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20-420 Avoid Compliance Issues: New Drug Utilization Review Requirements Target Opioids

Date: 05/28/20

Changes can reduce fraud, misuse and abuse of prescription drugs

As a provider contracted with California Health & Wellness Plan (CHWP), you are receiving this information to keep you informed of CHWP’s responsibilities for a drug utilization program. Entities delegated to fill prescriptions for outpatient drugs (“applicable entities”) would also be responsible for the requirements.

CHWP and applicable entities must comply with the following:

Effective date

Requirement

October 1, 2019

  • Operate a drug utilization review (DUR) program1

No later than
April 1, 2020 

  • Submit the following to the Department of Health Care Services (DHCS):

 -    Updated policies and procedures that address each of the   requirements as detailed in this update.

 -    Annual DUR Report.

Be aware of what’s required in the DUR program

Requirements include the key elements listed below.

Safety edits, including early, duplicate and quantity limits

Describe the opioid-related prospective safety edits, as well as the automated process for retrospective claims review that Health Net or the applicable entity has in place to address: duplicate fill, early fill and quantity limits. Health Net and applicable entities must not allow refills earlier than 75% of the time when the previous fill should be exhausted; duplication of the same service on the same date of fill; and the provision of acute medications in excess of a 30-day supply, or for chronic medications, a 90-day supply without prior authorization approval.

Maximum daily morphine milligram equivalents (MME) safety edits

  • Describe the prospective safety edits for the maximum MME/daily that can be prescribed to a member enrolled for treatment of chronic pain, not to exceed 500 MME/daily without prior authorization. This safety edit must include an MME/daily threshold amount to assist in identifying members at potentially high clinical risk who may benefit from closer monitoring and care coordination.
  • Describe the automated process for claims review (retrospective review) that indicates when a member is prescribed the morphine equivalent for such treatment in excess of the maximum MME/daily dose limitation.

Concurrent utilization alerts

Describe the automated process for claims review (retrospective) that monitors when a member is concurrently prescribed opioids and benzodiazepines or opioids and antipsychotics. (This does not preclude the establishment of a prospective safety-edit system to provide additional information to patients and providers at the point-of-sale about concurrent utilization.) Managed care plans (MCPs) and applicable entities that are not capitated for antipsychotic drugs will be provided claims data, including for antipsychotic medications. Health Net and applicable entities are expected to perform, retrospectively, regular care management activities, including a review of concurrent use of opioid and antipsychotic medications, and take action accordingly on issues of concern to them.

What’s excluded from the program

The above described safety edits and claims review requirements do not apply to members who are receiving hospice or palliative care; receiving treatment for cancer; residents of a long-term care facility, a facility described in section 1905(d) of the Act, or of another facility for which frequently abused drugs are dispensed for residents through a contact with a single pharmacy; members who are receiving opioid agonist medications for treatment of substance use disorder; or other individuals the state elects to treat as exempted from such requirements.

Monitor antipsychotic medications used for children

MCPs (and applicable entities) that are capitated for all psychiatric drugs, including antipsychotic medications, must describe the program they use to monitor and manage utilization of antipsychotic medications in children and foster children. MCPs and applicable entities must also describe the actions they will take based on DUR program monitoring. The use of antipsychotic medications outside of U.S. Food and Drug Administration-approved indications or doses needs prior authorization approval. Also, ongoing use of two or more antipsychotic medications must be medically justified and closely monitored.

Identify fraud, waste and abuse

Describe the process for identifying and addressing fraud and abuse of controlled substances by members, health care providers who are prescribing drugs to members, and pharmacies dispensing drugs to members. Also describe the actions that will be taken based on issues identified through program-monitoring findings.

Background

Federal law2 requires each state to develop a DUR program that is targeted, in part, at reducing clinical abuse and misuse of prescription drugs covered under the state’s Medicaid program. The SUPPORT Act adds measures to combat the opioid crisis in part by reducing opioid abuse and misuse by advancing treatment and recovery initiatives, improving prevention, protecting communities and bolstering efforts to fight deadly illicit synthetic drugs. There are several Medicaid-related DUR provisions contained within section 1004 of the SUPPORT Act with respect to fee-for-service and managed care organization pharmacy programs. These provisions establish drug review and utilization standards to supplement existing requirements under federal law, in an effort to reduce opioid-related fraud, abuse and misuse. Implementation and review of these strategies was required effective October 1, 2019.

The Centers for Medicare & Medicaid Services issued an Informational Bulletin on August 5, 20193, providing states with detailed guidance on implementation of these specific new requirements. In addition, DHCS All Plan Letter (APL) 19-012, Federal Drug Utilization Review Requirements Designed to Reduce Opioid-Related Fraud, Misuse and Abuse, describes MCPs’ responsibilities related to the implementation of the federal law. You can view the APL at www.dhcs.ca.gov/formsandpubs/Documents/MMCDAPLsandPolicyLetters/APL2019/APL19-012.pdf.

Relevant sections of Health Net’s provider operations manuals have been revised to reflect the information contained in this update as applicable. Provider operations manuals are available electronically in the Provider Library, located on Health Net’s provider website at provider.healthnet.com.

1 The DUR program must comply with Medicaid-related DUR provisions contained in section 1004 of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (H.R. 6, the SUPPORT Act, P.L. 115-271).

2 Section 1927(g) of the Social Security Act (the Act).

3 The August 5, 2019, Informational Bulletin can be accessed at www.medicaid.gov/federal-policy-guidance/downloads/cib080519-1004.pdf.