Delaware Enforcement

Delaware – Health Plans Fined $1.33 Million for Mental Health Parity Violations in 2020/2021

The Delaware Insurance Department recently has published two rounds of market conduct exams, the first audit results were published in November 2020 and the second in July 2021.  The summary below highlights the five health plans that have been audited and fined by the state insurance department.  The findings in each report mostly cover mental health and substance use disorder (MH/SUD) coverage violations based on requirements established by Mental Health Parity and Addiction Equity Act of 2008 and similar state provisions.  As describe below, the five health plans are:

• Aetna Health Plan;
• Cigna Health Life and Insurance Company;
• Highmark BCBSD Inc.;
• United Health Care; and
• Optimum Choice.

Insurance Commission Announces Second Round of Market Conduct Mental Health Parity Exams including $735,000 for Parity Violations (July 26, 2021)

On July 26, 2021, Commissioner Trinidad Navarro published a press release announcing the completion of the second round of mental health parity examinations.  Three health plans, United Health Care, Optimum Choice and Cigna Health Life and Insurance Company, entered into separate consent orders two years after the initial market conduct exams were completed.

United Health Care

The market conduct exam focused on United’s general operations, forms, complaint handling, grievance and appeals, policy holder services, utilization review and mental health parity compliance – among other topics.

United was fined $253,000 by the Delaware Department of Insurance.  Among other infractions, United imposed:

• Prior authorization NQTLs that were applied more stringently to MH/SUD benefits than to medical/surgical benefits in the same classification. For example, the auditors found that United inappropriately imposed a MH/SUD NQTLs on:
  • Stimulant-based ADHD medications which included an age limit restriction of 12 and older.
  • Smoking cessation medications with a maximum coverage limitations for each 12 months period.
  • Buprenorphine containing medications used for opioid dependence treatment, and then later removed the prior authorization requirement but for just one Buprenorphine/naloxone – Zubsolv. Other similar medications were placed on higher cost tiers.
  • Coverage limits for Vyvance for Binge eating disorders.
• A quantity limit restriction on Buprenorphine HCL sublingual tablets for a maximum allowance of a 5-day suppler and on duloxetine capsules to 3 per day or a 90 mg dose total.
• Inappropriate dose restrictions on Suboxone sublingual film contrary to FDA recommendation.
• Limits on “The refill and save program” by removing Pristiq in a discriminatory manner.
• Restrictive medical necessity criteria on Evzio injection for members who require rescue naloxone and are treated with MAT.
• Exclusions or higher tier placement on generic mental health medications (including antipsychotics) on their Advantage and Essential formularies, and sometimes for United’s non-formulary status.
• Exclusion for methadone maintenance treatment from outpatient treatment facilities approved by SAMSHA in accordance with ASAM guidelines.

A number of other deficiencies were identified related to timeframes related to the review of grievances, fair and prompt payment of certain claims,  over-stepping additional information requests and other operational issues.

Click on these links for the:

• United Market Conduct Examination Report (June 2019)
• United Consent Order (June 2021)

Optimum Choice

The market conduct exam focused on Optimum’s general operations, forms, complaint handling, grievance and appeals, policy holder services, utilization review and mental health parity compliance – among other topics.

Optimum was fined $100,000 by the Delaware Department of Insurance.  Among other infractions (many similar to United’s above), Optimum imposed:

• Greater limits in the coverage of MH/SUD prescription medicines when compared to other medical/surgical medications.
• Prior authorization NQTLs that were applied more stringently to MH/SUD benefits than to medical/surgical benefits in the same classification. For example, the auditors found that Optimum inappropriately imposed a MH/SUD NQTLs on:
  • MH/SUD current procedural terminology (CPT)s when compared to corresponding evaluation and management (E/M) code used by medical professionals.
  • All stimulant-based AHDHD medications.
  • Smoking cessation medications with a maximum coverage limitations for each 12 months period.
  • Buprenorphine containing medications used for opioid dependence treatment, and then later removed the prior authorization requirement but for just one Buprenorphine/naloxone – Zubsolv. Other similar medications were placed on higher cost tiers.
  • Coverage limits for Vyvance for Binge eating disorders.
• Inappropriate concurrent utilization review criteria requirements for additional treatment.
• A quantity limit restriction on Buprenorphine HCL sublingual tablets for a maximum allowance. of a 5-day suppler and on duloxetine capsules to 3 per day or a 90 mg dose total.
• Inappropriate dose restrictions on Suboxone sublingual film contrary to FDA recommendation.
• Limits on “The refill and save program” by removing Pristiq in a discriminatory manner
• Restrictive medical necessity criteria on Evzio injection for members who require rescue naloxone and are treated with MAT.
• Exclusions or higher tier placement on generic mental health medications (including antipsychotics) on their Advantage and Essential formularies, and sometimes for its non-formulary status for antidepressants.
• Exclusion for methadone maintenance treatment from outpatient treatment facilities approved by SAMSHA in accordance with ASAM guidelines.

A number of other deficiencies were identified related to timeframes required to acknowledge and respond to insurance claims,  make timely and proper payments, failure to notify in writing why a claims was not be paid within 30 days of receipt, misrepresented pertinent facts or policy provisions related to coverage issues, and other operational issues.

Click on these links for the:

• Optimum Market Conduct Examination Report (June 2019)
• Optimum Consent Order (June 2021)

Cigna Health Life and Insurance Company

The market conduct exam focused on Cigna’s general operations and related activities.  Issues were identified for the plan’s  complaint handling, underwriting & rating, claims, utilization review and pharmacy services.

Cigna was fined $382,000 by the Delaware Department of Insurance.  Among other infractions, Cigna  imposed prior authorization NQTLs that were applied more stringently to MH/SUD benefits than to medical/surgical benefits in the same classification.  For example, the auditors found that Cigna inappropriately imposed a MH/SUD NQTLs by requiring  additional utilization review to cover long and short acting ADHD medication and in order to obtain a doctor’s authorization for a member to take two different strengths of the same medication.  On a similar note, a NQTL violation was identified in terms of how the plan identified prior authorization and formulary exclusions for Vyvance for to cover binge eating disorders.

Similarly CIGNA improperly implemented a step therapy limitation as applied to two mental health medications through a depression diagnosis screening form.  A similar problem was identified in how the plan applied an age threshold in its step therapy policy for ADHD medication for individuals under 18 years old.

Regarding other MH/SUD coverage issues, Cigna failed to correctly identify ASAM criteria when making coverage decisions regarding substance use disorders.  The plan also implemented quantity limitations restriction for certain substance abuse medications (such as buprenorphine/naloxone coverage) and antidepressant medications that were more stringently applied than medical/surgical medications.   In addition, the structure of some of its formularies (such as placement of antipsychotics,  ADHD medications and smoking cessation medications on a non-preferred tier level) were determined to be parity violations.

A number of other deficiencies were identified related to the receipt and processing of written grievances, timely communications responding to claim inquiries from insureds, failure to send timely requests for independent utilization reviews, failure of proper notice for denials of care, lack of proper coverage for  autism spectrum disorders, failure to cover infertility claims because mandated coverage was not loaded into the system, failure to provide pre-authorization for certain pharmaceutical benefits and other operational issues.

Click on these links for the:

• Cigna Market Conduct Examination Report (June 2019)
• Cigna Consent Order (June 2021)

Insurance Commissioner Announces First Market Conduct Mental Health Parity Exams including $597,000 for Initial Parity Violations (November 2020)

On November 19, 2020, Insurance Commissioner Trinidad Navarro published a press release announcing the completion of the first in a series of Mental Health Parity examinations involving our major health insurers in Delaware.  Two of the four exam reports have been published, resulting in $597,000 in parity violations thus far.  The press release notes:

The 2018 passage of SB 230 required companies to submit an initial analysis of mental and behavioral health coverage to the department in 2019, after which the department would include compliance reviews in their annual market conduct exams. A high number of violations was expected due to this being the first assessment by the department.

“After an incredibly thorough review, our team identified many changes that needed to be made to improve parity. Today’s announcement shows that there is more work to do to ensure those seeking mental health care can do so without undue expense or difficulty. I will continue to hold insurers accountable to meet our state’s standards,” said Commissioner Navarro. “Each violation incurred a fine, but it also brought about important conversations that will result in action, and insurers have been cooperative throughout the process and are already making improvements. We will be following up with insurers frequently and expecting substantial progress.”

In general, the violations found in policies and practices revolved around a lack of parity between mental health and medical/surgical procedures, medications and procedure preauthorization requirements. Mental health patients often had to meet higher standards for Non-Quantitative Treatment Limitation (limits on the scope or duration of benefits) than other patients, and pharmacy requirements appeared to differ as well. The companies are working to resolve these differences.

Parity Violations Published Reports

The two major health insurers where the market exam findings have been published are Aetna Health Plan and Highmark BCBSD Inc.  The audit focused on the following health plan lines of business:  forms, complaint handling, grievances and appeals, and claims.

Aetna Health Plan

In terms of parity-related violations, the Delaware Department of Insurance identified the following deficiencies against Aetna (Note:  Findings are quoted directly from the report in most instances):

• Improper SUD Pre-Authorization Requirements.
  • Aetna’s pre-authorization requirement includes establishing a diagnosis of opioid dependence, proof of counselling and abstinence from all opioids monitored through drug screening. This additional prior authorization requirement causes treatment delay and is excessive and discriminatory to members who need mental health/substance abuse care.
  • Aetna imposed a NQTL of a prior authorization every 6 months on all buprenorphine and buprenorphine/ naloxone containing medications (both brand and generic) used for the treatment of Opioid Use Disorder (OUD). When comparing to opioid medications used for pain management (MED/SURG) the Company offers Butrans (buprenorphine) transdermal patch approved for chronic pain (MED/SURG), without a prior authorization requirement, and Belbuca (buprenorphine) buccal film approved for chronic pain (MED/SURG) with a prior authorization duration of 1
• Unfair Formulary Tiers.  Aetna imposed higher tier placements (Tier 3) on buprenorphine hcl sublingual tablets, buprenorphine/naloxone sublingual tablets, methadone (all strengths), naltrexone tablets, Suboxone films, and Bunavail. This is a violation by placing higher tiers (Tier 3) on the substance abuse medications used to treat Opioid Use Disorder (OUD) compared to MED/SURG medications which exhibit lower tier designations (Tier 1 and Tier 2) in every medication classification throughout this formulary. Comparing these aforementioned substance abuse medications to MED/SURG medications classified                in this formulary, the patient/member would be paying higher copays resulting in higher cost to treat their
• Inappropriate Medication Restrictions.
  • Aetna applied a NQTL (quantity limitation/dose restriction) on max dosing of duloxetine for Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD) that was not included on max dosing for its MED/SURG indications. The recommended maximum dose for duloxetine is 120mg per day for Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD) in accordance with both the FDA and the American Psychiatric Association’s (APA) recommended Duloxetine’s other indications such as Diabetic Peripheral Neuropathic Pain (DPNP), Fibromyalgia (FM), and Chronic Musculoskeletal pain all have a maximum dosage of 60mg per day. None of these MED/SURG indications require a prior authorization at their maximum dose. However, a prior authorization override is required at doses of 120mg per day for only mental health indications (MDD and GAD). This policy is discriminatory towards mental health members since the same maximum dosing criteria is not provided equally to MH/SUD and MED/SURG indications.
  • Aetna applied a NQTL (quantity limitation/dose restriction) on max dosing of duloxetine for Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD) that was not included on max dosing for its MED/SURG The recommended maximum dose for duloxetine is 120mg per day for Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD) in accordance with both the FDA and the American Psychiatric Association’s (APA) recommended guidelines. Duloxetine’s other indications such as Diabetic Peripheral Neuropathic Pain (DPNP), Fibromyalgia (FM), and Chronic Musculoskeletal pain all have a maximum dosage of 60mg per day. None of these MED/SURG indications require a prior authorization at their maximum dose. However, a prior authorization override is required at doses of 120mg per day for only mental health indications (MDD and GAD). This policy is discriminatory towards mental health members since the same maximum dosing criteria is are not provided equally to MH/SUD and MED/SURG indications.
  • Aetna placed quantity limitations on ADHD stimulant-based medications When comparing the same criteria to MED/SURG, many MED/SURG medications exceeded their FDA, manufacturer, and peer reviewed literature dosing guidelines during the scope of the exam. This resulted in many paid MED/SURG claims with no dosing restrictions on above label/off label dosing. The Company is being more stringent/restrictive on ADHD medications, prescribed under physician supervision, by holding this type of mental health medication to FDA and manufacturer recommended guidelines. Quantity limits were later adjusted and raised on various ADHD medications as a result of excessive overturn rates on appeals (74%) from the entire class of ADHD medications. The Company applied quantity limitations (off label dosing) to ADHD medications more stringently than the processes, strategies, evidentiary standards, and other factors being applied to MED/SURG

See 18 Del. C. § 3343(b)(1)(b) Insurance coverage for serious mental illness and 45 CFR § 146.136(c)(4)(ii)(a)(b) Nonquantitative treatment limitations.

Highmark BCBSD Inc.

In terms of parity-related violations, the Commissioner identified the following deficiencies against Highmark (Note:  Findings are quoted directly from the report in most instances):

• NQTL Coverage Violation.
  • Highmark excluded methadone medication treatment in 2016, 2017, and all preceding years for opioid use disorder (OUD) at outpatient/ambulatory care prior to January 2018.
• Improper Utilization Management/Claims Processes. Highmark:
  • Imposed a restrictive prior authorization with a 60-day lookback on medication fills greater than a 5-day supply of buprenorphine sublingual tablets (monotherapy) for Opioid Use Disorder (OUD) thus denying immediate access in emergency situations;
  • Failed to correctly identify ASAM criteria when used with SUD; and
  • Failed to provide notice of acceptance or denial or status within 30 days for the noted
• Inappropriate Medication Restrictions. Highmark:
  • Used criteria that are more stringently applied to these mental health medications and are not comparable to policies for medical/surgical medications;
  • When compared to medical/surgical medications, imposed improper NQTLs on coverage for:
    • Venlafaxine ER 150mg capsules for the treatment of Major Depressive Disorder (MDD) by establishing a step therapy policy that is more stringently applied to this medication;
    • Brintellix/Trintellix, desvenlafaxine ER, Fetzima, Khedezla, Pristiq, and Viibryd for the treatment of Major Depressive Disorder (MDD);
    • Various atypical antipsychotics (quetiapine, risperidone, and ziprasidone); and
    • Evzio and Narcan nasal spray (vials, syringes) of 4 doses every 360 days.

See 18 Del. C. § 3343(b)(1)b and (b)(2)a. Insurance coverage for serious mental illness, and 18 Del. C.§ 3350(b) Prescription medication; 45 CFR 146.136 (c)(4)(i) General rule and 45 CFR 146.136 (c)(4)(ii)(A); 8 Del. Admin. C. 902 § 1.2.1.5 Authority for Regulation; Basis for Regulation