National Center on Addiction and Substance Abuse

August 10, 2017
Laurel Fuller, MPH Policy Analyst
Office of the Assistant Secretary for Planning and Evaluation
U.S. Department of Health and Human Services
200 Independence Avenue, S.W., Room 424E.21
Washington, D.C. 20201

Re: Stakeholder Listening Session: Strategies for Improving Parity for Mental Health and Substance Use Disorder Coverage

Dear Ms. Fuller:

Thank you for the opportunity to submit comments regarding the Department of Health and Human Services" (HHS) action plan for improved federal and state coordination to enforce the Mental Health Parity and Addiction Equity Act (hereinafter, the "Parity Act").

The National Center on Addiction and Substance Abuse is a national non-profit research and policy organization focused on improving the understanding, prevention, and treatment of substance abuse and addiction. Last year, we reviewed each state’s Essential Health Benefits benchmark plan and published the findings in our report,Uncovering Coverage Gaps: A Review of Addiction Benefits in ACA Plans.¹ We found that 18% of the 2017 EHB benchmark plans, the plans that establish the minimum required substance use disorder (SUD) treatment coverage in each state, contained facial parity violations.

We recently completed another report, Parity Tracking Project: Making Parity A Reality, in collaboration with the Legal Action Center, Treatment Research Institute and Partnership for Drug Free Kids. In this study we sought to evaluate whether the two groups on the front-lines of Parity Act enforcement — regulators and consumers — could identify Parity Act violations. Regulators typically identify parity violations through the standard regulatory review process known as form review. Consumers must rely on publicly available plan documents to identify benefit and prescription drug coverage, out- of-pocket costs and any restrictions on accessing substance use disorder care, and identify plan design features that raise "red flags" for violations. We found that neither process is sufficient to identify parity violations. The report has been submitted as an attachment to the comment letter submitted by the Legal Action Center.

In the course of our research on addiction treatment access and insurance coverage, we have identified several areas where additional guidance, clarification and/or enforcement of the Parity Act are needed. Clarifying and strengthening some of the existing parity framework will go a long way towards helping the millions of Americans suffering from addiction get the care they need. In addition, we urge HHS to enhance Parity Act enforcement by shifting the enforcement paradigm away from an individual complaint- driven model to a prospective compliance review model.

Thank you for the opportunity to share our experiences on this issue and our recommendations for improving federal and state coordination to enforce the Parity Act.

Issues

1. Lack of clarity regarding requirement for intermediate services

There is ambiguity around the parity requirements for intermediate services to treat SUDs (e.g., residential, intensive outpatient and day/partial hospitalization treatment). Intermediate services do not fit squarely into the Parity Act’s six benefit classifications and the law only requires plans that cover intermediate services for SUDs to place such services in the same classification (e.g., outpatient/inpatient) as comparable intermediate medical services (e.g., skilled nursing facility and home health care). In both studies, we found that due to the limited information provided in plan documents, it is not possible to determine how the benefits are classified and thus whether there is parity among SUD benefits and medical/surgical benefits in the same benefit classification.

The Parity Law is also ambiguous with respect to the exclusion of intermediate addiction services (i.e., residential treatment) when plans cover comparable intermediate medical services (i.e., skilled nursing facilities). Some plans interpret the Parity Law regulations strictly and believe the regulations allow such exclusions. Many advocates believe that a broader reading of the Parity Law would not permit the scope of services to be covered in such an unequal manner. ² Our review of the 2017 EHB-benchmark plans identified 13 states whose EHB-benchmark plans cover intermediate medical care in a skilled nursing facility, but exclude the comparable intermediate SUD care — treatment in a residential facility.

2. Lack of transparency in plan documents

In both of our parity studies, we found that plan documents do not fully describe the scope of covered addiction benefits, making it impossible to determine whether there is parity among the addiction and medical benefits. Despite the importance of thorough benefit information, our review of the 2017 EHB benchmark plans found that 88 percent of the plan documents lack sufficient information regarding SUD benefits and/or cost-sharing to determine exactly what benefits were actually covered.

In Making Parity A Reality, we found that plan documents were frequently missing important information that consumers must rely on to determine benefit coverage and exercise their appeal rights, including:

• Limited descriptions of substance use disorder benefits (services are frequently just named without providing any description of the full benefit).
• Internal inconsistencies about benefit coverage (e.g., between the Evidence of Coverage and the Schedule of Benefits).
• Descriptions of substance use disorder benefits do not confirm coverage of all critical benefits, as outlined by the American Society of Addiction Medicine’s (ASAM) criteria to treat addiction.
• Lack of specificity about the benefits that are subject to utilization management, the full range of utilization management requirements (including continuing care requirements) and how those requirements are applied.
• The Parity Act’s non-discrimination protections are not explained in plan documents and information about filing a complaint does not specifically reference how to file a parity complaint.

3. Inadequate coverage of medications to treat opioid addiction

Our review of the 2017 EHB benchmark plans found that none of the plans covered all of the FDA- approved medications to treat opioid addiction — methadone, buprenorphine (oral or implantable), buprenorphine in combination with naloxone (Suboxone), oral naltrexone and long-acting, injectable naltrexone (Vivitrol) — which are used in medication-assisted treatment (MAT).

A further concern is the application of treatment limitations to these medications. In Making Parity a Reality, we reviewed whether SUD medications are covered on par with medications for Type 2 diabetes (which was selected as an example of a chronic disease typically covered by insurance) and placed on tiers with a consistent approach based on clinical efficacy and cost. Our review found wide discrepancies in the coverage of FDA-approved addiction medications and uncovered some significant discrepancies on authorization requirements that should raise red flags for regulators.

4. Nonquantative treatment limitations (NQTLs) are frequently imposed and particularly harmful for individuals with addiction

The Parity Act requires that the NQTLs placed on SUD benefits be comparable to and applied no more stringently than the NQTLs placed on medical/surgical benefits. Although widely used by insurers, NQTLs are particularly harmful for patients with addiction because the design and application of NQTLs can limit patients’ access to necessary, clinically indicated care and undermine treatment. For example:

Another example is to require a patient to fail one medication before authorizing another medication. Addiction medications have distinct mechanisms of action and help the patient achieve different outcomes (e.g., for alcohol use disorders, acamprosate is better for maintaining abstinence while naltrexone is better for reducing heavy drinking and craving), they are not interchangeable. The drug that is indicated for the patient should be prescribed first, no other hierarchy is clinically appropriate. The use of fail-first policies in these examples has the potential to compromise health and increase costs to the health plan.

• Prior Authorization. Requirements for prior authorization can add a further barrier to the already complex process of motivating patients to begin and stay in treatment. Addiction affects the parts of the brain associated with motivation, decision making, self-care and impulse control; therefore, engaging and retaining patients in treatment can be difficult. Because a patient’s window of motivation to engage in treatment may be narrow and shifting, imposing delays in the initiation of care can result in a failure to follow up or return for subsequent appointments. Failing to retain patients can result in serious consequences for the patient, including returning to substance use, medical complications, overdose and death. Our review found that a majority of the 2017 EHB benchmark plans (33) explicitly require prior authorization for a range of SUD treatment services, including inpatient, outpatient, and intermediate services.
• Fail-first Policies. There is no clinical evidence to support the use of fail-first policies in addiction treatment. Clinical practice guidelines call for a comprehensive assessment of each patient to determine the appropriate therapies and level of care given the severity of the patient’s addiction and the presence of co-occurring health conditions and other social/environmental factors. Requiring a patient to fail treatment at one level of care or to fail one specific therapy before starting clinically indicated care does not accord with these guidelines. In fact, the application of fail first policies in addiction treatment can negatively impact the timing and efficacy of treatment or deter patients from seeking needed treatment. For example, requiring a patient to fail psychosocial therapy before authorizing pharmaceutical therapy can cause patients to drop out of treatment. Pharmaceutical treatments reduce cravings and keep people in treatment longer; these medications work best when delivered together with psychosocial therapies, which is why the concurrent delivery of these treatments is generally recommended.
• Level of Care Exclusions. Tailoring treatment to the specific needs of the individual patient is an essential component of effective care and can only be achieved when different levels of care are available. For example, when residential care is not available, the patient may seek care at an outpatient setting where his or her needs may not be addressed adequately, or at a hospital inpatient setting where unnecessary care may be provided at a higher cost. Allowing for access to a range of levels of care, including inpatient, outpatient and intermediate services, may improve patient outcomes by matching patients to the appropriate level of care for their needs and may decrease costs to the health plan in the long-term. Our review identified 14 EHB benchmark plan with an exclusion for residential treatment. As explained in greater detail above, we believe level of care exclusions on intermediate SUD services when intermediate medical services are covered violates both the Parity Act and the ACA.
• Reimbursing Only for Short-term or Acute Care Services. Reimbursing only for short-term services is neither clinically appropriate nor consistent with the robust scientific evidence indicating that longer durations of treatment are more effective than short-term treatments for those with addiction. The medically-indicated length of treatment varies depending on the severity and complexity of the patient’s disease and other factors. Length of treatment should be flexible and contingent on periodic evaluation of the patient’s progress. Blanket limitations on allowed visits or lengths of stay do not accord with best practices for treating cases of addiction that are chronic and relapsing. When plans apply blanket limitations such as visit limits on SUD services only, this also constitutes a parity violation.

In addition to the harm caused by NQTLs, plan documents often lack information about the creation and application of NQTLs, making it difficult to determine whether plans are in compliance with the Parity Act’s NQTL requirements. In our review of plans for Making Parity a Reality, we found that form review provides no information about non-quantitative treatment limitations, with the exception of pre- authorization requirements for specific levels of care.

5. Inadequate Enforcement Framework

As detailed in our Making Parity a Reality report, we are concerned that compliance and enforcement efforts at both the state and federal level have focused primarily on strategies that are of limited utility to root out parity violations. Discriminatory insurance coverage of mental health and substance use disorder benefits persists because the traditional regulatory approach to compliance review — plan document review, utilization review agent certification, and consumer compliant investigations — will not uncover the vast majority of Parity Act violations. Regulators are not given information that is required for complex analysis of parity compliance; consumers do not have information, capacity or resources to navigate the inefficient appeals process, particularly in the middle of a health crisis; and treatment providers face significant challenges to responding to the worst opioid epidemic in history, leaving little time to challenge the exclusion of medically necessary benefits (e.g., residential treatment and methadone maintenance therapy), excessive prior authorization requirements, denials of authorization or exceedingly short authorization periods.

Recommendations

1. Issue additional parity guidance

As previously described, our research has identified several areas where additional guidance from the federal government may help generate parity compliance. Specifically,

A. Prior authorization

In our review of the 2017 EHB-benchmark plans, we found that a majority require prior authorization for a range of SUD services. As described above, even in cases where such requirements are technically in parity with prior authorization requirements for comparable medical services, the effect of such limitations on patient care is not equal — because of the discomfort of withdrawal and addiction’’s effect on the patient’s motivation, excessive prior authorization requirements on addiction treatment effectively bar access to appropriate clinical services. The federal agencies responsible for Parity Act implementation should confirm whether prior authorization requirements for addiction benefits violate parity or, if no parity violation is found, ask plans to consider removing these requirements.

B. Coverage of intermediate services

Additional guidance is needed with respect to parity requirements for intermediate services because the regulations are ambiguous. The current requirement for plans that cover intermediate addiction services to assign such benefits to the same benefit classification as comparable intermediate medical services is inadequate for ensuring equal coverage of intermediate services. Several 2017 EHB- benchmark plans cover intermediate medical services (i.e., skilled nursing facility, home health care) but exclude or omit information about coverage of intermediate addiction services (i.e., residential treatment, intensive outpatient, day/partial hospitalization programs). Allowing plans to cover intermediate medical services but exclude comparable intermediate addiction services undermines the purpose of the Parity Act as patients with addiction have unequal access to the full continuum of services provided for patients with medical conditions. Covering intermediate medical services but excluding comparable intermediate addiction services should not be permissible under the Parity Act or the Affordable Care Act.

C. Coverage of prescription medications for the treatment of opioid addiction

Medications prescribed by a physician are the most effective, potentially lifesaving, treatment for opioid addiction. MAT reduces drug use and overdose rates and helps retain people in treatment longer, which is associated with better outcomes. MAT also reduces criminal behaviors and infectious disease risk and improves occupational, psychological, and family functioning. It is well known that only a small percentage of patients with opioid addiction receive MAT.

Each of the FDA-approved medications for the treatment of opioid addiction has a different mechanism of action, different side effects, different regulatory restrictions and different protocols for administration. Methadone and buprenorphine deliver an oral, longer-acting, and safer version of opioids to help manage opioid addiction, withdrawal symptoms, cravings, and prevent overdose by blocking or occupying opioid receptors. Naltrexone, which is taken daily, or Vivitrol, a once monthly shot, blocks opioid receptors completely, preventing any effect of opioids, including intoxication or overdose. Buprenorphine/naloxone combination therapy is an abuse deterrent formulation of buprenorphine; the naloxone component reduces rewarding effects if the drug is crushed for misuse or abuse. The medications are typically prescribed or administered in distinct health care settings. To ensure proper treatment, patients must have access to all of these medications and the settings in which they are administered, so they can take the one that is most effective for them.

All FDA-approved medications designed to treat and manage addiction should be covered by health plans. Plans should also be required to cover methadone, which is frequently excluded.³There is no medical justification for excluding coverage of methadone for the treatment of opioid addiction. Methadone has been used to treat opioid addiction for the past 50 years and its efficacy is well demonstrated. Further, patients on methadone maintenance therapy cannot be easily switched to another type of medication without risk of harm. Benefits should include all clinical services required for patients to access these medications, such as physician visits for medical management of pharmaceutical therapies as well as coverage for treatment at licensed Opioid Treatment Programs when required for access to a medication modality (e.g., methadone to treat addiction involving opioids).

We request that federal agencies issue guidance to strengthen parity requirements related to prescription medications. Specifically, we believe that parity requires that all approved medications for addiction be covered, especially considering that few medications are available and they are not interchangeable. We ask for requirements that ensure adequate access to all medications for addiction, without any more stringent limitations than those imposed on other medications. We also encourage the federal agencies to prioritize prescription medication coverage in its enforcement of parity, and to carefully monitor claims data to quickly identify and remedy any problems.

2. Improve transparency in plan documents

A. Require plans to revise plan documents with insufficient benefit information

In order for plan members to understand what benefits their plan covers, plan documents must provide easily understood information about the scope of benefits and cost-sharing obligations. Such detail is also required for compliance and enforcement purposes. Transparency is necessary to hold plans accountable.

Carriers should be required to revise plan documents with insufficient information to ensure that benefit information is detailed and comprehensive and includes information about the types and levels of SUD services and medications that are covered as well as applicable cost-sharing. We also encourage federal and state regulators to develop guidance and processes to ensure plan documents for all plans subject to the Parity Act contain adequate information about addiction benefits. Carriers should also be required to include specific, easy to read language about patient parity rights in the plan documents.

B. Develop Model Contract Language that Fully Informs Consumers about Coverage and Parity Rights

One way to improve the information in plan documents and inform consumers of their rights under the Parity Act is to develop model contract language. States, such as New York, have begun using model contracts to help carriers demonstrate compliance with the range of federal and state insurance laws. An enhanced model contract is a useful tool to address limitations in the description of benefit coverage and notification of Parity Act protections. We recommend that federal and state regulators develop examples of model contract language that are written at an appropriate reading level and contain the following information:

• Complete list of substance use and mental health benefits and exclusions based on ASAM criteria.
• Detailed descriptions of covered services, aligning descriptions with levels of care contained in the ASAM criteria.
• Complete list of medications for the treatment of substance use disorders, which should include all FDA-approved medications for opioid use disorders.
• Complete list of utilization management requirements, including concurrent and retrospective review, and any other parity-compliant limitations on access to care.
• The consumer’s right to obtain services from in-network providers and options for obtaining services if the carrier does not have an in-network provider.
• Identification of the Parity Act’s non-discrimination standards, availability of plan documents to assess possible violations, and the process for appealing a denial of services or reimbursement that implicates the Parity Act.

3. Improve enforcement of Parity Act

Based on the number of parity issues that we have identified in our review of plan documents, it does not appear that states, the primary enforcers of parity, are fulfilling their obligations. Further, enforcement of parity is complicated and the federal government should provide whatever resources are necessary to assist the states and to provide more information about its role in overseeing states’ compliance. The federal government should engage in greater oversight and monitoring of state parity enforcement. Where a state has declined to enforce parity, the federal government must assume this obligation. The New York Attorney General (AG)’s office has taken the lead on enforcement in our state. The AG’s office provides a consumer complaint hotline and has dedicated staff to investigate complaints, with the ability to collect and analyze large amounts of data from insurance companies. Unless federal agencies and/or other states set up similar systems, it is unlikely that meaningful enforcement will be possible.

Specifically, we ask the federal government to improve enforcement by (1) adopting a framework based on prospective review; and (2) enhance the provider community’s capacity to identify Parity Act violations and advocate for plan compliance.

A. Parity Act Transparency and Compliance Report tool

As described in Making Parity a Reality, we recommend a prospective parity compliance review requirement, implemented through a Parity Act Transparency Compliance Report tool. Federal and state regulators should require insurers to submit this tool upon plan approval to prevent the sale of discriminatory health plans. This tool would be different from the current tools employed by state regulators (e.g., market conduct surveys and audit coverage through data reporting) which only allow for limited review of the plan rather than the full scope of plan design features, as written and in operation. Further, market conduct examinations occur after a plan is approved for sale and therefore insufficient for ensuring consumers have real-time access to non-discriminatory coverage by their health plans.

Pre-market compliance reports would place the responsibility for demonstrating compliance on the entities that have a legal obligation to offer parity compliant health plans and possess the documentation to demonstrate plan compliance. Other federal consumer health protection standards, such as the health privacy standards under the Health Insurance Protection and Portability Act (HIPAA), rely on an enforcement framework that places the onus on covered entities (including insurers and health care providers) to comply with the law rather than relying on consumer complaints.

The use of prospective review is fully consistent with other regulatory standards on carriers to demonstrate compliance to obtain market approval to sell plans to consumers and thereby creates an economic incentive for carriers to address violations. CMS already requires Medicaid managed care organizations and States to demonstrate that their Medicaid programs comply with the Parity Act.⁴ Most important, prospective review would relieve consumers of the nearly impossible burden of identifying Parity Act violations and asserting their right to health care in the midst of a health crisis. The American Medical Association supports this strategy to improve parity compliance.⁵

B. Enhance role of providers

Providers are impacted by the Parity Act’s requirements protections related to network admission and reimbursement rates. They are also uniquely position to help support their patients in accessing parity compliant care because they handle plan authorizations for services and can best identify when plans impose medical necessity standards that are inconsistent with evidence-based practices. Consumer access to care is clearly dependent upon a provider community that is knowledgeable about Parity Act protections and equipped to assert those standards.

To enhance provider capacity, the federal government should follow its model for enhancing state regulatory capacity by: making funding and technical assistance available to mental health and substance use disorder providers to improve their substantive knowledge of the Parity Act; provide technical assistance on insurance contracting and credentialing; and assist with the development of strategies that enable providers to file complaints effectively and efficiently. While a provider/consumer complaint process is not a substitute for a prospective compliance reporting requirement, this tool will remain an important part of enforcement efforts.

4. Adopt the Parity Task Force’s recommendations

Any recommendations developed and issued last year by the White House Parity Task Force should be promptly implemented. We specifically recommend (1) implementation of the recommendation for federal agencies to publicly disclose de-identified findings from parity compliance investigations to help provide guidance to the public and to plans about parity enforcement; and (2) creating legislative authority for the federal government to assess civil monetary penalties on carriers for parity violations.

Thank you very much for your willingness to receive and consider our comments. We applaud the federal government’s efforts to examine and understand the issues related to parity implementation and enforcement and develop an action plan to improve federal and state coordination. When properly implemented and enforced, the Parity Act will have a tremendous positive impact on patients seeking medically necessary and lifesaving care.

Sincerely,
Lindsey C. Vuolo, J.D., M.P.H.
Associate Director of Health Law & Policy

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