Download Epilepsy Foundation Opposes Proposed Changes to Six Protected

Epilepsy Foundation Opposes
Proposed Changes to
Six Protected Classes Policy
8301 Professional Place, Landover, MD 20785-2353
The Epilepsy Foundation strongly opposes the Centers for Medicare and Medicaid Services (CMS)
proposal to eliminate three of the six protected classes in Medicare Part D and calls on CMS to
provide meaningful access to physician directed care for all Medicare beneficiaries, especially the
most vulnerable patients that the six protected classes was designed to protect. Restricting vulnerable
patients’ access to necessary and appropriate medications is penny wise and pound foolish, and will
lead to higher costs for the Medicare program.
The six protected classes policy is working and any changes should strengthen protections for
Medicare beneficiaries to ensure access to physician directed therapy and the protections that
Congress intended.
• Despite the success of the six protected classes policy, beneficiaries seeking epilepsy
treatment still experience access barriers related to utilization management, high cost
sharing and medication substitution.
• A 2013 study by Avalere Health found that Medicare Part D plans provide lower
levels of coverage for anticonvulsants than commercial health insurance plans.
Eroding this already lacking protection is not patient-centered.
Under the criteria of the proposed policy, the status of all the original six protected classes
could be eroded, including anticonvulsants, HIV, and oncology.
• The subjective nature of the way CMS is applying its new criteria for protected class status
could place in jeopardy access to these drugs, and the criteria themselves are not adequate
measures of when a class of medication needs protected status under Medicare.
The proposed rule focuses on “typical individuals” yet Medicare beneficiaries, especially those
living with epilepsy, are not “typical.”
• They are elderly persons, often with severe disabilities, multiple co-morbidities, and very
complex health care needs.
People living with epilepsy must have access to appropriate anti-epilepsy treatment to maintain
seizure control and avoid breakthrough seizures as well as related complications and costs.
• The proposed rule would significantly restrict access to medications under the classes that
would lose protected status. Limiting access to the most appropriate medications will drive
higher costs in Medicare Part A and Part B and Medicaid by increasing admittance to inpatient care and emergency departments due to the destabilization of patients’ conditions.
Patients with epilepsy who have their medications switched, (from brand name to generic or
from generic to generic) may be at risk for developing breakthrough seizures, especially when
the change happens without a physician's oversight and monitoring.
• About two-thirds of people diagnosed with epilepsy will become seizure free on the first or
second anti-epilepsy drug administered. For elderly epilepsy patients with multiple chronic
conditions, it is critical that they have access to a wide range of treatment options.
PHONE: 301-459-3700 • 800-332-1000 • FAX: 301-577-2684 • www.epilepsyfoundation.org
No data exists to demonstrate that the internal process used by Part D plans to review and
make decisions of granting exceptions to their formularies work for beneficiaries or that it is
timely.
• The proposed rule relies on the current exceptions, appeals and grievance processes to
provide timely access to life-saving and life-enhancing medications when a formulary
restricts access. The patient community has long expressed concerns with this process, and
called on CMS to provide timely, accessible, and consumer-oriented standard appeals policies
to ensure patient safety and appropriate access to medically necessary treatments.
The proposed rule would deem a beneficiary a “new start” and thus eligible to be switched to a
new medication every time an individual changes plans.
• Medicare beneficiaries that are new to a plan are not necessarily new to a treatment option, or
to treatment failures.
• Under Part D, duals must enroll in a zero cost Part D plan so many must switch plans every
year. As a result, dual eligible beneficiaries – the sickest and frailest and most costly –
may be forced to change medications each year. Medication substitution is risky and costly
for elderly epilepsy patients with multiple chronic conditions.
• This policy endangers the vulnerable and ignores physician directed care and individual
patient needs.
Background:
In a proposed rule issued in early January CMS proposes to scale back the life-saving six protected
classes policy by limiting and redefining Medicare Part D’s protected drug classes to exclude
antidepressants, immunosuppressants, and antipsychotics. This would be devastating for vulnerable
patients—and costly to our health care system. Although anticonvulsants would remain a protected
class for now, the status of all protected classes, including antiretrovirals, antineoplastics and
anticonvulsants, could be eroded under the new criteria proposed CMS and the subjective nature of
the way the criteria are being applied.
The six protected classes policy has enjoyed strong, bipartisan support since its inception in 2006 and
both CMS and Congress have affirmed it as a critical mechanism for the most vulnerable and
medically fragile Medicare beneficiaries. The policy, intended to ensure additional protections
beyond the statutory minimum of two drugs per therapeutic, has also been cost-effective. Recent data
show that Part D costs are less than the original CBO score projected.
For the vulnerable patients in the six protected classes, it is essential that physicians be able to
prescribe medications that are best for the patient, based on independent clinical judgment, and that
patients are afforded access to these medications under Part D plan coverage. Therapies in the six
protected drug classes are not interchangeable, and patients with these conditions need access to the
medication or combination of medications most effective in treating the condition based on factors
unique to the individual. Patients often react quite differently to the available treatments. As a result,
managing these serious—often chronic and life-threatening—conditions requires meaningful access
to the full range of therapies available. Failure to effectively manage these conditions will result in
decreased quality of life and health complications for patients, as well as higher costs to the Medicare
program and society, through increased hospitalizations, relapses, deteriorating conditions which
necessitate additional and expensive care, and cause loss in productivity.
Clinical decisions must be made by the patients’ health care providers—the medical experts who have
direct contact with the patients—and these clinical decisions should not be impaired unreasonably by
burdensome barriers to access. Medication restrictions or interruptions are harmful and ultimately are
not cost-effective for the Medicare program.
PHONE: 301-459-3700 • 800-332-1000 • FAX: 301-577-2684 • www.epilepsyfoundation.org