CANCER LEADERSHIP COUNCIL
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