CLC Comments on Essential Health
Benefits Proposed Rule
(December 26, 2012)
December 26, 2012
Via Electronic Filing
– http://www.regulations.gov
The Honorable Kathleen Sebelius
Secretary
Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201
Re: CMS-9980-P, Patient Protection and
Affordable Care Act; Standards Related to Essential Health
Benefits, Actuarial Value, and Accreditation
Dear Secretary Sebelius:
The undersigned organizations representing cancer
patients, physicians, researchers, and caregivers
appreciate the opportunity to comment on the proposed rule
setting standards related to essential health benefits,
actuarial value, and accreditation. In our comments
on the December 2011 bulletin that outlined a state
benchmark approach to the establishment of essential
health benefits, we urged the Department of Health and
Human Services (HHS) to move away from a benchmarking
system and instead to provide a national definition of
benefits. The proposed rule, although adhering to an
approach that gives states great flexibility, is in
certain ways more responsive to the needs of all patients,
including those with serious and life-threatening
illnesses, than the December 2011 bulletin. We
applaud those changes. However, the
state-based approach to definition of essential health
benefits must be further refined to ensure that cancer
patients have access to appropriate care.
Our comments are guided by key principles of quality
cancer care: 1) patients should participate in
decision-making about treatment, based on complete
information about all therapeutic options and the benefits
and side effects of those treatments and 2) patients
should have access to the treatments that are
appropriately targeted to their molecular profile,
diagnosis, and treatment preferences, including palliative
care, as identified through open communication with their
cancer care team. We believe these principles will
help foster a cancer care system that balances access to
comprehensive care and affordability.
Prescription Drug Benefits
We are pleased that HHS has amended the “one drug per
class” standard that was included in the December 2011
bulletin, replacing it with a requirement that health
plans providing essential health benefits (EHB) cover the
greater of one drug in every category or class or the same
number of prescription drugs in each category and class in
the EHB-benchmark plan. The standard in the proposed
rule, although an improvement over the standard set out in
the bulletin, is inadequate to meet the needs of cancer
patients. Even if some of the chosen benchmark
plans have adequate prescription drug coverage, the
imposition of a requirement that plans offer the same
number of drugs per class or category as the benchmark
will not ensure that plans match the benchmarks in
adequacy of prescription drug coverage. Measuring
coverage simply by number of drugs on a formulary is not
an adequate marker of formulary adequacy or access to
quality care.
The treatment of cancer patients requires a robust
formulary that will permit appropriate treatment,
including combination drug therapies, targeted and
personalized therapies, a potentially wide range of drugs
in a class over the course of illness and treatment, and
drugs for supportive care. The scope of coverage
outlined in the proposed rule will not meet those
standards of quality cancer care. We recommend that
HHS consider incorporating the so-called “protected
classes policy” of Medicare Part D, which provides that
all or substantially all drugs in certain therapeutic
areas be included on Part D formularies.
The protected classes policy has provided important
safeguards for cancer patients enrolled in Medicare Part
D, and we urge it be considered as an EHB policy. It
is a means of assuring that cancer patients have access to
the therapies they need over the cancer care continuum and
that the movement toward more evidence-based
personalization of care is not halted by inadequate
formularies. The protected classes policy is
especially important in the new era of cancer
genomics. Also necessary to ensure the
delivery of targeted cancer treatment is access to
diagnostic tests that inform treatment decisions.
HHS should provide guidance that these tests, which would
ensure appropriate targeting of treatment and proper
utilization of health care resources, are considered part
of the EHB package.
The prescription drug policies in the proposed rule also
fall short in the definition of appeals procedures that
are provided for patients seeking access to drugs not
covered by the health plan. The proposed rule says
only that a health plan “must have procedures in place
that allow an enrollee to require clinically appropriate
drugs not covered by the health plan.” We strongly
recommend that HHS more specifically define the
protections afforded to patients, so that states
administering exchanges and health plans have clear
guidance about processes for appealing drug coverage
decisions. We recommend that the appeals process be
an expedited and external appeals process.
Cancer patients and all others must also have access to
new drugs that may represent therapeutic breakthroughs for
their diseases or essential treatment options when other
alternatives have been exhausted. The proposed rule
sets no standard for updating formularies to incorporate
new drugs. We recommend that the final rule define a
process, possibly relying on the plan’s independent
Pharmacy and Therapeutics (P&T) committee, which would
consider incorporation of new drugs into formularies
within 90 days of their approval by the Food and Drug
Administration (FDA). Moreover, we urge that
patients be ensured the right to appeal a denial for a
newly approved drug even before the P&T Committee has
reviewed the new product.
Drugs Covered by Plans’ Medical Benefit
Because physician-administered drugs that are typically
covered by plans’ medical benefit are critical to cancer
treatment, we urge that there be clarity about the
standard for coverage for these drugs. We recommend
that patients have access to all physician-administered
cancer therapies that have been approved by FDA and that
would typically be included in the medical benefit.
This is the most effective means of ensuring that patients
have access to all of the drugs necessary for appropriate
cancer treatment as determined through a decision-making
process between the patient and physician. We do not
believe the United States Pharmacopeia is an adequate
system for measuring the adequacy of medical benefit drug
coverage, but such adequacy can be encouraged if all
FDA-approved therapies are covered.
Patient Cost-Sharing for Out-of-Network Care
We are very concerned that proposed rule provides that an
enrollee’s cost-sharing for out-of-network care will not
count toward the enrollee’s annual dollar limit on
out-of-pocket expenditures or the annual dollar limit on
deductibles. This policy gives plans a powerful tool
to encourage enrollees to receive their care within the
plan’s network. We do not think that such a policy
can be made acceptable for cancer patients simply by
encouraging a broad network with a wide range of
providers. It is unlikely that plans will be able to
maintain a network of providers that would be sufficient
to meet the needs of all enrollees with cancer, especially
those with rare or hard-to-treat cancers. Some
cancer patients, for example, require sophisticated
radiation therapy not widely available or complex surgery
available only in certain centers. For these
enrollees, the out-of-network cost-sharing standards would
effectively undermine the out-of-pocket spending and
deductible limits.
We strongly recommend that plans be required to implement
an exceptions process through which enrollees could
receive treatment from an out-of-network provider and
still count the associated cost-sharing toward annual
cost-sharing and deductible limits. An expedited
exceptions process should be allowed when delay in
initiating treatment might affect the patient’s
outcome.
Definition of Habilitative Services and
Rehabilitative Services
We understand that a number of benchmark plans do not
include habilitative services as a category of benefits
and that there is also some question about the appropriate
definition of habilitative services. In light of
these questions, the proposed rule gives great deference
to plan issuers to provide habilitative services on a par
with rehabilitative services or to define the scope of
habilitative services they will offer and report those
benefits to HHS. We urge HHS to provide more
significant guidance to states and plans regarding
habilitative services. This category of benefit, if
properly defined, holds the promise of providing childhood
cancer patients access to services necessary to help them
develop critical skills and functions.
Although rehabilitative services may be more clearly
defined by many plan issuers than are habilitative
services, we recommend that HHS also offer more expansive
guidance about rehabilitative services. We believe
this category of benefits should be defined in a way that
will ensure the coverage of services that will help cancer
survivors protect or regain functions and abilities that
might be harmed by cancer and cancer treatment. Many
cancer survivors experience late and long-term effects of
cancer and cancer treatment, and access to survivorship
services to help them address these effects may have a
positive impact on health status and quality of
life.
Preventive and Wellness Services and Chronic Disease
Management
We understand that HHS is adhering to a policy that grants
discretion to the states in the selection of a benchmark
EHB and to plan issuers in the design of plans consistent
with the benchmark EHB. We urge the agency to
provide additional guidance to the states regarding the
benefit category for “preventive and wellness services and
chronic disease management.” A departure from
discretion to the states and plans would be in order for
defining chronic disease management, to ensure that
enrollees have access to care planning and coordination
services. Availability of such services can foster
patient-centered care and assist in achieving the balance
between comprehensiveness of services and affordability
that HHS is pursuing and that is critical for the future
of the health care system.
Coverage for Individuals Participating in Approved
Clinical Trials
We urge the Department to amend the proposed rule to state
that a plan does not provide EHB unless it provides
coverage for individuals participating in approved
clinical trials, as designated in section 2709 of the
Public Health Service Act, as added by section 10103 of
the Affordable Care Act (ACA). The Department has
taken such action with regard to the provisions of section
2713 of the Public Health Service Act (as added by Section
1001 of the ACA) establishing standards for certain
preventive services without
cost-sharing. HHS states in the proposed
rule that such action is necessary because EHB-benchmark
plan benefits are based on 2012 plan designs that are not
subject to the preventive services provisions. The
same is true for clinical trials coverage
protections. Care in a clinical trial often
represents the best option for quality care for a cancer
patient, and HHS can protect such access by including
coverage of clinical trials (according to PHS Act Section
2709) under the definition of
EHB.
State-Required Benefits
In the preamble to the rule, HHS proposes that, for plan
years 2014 and 2015, state-required benefits that were
enacted on or before December 31, 2011 (even if not
effective until a later date) will be considered
EHB. This determination relieves the states of the
responsibility to pay for these benefits. Moreover,
the preamble says that “state rules related to provider
types, cost-sharing, or reimbursement methods would not
fall under our interpretation of state-required
benefits.” We are gratified by this determination,
as it means that states will not be required to defray the
costs associated with the cancer drug cost-sharing laws
that have been passed in the majority of states. We
believe this HHS decision offers important protections to
cancer patients.
Although the preamble offers assurances about state
responsibilities related to state-required benefits, the
language of the proposed rule does not. The proposed
rule states only, “A state-required benefit enacted on or
before December 31, 2011 is not considered in addition to
the essential health benefits.” We urge a revision
of the proposed rule to reflect the preamble language
regarding state rules related to provider types,
cost-sharing, or reimbursement methods. Only with such
amendment of the regulation can we be assured that the
cost-sharing protections so important to cancer patients
will be sustained.
*****
We commend the work of HHS in responding to public
comments regarding the December 2011 EHB bulletin.
The refinements in the definition of EHB and standards for
state selection will foster a system of care that is more
responsive to the needs of cancer patients and others with
serious and life-threatening and chronic illnesses than
the system defined in the bulletin. We look forward
to working with you during the critical implementation
period of 2014-2015 and to reporting on the experiences of
cancer patients as important health reforms move forward.
Sincerely,
Cancer Leadership Council
American Society for Radiation Oncology
Bladder Cancer Advocacy Network
Cancer Support Community
The Children's Cause for Cancer Advocacy
Fight Colorectal Cancer
International Myeloma Foundation
LIVESTRONG
The Leukemia & Lymphoma Society
Lymphoma Research Foundation
National Coalition for Cancer Survivorship
Ovarian Cancer National Alliance
Pancreatic Cancer Action Network
Prevent Cancer Foundation
Sarcoma Foundation of America
Susan G. Komen for the Cure Advocacy Alliance
Us TOO International Prostate Cancer Education and Support
Network
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