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Donald Berwick, M.D., M.P.P.
Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Room 445-G
Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, DC  20201

RE: CMS-9989-P, Proposed Rule on Establishment of Exchanges and Qualified Health Plans

Dear Dr. Berwick:

The National Coalition for Cancer Survivorship, a national organization representing survivors of all forms of cancer, appreciates the opportunity to comment on the proposed rule related to the establishment of health insurance exchanges and qualified health plans.  The publication of this proposed rule represents an important milestone in the establishment of a marketplace in which consumers and small businesses will be able to purchase health insurance coverage that meets the standards of the Affordable Care Act (ACA) and that offers consumers the assurance of coverage without regard to pre-existing conditions.  For the 12 million Americans living with cancer and the 1.5 million newly diagnosed each year, the exchanges may represent their only avenue for insurance coverage and access to cancer care.   It is critically important to these survivors that exchanges become a user-friendly and competitive marketplace for evaluating and purchasing insurance coverage.

Entities Eligible to Carry Out Exchange Functions (§155.110)

We endorse the basic standards for the operation of an exchange, including 1) the administration of the exchange under a formal, publicly-adopted charter, 2) scheduling of public governing board meetings that are announced in advance, 3) adoption of a requirement that the governing board not include a majority of members with conflicts of interest, and 4) imposition of a requirement that the majority of governing board voting members have relevant experience in health benefits administration, health care finance, health plan purchasing, health care delivery system administration, public health, or health policy issues related to the small group and individual markets and the uninsured.

 
We recommend that the membership of the governing board be expanded to include consumer representatives and patient representatives, who will be able to offer important advice about the design and administration of the exchanges so that they are responsive to the needs of health care consumers.  The matters on which consumer and patient governing board members could provide useful insights include but are not limited to design and content of plan information, the enrollment process, the benefit package, and special enrollment periods.   We consider patient and consumer representatives to be different and distinct from the governing board voting members identified in the proposed rule (such as those with health care finance and public health experience), as they are able to provide concrete and specific advice about exchange operations from the perspective of those who will be utilizing exchange services. 

Stakeholder Consultation (§155.130)

We support the provision of the ACA requiring the exchanges to consult with a wide range of stakeholders, but we recommend that additional groups of stakeholders be defined in these regulations.  The current language recommends consultation with several groups of stakeholders, including “Advocates for enrolling hard to reach populations, which include individuals with a mental health or substance abuse disorder.”  We recommend that the regulations also identify “advocates representing individuals with serious and life-threatening illnesses, including but not limited to cancer.”

We recommend consultation with such advocates because they will be able to offer counsel about the design of exchange materials, including but not limited to the exchange website, that will permit individuals with serious and life-threatening illnesses to make well-informed plan choices.  Such advocates could also provide guidance regarding the response of the exchanges to additional issues related to the acute and chronic health care needs of those with serious and life-threatening illnesses.   We anticipate that these individuals will have special needs related to information about plan coverage and other plan details.  They may also be more likely than the average plan enrollee to take advantage of special enrollment periods.   

Consultation with a wider range of stakeholders, including advocates for those with cancer and other life-threatening illnesses, is not a substitute for inclusion of consumer and patient advocates on exchange governing boards.

Functions of an Exchange (§155.200)

We are pleased that the proposed rule details, consistent with the ACA, the quality activities that the Exchanges must undertake, including: 1) evaluation of quality improvement strategies, 2) oversight of enrollee satisfaction surveys, and 3) assessment and rating of health care quality and outcomes, information, disclosures, and data reporting.  The quality activities are an important complement to the eligibility determinations that are a primary responsibility of the exchanges. 

Consumer and patient advocates who serve as exchange governing board members and stakeholder consultants can provide important insights about the quality activities of the exchanges.  Their advice may be especially valuable with regard to the design and implementation of enrollee satisfaction surveys, which can serve as useful tools for improving the operation of the exchanges and qualified health plans (QHPs).

As a result of the state-based implementation of the exchanges authorized by the ACA, it will not be a simple matter to accomplish a quality reporting and improvement system that is consistent across all exchanges.   However, we recommend that the Centers for Medicare & Medicaid Services (CMS) consider strategies for communication among the exchanges regarding their quality improvement efforts.  Consumers and patients will be well served if they can compare and contrast the quality reporting and improvement activities of the exchanges and the qualified health plans across the exchanges.  A mobile society will benefit from quality activities that are comparable across the exchanges, and the exchanges will benefit from comparison with their peers.

Navigator Program Standards (§155.210)

The standards for navigators included in the proposed rule are reasonable ones aimed at assuring consumers that they will receive reliable information about health insurance options through the exchanges.  A serious problem associated with the navigator program is the statutory prohibition against the use of federal funds granted to the states for the operation of the exchanges for other purposes, including patient navigation.  At a time of serious budget constraints in the states, they will be challenged to find the resources necessary to establish a navigation program that will fulfill the responsibilities anticipated by the ACA. 

We therefore recommend that the state exchanges investigate existing navigator efforts, including those patient advocacy and patient service programs that routinely counsel patients regarding insurance options and patient assistance for health care they would otherwise not be able to afford.  These existing programs may be able to function effectively as navigators for exchanges that may have limited or no funds to support navigation services.  The exchanges may be able to create a network of navigator services, if the exchanges can provide training about insurance enrollment through the exchange to existing navigator programs.  This is not an optimal solution to providing navigation services to consumers, but it may represent an immediate solution to ensure the flow of accurate information to consumers as the exchanges are launched. 

Establishment of Exchange Network Adequacy Standards (§155.1050)

The proposed rule provides only that an exchange “must ensure that the provider network of each QHP offers a sufficient choice of providers for enrollees.”   In our view, this standard alone is not sufficient to ensure enrollees access to timely and geographically accessible care, as well as to providers with the type of particularly specialized expertise that certain serious illnesses, such as certain types of cancer, require.   Importantly, in the summary of the proposed rule,  HHS also seeks comment on five potential additional requirements.  The first set of additional standards would require qualified health plan (QHP) issuers to maintain: 1) sufficient numbers and types of providers to assure that services are accessible without unreasonable delay; 2) arrangements to ensure reasonable proximity of participating providers to the residence or workplace of enrollees… ; 3) an ongoing monitoring process to ensure sufficiency of the network for enrollees; and 4) a process to ensure that an enrollee can obtain a covered benefit from an out-of-network provider at no additional cost if no network provider is accessible for that benefit in a timely manner.”   The Exchange could set quantitative standards in order to establish clear expectations of access to care, consistent with these standards.

In addition, and very importantly, the agency also sought comment on an additional standard that would require the Exchange to ensure that QHPs’ provider networks provide sufficient access to care for all enrollees, including those in medically underserved areas.  The summary also clarified that, under this standard, the provider network must ensure reasonable access to care for all enrollees enrolled through the Exchange regardless of an enrollee’s medical condition. 

We support the inclusion of the additional standards cited above.  These would help ensure that patients with serious and life-threatening illnesses or special health care needs have access to necessary care.  As an organization representing cancer survivors, we are specifically concerned about the treatment needs of cancer patients.  Two issues confronting cancer patients may be addressed through the additional standards highlighted above, but additional detail could best assure the needs of cancer patients.  First, cancer patients need the ability to receive multi-disciplinary cancer care close to home and without the burdens that may be created by the need to travel substantial distances for rigorous and sometimes daily care.  This appears to be envisioned in the first and second additional standards listed above, but those standards do not specify the particular needs for frequent and multi-disciplinary care that cancer patients, and others with serious illnesses, often need. 

Secondly, patients with rare cancers and other rare diseases need to be able to obtain high quality care from leading experts who may be outside the QHP network.  The fourth potential additional standard noted in the regulation---providing access to out-of-network providers at no cost if timely access to a benefit is not available---could apply in this circumstance, but it doesn’t sufficiently highlight the need for heightened and specific expertise.  For example, a network may include cancer experts, and therefore meet the requirement for access to a particular “benefit,” but those experts may not be expert in the particular cancer at issue or may not be able to deliver it with a similar success rate to sub-specialists elsewhere.  We therefore urge that CMS establish more detailed standards for network adequacy that recognize the importance of timely access to providers with the relevant expertise,  particularly in the case of patients facing rare or serious diseases or cancers. 

QHP Issuer Participation Standards (§156.200)

We look forward to additional rulemaking to define the quality improvement strategies, health care outcome reporting, and enrollee satisfaction surveys that will be required of QHPs participating in exchanges.  For cancer care, quality reporting and improvement efforts can be guided by the quality measures that have been developed by medical professional societies and validated by quality measurement organizations.   We urge that a specific performance measure – completion of cancer care plans – be incorporated into health care outcome and quality reporting for QHPs.  There is broad-based consensus that development and communication of written cancer care plans is a fundamental pathway to enhancing cancer care quality and facilitating patient-centered care.  As additional rulemaking related to quality measurement is undertaken, we urge that cancer care planning and coordination be incorporated as a fundamental measure to be met by all QHPs. 

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We commend CMS for its decision to permit states to receive conditional approval of their exchange plans, as this approach will effectively provide the states additional time after receipt of conditional approval in which to make necessary modifications and then fully implement their exchange plans.  We nonetheless recommend that the changes identified in our comments, which will strengthen the input from consumer and patient representatives, be incorporated in the initial plans for the exchanges.

We look forward to additional rulemaking that will address many remaining issues related to the operation of the exchanges, including quality measurement and improvement activities and the essential health benefits package.  Please do not hesitate to contact us if you wish to discuss, or have questions about, our comments.