Download informed enrollment choices. We applaud the Department of Health

 December 22, 2014
The Honorable Sylvia Mathews Burwell
Secretary of Health and Human Services
200 Independence Avenue SW
Washington, DC, 20201
Re: CMS-9944-P –Patient Protection and Affordable Care Act: HHS Notice of Benefit and Payment Parameters for
2016, 79 Fed. Reg. 70673 (November 26, 2014)
Dear Secretary Burwell:
Thank you for the opportunity to comment on the proposed rule, Notice of Benefit and Payment Parameters for 2016.
The Epilepsy Foundation is the leading national voluntary health organization that speaks on behalf of more than 2.8
million Americans with epilepsy and seizures. We foster the well-being of children and adults affected by seizures
through research programs, educational activities, advocacy and direct services. Epilepsy is a medical condition that
produces seizures affecting a variety of mental and physical functions. Approximately 1 in 26 Americans will
develop epilepsy at some point in their lifetime, and people living with epilepsy must have meaningful and timely
access to physician-directed care and specialists, to avoid breakthrough seizures and related complications and costs.
Many individuals living with epilepsy who had been denied access to health insurance in the past due to pre-existing
conditions have now gain access to quality and affordable care. But many are still facing barriers to care, including
discriminatory benefit designs that limit access, such as restrictive formularies and inadequate provider networks;
high cost-sharing; and a lack of plan transparency that deprives them of the information that is essential to making
informed enrollment choices. We applaud the Department of Health and Human Services (HHS) for proposing
increased patient protections, but urge the Secretary to pursue additional protections to ensure meaningful and timely
access to quality care for all individuals enrolled in Marketplace plans. Discriminatory Benefit Design
We commend HHS for including language in the proposed rule’s preamble that cautions issuers to avoid discouraging
enrollment of individuals with chronic health needs, by reminding them that they must not design plan benefits in a
discriminatory manner, for example placing limits on or excluding services, such as placing all or nearly all drugs for
a particular condition in the highest cost-sharing tier, labeling certain benefits as pediatric-only, or limiting services
based on age or health condition. We urge HHS to enforce the ACA non-discrimination provisions and to issue
regulations that further define what is discrimination.
Benchmark Plans
We appreciate the recognition that benchmark plans used to determine the essential health benefits for each state need
to be updated. Basing them on 2014 plans is an improvement. However, we would rather see a different process
identified to determine essential health benefits, one that better meets patient needs and is more consistent across the
country. Since an alternative approach is not being proposed at this time, and HHS is continuing to use the benchmark
process to define essential health benefits for each state, we support using 2014 plans as the benchmark, but would
like to see this implemented beginning for the 2016 plan year and not the 2017 plan year.
Prescription Drug Benefits
Drug Formularies: We support the proposal to replace the current system of determining the Essential Health
Benefit’s prescription drug benefit. The current process of relying on the greater of one drug per class or the number
of drugs in each class in the state’s benchmark based on the US Pharmacopeia (USP) classification system has many
shortcomings. USP was designed for the Medicare Part D program, which is a different population than the qualified
health plans. This has resulted in numerous drugs not being covered, including newly approved medications. We urge
HHS to move forward with retaining, as a minimum, the current greater than one drug or the number of drugs covered
by the benchmark requirement using either the most recent AHFS or USP system, and using the most granular level
of either counting system in tandem with the expert recommendations of the pharmacy & therapeutics (P&T)
committee. If HHS uses the USP system in 2016, plans should be required to use USP Version 6.0, which was
finalized in February 2014 and is more current than Version 5.0.
American Hospital Formulary System: We support moving to the American Hospital Formulary System (AHFS) as a
standard for classifying drugs, because AHFS is more detailed, widely used and accepted, and more frequently
updated. But we caution about overreliance on AHFS or any system to ensure strong formularies that can ensure
meaningful access to physician-directed care. The AHFS categorizes anti-epilepsy drugs (AEDs) by chemical
structure (and not by mechanism of action as in USP), and has more subclasses. This reflects the unique nature of
each AED, and should lead to better coverage of the wide range of AEDs on the market today. However, many of the
AEDs approved within the past two decades are grouped into one AHFS category (anti-convulsant, miscellaneous),
which could lead to poor coverage of the newest and most effective treatment options. This reinforces the need for the
drug review process by the proposed pharmacy and therapeutic (P&T) committees to be based on treatment guidelines
and expert knowledge of specific health conditions, not just basic drug counts and AHFS or USP classes. Currently
many commonly prescribed AEDs are not on plan formularies, and transitioning to AHFS should address, not
exacerbate, this disturbing trend.
Pharmacy & Therapeutics Committees: We support utilizing pharmacy and therapeutic (P&T) committees that select
what medications plans cover based on treatment guidelines and expert knowledge of specific health conditions and
their treatment, with the expectation that decisions of P&T committees should result in more robust, equitable, and
clinically appropriate formularies that do not discourage certain patient groups from enrollment. We strongly support
the proposed transparency requirements for the P&T committees included in the proposed rule, and urge HHS to
establish and uphold additional oversight standards. We support the requirement that P&T committees meet at least
quarterly to ensure newly approved drugs, or existing drugs for new indications, can be added to plan formularies. We
urge HHS to establish specific timelines for review of new drugs, and drugs with new indications, for inclusion on
formularies. We also support HHS’s expectation that the P&T committee members include experts in chronic diseases
and in the care of individuals with disabilities. Additionally, we recommend that plans be compelled to seek outside
guidance from experts in rare disorders and enrollees with conditions whose treatments are under review. P&T
committee accountability should include public disclosure of members, conflict of interest standards and disclosures,
and documented procedures for reviewing new drugs and new uses of drugs. We urge HHS to identify and adopt a
public conflict of interest standard for P&T committees serving Qualified Health Plans that ensures transparency and
accountability. Finally, since plans already utilize P&T committees and are familiar with the AHFS classification
system, we urge HHS to institute this process for plan year 2016 and not wait until 2017.
Limits to Midyear Benefit Changes: We support the proposal that non-grandfathered plans may not change benefits or
cost-sharing mid-year but may only make modifications at the time of coverage renewal. Individuals with chronic
conditions rely on certain medications and services when selecting a plan, and losing access to a drug or service,
whether because it is removed from coverage or becomes subject to higher cost-sharing, can have a significant
negative impact on their health and quality of life.
Utilization Management: We urge HHS to clarify appropriate utilization management techniques by plans, to ensure
timely access to physician-directed care.
Formulary Coverage During Plan Transition: We urge HHS to require 90-day access to non-formulary drugs for new
enrollees to provide sufficient time for patients and providers to discuss potential alternatives or pursue an exception
if needed.
Exceptions Process: We support the proposal regarding an “exceptions process” for enrollees to access medications
not on a plan’s formulary, along with a secondary external review process. We are pleased that HHS is clarifying that
patient cost sharing for excepted drugs should count toward the maximum cost-sharing limit, but urge HHS to ensure
that all off-formulary drugs, even not obtained through the exception process, also count towards the maximum costsharing limit. We urge HHS to incorporate additional safeguards in the exceptions processes, to include requiring
plans to provide information to beneficiaries about each coverage determination, the reason(s) for any denial, and the
timeframes and procedures for appealing a denial. Plans also should be required to provide to the external review
panel copies of any materials used to reach the denial decision. We believe implementation of the proposed
exceptions process measures should begin in plan year 2016, as proposed.
Choice in Pharmacy Delivery: We support the proposal to prohibiting the practice of a mail-order only option, instead
providing patients with the choice of how they receive their prescriptions. As the proposed rule describes, there are
legitimate instances in which a patient may want to access a retail pharmacy and patients can benefit from interaction
with a pharmacist. We urge HHS to require this proposal be implemented in 2016.
Transparency
Drug Formularies and Provider Lists: We support the proposals to increase formulary and provider transparency, and
encourage HHS to require this level of transparency be available to patients when comparing and selecting plans,
during the enrollment period. In order for patients to select the plans that best meet their individual health care needs,
they must have access to easy-to-understand, detailed information about plan benefits, formularies, provider
networks, and the costs of medications and services. We support the requirement that each plan publish up-to-date,
complete formularies with tiering information and any restrictions on accessing the drug. Additionally, since plans are
employing the use of co-insurance more frequently, we urge HHS to require plans to detail what the actual patient
cost-sharing will be in dollar terms, as well as other relevant cost sharing information like pharmacy deductibles and
cost-sharing. Currently patients lack the information they need to know how much they will have to pay for a drug or
service, and this information is critical when selecting a plan, and when trying to access a drug or service.
Additionally, we urge HHS to require greater transparency with respect to a plans’ medical benefits, in addition to
pharmacy benefits, given certain medicines may be covered through the medical benefit.
Summary of Benefits and Coverage: We support requiring issuers to provide a Summary of Benefits and Coverage
(SBC) that accurately portrays the cost-sharing requirements for all silver plan variations with cost-sharing reductions
applied. This would ensure that individuals with lower incomes can understand their cost-sharing requirements prior
to plan selection in 2016. We also support requiring issuers to provide notice (including an updated SBC) within 7
days for individuals whose eligibility for cost sharing reductions changes during the year.
Data on Drug Formularies and Provider Lists: We support the requirement that issuers submit drug formularies and
provider lists in machine-readable file. Currently, there is no standard formulary design and only some have search
capabilities. All consumers would benefit from an interactive web tool such as a plan finder or benefit calculator that
matches an individual’s prescriptions and provider needs with appropriate plans (such as the one utilized by the
Medicare Part D program). Submitting information in a standard machine-readable format can assist in developing
such tools.
Auto-Enrollment: We urge HHS to ensure that if a patient is auto-enrolled “by default” in a new plan, the patient
should receive advance notice of the change that includes an explanation of benefits under the new plan (including but
not limited to prescription drug coverage and all tiering, utilization restrictions, and cost-sharing that would apply); an
express opportunity and timeframe to select a different plan instead of the “default” plan. Additionally, HHS should
ensure that the patient is not required to repeat step therapy that the patient already completed under a prior plan (a
similar protection exists under Part D for patients who are “auto-reassigned” to a different plan).
Cost-Sharing
Non-calendar year plans: We support the proposal that non-calendar year plans must adhere to the cost-sharing limits
effective for the year in which the plan begins and cannot reset cost sharing requirements at the end of the calendar
year.
Cost-sharing limits: We support the clarification that cost-sharing for drugs obtained through the exceptions process
must count towards the plan’s annual limits on cost-sharing. We support self-only cost-sharing limits that apply to all
individuals regardless of whether the individual is covered by a self-only plan or an other-than-self only plan.
Additional cost-sharing limits and transparency: We urge HHS develop additional patient protections for co-pays and
co-insurance, including require cost-sharing for patients who rely on off-formulary medications to be included in the
patient maximum out of pocket amount; standard copay and coinsurance charges when a qualified and accessible innetwork provider is not available; and an external appeal process to review whether an in-network provider is actually
accessible and available and appropriate for the patient’s needs. We urge HHS to ensure that plans require network
providers and facilities to disclose the cost and the use of non-network providers in advance of a member’s decision
to use out-of-network services, and to develop additional protection from surprise or unavoidable out-of-network
charges, such as when an undisclosed out-of-network provider provides a service for a scheduled non-emergency
procedure at an in-network hospital.
Network Adequacy
Provider Networks: We urge HHS to adopt network adequacy standards that require health plans to have a full range
of providers in-network capable of providing all covered services. The use of out-of-network exceptions and appeal
process, as well as updated provider directories, cannot be a substitute for robust provider network standards.
Essential Community Providers
We supports HHS effort to ensure that more providers are included as essential community providers (ECP) in
Qualified Health Plans by requiring at least one ECP from each ECP category, but urge HHS to consider additional
protections to encourage access to more than one ECP in each category.
Access to Out-of-Network Providers: If an individual must use an out-of-network provider because there is no
provider available in-network that is capable of providing a covered benefit due to insufficient in-network options,
that individual must not be penalized by the health plan. We urge HHS to ensure that, in such a case, the individual be
responsible only for in-network cost-sharing for out-of-network providers, and that any cost-sharing incurred count
towards the annual limit. Cost sharing and other requirements for the receipt of out-of-network care should follow the
same protections set forth by the plan as if the care was contracted as in-network. Plans should demonstrate that they
maintain an adequate and timely approval process for out-of-network services, utilize appropriate clinical standards in
evaluating requests, and have a clear, transparent, and timely appeals process for denied services.
Continuity of Care: We commend HHS for highlighting the importance of seamless care transitions that ensure that
patients undergoing a course of treatment can continue their relationship with their provider during that treatment. We
support coverage of transitional care for an ongoing course of treatment, as patients transition to a new in-network
provider.
Physical Accessibility: We support the inclusion of physical accessibility as part of network adequacy standards.
Accessibility information should be made available in provider directories to help consumers, because consumers
must know if they and their family members will be able to use the services of that provider comparing and selecting
plans.
Habilitative and Rehabilitative Services
Uniform Definition of Habilitative Services: We applaud HHS for seeking to establish a federal definition of
habilitative services, and for suggesting the adoption of the National Association of Insurance Commissioners’
(NAIC) definition of habilitative services. We urge HHS to require that all states adopt a minimum definition like the
one used by the NAIC, with the addition of “devices” to the definition. Habilitative services should be provided based
on the individual’s needs, in consultation with a clinician, and based on an assessment by an interdisciplinary team
and resulting care plan.
Uniform Definition of Rehabilitative Services: We urge HHS to adopt a federal definition of “rehabilitative services”
like the one used by the National Association of Insurance Commissioners (NAIC), and require that all states adopt a
minimum definition like the one used by the NAIC, with the addition of “devices,” much like the habilitative services
definition. Rehabilitative services should be provided based on the individual’s needs, in consultation with a clinician,
and based on an assessment by an interdisciplinary team and resulting care plan.
Exceptions Process: We urge HHS to require a clearly-defined exceptions process for individuals who need
habilitative services that exceed a plan’s coverage. While an exceptions process must not replace access to a full
scope of habilitative services, a clearly delineated and simple appeals procedure must be available for families when a
particular habilitative service is in dispute. Typical rehabilitative and habilitative benefit packages often limit the
number of visits per year and/or per episode of care, but the need for habilitative services often exceeds these types of
limits.
Transparency: We urge HHS to require plans to provide accessible and understandable information about
rehabilitative and habilitative benefits, including information on therapies covered, visit limits, and how cost-sharing
applies. This information should be included in Summaries of Benefits and Coverage (SBC).
Data Collection
We support HHS’ proposal to require issuers to make available information about provider networks and drug
formularies in machine readable files and encourage HHS to consider what other data could be made available for
research purposes and to develop additional tools for consumers, and make more information available in machinereadable formats.
Quality
We supports HHS efforts to align quality improvement strategies (QIS) and support the proposal that QIS standards
should be developed in a public and transparent manner that seeks stakeholder feedback. Additionally, we believe all
Qualified Health Plans should be required to participate in QIS.
Consumer Tools and Navigator Standards
We support the proposal to require Marketplaces, issuers, agents, and brokers to provide oral interpretation services,
because accurate and appropriate translation services are crucial for people with limited English proficiency,
especially if they have disabilities or chronic conditions. We appreciate that HHS did not propose this standard for
Navigators and non-Navigator assistance personnel because of the potential burden on small community nonprofit
organizations that are encouraged to become Navigators or otherwise assist with outreach and enrollment.
The Epilepsy Foundation supports many of the elements in the proposed rule and we look forward continuing to work
with HHS to improve benefit design, cost-sharing, and transparency in Marketplace plans, to ensure that the ACA
meets the needs of the millions of individuals who rely upon these plans to access quality health care, especially those
living with complex chronic conditions. Please do not hesitate to contact Angela Ostrom, Chief Operating Office &
Vice President Public Policy, at 301-918-3766 or [email protected] with any questions or concerns.
Sincerely,
Philip M. Gattone, M. Ed.
President & CEO
Epilepsy Foundation