Opioid-related deaths in the United States from prescription opioid analgesics is a public health problem with increases from 3,442 deaths in 1999 to 17,029 in 2017 or a nearly 5-fold increase (1). In 2018 the number of deaths declined to 14,975 (2), the first documented decline since the current mortality coding system was implemented in 1999. Although the number of deaths declined, too many people continue to die from accidental or intentional prescription opioid analgesic ingestion.
To address the high number of prescription opioid analgesic-related deaths, multiple strategies have been implemented to reduce unsafe prescribing and dispensing of opioids. At the federal level, actions include changing hydrocodone from Schedule III to the more restrictive Schedule II controlled substance classification (3). At the state level, actions include implementing Prescription Drug Monitoring Programs (PDMP), an electronic database of prescription opioid analgesics and other controlled substance medications dispensed with related prescription-specific information and limited information on patient, prescriber and dispensing pharmacy (4-5). States varied in when they established a PDMP, type of information collected, and the requirements for use (6). Several states including Michigan have integrated their PDMP systems into electronic health records and pharmacy dispensing systems (7). States also vary in other initiatives such mandatory review by prescribers of patients receiving long-term opioid analgesic therapy (8) and type of user allowed to request and review prescription history reports under defined situations (9). In 2012, access to the PDMP was extended to pharmacy benefit managers in several states including Michigan to allow opioid prescription utilization oversight for purposes of identifying fraud or misuse (10). At the federal level, Medicare (the payer for adults ages 65 years and older and those with disabilities) has published new regulations for prescribing opioid analgesics annually since 2015; the regulations apply to all covered lives regardless of state of residence. If the state regulations or laws are more restrictive than those of Medicare, the prescriber must comply with those of the state. Commercial and state public (i.e., Medicaid) payers have also implemented opioid prescribing policies (note: we will use the term “policy” to refer to commercial payer policies and public payer regulations). Overall, with the exception of evaluations regarding use of states’ PDMP, reviews of state laws and regulations, and payer policies have highlighted the lack of published evaluations and for those published, their low quality (11-13).
For the few payer policies evaluated, there have been comparisons between states (and over time) for prior authorization by Medicaid (14) but policies of commercial payers have been mostly limited to pre and post implementation of providers’ behavior (15) or number of prescriptions (16). In Massachusetts, Blue Cross Blue Shield implemented a comprehensive policy for opioid prescribing with seven different actions or components in 2012 (16). The investigators showed a 14.7% decline in average monthly prescribing rate for all opioids during the 3 years post-implementation but it is not clear that the decline was specific to their members or independent of other interventions such as education, media attention or policies of competing commercial payers. For example, two studies showed that policies can result in members dropping coverage (17) or paying cash for prescriptions (18). Other complications include patients with more than one health plan coverage and prescribers paneled by more than one commercial payer and therefore exposed to multiple opioid prescribing policies. As stated by Comerci and colleagues (19):
Increasingly, prescription-drug plans are instituting complicated and confusing opioid-prescribing rules. Often, limits are placed on dosage forms, quantities, or both without any evidence that such restrictions will ameliorate opioid overuse and misuse. Navigating these rules is time consuming for both clinicians and pharmacists…
Before the impact of payer policies can be evaluated, the magnitude of the “complicated and confusing” policies have to be articulated. The aim of this study is to quantify the number and type of opioid analgesic prescribing policies implemented by commercial payers and Medicaid in one state, Michigan. This approach allows us to explore the policies while holding constant state laws and regulations.
Michigan as a case study
Michigan makes a reasonable case study as it was affected by the opioid epidemic with drug overdose deaths increasing from age-adjusted rate of 6.1 per 100,000 in 1999 to 21.7 in 2017 (20). The age-adjusted rate then declined by 4.1% to 20.7 per 100,000 in 2018 with 78% involving at least one opioid (20). In 2018 Michigan providers wrote 62.7 opioid prescriptions per 100 residents compared to U.S. rate of 51.4 prescriptions (20).
In Michigan, the number of opioid prescriptions paid by commercial insurance accounted for 62.1% of such prescriptions in 2015 with the total number of opioid prescriptions declining in subsequent years (21). From 2015 to 2018, the number of prescriptions declined 30.5% for commercial payers, 11.4% for Medicaid, 15.2% for Medicare and 25.0% for cash (21). The number of opioid prescribers also declined during this time period from 55,180 to 53,850 similar to national analysis (22) even though opioid prescriptions and prescribers were added with the phased inclusion of Veteran’s Administration prescription data into the PDMP (23). The Veteran Administration prescribers were using Michigan’s PDMP by 2018 when prescribers and pharmacists were required to register (24).
Other changes include Michigan requiring Physician Assistants and Advanced Practice Nurses in 2017 to obtain their own Drug Enforcement Administration registration number instead of prescribing under a delegating physicians’ number (25). The PDMP originally adopted in 2008 was replaced in 2017 with an updated version having electronic medical record interface and improved drug prescription history reporting capabilities. A proprietary patients’ overdose risk score was also added. In 2017, Michigan passed a law protecting pharmacists from civil liability if they refuse to dispense controlled substance prescriptions when they have a reasonable and good-faith belief that the prescription was not written by a prescriber in good faith or the prescription did not have a medical purpose (26).
Opioid-related deaths in the United States from prescription opioid analgesics is a public health problem with increases from 3,442 deaths in 1999 to 17,029 in 2017 or a nearly 5-fold increase (1). In 2018 the number of deaths declined to 14,975 (2), the first documented decline since the current mortality coding system was implemented in 1999. Although the number of deaths declined, too many people continue to die from accidental or intentional prescription opioid analgesic ingestion.
To address the high number of prescription opioid analgesic-related deaths, multiple strategies have been implemented to reduce unsafe prescribing and dispensing of opioids. At the federal level, actions include changing hydrocodone from Schedule III to the more restrictive Schedule II controlled substance classification (3). At the state level, actions include implementing Prescription Drug Monitoring Programs (PDMP), an electronic database of prescription opioid analgesics and other controlled substance medications dispensed with related prescription-specific information and limited information on patient, prescriber and dispensing pharmacy (4-5). States varied in when they established a PDMP, type of information collected, and the requirements for use (6). Several states including Michigan have integrated their PDMP systems into electronic health records and pharmacy dispensing systems (7). States also vary in other initiatives such mandatory review by prescribers of patients receiving long-term opioid analgesic therapy (8) and type of user allowed to request and review prescription history reports under defined situations (9). In 2012, access to the PDMP was extended to pharmacy benefit managers in several states including Michigan to allow opioid prescription utilization oversight for purposes of identifying fraud or misuse (10). At the federal level, Medicare (the payer for adults ages 65 years and older and those with disabilities) has published new regulations for prescribing opioid analgesics annually since 2015; the regulations apply to all covered lives regardless of state of residence. If the state regulations or laws are more restrictive than those of Medicare, the prescriber must comply with those of the state. Commercial and state public (i.e., Medicaid) payers have also implemented opioid prescribing policies (note: we will use the term “policy” to refer to commercial payer policies and public payer regulations). Overall, with the exception of evaluations regarding use of states’ PDMP, reviews of state laws and regulations, and payer policies have highlighted the lack of published evaluations and for those published, their low quality (11-13).
For the few payer policies evaluated, there have been comparisons between states (and over time) for prior authorization by Medicaid (14) but policies of commercial payers have been mostly limited to pre and post implementation of providers’ behavior (15) or number of prescriptions (16). In Massachusetts, Blue Cross Blue Shield implemented a comprehensive policy for opioid prescribing with seven different actions or components in 2012 (16). The investigators showed a 14.7% decline in average monthly prescribing rate for all opioids during the 3 years post-implementation but it is not clear that the decline was specific to their members or independent of other interventions such as education, media attention or policies of competing commercial payers. For example, two studies showed that policies can result in members dropping coverage (17) or paying cash for prescriptions (18). Other complications include patients with more than one health plan coverage and prescribers paneled by more than one commercial payer and therefore exposed to multiple opioid prescribing policies. As stated by Comerci and colleagues (19):
Increasingly, prescription-drug plans are instituting complicated and confusing opioid-prescribing rules. Often, limits are placed on dosage forms, quantities, or both without any evidence that such restrictions will ameliorate opioid overuse and misuse. Navigating these rules is time consuming for both clinicians and pharmacists…
Before the impact of payer policies can be evaluated, the magnitude of the “complicated and confusing” policies have to be articulated. The aim of this study is to quantify the number and type of opioid analgesic prescribing policies implemented by commercial payers and Medicaid in one state, Michigan. This approach allows us to explore the policies while holding constant state laws and regulations.
Michigan as a case study
Michigan makes a reasonable case study as it was affected by the opioid epidemic with drug overdose deaths increasing from age-adjusted rate of 6.1 per 100,000 in 1999 to 21.7 in 2017 (20). The age-adjusted rate then declined by 4.1% to 20.7 per 100,000 in 2018 with 78% involving at least one opioid (20). In 2018 Michigan providers wrote 62.7 opioid prescriptions per 100 residents compared to U.S. rate of 51.4 prescriptions (20).
In Michigan, the number of opioid prescriptions paid by commercial insurance accounted for 62.1% of such prescriptions in 2015 with the total number of opioid prescriptions declining in subsequent years (21). From 2015 to 2018, the number of prescriptions declined 30.5% for commercial payers, 11.4% for Medicaid, 15.2% for Medicare and 25.0% for cash (21). The number of opioid prescribers also declined during this time period from 55,180 to 53,850 similar to national analysis (22) even though opioid prescriptions and prescribers were added with the phased inclusion of Veteran’s Administration prescription data into the PDMP (23). The Veteran Administration prescribers were using Michigan’s PDMP by 2018 when prescribers and pharmacists were required to register (24).
Other changes include Michigan requiring Physician Assistants and Advanced Practice Nurses in 2017 to obtain their own Drug Enforcement Administration registration number instead of prescribing under a delegating physicians’ number (25). The PDMP originally adopted in 2008 was replaced in 2017 with an updated version having electronic medical record interface and improved drug prescription history reporting capabilities. A proprietary patients’ overdose risk score was also added. In 2017, Michigan passed a law protecting pharmacists from civil liability if they refuse to dispense controlled substance prescriptions when they have a reasonable and good-faith belief that the prescription was not written by a prescriber in good faith or the prescription did not have a medical purpose (26).
In 2017 Michigan mandated prescribers and pharmacist to register and check the PDMP prior to prescribing or dispensing opioids and other controlled substances (25). Additional laws applicable to all payers implemented during 2018 and 2019 were informed consent for opioid treatment for minors and providing patient information on opioid risks (27); requiring a bona-fide provider-patient relationship for prescribing controlled substances (28) (implemented March 31, 2018 but later extended to March 31, 2019); and limit of seven days prescribing of opioids for acute pain (29), (implemented July 1, 2018).
Purpose
Quantifying of number and type of payer policy is a necessary first step in describing the opioid analgesic prescribing restrictions for clinicians and pharmacists prior to evaluating their policy impact. As such, our expectations were that all payers examined would have opioid analgesic prescribing policies, and consistent with the observation by Comerci and colleagues (19), more policies would be implemented over time.
Purpose
Quantifying of number and type of payer policy is a necessary first step in describing the opioid analgesic prescribing restrictions for clinicians and pharmacists prior to evaluating their policy impact. As such, our expectations were that all payers examined would have opioid analgesic prescribing policies, and consistent with the observation by Comerci and colleagues (19), more policies would be implemented over time.