In January 2018, Congress passed the “Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act,” amending the Social Security Act (SSA) in order to provide prevention, recovery, and treatment, among other things, for persons with opioid use disorder (OUD). The U.S. Department of Health and Human Services (HHS) Centers for Medicare and Medicaid Services (CMS) released an informational bulletin that provides guidance for implementation of the Act on August 5, 2019, addressing Section 1004 of the SUPPORT Act. The bulletin reviews the requirement that states implement changes to their Medicaid Drug Utilization Review (DUR) process to include minimum opioid standards within their fee-for-service (FFS) and managed care programs. This article reviews the need for strategies to address OUD in the United States and outlines the information provided by CMS to assist states in meeting the Medicaid DUR requirements of the SUPPORT Act.
Historically, opioids have been used to manage pain in patients recovering from injury or illness. Both natural and synthetic opioids have high risk of addiction. Drug poisoning (overdose) deaths related to OUD were six times higher in the U.S. in 2017 than they were in 2009.
In 2017 alone, there were 70,237 drug overdose deaths in the United States, with persons in their middle ages--between 25 years old and 54 years old)--experiencing higher rates of overdose death. Deaths related to synthetic opioid use, excluding methadone, increased by 45 percent from 2016 to 2017. Deaths wherein the victims ingested fentanyl, fentanyl analogs, or tramadol increased at an average rate of 8 percent per year from 1999 to 2013 and by 71 percent from 2013 to 2017.
Over 191 million opioid prescriptions were written for Americans in 2017, though the prevalence of prescriptions varies from state to state. For instance, prescribers in Alabama, where the highest number of prescriptions were written, had three times the number of prescriptions than patients living in Hawaii, the state with the least number of opioid prescriptions. The Centers for Disease Control and Prevention (CDC) indicates that a population’s health status is unrelated to the varying rates of prescription opioid use and that altering the way in which Americans manage pain and avoiding the use of common opioids like methadone, oxycodone, and hydrocodone, will have a greater impact on the efforts to curb overdose deaths in our communities. CDC’s focus on prevention includes strategies to:
Build prevention efforts in states;
Improve data quality and tracking trends;
Support healthcare providers and health systems;
Partner with public safety (law enforcement and the like);
Encourage Americans to make safe pain management choices.
There is no common theme pointing to who will fall victim to OUD, disallowing any sort of stereotyping of the representative opioid user. In January 2019, the National Institute on Drug Abuse (NIDA) reported that 130 people die from opioid overdose in the United States every day. The CDC reports that the, “total ‘economic burden’ of prescription opioid misuse alone in the United States is $78.5 billion a year, including the cost of healthcare, lost productivity, addiction treatment, and criminal justice involvement.”
According to the Medicaid and CHIP Payment and Access Commission (MACPAC) the epidemic disproportionately affects Medicaid beneficiaries, who are prescribed pain relievers at higher rates than those with other sources of insurance and have a higher rate of opioid use disorder. Medicaid covers nearly 4 in 10 of the 1.98 million non-elderly adults with OUD. However, as of 2015, only about 32 percent of Medicaid enrollees with an opioid use disorder were receiving treatment. In 2017, CMS issued guidance to states promoting strategies for expanding access to substance abuse treatment, including the availability of 1115 waiver authority. While many states have focused on expanding access to treatment, the SUPPORT Act takes a new approach in creating minimum standards for opioid prescribing and dispensing.
Medicaid Drug Utilization Review (DUR)
Each state is required, under the SSA, to develop a DUR to decrease clinical abuse and misuse of prescription drugs under the Medicaid program through the use of predetermined standards against which they assess drug use information. Section 1004 of the SUPPORT Act requires states to implement new safety edits and claims review automated processes that will enforce minimum opioid standards within their FFS and managed care programs. This guidance encourages states to develop DUR reviews that are consistent with medical practice patterns in the state and to utilize guidelines such as the 2016 CDC Guideline for primary care practitioners on prescribing opioids for chronic pain in outpatient settings. The CMS guidance provides information on how states must comply with four requirements under the SUPPORT Act:
Claims Review Requirement;
Program to Monitor Antipsychotic Medications in Children;
Fraud and Abuse Identification Requirements; and,
Managed Care Organization (MCO) Requirements.
Claim Review Requirements
CMS interprets these additional safety edits as requiring a prospective review of each prescription. These edits will encourage the identification of prescription misuse or abuse at the point of sale (POS) to avoid the possibility of overdose death in patients prescribed opioid-based pain medications. CMS interprets these to be real-time safety precautions that will curb the dispensing of high-risk medications. When a safety edit is triggered, the pharmacist will receive an alert and must take further action before dispending the product to the patient.
CMS interprets the claims review automated process to require that states perform a retrospective review of claims data. Such a review will include the examination of claims data to identify patterns of fraud, abuse, gross overuse, or inappropriate or medically unnecessary care. It will offer healthcare providers insight into any patterns apparent in the delivery of services, including the prescribing of medication. Finally, it will allow for a careful review by the provider that results in the minimization of the dispensing of opioid prescriptions to patients.
Under the Claims Review Requirement states must put in place:
Safety Edits Including Early, Duplicate, and Quantity Limits— Because the use of multiple opioids is associated with a higher risk of mortality, the following edits must be implemented:
Prospective automated rules at the POS that limit patients from receiving duplicate fills and early fills; and,
Retrospective review of subsequent fills in excess of specified quantity limitations.
Maximum Daily Morphine Milligram Equivalents (MME) Safety Edits— Because higher dosages of opioids are associated with higher risk of overdose and death, states must implement:
Prospective edits to limit the maximum MME that can be prescribed; and,
Retrospective claims review to identify individuals who are prescribed a morphine equivalent for treatment of chronic pain in excess of the maximum MME dose limitation.
Concurrent Utilization Alerts—Because concurrent use of opioids and benzodiazepines and/or opioids and antipsychotics significantly contributes to the risk of opioid overdose, states must have a retrospective process for reviewing claims to identify when an individual has concurrent prescriptions
The above described edits and claims review requirements do not apply with respect to individuals who are:
Receiving hospice or palliative care;
Receiving treatment for cancer;
Residents of a long-term care facility; or
Other individuals the state elects to treat as exempted from such requirements.
Monitoring Antipsychotic Medication Use By Children
In response to the emergence of safety concerns in pediatric antipsychotic medication use in the late 2000s, federal, state, and public‐sector agencies invested in a breadth of systems‐level strategies to monitor antipsychotic medication use in children and support best practice prescribing. In 2012, federal law was passed requiring states to develop protocols for the appropriate use and monitoring of psychotropic medications for children in foster care. While many children in foster care are also Medicaid eligible, this law did not extend to all children in Medicaid. While some states implemented monitoring programs for both foster care and Medicaid children, many Medicaid programs relied solely on prior authorization to manage this issue.
The SUPPORT Act now requires that all states implement programs to monitor and manage the appropriate use of antipsychotics in children in the Medicaid program. States will have to submit a DUR report annually that provides information on the activities states carried out to meet this requirement for persons 18 years and under with a specific highlight on children living in the foster system.
Fraud and Abuse Identification Requirements
States must develop an internal process to monitor the distribution of controlled substances to monitor the occurrence of fraud and abuse related to prescriptions issued to persons enrolled under the state plan, including those under a waiver. CMS encourages the use of lock-in programs and prescription drug monitoring systems in light of the National Criminal Justice Reference Services (NCJRS) Office of National Drug Control Policy report indicating that these programs play a large role in identifying and curbing abuse.
Managed Care Organization Requirements
MCO’s operating in a state must comply with the DUR requirements. States will need to alter contracts to reflect the requirement that MCOs operate a DUR that meets the new requirements under the SUPPORT Act. Additionally, states are required to ensure that MCOs serving enrolled patients comply with the implementation of an antipsychotic medication monitoring program for children and fraud and abuse identification requirements related to the use of controlled substances in Medicaid.
States must amend their State Plan and receive CMS approval of the application for implementation of these DUR requirements. State Plan amendments must be submitted no later than December 31, 2019 with an October 1, 2019 start date. Amendments must include sufficient detail describing how the state either currently supports or is implementing and providing oversight for each of the four new requirements under the SUPPORT Act.
While public notice is not required for a state plan amendment of this nature, many states have formal processes that they utilize to provide stakeholders the opportunity to track and comment on policy changes. Stakeholders who are interested in understanding how their state is implementing these requirements should engage with a representative from their state Medicaid agency.