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Access to Medication: NAMI Advocacy Goals and Strategies

The Access to Medications Task Force met on December 9, 2002 to review the trends, practices and alternatives in pharmaceutical cost containment; and discuss and develop recommendations and strategy.

Guidelines Underlying Advocacy Goals and Strategies

The Task Force developed guidelines to organize its work. The policies and advocacy strategies that flow from these guidelines were based on extensive discussions and address both short and long term issues, as well as the needs and interests of NAMI’s members at federal, state and local levels.

• Do No Harm
  • Cost containment and stringent utilization controls often hurt access. Prescription drugs are essential to the recovery and continuing health of most people with severe mental illness. Ensuring access to the most effective psychotropic medications is essential.
• Ensure that Benefits Outweigh Costs
  • Pharmaceutical companies must bring drugs to the market place at reasonable and affordable prices. At the same time, state agencies must provide sufficient funding to guarantee access to potentially cost-saving medications and must avoid regulations that simply shift healthcare costs.
  • Appropriate medication is as important to recovery from mental illnesses as it is for recovery from somatic illnesses. It offers the same alternative to more expensive care and treatment in both cases. If policymakers choose to do less for fewer people with mental illness, the cost of this neglect will not only be counted in human suffering, it will reappear in other areas of their budgets and/or in other levels of government.
  • Policymakers should weigh the costs of any strategy being considered against the anticipated benefits. Medicaid programs must measure the costs and health consequences and identify the risks inherent in a strategy. Cost containment and accountability must go hand in hand.
  • Rising pharmacy costs must be understood as part of the larger picture: dramatic reductions in long-term hospitalizations and criminalization result from access to effective medication, comprehensive outpatient treatment and timely short term inpatient treatment. We need to ensure that people with mental illnesses have adequate medications so fewer people end up being hospitalized longer than necessary or inappropriately incarcerated.
• Focus on Long-Term Value
  • The mission of an effective patient care system is to deliver long-term value to the patient and society. Improving clinical quality by using evidence-based prescribing practices may require short-term investments and garner long-term savings.
• Keep Doors Open
  • It is very likely that using prior authorization programs along with other cost controls will reduce the medication compliance of people with severe mental illness. Previous implementation of multiple cost containment programs led to a significant number of persons with severe mental illness not receiving their medications. Barriers to appropriate care should be avoided. If individuals are denied access to medications, adverse events or outcomes should be reported by a physician charged with that responsibility. We believe this requirement is consistent with evidence-based health care practice.
• Ensure that Treatment is Based on the Best Science
  • Will advances in the pharmaceutical treatment of mental illness add to overall health care costs or yield savings as they supplant or reduce the need for other costly treatments? Patients should receive care based on the best available scientific knowledge. Cost control paradigms may reduce pressure on specific budget line items and they may be designed to minimize access concerns but they do not and are not designed to ensure quality care.
  • Access to psychotropic medications should not vary from state to state or from clinician to clinician because of cost containment decisions made by policymakers. Policymakers should base their decisions on the best available data from research on the cost benefit of the new generation of psychotropic medications. The Task force believes that access to medications should focus on a disease management approach to treatment.

Specific Advocacy Goals and Strategies from the Recommendations of the Access to Medications Task Force

The Task Force recommends that NAMI pursue the following strategies to ensure open access to medications in the current budget deficit environment. They should be seen as an integrated, comprehensive approach to addressing the needs and interests of the people we serve.

Federal Strategies

Legislative Initiatives

1. Support an Increase in Federal Medicaid Assistance Percentage (FMAP)

The federal government reimburses states for a substantial portion of their Medicaid costs. The Medicaid budget problems that states are experiencing are being exacerbated by reductions in federal Medicaid matching payments to some states. These payments are based on the FMAP, which is determined by historical economic data.

The current FMAP rates are based on data from years prior to the recession, placing a number of states in the position of having to fund their Medicaid programs with fewer federal dollars at a time when states are facing record state revenue shortfalls.

Realizing the service, infrastructure, and community economic impacts of the loss of federal funds if states cut back on their Medicaid spending, governors are aggressively supporting initiatives in Congress that will increase the federal match rates. Governors are also aware that there are serious implications regarding the safety of patients, cooperation of unions and loss of accreditation for Medicaid funds as state hospital staff cuts reach dangerous levels. Proponents of an FMAP increase contend that increased federal support will temper the need for drastic cuts in Medicaid programs.

NAMI should support congressional legislative efforts to increase FMAP in 2003, and work closely with the National Governors’ Association, Association of County Commissioners and Association of State Legislators, as they work to increase federal Medicaid matching rates.

• See also: Increasing State Medicaid Funding Matches: A Guide for Adovcates

2. Medicare Prescription Drug Benefit

NAMI should closely monitor and support appropriate, emerging legislative initiatives to expand prescription drug coverage for Medicare beneficiaries. State pressure to control prescription drug spending will mount in the absence of a Medicare drug benefit.

Many states must pay the expense of drug assistance programs for Medicare beneficiaries who do not have incomes low enough to qualify for Medicaid. They must also provide the state match for dually eligible recipients under Medicaid. The federalization of prescription drug expenses for these groups through the provision of a Medicare drug benefit has profound implications for state budgets and for the Medicaid program.

• See also: A Medicare Prescription Drug Benefit: A Guide for Adovcates

3. Support System-Wide Health Care Reform

The Task Force supports systemic health care reform to address the coverage, cost and quality problems in the health care delivery and financing system.

NAMI should monitor systemic health care reform initiatives and support those that lead to better access to the most effective treatments. NAMI should participate in appropriate hearings and meetings addressing mental illness system reform and health care system reform. These two initiatives are inextricably intertwined.

Specifically, as a part of mental illness system reform, an information and tracking system should be established to support officials (e.g., a physicians), who are responsible, for monitoring individuals served and individuals denied service. It is critically important that a risk management type-officer be held accountable for monitoring and keeping appropriate records, otherwise reform efforts will be slowed.

There must be better data collection processes at the state level, with federal oversight, so that a reasonable evaluation of the system of care can occur.

Regulatory Initiatives

NAMI should continue to press the Center for Medicaid and State Operations within the Centers for Medicare and Medicaid Services, to provide written guidance to state directors advising them of both their legal authority to create carve outs for medications for severe mental illnesses and the policy justification for such a measure.

We believe that such guidance is consistent with federal Medicaid law and the current Administration’s policy with respect to access to treatment for people with disabilities.

Evidence-Based Research

NAMI supports increased research budget allocations to the National Institute of Mental Health. That research will develop a better understanding of access to services and treatment as well as the potential impact of the new generation of psychotropic medications. It would enable NAMI and other advocates to identify evidence-based practices that should shape public policy recommendations.

NAMI also supports increased funding for the Agency for Healthcare Research and Quality (AHRQ) initiatives that translate research into evidence-based practices. AHRQ should sponsor research on newer psychotropic medications compared to older medications, so patients receive medical care based on the best available scientific knowledge.

NAMI should monitor the TMAP initiative (see below) to determine if its protocols can lead to more effective and more cost-effective, prescribing practices.

State Strategies

Legislative Initiatives

1. Exemption of Psychotropic Medications

• Carve Outs
  NAMI should promote and develop model language on carve-outs for anti-psychotic, anti-depressant, anti-anxiety and anti-convulsant medications as a starting point in discussions with state officials. The legislative language that would create a narrower carve-out like "anti-psychotic medications only," should be considered only as a last resort, when a broader approach is not politically or economically achievable.
  • See also: Medication Carve Outs for Mental Illness: A Guide for Advocates

• Fail-First
  Advocates should emphatically oppose the use of fail-first provisions prior to authorization of state-of-the-art psychiatric medications.
  • See also:Fail-First Policies to Limit Access to Medications: A Guide for Advocates

2. Monitor and Participate in the Budget Process – "Do Not Balance State Budgets on the Backs of Vulnerable Populations"

• NAMI must make it clear, in the appropriations process, that adequate funding of the state’s mental health care system is critical to ensure the health of the state’s citizens and communities. People with severe mental illness are the most vulnerable consumers – removing access to treatment is life threatening and provides no cost savings to the state over the long term.
• Adequate funding and support of a strong mental health system and Medicaid program in every state must be one of NAMI’s highest priorities. The Task Force supports the development of a tracking system that would identify which individuals are or are not served. It is important to be able to document that our nation’s failure to provide adequate services for children and adults with mental illnesses has resulted in a crisis for schools, families, communities, and the states.
• To further influence policy on access, NAMI advocates should arrange meetings with state Medicaid officials and officials in the executive branch, as well as with state policymakers and their staffs.
• See also: The Current Revenue Crisis and Implications for State Mental Health Services

3. Pharmaceutical Pricing

• The Task Force supports research and development efforts in the development of new and effective medications. However, NAMI must not support pricing practices which make these same medications inaccessible to mentally ill people who depend on them.
• NAMI should monitor efforts on the part of pharmaceutical companies to not only contain but also reduce costs and to bring to market affordable medications.
• NAMI should monitor efforts by states to contain the cost of medications through more efficient purchasing arrangements that control the rate of escalation in prescription drug costs without harming access to medications.

Regulatory Initiatives

Notification, Grievance and Appeals Procedures

Additional advocacy efforts should insist on procedures to protect Medicaid recipients with severe mental illness from harm. The following actions are recommended:

• Where carve outs are not attainable, informed clinicians must be involved in the development of any formularies and in making prior authorization determinations. All Pharmacy and Therapeutic Committees must include at least one practicing psychiatrist.
• A simple and fully accessible system must be created for requesting prior authorization by phone or fax, including the broad dissemination of easy to use prior authorization forms to all participating medical service providers.
• A short turnaround time for obtaining a response to requests for prior authorization (two hours) must be operational, with the full amount originally prescribed automatically approved, if the Department is not able to make verbal contact with the prescriber within two hours of the request.
• When decisions to deny medications are appealed, a limited (ten day) supply of the originally prescribed drug must be provided.
• An expedited appeal procedure must be followed whenever an appeal is filed following the denial of a medication. All appeals should be decided within 10 days of the date the appeal is filed.
• A person, ideally a physician, should be appointed by the governor to see that all individuals served or denied care are tracked and that all adverse events are reported in a timely and pubic manner.
• See also:
  • Medicaid Prior Authorization Programs: A Guide for Advocates
  • Model Prescription Drug Prior Authorization Process for State Medicaid Programs -- from the Kaiser Commission on Medicaid and the Uninsured, April 2003

Legal Initiatives

1. Class-Action Suits

Background

It is clear from presentations to the Task Force, that Medicaid prior authorization programs are high risk cost containment strategies and they are not an effective management strategy based on private sector experience.

It is clear to the Task Force that the consequences for people with severe mental illness will be devastating if Medicaid prior authorization programs become more commonplace.

Prior authorization programs may help state Medicaid programs control their budgets in the short term, but unintended consequences such as increases in the costs of hospitalization and incarceration in the criminal justice system will offset any savings.

Further, the Task Force heard presentations that supplemental rebate programs are confusing to consumers and physicians because they may not be aware of when a drug is covered or not at any given time.

Strategy

Therefore, NAMI should closely track state supplemental rebate reform initiatives and exclusions from formularies as part of its overall legal strategy. NAMI should consider participating in class-action suits that would oppose restricting low-income Medicaid clients’ access to prescription drugs through burdensome prior authorization requirements.

NAMI should consider filing amicus briefs and should support efforts to maintain access to treatment through other court actions.

2. Align with Appropriate Groups – Build Coalitions

NAMI should work with broad-based coalitions of consumers, providers, legal rights groups, other health care advocacy organizations, and other appropriate groups to support such initiatives. Establishing short-term broad-based coalitions with interest groups who have similar objectives regarding access to prescription drugs can enhance NAMI’s effectiveness on the access issue.

Evidence-Based Initiatives

Support Polypharmacy Education Programs

Massachusetts Medicaid and Mental Health Departments have introduced a voluntary polypharmacy review process, with medical service provider education and compliance tracking, as an alternative to a preferred drug list.

By educating prescribers and applying prior authorization procedures to polypharmacy practices for which there is minimal or no evidence base, Medicaid agencies may be able to improve care and moderate increases in expenditures for psychotropic medications.

The Task Force heard that recent research points to significant physical health risk to patients who are taking multiple psychotropic medications. The Massachusetts approach is an attempt to change the clinical culture and to actively engage physicians in a dialogue about prescribing practices.

NAMI should support adjunctive pharmacy, which is defined as the use of an antipsychotic medication with one or more additional psychoactive medications (including another antipsychotic) when monotherapy options have been exhausted or specific psychiatric symptoms are being targeted.

Support and Expand Development of Explicit Protocols

NAMI should encourage the use of clinically tested medication algorithms to ensure the utilization of evidence-based medication practices. The Texas Medication Algorithm Project (TMAP) has produced treatment algorithms (including prescription drug therapy) for three serious mental illnesses – schizophrenia, major depressive disorder and bipolar disease. The paradigm has been adopted in other states. NAMI should support the continued development and evaluation of the efficacy of TMAP as an alternative to Medicaid cost containment strategies.

Community Strategies

Cost containment within the Medicaid program for medications to treat mental illnesses is an irrational process. There is no template. Solutions tend to vary by state as all politics is local and Medicaid programs differ state by state. It is critical that advocates get to the table to help policymakers connect the dots. It is important to remember that not all access policy changes are legislative. Much work occurs within appointed Drug Utilization Review and Pharmacy and Therapeutics Committees and in negotiation with governor’s and their staff members.

1. Work with state and county policymakers

Advocates should contact their legislators, county commissioners, mental health directors and other local stakeholders to collaborate in engaging state Medicaid agencies on the access issue. It is important to hold policymakers accountable for the risks and offsets caused by the Medicaid access shell game.

2. Work the Media

Advocates should contact the media’s health care reporters to discuss the potential implications of impeding access to prescription drugs. It is important to define and publicize the impact of cuts and restrictions on consumers and families.

Don’t Mourn: Organize

It is a mile into the woods and a mile out. The threats in Medicaid to access to the "new generation" of medications to treat mental illness will continue over the summer and fall and into 2004. It is critical that advocates form and sustain diverse partnerships and alliances to educate the media and policymakers as to what is good evidence based policy.

See also: Policy Recommendations on Access to Medications: Guidance for Advocates 

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