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Category: Access to Pain Care

Regulations through Medicaid, insurance or other health coverage programs can limit access to a variety of proven, safe and effective pain therapies. In some cases, the medication that your physician prescribes may not be on a state government’s “Preferred Drug List,” and will therefore be denied coverage.

Some states have oversight committees to evaluate spending for health technology. Washington state is one example, with a group called the Health Technology Clinical Committee (HTCC), which has denied a number of pain therapies for state employees, including TENS units and spinal cord stimulators.

Other ways that regulations can affect pain care include granting or denying FDA approval of pain medications and the creation of policies that modify/increase how drugs are monitored. In many cases, increased regulation leads to increased difficulty in accessing pain treatment that health care teams recommend. With every layer of regulation that is added, it is the people who live with pain that ultimately pay the price in terms of increased copays for doctors visits and cost of medication.

Another way that access is limited is through a growing practice among pharmacies to enact policies that prevent staff from filling prescriptions for pain medication.

These are just a few examples of how access to timely and appropriate pain care can be limited through “systemic barriers.” When you do hit roadblocks in your search for pain care, remember that you are your best advocate and that your voice deserves to be heard.

What is a Preferred Drug List (PDL) and Prior Authorization Program?

The preferred drug list (PDL) is a list of medications pre-approved by the state for use by Medicaid patients. All drugs that are not on the PDL are classified as “non-preferred” drugs. A physician can only prescribe a non-preferred drug for a Medicaid patient after going through the prior authorization process in which the state reviews the case patient profile and determines whether or not a patient should receive the prescription.

Some states’ Pharmaceutical and Therapeutics (P&T) Committees, Prior Authorization (PA) Committees, or Drug Utilization Review (DUR) Committees review classes of drugs and make recommendations on which drugs to include on the PDL. Most states make decisions based on safety, clinical efficacy, and cost. However, some states evaluate a manufacturer’s cost as a primary factor in determining a PDL.

How Does Prior Authorization Work?

Health care providers must contact a call center to obtain permission to prescribe a drug on the non-preferred list. Only the prescribing physician, an authorized prescriber, or staff member can request the prior authorization in most states. Other states allow the pharmacist to call the call center.

If a physician prescribes a non-preferred drug without seeking permission, the pharmacist will contact the physician and give him/her the option to change the prescription to a preferred drug or make the prior authorization request.

Prior authorization (PA) approvals vary in the length of time for which they are in effect. Some states honor prior authorizations for 6 to 12 months, while other states require a monthly PA.

Federal law mandates that states approve or deny a PA within 24 hours. If authorization cannot be approved or denied, Medicaid must provide a 72-hour emergency supply of the drug at the pharmacy for those patients who are Medicaid recipients.

Each state has implemented slightly different criteria that outline when a physician can prescribe a drug not on the preferred drug list. In some states, this can occur only after a patient tries a number of preferred drugs in a class and those previous therapies fail (step-therapy – see below for more information).Preferred drug lists and prior authorization approvals have the potential to:

• Prevent vulnerable patients from receiving necessary medical care

• Delay treatment

• Dissuade physicians who must obtain prior approval on a medication from prescribing that drug due to time constraints and administrative hassles

• Create higher administrative costs associated with program management and increase health care costs

Understanding How the PDL Committee Process Works

On the state level, appointed members are charged with reviewing various drug classes to recommend preferred medications in each class. Some drug classes are omitted. Consultants are generally hired to review available data and/or make recommendations and advise others who may similarly be interested in participating. Committees typically hold public hearings where the public can testify. Note that these committees make rules in advance of testimony, which may include whether testimony is written or oral.

Familiarize yourself with your State Medicaid office and procedures. 

Understand the procedure for adding or restricting therapeutic classes of medication. If your state has public hearings or debates on amending policies, find out how to apply to appear and voice your opinion and advise others who may be similarly interested in participating. Know the facts about your therapeutic class and outline key message points in advance. Find out whether decisions regarding medications will be based solely on cost or whether patient safety will be a consideration.

Ask questions about the proposed policies:

• Are the changes legal?

• Are the changes fair?

• Will the changes cause unnecessary hardship to patients?

Form alliances with other stakeholders for additional clout and ideas from adding other voices to the discussion. Additionally:

• Identify the advocacy group you represent

• Briefly cite relevant statistics related to pain management

• Mention strides in overcoming pain management barriers

• Reference effects of restricting access to medications

• Explain how a PDL for pain medications may greatly restrict access to appropriate care

• Discuss why Medicaid beneficiaries are vulnerable (poor/elderly/disabled, chronic pain, disproportionately minority)

• Explain that the variability in the effects of many medications on individual patients requires ready access to all FDA-approved medications for maximum effectiveness

• Point out the additional burdens placed on health care providers and patients by the paperwork, medication delays, and limited pharmacy access that may accompany limiting access to medications

Therapeutic Switching and Step Therapy 

Cost-saving measures such as therapeutic switching and step therapy can also raise barriers to accessing good pain care.  People who live with pain have special considerations when it comes to both step therapy and therapeutic switching. Step therapy can force a patient to suffer – sometimes for months – in order to receive the medication that his or her physician feels is the best treatment. This is cruel and inhumane. Therapeutic switching can also cause problems for people with pain, who have often faced years of frustration in seeking a proper diagnosis and treatment, only to be blocked from the access to care at the pharmacy.

• Step therapy - Requires alternate medications, which in some cases include over-the-counter medication, be taken before the physician-recommended medication is approved for reimbursement. Patients are required to fail numerous other treatment options before the insurer will grant the patient access to the treatment option that was originally prescribed by the patient’s physician, which is why this is sometimes referred to as “fail first.” This protocol is used as a cost-saving measure for the insurer. However, this policy can actually increase costs for the insurer because creating a delay in care can cause other health complications.
• Therapeutic switching (or “therapeutic substitution”) - The insurer substitutes less expensive medications or alternate medications. These are not the medications prescribed by the doctor and the patient is not aware of the change until he or she arrives at the pharmacy to pick up their medication. These medications may have more side effects and be less effective for the person with pain. Pharmacists’ and doctors’ offices are put in the unfortunate position of confronting insurers in order to provide the patient with the treatment that they prescribed. This is different than “therapeutic interchange,” where exchanges are in accordance with previously established and medical staff-approved written guidelines or protocols, within a drug formulary system.

The U.S. Pain Foundation offers information and advocacy opportunities specifically surrounding step therapy in their “Advocacy” section. The organization led efforts in its home state of Connecticut to advocate for legislation protecting people with pain from “fail first” policies.

Step therapy and prior authorization are among the State Pain Policy Action Network’s (SPPAN) priorities. SPPAN also provides an online and current state pain policy finder tool, where pending legislation and policies can be searched by issue and state.

The National Fibromyalgia and Chronic Pain Association published their “Position Paper on Access to Care for Step-Therapy, Fail-First, and Special Tiers” in October 2011.

The Institute for Patient Access (ifPA) is a physician-led policy research organization dedicated to maintaining the primacy of the physician-patient relationship in the provision of quality health care. The Institute provides a number of white papers on subjects related to pain advocacy, including “Why Doctors Need to Know when Pharmacists Substitute Biological Medicines.”

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Category: Access to Pain Care

Health care expenses are covered through one or a combination of ways, based on circumstances and eligibility. These include private health insurance, Medicare or Medicaid, state-based workers’ compensation programs or active-duty military or Veterans Health Administration. The implementation of the Affordable Care Act means that most people must have health coverage, or face fees and penalties. Some states will have their own health care exchanges, some will be forming partnerships with other states, and others have opted to let the federal government run their health exchange program.

Within each of these programs, there are an often overwhelming array of policies, regulations and procedures that dictate coverage of pain treatments. As you’re likely aware, just because a physician recommends a certain course of treatment or medication does not mean that an insurer will cover those costs. For people with pain and their caregivers, this may mean that you have to work harder to ensure access to benefits that you are entitled to through appeals or working to change policies.

By understanding how your insurance plan operates you may be in a better position to advocate for improved pain care. It is also important to be aware of cost-saving strategies that insurers use that may affect pain treatment. Caregivers and health care professionals can also advocate for improved access on behalf of themselves and their loved ones.

According to the Agency for Healthcare Quality and Research, access to health care means having “the timely use of personal health services to achieve the best health outcomes.” Attaining good access to care requires three discrete steps:

• Gaining entry into the health care system.

• Getting access to sites of care where patients can receive needed services.

• Finding providers who meet the needs of individual patients and with whom patients can develop a relationship based on mutual communication and trust.

Health care access is measured in several ways, including:

• Structural measures of the presence or absence of specific resources that facilitate health care, such as having health insurance or a usual source of care.

• Assessments by patients of how easily they are able to gain access to health care.

• Utilization measures of the ultimate outcome of good access to care—i.e., the successful receipt of needed services.

The Affordable Care Act (ACA) is now law. The law puts into place comprehensive health insurance reforms with the stated goals to: hold insurance companies more accountable, lower health care costs, guarantee more health care choices, and enhance the quality of health care for all Americans. Health insurers can no longer charge more or deny coverage to anyone because of a pre-existing condition, which can make a big difference for a person who lives with pain. The Act will not be implemented all at once. Portions of the law have already taken effect. Other changes will be implemented over a number of years. To find the latest information, visit www.healthcare.gov.

Information about health care reform can also be found at the Kaiser Family Foundation’s website: http://healthreform.kff.org.