CLC
Comments on Proposed Rule on Benefit
and Payment Parameters for 2016
(December 22, 2014)
December 22, 2014
The Honorable Sylvia Mathews Burwell
Secretary
Department of Health and Human Services
200 Independence Avenue SW
Washington, DC 20201
Re:
CMS-9944-P, Proposed Rule on Notice of Benefit and Payment
Parameters for 2016
Dear Secretary Burwell:
The undersigned organizations represent cancer patients,
health professionals, and researchers. Many of the
individuals represented by our organizations have
purchased qualified health plans (QHPs) through the health
insurance exchanges, and their access to quality care
depends on the adequacy of those health plans. We
appreciate the actions that the Department of Health and
Human Services (HHS) has outlined for plan year 2016 and
years after that would strengthen key elements of
QHPs. We offer advice on a number of these
proposals and on the move toward more transparency in
reporting QHP data. We commend HHS for taking
important steps to protect consumers in the health
insurance exchanges.
Essential Health Benefits: The Benchmark Approach
We are pleased that the proposed rule would update the
benchmarking approach to definition of essential health
benefits (EHB) by requiring states to choose a 2014 plan
as the benchmark plan beginning in 2017. We urge the
department to utilize the health plan data that it will
require to be reported – beginning with 2014 plan year
information – to inform efforts to move beyond the
benchmarking approach and to provide specific department
guidance about EHBs. We also recommend that reliance
on 2014 benchmark plans be effective for the 2016 plan
year, an implementation schedule that we understand is
ambitious.
Prescription Drug Benefits: Establishing a
More Robust Formulary
We commend HHS for its thoughtful approach to improving
prescription drug formularies in QHPs. HHS states
that its proposal for formulary development would result
in QHP coverage of drugs “based on a qualitative rather
than quantitative perspective, which we believe will
provide enrollees with a more robust formulary drug
list.” In the current plan year, many enrollees with
cancer have found that the drugs they have been prescribed
are not on their plan’s formulary. If these patients
cannot obtain access through the exceptions process, they
must make difficult choices about their treatment.
Some have responded by altering their treatment plan and
others by paying out-of-pocket for off-formulary
drugs. These choices just underscore that QHP
formularies may fall short for cancer patients and others
with serious and life-threatening illnesses.
HHS suggests that a formulary process combining
utilization of the American Hospital Formulary Services
(AHFS) formulary reference system and a pharmacy &
therapeutics (P&T) committee system will result in a
more robust formulary in each QHP. The P&T
committee standards defined in the proposed rule are
strong. HHS sets forth rules for P&T membership,
management of conflicts, and frequency of P&T
committee meetings. In addition, the proposed rule
includes standards for P&T deliberations.
Specifically, the proposed rule states that, “With respect
to formulary drug list establishment and management, we
are proposing that the P&T committee must develop and
document procedures to ensure appropriate drug review and
including on the formulary drug list, as well as make
clinical decisions based on scientific evidence, such as
peer-reviewed medical literature, and standards of
practice, such as well-established clinical practice
guidelines.” A P&T committee that deliberates
according to these standards will make an important
contribution to the development of a QHP formulary.
Although the P&T committee standards provide some
reassurance about QHP formulary development, we have
questions about the AHFS and about the manner in which
AHFS listings and the P&T committee system will
relate. HHS states that the AHFS is a “widely used
formulary reference system in the private insurance market
and is often used for developing formularies for the
population being covered by EHB.” Moreover, HHS
states that AHFS has more drug classifications than the
United States Pharmacopeia system that has been used to
date and that utilization of the AHFS will result in a
broader distribution of drugs on the formulary. In
spite of the assurances of HHS, we are concerned that the
AHFS is not adequate in its cancer drug
classifications.
We recommend instead that the National Comprehensive
Cancer Network (NCCN) Drugs & Biologics Compendium be
referenced for development of the oncology portions of a
QHP formulary. The NCCN Compendium is used by a
number of payers, including the Centers for Medicare &
Medicaid Services and private payers, to guide coverage
decisions, and describes the evidence that is utilized to
make usage recommendations. QHP formulary drug lists
developed by use of the NCCN Compendium and a strong
P&T committee system would be more likely to meet the
cancer care needs of QHP enrollees than the formularies in
many current plans.
Exceptions Process
The recommended improvements in the exceptions process
will provide cancer patients important protections.
We commend the department for establishing a standard
exceptions process, which must be completed in 72 hours,
in addition to the expedited exceptions process that
requires action in 24 hours. In addition, patients
will benefit from the secondary external review process
that will be available if the first exception request
(whether standard or expedited) is denied by the plan.
The proposed rule offers another consumer protection by
requiring that drugs covered through an exceptions process
be considered essential health benefits and counted toward
the out-of-pocket cost-sharing maximum.
Formulary Drug List Transparency
Consumers will be served well by the requirement that
health plans publish an “up-to-date, accurate and complete
list of all covered drugs on its formulary drug list,
including any tiering structure that it has adopted and
any restrictions on the manner in which a drug can be
obtained.” HHS asks for advice regarding the
inclusion of cost-sharing information, including the
pharmacy deductible, copayment amounts, or cost-sharing
percentage, on the formulary drug list. We recommend
that such information be included.
HHS has indicated that it is considering a requirement
that issuers make information about formulary drug lists
available on their websites in a machine-readable file and
format identified by HHS. The department indicates
that imposing this data requirement would permit third
parties to aggregate information on a range of health
plans. Consumer access to aggregate information of
this sort would help to transform the insurance
marketplaces into patient- and consumer-friendly plan
selection and purchasing options.
Prohibition on Discrimination
We commend the department for addressing the topic of
discriminatory benefit design and identifying designs that
might be discriminatory. However, noting the problem
of discriminatory plan design is not sufficient. We
urge HHS to take more concrete regulatory action against
discriminatory benefit design. This is a matter of
urgency for cancer patients, who confront discriminatory
benefit packages that place most or all cancer therapies
on specialty tiers.
Network Adequacy and Cost-Sharing Requirements
The narrow provider networks in many health plans serve in
some situations to block cancer patient access to
appropriate care. For many individuals with rare
cancers or cancers with limited treatment options, the
best option may be to pursue care at a cancer center with
special expertise in the cancer or from another health
system that treats a high volume of cases of the specific
cancer. Children with cancer may also have the
best treatment options in children’s hospitals or other
health care systems with experience and expertise in
childhood cancer. In those circumstances, it is
possible that those treatment options are
out-of-network. A decision to pursue out-of-network
care is likely accompanied by significant patient
cost.
HHS must address network adequacy problems by requiring
health plans to maintain networks that are adequate for
treatment of complex, rare, or hard-to-treat diseases or
providing financial protections to patients who must
pursue out-of-network care. The department has taken
modest but insufficient steps on network adequacy in the
proposed rule for 2016. We understand that the
department is relying on the National Association for
Insurance Commissioners (NAIC) effort to define standards
for network adequacy, an effort that we will also be
engaged in.
HHS states that plan issuers may count cost-sharing for
out-of-network services toward the annual limitation on
cost-sharing. However, encouraging this effort is
far from a requirement that issuers do so. As a
result, we expect little financial protection for patients
who receive care out-of-network. The department
would require plan issuers to permit new enrollees access
to their network of providers for 30 days after enrollment
in the new plan. This transitional protection would
be useful to patients but far from the network adequacy
standards they need.
We also support the proposal to strengthen the provider
directory requirement, which would mandate that issuers
publish an up-to-date, accurate, and complete provider
directory. Supplying this information
will help consumers make informed decisions about their
health plan and will also assist them in managing their
care after enrollment. Although information for
consumers is a positive, this requirement does not address
the matter of network adequacy.
Habilitative and Rehabilitative Services for Cancer
Patients
We are pleased that HHS is moving to define habilitative
services, and we think that the definition of habilitative
services as “health care services that help a person keep,
learn, or improve skills and functioning for daily living”
is a viable definition. Some of the supportive care
services that are provided to cancer patients during
cancer treatment fit squarely within this
definition. These include nutritional support
services to maintain good nutrition during radiation
therapy and chemotherapy, mental health services to
address issues of anxiety and depression, and services to
address the psychosocial issues that patients confront
during treatment.
We applaud the decision to require plan issuers to treat
habilitative services as a different category from
rehabilitative services, a decision that will prevent the
application of a single limit on services to the
combination of habilitative and rehabilitative services.
Data Collection
Consumers, patients, and the entire health system will
benefit from the collection and availability of data from
2014 plans, and we support the decision to make these data
available. For maximum benefit to be achieved from
release and use of these data, they should be displayed in
a simple and consistent manner across plans.
HHS indicates that information about enrollments,
disenrollments, claims denials, and cost-sharing for
out-of-network care will be collected and made
public. We recommend that data on both appeals and
exceptions processes also be collected and
published. These categories of data may provide some
perspective on the adequacy of benefits for individuals
with cancer and other serious illnesses and whether the
exceptions and appeals processes are providing patients an
avenue for access to necessary care. We have
concerns that cancer patients may change their treatment
choices or even forgo treatment if care is not available
on-formulary or in-network, and the appeals and exceptions
data may help with investigating and understanding this
problem.
Quality Improvement Strategy
Beginning in 2016, plans that have participated in the
exchanges for two years would be required to report on
their quality improvement strategy (QIS)
plans. HHS has directed issuers to implement a
payment structure that would improve health outcomes,
reduce hospital readmissions, improve patient safety and
reduce medical errors, implement wellness and health
promotion activities, and reduce health and health care
disparities. We urge HHS to provide guidance to
plans to structure their reimbursement plans in a way that
emphasizes care planning and care coordination for cancer
patients and others with serious chronic illnesses.
A payment plan that emphasizes these elements of care
delivery will also contribute to health outcome
improvement, readmission reductions, patient safety
improvements, and a reduction in medical errors.
**********
We appreciate the opportunity to comment on the Notice of
Benefit and Payment Parameters for 2016. We look
forward to the implementation of QHP standards outlined in
this proposed rule, as they promise modest but steady
progress toward stronger health plans for enrollees.
Sincerely,
Cancer Leadership Council
American Society of Clinical Oncology
CancerCare
Cancer Support Community
The Children's Cause for Cancer Advocacy
Fight Colorectal Cancer
Hematology/Oncology Pharmacy Association
International Myeloma Foundation
Kidney Cancer Association
The Leukemia & Lymphoma Society
LIVESTRONG Foundation
Lymphoma Research Foundation
National Coalition for Cancer Survivorship
National Comprehensive Cancer Network
National Patient Advocate Foundation
Ovarian Cancer National Alliance
Prevent Cancer Foundation
Sarcoma Foundation of America
Susan G. Komen
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