Mental Health America (MHA) envisions a society in which all people in need have access to the full array of high quality, evidence-based, culturally and linguistically competent, integrated mental health and substance abuse services delivered in the community, regardless of ability to pay. For many mental health consumers, access to the full range of the most effective medications is a crucial component of successful treatment and recovery. Such medically necessary psychotropic medications, and their combination with other services and supports, are often essential to permit people with mental health and substance use conditions to recover and thrive, leading healthy and productive lives in their communities.
Policies That Restrict Access to Medically Necessary Medications
Mental health treatment is complex and studies show that medications in the same class for the treatment of mental illness are not interchangeable the way medications in other classes may be. MHA opposes policies that restrict access to medically necessary medications. Such policies, that have the sole purpose of reducing pharmacy costs, and which include preferred drug lists with prior authorization requirements, restrictive formularies, fail-first requirements, monthly prescription limits, and tiered co-payment structures, not only fail to achieve what should be their intended purpose of reducing overall healthcare costs but prolong human suffering and reduce the potential for an individual with a mental health or substance use condition to achieve full recovery. Moreover, restrictive policies fail to acknowledge that physicians and consumers should make individualized treatment decisions, recognizing the unique and non-interchangeable nature of human beings and psychotropic medications, and acknowledging that lack of access to medications has serious human as well as financial consequences.
The cost of medications has risen over time, especially the newer “biologic” medications, and some biologics and other expensive medications have become unaffordable under drug insurance plans that charge high copays under “tiered” reimbursement structures. This is a serious long-term concern, and MHA has joined with other Medicare advocates in urging reform.[i]
The Six Medicare Protected Classes
Part D is the Medicare prescription drug program. MAPRx is a national coalition, of which MHA is a member. Since Medicare Part D was created, people living with disabilities have been assured appropriate access to six specific classes of medicines (known as the “protected classes”): anticonvulsants, antidepressants, antineoplastics, antipsychotics, antiretrovirals, and immunosuppressants.[i] People with serious mental illness and substance use disorders need access to antipsychotics and antidepressants and also have high rates of co-occurring HIV-AIDS infections for which the protected class antiretrovirals are lifesaving. Anticonvulsants are often used as mood stabilizers in bipolar illness.[ii] The remaining two protected classes, immunosuppressants[iii] (to protect transplanted organs) and antineoplastics[iv] (anti-cancer agents) also are of great importance to those with serious mental illness. Thus, MAPRx and MHA strongly advocate retaining the existing protected class protections.
MHA recognizes that health care administrators are faced with the challenge of containing costs while maintaining or improving the quality of the care provided to consumers. MHA supports efforts to implement appropriate utilization management strategies that promote and improve the quality of care for individuals with mental health and substance use conditions while seeking containment and reduction of pharmaceutical costs. But insurers must consider overall healthcare spending and health outcomes in deciding which medications to authorize. Such broad healthcare strategies – which are premised on access to all medications approved for the treatment of mental health conditions – include closer scrutiny of utilization data to manage cases of polypharmacy, fraud and abuse; provider education initiatives targeted at high volume prescribers; appropriate disease management programs; best practice prescribing edits;
and algorithms and other practice standards that promote appropriate prescribing based on clinical data, patient experience, and evidence-based practices. Additionally, MHA supports the use of tools to enhance appropriate prescribing and other treatment practices in light of best practice models. Sophisticated modeling and the appropriate use of consumer and professional boards can assure credibility in the prescription of medicine as well as assuring consideration of the full range of treatment options and the active involvement of beneficiaries in treatment decisions.[i]
MHA believes that decisions should always be clinically based and reflect patient goals, and that such best-practice prescribing should provide long-term cost containment. If implemented based upon the evidence, the practices and tools identified below can be useful for policy makers, practitioners, and people in treatment to ensure appropriate access to and prescribing of medications, leading to quality improvement and cost containment. MHA opposes policies that do not carefully and completely address all of the potentially serious health and societal consequences that can occur as a result of inappropriate medication management .
- Best practice prescribing edits are intended to promote adherence to accepted mental health medication regimens that reflects the preferences of people in treatment based on their individual experience, and ensure safe and effective use. Edits are not formulary restrictions, but rather utilize clinical evidence to encourage quality and effective prescribing by preventing therapeutic duplication, overdosing, subtherapeutic dosing, and adverse medication related reactions. Claims data can be reviewed to identify any providers who appear to have unsafe or inappropriate prescribing practices. This practice of processing edits should identify problems or inconsistencies with the clinical evidence around drug interactions, frequency of refills, dose optimization, days supply, and quantities dispensed. Once identified, those providers with prescribing practices that are not clinically based can be targeted for training on best practices and monitored for fraud and abuse.
- Algorithms are treatment protocols for medication prescribing, guiding a practitioner with regard to what drug to try first, and in turn, if it is not effective, which medications can subsequently be prescribed. Algorithms that are clinically based, and which include patient previous experience are especially helpful for those providers with less expertise with treating mental illnesses, like primary care providers. If used appropriately, algorithms may help in providing a more thorough and informed clinical response, potentially leading to greater long-term use of outpatient services instead of hospital and institutional care. Algorithms can also define where a new medication fits in the sequence of steps for optimal clinical outcomes. It is important to remember that while algorithms can help assist the clinician in clinical decision-making, they must be voluntary, and they are not a substitute for clinical judgment and common sense. A well-constructed medication algorithm is not a cookbook for care, but can guide the clinician (optimally with input from the patient) through multiple treatment options. By including prior history, beneficiary preference, and past responses in each step of the algorithm, a clinician can tailor the treatment to an individual’s needs with the goal of achieving full remission, community inclusion and recovery. Like other clinical tools, algorithms should not be based on a fail first mentality, use cost rather than clinical evidence as a determiner, or specify which brand of drug is preferable.
- Consumer and professional boards, such as state Medicaid pharmacy and therapeutics committees, are
yet another venue for monitoring the appropriate prescribing of mental health medications. Optimally, consumers and members of the psychiatric community are included as voting members on such state boards, to ensure representation of those living with mental health conditions. A consumer and professional board can be established by statute to review and implement the coverage practices of state Medicaid plans and the prescribing practices of providers to ensure safety and improve adherence, quality and outcomes. The board may make recommendations based on peer reviewed medical literature, observational studies, health economic studies, and input from physicians and people in treatment. An effective board also recommends prescribing edits that are consistent with best practice and clinical evidence.
- Broadly, MHA opposes measures, such as fail first policies, that are intended to limit the availability of the most individually appropriate, effective, and clinically indicated medications. Fail-first requirements (currently referred to as “step therapy”) and “therapeutic substitution” of less expensive medications are inherently objectionable in that they restrict access to medically necessary medications. Such requirements should be reconsidered and modified or eliminated to provide optimal mental health and substance use care. These policies often prevent physicians and consumers from using their first choice – usually a branded, newer, more expensive medication unless and until a trial of an older generic, usually less expensive, medication fails to mitigate the condition or causes unacceptable side effects. MHA is concerned that the treatment will often fail, and this failure will often have serious negative consequences for mental health, overall health and life outcomes. Often when individuals do not experience positive results or experience adverse side effects; they are not compliant. A decline in medication adherence will lead to poorer health outcomes, which will in turn, cost even more in avoidable hospitalizations and other unnecessary medical care.
Additionally, failed treatment often results in serious symptoms jeopardizing educational and job performance, continued employment, housing arrangements, and family relationships, and even resulting in hospitalization, or criminal justice involvement. Thus, these policies are particularly dangerous for people in crisis, and policies that defer medically necessary inpatient treatment are most suspect.
- A fail first policy can only avoid or minimize these serious harms if it:
(a) takes into account the history of the illness, family history and past treatments;
(b) exempts anyone who is already being successfully treated with another medication (“grandfathering”);
(c) provides a quick and easily accessible mechanism (prior authorization process) through which a physician can establish a clinical basis for using another medication without trying and failing with the less expensive medication; and
(d) establishes policies, standards and practices which minimize the nature and duration of any failure.
A fail first policy must also take into account the financial realities of the physician and the person in treatment. For example, a fail first policy imposed in a Medicaid program with very low physician reimbursement rates and which does not compensate them for time spent obtaining an exemption from the fail first policy virtually guarantees that many more people with serious mental illnesses will suffer from the failure of their medication. MHA opposes fail first policies that do not carefully and completely address all of these serious problems. Given the prevalence of fail first policies and their increased use in recent years, MHA affiliates and other advocates should make it a priority to monitor compliance with these standards. Prescribers should have the option to designate “Dispense as Written” to prevent automatic switching at the pharmacy point-of-sale, and a “grandfathering” policy should exist to ensure that consumers who are successfully being treated on a non-preferred medication are not forced to switch.
For further background information and detailed examples of alternative utilization management strategies, refer to Mental Health America’s Issue Brief Series: Access to Medications for Public Health Programs,[ii] which includes the following components:
- The Case for Open Access to Medications
- State Policies that Restrict Access to Medications
- Essential Consumer Protections for Medication Policy
- Promoting Appropriate Use of Medications
More broadly, policymakers should work toward solutions that reduce beneficiaries’ out-of-pocket costs. MHA endorses the 2018 MAPRx report[iii] that makes the case that recently enacted and proposed policies erode beneficiary protections in favor of health plan flexibility and outlines a number of program features that hinder beneficiaries’ ability to appropriately access needed prescription drugs. The MAPRx coalition and MHA call on the Administration and Congress to address challenges facing Part D beneficiaries, including:
- Increased out-of-pocket costs, including a shift to coinsurance (beneficiaries pay a percentage of the cost of the prescription versus a fixed copay), which can significantly increase out of pocket costs;
- Lack of an annual out of pocket cap on costs to beneficiaries – unlike other insurance, both public and commercial, there is no limit on what beneficiaries may be required to pay for their prescription drugs throughout the year;
- An out-of-pocket cliff, which if not addressed by Congress early in 2019, will result in beneficiaries paying $1,200 more out of pocket in 2020 before reaching the catastrophic coverage phase of the benefit; This cliff will increase the catastrophic threshold from $5,100 in 2019 to $6,350 in 2020;
- Failure by pharmacy benefits managers to pass along manufacturer rebates to beneficiaries at the point of sale, which currently prevents people from benefiting from reduced drug prices negotiated by manufacturers and health plans;
- Adverse tiering that disproportionately affects chronically ill beneficiaries, such as utilization of specialty tiers that entail high cost sharing for Medicare beneficiaries (as much as 33%) who rely on drugs for multiple sclerosis, rheumatoid arthritis, multiple myeloma and many other conditions;
- Restrictions on the ability of beneficiaries to request specialty tier exceptions and the usage of non-preferred brand tiers;
- Utilization management practices, such as step therapy (also known as “fail-first” policies) that require a person to first take a drug (and fail on that drug, even if it has been tried in the past) before moving to taking the drug originally prescribed by their doctor;
- Lack of easy-to-navigate resources explaining plan options and opportunities to submit appeals and exceptions;
- Narrow formularies that have fewer prescription drug options for low-income subsidy beneficiaries; and
- Formulary changes that happen within a plan year, so that medication that a person may be taking is no longer preferred.
Call to Action
Advocates and MHA affiliates should be vigilant to determine whether the shifting limits on access to medications are both reasonable and flexible and comport with this position statement, and that they comply with mental health and substance use parity laws. Affiliates should give special attention to these concerns in the implementation of the state exchanges and in state Medicaid programs. MHA urges that:
- The six “protected classes” of medication continue to enjoy federal protection under Medicare;
- Prior authorization be timely and efficient so as not to delay access to medication nor to deter the prescriber from ordering medications that will have optimal benefits;
- “Fail first” policies comport with MHA’s recommendations;
- Utilization management strategies be developed by a pharmacy and therapeutics committee that includes practicing physicians in the field of mental health and substance abuse treatment, and those with “lived experience,” and be regularly reviewed and audited to ensure that they do not have unintended negative effects;
- The process for developing state utilization management strategies include meaningful involvement from beneficiaries and adequate opportunity for public input;
- Appeals and grievance procedures be clearly disseminated to beneficiaries and be both accessible and timely;
The Mental Health America Board of Directors approved this policy on March 9, 2019. It will remain in effect for five (5) years and is reviewed as required by the Mental Health America Public Policy Committee.
Expiration: December 31, 2024
[i] MAXRx, “Revising Specialty Tiers: Protecting Medicare Part D Beneficiaries from Burdensome Cost Shifting,” http://maprx.info/wp-content/uploads/2013/07/20130725-MapRX-Revising-Specialty-Tiers.pdf
 The protected class policy evolved in 2008 under section 176 of the Medicare Improvements for Patients and Providers Act (MIPPA), which authorized CMS to establish a new regulatory review process for the purpose of identifying those drug classes for which a Part D plan would be required to include all drugs on its formulary. Though the Part D statute did not reference the existing six protected classes, language within the bill directed the Health and Human Services Secretary to identify those categories and classes of drugs which meet two criteria: (1) Restrictions on that class would have major or life threatening consequences; and (2) There is a significant need for individuals which a disease or disorder treated by the drugs in the class to have access to multiple drugs within that class. In 2010, section 3307 of the Affordable Care Act (ACA) codified reliance on the two-prong test, and kept intact the existing six protected classes until the Secretary established more formal criteria for designating these classes. https://maprx.info/briefing-memo-protected-classes/ . Although repeatedly threatened, the protected class policy remains unchanged as of the date of this position statement.
[iii] Eg. https://journals.lww.com/clinicalneuropharm/Abstract/2010/11000/Evidence_for_Use_of_Mood_Stabilizers_and.8.aspx
[iv] People with bipolar disorder on long-term treatment with lithium have high rates of end-stage renal disease https://atcmeetingabstracts.com/abstract/excellent-outcomes-of-kidney-transplant-in-patients-with-bipolar-disorder/
[v] There is strong evidence to suggest that adults living with serious mental illness have a higher risk of mortality and morbidity than the general U.S. population, including a higher risk of mortality associated with certain cancers and cancer-related deaths. https://www.ajpmonline.org/article/S0749-3797(13)00641-7/pdf
[i] See, e.g., The Indiana legislation that creates the Indiana Drug Utilization Review Board, IC 12-15-35.5 and IC 12-15-35-51, http://www.in.gov/legislative/ic/code/title12/ar15/ch35.5.html , The Wisconsin Mental Health Drug Advisors Group, https://www.forwardhealth.wi.gov/WIPortal/Tab/42/icscontent/provider/pac/mhda/index.htm.spage and complex algorithms like California’s CalMEND program. The CalMEND “Decision Aid for Antipsychotic Use,” is a good example. See also, Parks, J., Radke A., Parker G.,, Foti, M-E. Eilers, R., Diamond, M., Svendsen, D., and Tandon1, R., “Principles of Antipsychotic Prescribing for Policy Makers, Circa 2008. Translating Knowledge to Promote Individualized Treatment.” 35 Schizophrenia Bulletin 931-6 (2000). doi: 10.1093/schbul/sbn019. Epub 2008 Apr 2. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2728806/.
[iii] MAXRx, “Navigating Part D” (September, 2016), https://maprx.info/wp-content/uploads/2018/12/MAPRx-Report-Navigating-Medicare-Part-D.pdf