by the board of pharmacy.   Other clarifications of coverage and fees were amended. 

Appropriations approved funding at $13,347 for this fiscal year per the Fiscal Note.

The League supports access to a level of health care that includes prevention of disease at an affordable cost. The bill would require insurance carriers to cover costs of drugs for prevention of HIV infection as provided by specially trained pharmacists.

Pre-exposure prophylaxis, PrEP is antiretroviral medication taken daily to prevent HIV in HIV-negative persons at risk of being exposed. Postexposure prophylaxis, PEP is antiretroviral medications taken by an HIV-negative person who has had a specific high-risk exposure within the previous 72 hours.

Sponsors and witnesses stressed the improved access to preventive care that the bill offers, especially in non-urban areas. Pharmacists are already offering certain preventive care (e.g., flu vaccine; birth control) by using specific protocols for prescribing drugs that include patient screening, lab tests, and counseling. Pharmacists will communicate with the patient’s existing (or referred) physician with test results and drugs dispensed. PrEP and PEP are currently under-utilized nationally despite having been found highly effective and on the market for over 10 years. “What is missing are access points for prevention.”

The League supports this bill because it provides for increasing transparency and accountability for cost of prescription drugs.

The bill objective includes regulation of Pharmacy Benefit Management (PBM) entities with respect to retroactive denial of clean claims and also sets a minimum reimbursement of $4 on drug dispensing fees. A clean claim is one with no defect or impropriety that prevents timely payment from being made and the claim is not based in fraud, waste or abuse.

Pharmacies are experiencing “clawback” on reimbursements, without explanation, often up to a year after initial claim payment. Small businesses in particular find it challenging to budget and plan forward in the face of unknowns in reimbursements.

Insurance carriers that contract with PBM are responsible for the compliance of the PBM with this Act and must audit such firms annually. The Division of Insurance shall set rules to establish how PBMs and carriers are to show compliance.

The objective is to provide disclosure of information relating to the cost and pricing of prescription drugs in order to provide accountability to the state for drug pricing.

According to the sponsors, transparency across the entire supply chain will allow collecting real data to support legislation.

The bill will apply some regulation of pharmacy benefit managers (PBM), which are not regulated in Colorado. PBMs contract with health insurers to manage pharmacy benefits to the health insurance consumer.

Information on costs will be required to be reported annually by health insurers, drug manufacturers, PBMs, and certain non-profits organizations for the top 50 drugs purchased by the state. 

Commissioner of Insurance is to publish this information except for trade secrets and to analyze the effects of prescription drug costs on premiums.

Section 6 requires manufacturers’ rebates to be passed through to consumers in the form of reduction in premiums.  Rebates are discounts or other payment or price concessions by a manufacturer to a PBM or health insurer.  During the hearing some tension was expressed between the PBMs ability to negotiate prices and possible disclosure of proprietary information in public. 

The League supports transparency in costs of health care, including costs of prescription drugs.

The objective of the bill was described in hearing as determining the components of production and development (and other components such as clinical studies and regulatory, acquisition, patent and licensing, and promotion) in the price of prescription drugs, to provide a baseline for costs and to enable framing policy on high-cost drugs by revealing the drivers of cost. 

Manufacturers will be required to provide costs break-down in eight categories that contribute to the Wholesale Acquisition Cost (WAC), the manufacturer’s list price for the drug or biological to wholesalers or direct purchasers.

HCPF will report the findings of analysis of cost for each fiscal year annually to the legislature.

The FN estimates $250K funding for contractors that will collect and analyze the information according to lists of high-cost drugs provided by state purchasers. 

Senators had questions about the rationale for the 8 categories of cost information and whether all the information could actually help frame policy.  The bill passed with amendments, such as:

• clarification that proprietary and trade secret information will be protected as confidential, that is, this will not appear in public reporting. 
• costs for research and development of products that failed to make it to market will not be included costs reports. 
• report will include amounts paid for Medicaid prescription drugs (Rx) that are rebated back to HCPF and will include this in calculation of percent of budget spent on Rx.
• adding the word “Consolidated” to the Comprehensive Lists of Rx, meaning a single consolidated list consisting of -
•             I.  list by names and WAC the 20 highest cost Rx by course of therapy (usually 30-day) and 20 highest cost Rx based on total spending for each department;
•             II. list by names and WAC the 20 highest Rx by course of therapy (usually 30-day) and 20 highest cost Rx based on total spending for the state Dept of Personnel that accounts for rebates, discounts, other cost savings. 

League position is to support policies and programs to increase efficient use of our health care dollars. 

Update 3/5

Amended in Senate to require HCPF to provides the legislature with evidence that compares the stringency of the proposed exporting nation’s regulatory system to that of the US FDA with respect to assurances of safety, purity, and potency of prescription drugs.  Specifically--

• Securing the supply chain.  This would include documentation for the imported drugs that uses serial identifiers, lot numbers and expiration dates, quantity of product shipped, at all time and transfer points durinf storage, handling, transportation and distribution.
• Manufacturing.  This would mean sourcing and formulation of the active ingredients with inactive ingredients, preparing a dosage form such as tablets, capsules, drops, etc., filling container-closure systems, and appropriate storage all performed using Good Manufacturing Practices.
• Labeling.  Containers of product must be re-labeled in English for import into the US.  Container labeling includes product names, drug code numbers, lot numbers, manufacturer’s name and other information.  Labeling also includes package inserts.
• Tracking and tracing.  This refers to FDA rules to allow drug tracing from manufacture to pharmacy; intended to prevent fraud and drug counterfeiting.

Update after hearing 2/13

Several Senators asked why this bill was being presented before a report, implementation, and results of the parent bill, SB19-005.  There are no states yet that have programs approved by DHHS (e.g., VT, FL).  The bill was criticized as being vague, for example by not specifying what countries might be included, and for moving ahead without supporting results from the pilot. Director, HCPF testified that a federal bill to allow expansion of importation from Japan, EU, UK and other countries was moving through Congress.  The bill was not identified by number, title, or sponsor. The Director was asked when the report on SB 005 would be issued and the application to DHHS.  This is expected to happen by March 9; the report in its entirety will be submitted as Colorado’s comments on the FDA Proposed Rule (PR) published in December 2019 .  Consultant to HCPF for the importation program(s) said that the PR contained some elements that were not expected, so CO is working that through.

The FDA has proposed that every program be sponsored by a State, tribal, or territorial government entity.  Certain non-federal entities could be co-sponsors. Only a government entity would be in a position of primary oversight with authority to inspect the supply chain.  Each program would identify a Foreign Seller in Canada that would purchase the drug directly from the manufacturer and the Importer in the U.S. would buy the drug directly from the Foreign Seller.

Opponents of the bill raised concerns about counterfeit drugs and smuggling illicit drugs in with legal drugs.  Some of the same concerns were raised on SB 005. 

It should be noted that the FDA Proposed Rule includes detailed requirements for safeguarding the integrity of each shipment from the manufacturer (in Canada) to the US Importer.

Supporters primarily discussed their hope that the program for importing from Canada and the current bill will make drug pricing more competitive and lower costs. During the discussion period the Committee had questions about temperature control [cold chain] and whether biologics, which usually require refrigeration, are included in the pending federal legislation.  Although an amendment to exclude drugs requiring refrigeration lost, there was concern that the Committee was being asked to plan using a federal law that does not yet exist. The League continues to monitor this bill for clarifying amendments. 

The League supports policies and programs to increase efficient use of our health care dollars.  For example, to realize cost savings for prescription drugs by importing drugs from approved countries where prices may be lower.   Colorado law 19-005 authorizes HCPF to carry out the necessary fact-finding to form the basis of a plan and waiver application to federal DHHS to allow importation of certain un-approved prescription drugs from Canada.  The estimated cost for the waiver application to DHHS was $1 million (Revised FN May 2019).   LWVCO supported the original bill SB19-005, allowing importation from Canada only; no further countries were indicated for the future.

FDA’s Safe Importation Action Plan (July 2019) describes importation from Canada as Pathway 1 (of two pathways) and a Notice of Proposed Rulemaking (Dec 23, 2019) would be the regulations that define requirements for implementing the law at 21 U.S. Code 384 to allow time-limited pilot projects for importations from Canada—essentially as described in Colorado 19-005.

This bill would allow HCPF to proceed with expanding such importation program with respect to nations other than Canada upon notifying the legislature 30 days before expansion.  Any expansion program would be contingent upon U.S. congressional action to so amend the law at 21 U.S. Code 384. 

 This bill has two major flaws:

1. There is no enabling legislation passed by the U.S. congress at this time.  Any expenditure of funds by HCPF to implement expansion to an additional country, for example by engaging consultants to identify products and assure compliance with federal regulations, would be based on speculation. 
2. The description “a nation other than Canada” is vague and open-ended.  Specific foreign suppliers are not named.  As a minimum requirement, limiting candidate countries to parties to the International Conference on Harmonization that specifies guidelines for current Good Manufacturing Practices for pharmaceuticals would be a prudent step.  Parties to the ICH have made the guidelines binding on their regulatory authorities; the parties are U.S., European Union, and Japan.  Other countries are observers to the ICH and may adopt the guidelines voluntarily.

The bill seems to be requesting pre-authorization by the legislature of a program(s) that may proceed without further hearing.  Fiscal Note states that no appropriation is initially required but funds in addition to those allocated for SB19-005 may be requested for feasibility studies, should the pre-conditions for expansion be met.

The League will monitor this bill for amendments that may address these and other concerns.  

Update 3/2

The bill passed out of committee without amendments and subsequently advanced with an appropriation of $41906 for the Dept. of Public Health & Environment. 

In the Senate the bill passed on 3rd Reading with amendments regarding the following content:

• Home-based schooling need not comply unless student(s) also attend public school for part of the school day.
• Personal information submitted to the tracking system is limited to name, date of birth, sex, school identification, parent/guardian name.
• Exemption certificates or completion of the online learning module must not require signing agreement with any language contrary to a person’s belief that is opposed to immunizations.
• Online learning module must fairly present both benefits and risks of immunizations.
• Assurances of confidentiality of personal data in the immunization tracking system are made.
• Health care provider who signs a non-medical exemption certificate may not be disciplined by a professional board.  Retaliation against such a person for signing is unlawful.

The bill objective is that all children be provided with the greatest protection from vaccine-preventable diseases and seeks to reach this objective by setting a vaccine-protected children standard of 95% vaccinated goal according to the school immunization schedule. 

Reaching this goal will be accomplished by enhanced compliance with current law that requires evidence of age-appropriate immunization before enrollment in public school or documentation of accepted exemptions from vaccination.  School-specific vaccination rates for the prior year will be published annually.  

CDPHE shall annually evaluate the state’s immunization practices using data sources such as the state immunization tracking system that contains information, as currently mandated, from local public health officials and medical practitioners.   The immunization tracking system also monitors the rates of medical and non-medical exemptions from vaccination. 

Vaccination and exemption tracking will be made more accurate by requiring the use of standardized forms for documentation.  Non-medical exemptions (for religious or personal belief, as defined) can be documented either by a signed certificate from an authorized health care provider or by completion of an online, science-based education module administered by CDPHE.

The League supports prevention of disease, health promotion and education within our health care system.  Public Health is the science of protecting and improving the health of people and their communities.  It is an essential component of all modern health care systems.  Disease and injury prevention depend on complete, quality data for analysis to support best practices.  This bill will promote accurate data collection and lead to improvement in public health policy with respect to control of infectious diseases.