To quantify the number and types of polices, we reviewed and categorized policies implemented by both public (i.e., Medicaid) and major commercial insurers in Michigan on opioid prescriptions from January 2012 through December 2018. This time frame included the estimated 2012 peak Michigan opioid prescribing rate and subsequent monotonic decline (30). We documented policy implementation by year to highlight trends and variability in policy activity by individual payers. Policies related to treatment of substance use disorder or naloxone access were excluded as the study focus was on opioid analgesic prescribing.
Commercial Payers
Commercial payers included in the study were Blue Cross Blue Shield of Michigan, Blue Care Network, Priority Health, Health Alliance Plan, Aetna, United Healthcare, and Cigna. They are for-profit except Health Alliance Plan (nonprofit), Blue Care Network and Blue Cross Blue Shield of Michigan (became a nonprofit mutual in 2014). During the 7-year period, Blue Cross Blue Shield of Michigan was the dominant commercial insurer in the state. In 2016 and 2017, Blue Cross Blue Shield of Michigan, Priority Health and Health Alliance Plan accounted for at least 80% of the large group commercial health insurer market in Michigan (31).
Obtaining opioid prescribing policies
To obtain information on specific payer opioid policies, one investigator (VTL) searched the Michigan Department of Health and Human Services website for Preferred Drug List updates by year using the following search terms: “CNS medications-opioid analgesics”, “narcotic analgesics”, “opioid analgesics”, and “pain relievers-narcotics (or opioids)”. The Preferred Drug List is the formulary for Medicaid in Michigan. The Michigan Pharmacy and Therapeutics Committee meets to review and recommend changes to the Preferred Drug List at least quarterly. The individual commercial plan websites were also reviewed for formulary updates by year using the same search terms. Commercial payers’ formularies are reviewed at least annually by their pharmacy and therapeutic committees.
Once updates for Medicaid and commercial payers’ formularies were identified, the search turned to the policies underlying them. For Medicaid, the Pharmacy and Therapeutic committee’s publicly available quarterly meeting minutes were reviewed for prescribing policies. The individual commercial payers’ websites were reviewed for press releases and policy updates to explain changes. For the few cases where there were formulary updates without policy explanation, responsible individuals at the payer plans were contacted for clarification. The Michigan Pharmacist Association website was also independently searched for communications regarding opioid prescribing policies to minimize the risk of inadvertently omitting a policy. From this examination, a chronological list of policies for each payer across the 7-year study period was compiled.
Categorizing policies
The formulary updates could include addition or removal of individual medications, and actions across multiple medications by dosage form (e.g., long acting opioids) or route (e.g., transmucosal fentanyl products). Other common formulary actions include time limitations, quantity limits, and prior authorizations for select medications.
To categorize the formulary updates the investigators started with a list of common formulary management strategies used by payers to promote safe and appropriate opioid prescribing (32, 33). The individual components, or actions, of the strategies were then developed through discussion with five experienced pharmacists practicing formulary management, community, hospital, long-term care and home infusion. Importantly, an individual policy can result in more than one action. An example would be “lock-in program” initiated by a payer to restrict members’ access to opioid analgesics (18). Lock-in programs identify members with pre-defined criteria and restrict their access to one prescriber and pharmacy for opioid prescription claims reimbursement (18). We coded lock-in programs as 1) creating a patient registry, 2) limitation on providers, and 3) limitations on pharmacies. This coding system allows flexibility for different policies with overlapping actions.
During the initial review of policies, it became apparent that another action, “pharmacy safety review” or “step-edits”, was required, resulting in 13 separate actions (Table 1). The action of safety reviews indicates that the pharmacist must review and document approval to dispense medication. Information required for the pharmacy review can include patient must have first tried and failed other (often first-line and less expensive) therapies, demonstrated an intolerance/allergy/adverse reaction to first-line therapies, or require prescribing by a specialist provider. It also specifies criteria and actions for pharmacists to ensure that a medication is appropriate for an individual patient with respect to dosage, concurrent medications or other factors.
Table 1. Policy actions by seven commercial insurers and Medicaid-for-service for prescribing opioid analgesics by year, Michigan
Specific Action
|
2012
|
2013
|
2014
|
2015
|
2016
|
2017
|
2018
|
Total
|
# payers implemented
|
LIMITATIONS on number days initial prescrpiton
|
8
|
4
|
4
|
7
|
11
|
22
|
27
|
83
|
8
|
PRIOR AUTHORIZATION on initial prescription
|
9
|
7
|
5
|
9
|
13
|
16
|
18
|
77
|
8
|
Formulary limitation
|
5
|
1
|
3
|
5
|
10
|
12
|
24
|
60
|
8
|
Registry of patients
|
11
|
4
|
6
|
6
|
6
|
7
|
18
|
58
|
8
|
Pharmacy safety review/step edit
|
4
|
6
|
6
|
9
|
6
|
14
|
12
|
57
|
8
|
PRIOR AUTHORIZATION for long-acting/extended release opioids
|
6
|
2
|
5
|
4
|
3
|
6
|
10
|
36
|
8
|
LIMITATIONS on providers
|
4
|
6
|
5
|
7
|
3
|
8
|
3
|
36
|
8
|
LIMITATIONS on number refills
|
6
|
2
|
3
|
2
|
0
|
10
|
13
|
36
|
7
|
LIMITATIONS on dosages within formulary
|
4
|
1
|
2
|
2
|
5
|
7
|
9
|
30
|
7
|
PRIOR AUTHORIZATIONS for refill prescription(s)
|
1
|
3
|
2
|
1
|
1
|
8
|
9
|
25
|
7
|
PRIOR AUTHORIZATIONS for higher potency opioids
|
2
|
1
|
2
|
1
|
1
|
5
|
9
|
25
|
8
|
Feedback to providers on opioid prescribing
|
2
|
2
|
0
|
3
|
0
|
1
|
1
|
9
|
3
|
Incentives to providers
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
Total
|
62
|
39
|
43
|
56
|
59
|
116
|
154
|
529
|
|
Policies were categorized by one investigator (VTL) when recording policies for the individual payers. To minimize subjectivity and bias, policy actions were categorized whenever possible using the original titles or formulary classifications (e.g. prior authorization for initial prescription) or intentions (e.g. feedback to providers regarding prescriptions). Another investigator (CLA) reviewed the abstracted policies for consistency in coding decisions. In the few cases of disagreement, the abstracted information was supplemented with additional information from the source document.
Analysis
The number of actions taken by different payers and years were summarized with descriptive statistics. To examine temporal trends, Joinpoint Regression (version 4.8.0.1) (34) was used with mean number of actions by year across all eight payers as well as subgroups of top three payers, all commercial payers and Medicaid. Joinpoint Regression identifies the model with the best-fitting set of inflection points in the regression model using permutation tests (35) and calculates the annual percent change (APC) to characterize trends over time per segment. Significance tests, 95% confidence intervals (95% CI) for annual percent change and average annual percent change (AAPC) for the entire time period (if there are no inflection points identified) were also computed.
The Wayne State University Institutional Review Board concurred that the project was exempt from human subject research review.