First Regular Session S.B. 1270
COMMITTEE ON HEALTH AND HUMAN SERVICES
SENATE AMENDMENTS TO S.B. 1270
(Reference to printed bill)
Page 1, line 15, strike "benefits" insert "benefit"
Line 16, strike "organization" insert "agent"
Line 18, after "means" strike remainder of line
Strike line 19
Line 20, strike "(a) Experiencing a health condition that" insert "the action of a health care insurer, pharmacy benefit manager or utilization review agent on a step therapy protocol exception request within the application of the time periods for making a nonexpedited decision, as determined and documented by the prescribing provider,"
Line 22, strike the period
Strike line 23, insert "or cause a significant negative change in the patient's medical condition."
Line 24, after the second quotation mark strike remainder of line
Strike lines 25 through 27, insert "has the same meaning prescribed in section 20-2501."
Line 31, strike "appropriate" insert "necessary"; after "means" insert ", with respect to a prescription drug,"
Between lines 36 and 37, insert:
"7. "methodologist" means a person that manages research design for the purpose of accurate and unbiased data collection and that has experience testing questions that are germane to the subject of the research."
Renumber to conform
Page 1, line 40, strike "benefits" insert "benefit"; after the second quotation mark strike remainder of line
Strike line 41, insert "has the same meaning prescribed in section 20-3321."
Between lines 41 and 42, insert:
"10. "Serious adverse reaction":
(a) means an adverse event or suspected adverse reaction if, in the view of either the investigator or sponsor, the event or reaction results in any of the following outcomes:
(i) Death.
(ii) A life-threatening adverse event.
(iii) Inpatient hospitalization or prolonging existing hospitalization.
(iv) A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions.
(v) A congenital anomaly or birth defect.
(b) Includes an event or reaction that might not result in death, be life threatening or require hospitalization but, based on appropriate medical judgment, could jeopardize the patient's health or medical situation by requiring medical or surgical intervention to prevent at least one of the outcomes listed in subdivision (a) of this paragraph."
Renumber to conform
Page 2, line 3, strike "appropriate" insert "necessary"
Line 6, strike the colon
Strike lines 7 through 17, insert "has the same meaning prescribed in section 20-2501."
Line 18, after "review" strike remainder of line
Strikes lines 19 through 21, insert "agent has the same meaning prescribed in section 20-2530."
Line 23, after "to" insert ":
1."; after "plan" insert "that is subject to state law regulating insurance,"
Page 2, between lines 25 and 26, insert:
"2. A Contractor, agent or similar entity that implements coverage for a step therapy protocol on behalf of a health care plan, including a pharmacy benefit manager or utilization review agent."
Line 28, strike "benefits" insert "benefit"; strike "organization" insert "agent"
Line 36, strike "all" insert "both"
Strike line 44
Page 3, line 10, strike "continually" insert "regularly"; after "updated" insert "at least once a year"
Line 18, strike "benefits" insert "benefit"
Line 19, strike "organization" insert "agent"
Line 21, strike "organization's" insert "agent's"
Line 23, strike "benefits" insert "benefit"
Line 24, strike "organization" insert "agent"; strike "organization's" insert "agent's"
Line 25, after the period insert "The department may require a health care insurer to submit an annual certification or clinical review criteria submission for a pharmacy benefit manager or utilization review agent that acts on behalf of the health care insurer, and the health care insurer and the pharmacy benefit manager or utilization review agent shall be held jointly responsible for any errors, omissions, misstatements or misrepresentations in that annual certification or submission. A health care insurer that submits an annual certification or clinical review criteria submission on behalf of the health care insurer's pharmacy benefit manager or utilization review agent shall provide the pharmacy benefit manager or utilization review agent at least fifteen days' advance notice of the certification or submission, and the pharmacy benefit manager or utilization review agent may submit an independent certification or submission, in lieu of having the health care insurer make the certification or submission on the pharmacy benefit manager's or utilization review agent's behalf."
Page 3, Line 32, strike "benefits" insert "benefit"
Line 33, strike "organization" insert "agent"
Line 34, strike "practitioner" insert "provider"
Line 36, strike "benefits" insert "benefit"; strike "organization" insert "agent"
Line 40, strike "benefits" insert "benefit"
Line 41, strike "organization's insert "agent's"; after "website" insert "and shall include a list of the information and documentation the health care insurer, pharmacy benefit manager or utilization review agent requires and where and to whom the patient and prescribing provider must send the step therapy exception request."
Line 42, strike "determination"
Line 43, strike "evidence is" insert "justification and any necessary supporting clinical documentation are"
Page 4, line 1, strike "required"; after "drug" insert "required by the step therapy protocol"
Line 2, strike "an" insert "a serious"
Lines 3, 6 and 11, strike "required"; after "drug" insert "required by the step therapy protocol"
Line 12, after "necessity" insert "because the patient's use of the prescription drug is expected to cause any of the following:
(a) A barrier to the patient's adherence to or compliance with the patient's plan of care.
(b) A negative impact on the patient's comorbid conditions.
(c) A clinically predictable negative drug interaction.
(d) A decrease in the patient's ability to achieve or maintain a reasonably functional ability in performing daily activities for which the patient has experienced a positive therapeutic outcome"
Line 13, strike "remained stable" insert "has experienced a positive therapeutic outcome"
Page 4, Line 19, strike "benefits" insert "benefit"; strike "organization" insert "agent"
Line 21, after "provider" insert "if the prescription drug is covered by the patient's health care plan"
Strike lines 22 through 35, insert:
"D. The health care insurer, pharmacy benefit manager or utilization review agent shall grant or deny a step therapy exception request within seventy-two hours after receiving the request. In a case in which an exigent circumstance exists, the health care insurer, pharmacy benefit manager or utilization review agent shall grant or deny the step therapy exception request within twenty-four hours after receiving the request. If the step therapy exception request is incomplete or additional clinically relevant information is required, the health care insurer, pharmacy benefit manager or utilization review agent shall notify the prescribing provider within seventy-two hours after receiving the request, or within twenty-four hours if an exigent circumstance exists, that additional or clinically relevant information is required in order to approve or deny the step therapy exception request pursuant to the requirements outlined in subsection A of this section. The health care insurer, pharmacy benefit manager or utilization review agent shall grant or deny the step therapy exception request within seventy-two hours after receiving the requested additional or clinically relevant information, or within twenty-four hours if an exigent circumstance exists. If the prescribing provider does not receive a determination or request for additional or clinically relevant information from the health care insurer, pharmacy benefit manager or utilization review agent within the time period prescribed by this subsection, the exception is deemed granted."
Line 37, after "determination" insert "as prescribed in chapter 15, article 2 of this title"
Line 39, strike "benefits" insert "benefit"
Page 4, line 40, strike "organization" insert "agent"; strike the second "a" insert "an AB-rated"
Line 43, strike "appropriate" insert "necessary"
Page 5, strike lines 1 through 6
Renumber to conform
Amend title to conform