Re: Comments on HHS Notice of Benefit and Payment Parameters for 2018 Proposed Rule, CMS-9934-P

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1 October 4, 2016 The Honorable Sylvia Mathews Burwell Secretary of Health and Human Services 200 Independence Avenue SW Washington, D.C Re: Comments on HHS Notice of Benefit and Payment Parameters for 2018 Proposed Rule, CMS-9934-P Dear Madame Secretary, On behalf of the more than 50 million adults and 300,000 children in the United States with doctor-diagnosed arthritis, the Arthritis Foundation welcomes the opportunity to comment on the HHS Notice of Benefit and Payment Parameters for 2018 Proposed Rule. As you know, arthritis is a complex chronic disease that can be difficult to treat, and people who suffer from the disease require regular, on-going care. As a patient advocacy organization, we value our role in helping policy-makers understand the nuanced nature of arthritis treatment and the needs of people who suffer from this disease. Our comments reflect the health care experiences of our constituents and the protections that are most important to help them maintain access to the treatments they need to live a full life. Below please find our comments on the proposed rule. Risk Adjustment We applaud HHS for proposing to update the HHS-Operated Risk Adjustment Model, incorporating prescription drug data to the risk adjustment methodology beginning with the 2018 benefit year. People with chronic diseases depend on medications to live healthy, productive lives, and we agree that drug utilization data can be useful in representing missing diagnoses, indicating the severity of an individual s condition and providing more timely and accessible information than medical claims. The prescription drug categories (RXC s) HHS has chosen to include are well-suited for indicating severity of an enrollee s condition as well as representing diagnoses. However, we encourage HHS to consider the fact that almost half (47%) of US adults with arthritis also have at least one comorbid condition i, and the number of drug classes should be sufficiently robust to adequately capture the patient s full health status. Despite the Affordable Care Act s promise to end discrimination based on pre-existing conditions, many health insurance plans currently engage in practices that discourage enrollment of patients with serious and chronic conditions. We believe that compensating payers through mechanisms like risk adjustment for their enrollees who need and use higher-cost prescriptions

2 and services will reduce incentives for issuers to engage in adverse selection for the patients who need health insurance the most. Standardized Options The Arthritis Foundation supports the concept of standardized plans as a way to offer consumers an easier way to compare plans across issuers. However, we continue to be concerned about outof-pocket costs, particularly with regard to specialty tiers. The proposed specialty tier coinsurance for the 2018 plan year ranges from 25% in one silver plan to 45% in the bronze plan, with most plans at either 30% or 40% co-insurance. While we understand that these percentages represent averages across plans, we think these rates are fundamentally too high and will make insurance out-of-pocket costs unaffordable for many of our constituents. Overall, the proliferation of specialty tiers and the increasing co-insurance requirements represent an alarming trend. The number of bronze and silver Exchange plans requiring over 30% cost-sharing increased 14% from 2014 to 2015, according to Avalere data, including 5 percentage points for rheumatoid arthritis (RA) drugs ii. A Health Affairs study found that enrollees switching from employer plans to Exchange silver level plans faced considerably higher out-of-pocket costs: for enrollees with arthritis, the study authors predicted a 95% increase in annual out-of-pocket spending, and this amount increases in enrollees with multiple chronic conditions iii. The lowest coinsurance level proposed is 25%, but the majority are 40% and above. This would pose an enormous financial burden on many people with arthritis. The average RA patient on a Biologic would be required to pay up to $1600 a month for that one drug at a 40% coinsurance rate. This translates to a patient reaching their maximum out-of-pocket (MOOP) in the first 3 or 4 months of the year, based on the co-insurance rate for a single medication. This is financially untenable for many, if not most people and their caregivers. Further, almost a third of RA drugs are placed on specialty tiers, giving many patients little if any choice but to face these steep co-insurance rates. We ask that HHS not lend credence to this trend by codifying these high co-insurance percentages in the standardized plans. We urge you to use a capped copayment structure rather than co-insurance, and to consider including an exceptions process whereby a person can apply to have their cost-sharing responsibility spread evenly over the 12 months of the plan year, so they will not reach their MOOP in the first quarter or third of the year. We applaud HHS for recognizing that many states have passed laws limiting out-of-pocket costs for specialty drugs, and for proposing variations of the standardized option to conform to state law. We believe that many of these state laws provide important patient protections, and allowing these additional options will ensure patients can choose standardized plan options while at the same time being covered by the protections afforded them in state law.

3 Essential Health Benefits We commend HHS for recognizing that some Bronze plans offer less coverage than even catastrophic plans, and for proposing to realign the Bronze plan requirements such that they conform to the catastrophic plans at a minimum. As part of this realignment, HHS proposes requiring Bronze plans to offer at least three primary care services under the deductible. Since people with chronic conditions rely on specialists like rheumatologists for their regular health care services, we encourage HHS to allow specialist visits for people with chronic conditions to count towards this requirement. Pre-Existing Condition Insurance Plan (PCIP) We applaud HHS for their focus on the preexisting condition insurance program (PCIP). We understand the challenges in identifying participants, their claims costs and the impact they are having on the current risk pool. As HHS looks for ways to identify these patients, the Arthritis Foundation strongly urges HHS to recognize any potential gaps in coverage these individuals could encounter. Preserving coverage and keeping a patient stable on their medications is critical to maintaining a high quality of life as a productive member of society. In the final rule, HHS should make sure that a patient s transition is a smooth, transparent process and that enrollee s do not experience any lapses in coverage. Guaranteed Renewability HHS seeks comments on how the guaranteed renewal requirement and duplication prohibition should be reconciled. As you work to determine this provision, our main concern is that patients do not experience lapses in coverage. HHS should utilize resources such as navigators, brokers and the state departments for the elderly to help patients transition into Medicare. Transparency and Resources Tools for consumers should be transparent, user-friendly, available to both current and prospective enrollees, and should allow consumers to accurately calculate their anticipated outof-pocket costs. Tools should clearly lay out the costs and provisions surrounding premiums, copays, co-insurance and deductibles, and with the growing trend in high deductible plans, we urge HHS to make clear which benefits are available to consumers without having to meet the plan deductible. Requiring the information to be available in a machine-readable format will also help enrollees, and we encourage HHS to explore alternative methods for providing plan information to people without internet access.

4 Network Adequacy HHS proposes to pilot a network breadth indicator in certain states and is considering inclusion of information on integrated delivery systems. This type of information can be very valuable to consumers, and we encourage HHS to move forward with this pilot. The average consumer may not understand the phrase integrated delivery system and HHS should make it a priority to clearly define this in its consumer tools. We recommend working with stakeholders like patient advocacy organizations to develop this language, and also recommend that HHS test the language with patient stakeholders prior to finalizing it. The Arthritis Foundation would welcome the opportunity to partner with HHS in this effort. We continue to be concerned about network adequacy standards, and do not believe that time and distance standards are sufficient to gauge network adequacy. This issue is of huge importance to people with arthritis, as this is a population that requires regular, on-going access to both primary and specialty care. Information such as wait times and whether a provider is accepting new patients are critical criteria to evaluate network breadth. As HHS determines the specific network adequacy criteria issuers will have to meet, the AF continues to recommend that at a minimum: i. Plans must ensure access to care in a way that does not negatively impact an enrollee s health. ii. Plans must ensure a sufficient number of geographically accessible health care providers for the number of enrollees in a given region. iii. Plans must ensure a minimum level of access to care based on clinical appropriateness, the nature of the specialty, and the urgency of care. iv. Plans must ensure a network that includes sufficient health care providers in each area of specialty practice to meet the needs of the enrollee population. v. An insurance plan that is unable to provide sufficient access to required providers must ensure that an enrollee may obtain a covered benefit at no greater cost to the person than if the benefit were obtained from participating providers. vi. Plans must ensure the ability to select specialty practice health care providers within a reasonable travel time and distance taking into account the conditions for provider access in rural areas. vii. Plans must ensure a sufficient range of services. viii. Plans must not exclude any type of health care provider as a class. The proposed rule addresses a provision from the 2017 final rule requiring EHB incurred out-ofnetwork to be counted towards the MOOP. We support the 2018 proposal to apply this policy to qualified health plans (QHPs) both on and off Exchanges in an effort to further limit surprise bills. However, we remain concerned about the policy to provide an exception if 48 hours notice of possible out-of-network services to consumers. A notice of 48 hours is not sufficient time for consumers to properly use this information, and if necessary, adjust their health care plans. Further, there are places in which no in-network providers are available for some services. In these cases, an exception process must be developed to ensure that patients do not receive

5 surprise bills for circumstances completely outside their control. We seek further clarification on what protections would be in place for patients who are unable to subsequently find an innetwork provider and have no choice but to receive care from an out-of-network provider. We strongly encourage CMS to include an exceptions process so that patients are not responsible for the full cost of out-of-network services when no in-network providers are available. Appeals We are disappointed that HHS did not include a provision to streamline the patient appeals process. We believe a transparent, streamlined and simple appeals process is critical to ensuring consumers know what options they have to appeal and are given the tools to act. We believe written disclosures of an adverse coverage decision or denial should be required, stating the specific reason for the adverse action, the period of time permitted to make an appeal, the form of the appeal (e.g. written or web based electronic) and the location where the appeal must be submitted (e.g. street address or URL). The proposed rule would once again delay the requirement that exchanges establish electronic appeals processes. Implementation of the electronic appeals processes requirement has been delayed several times, and the proposed rule would delay it indefinitely. We strongly urge HHS to develop standard appeals language and a process that is clear and user-friendly for consumers. Recertification and Decertification of Plans Under the proposed rule QHPs that are denied certification for a subsequent, consecutive certification cycle would be required to provide their enrollees notice within 30 days of the denial in order to give enrollees the opportunity to seek other coverage. While we support this requirement, we want to ensure that consumers have adequate time to prepare for open enrollment. According to the timeline HHS has set for issuer certification, the notice to enrollees could come as little as two weeks before open enrollment. We do not believe this is enough time for patients with complex health needs to prepare to shop for a new plan, and we urge HHS to instead require enrollees to be given notice at least 30 days before open enrollment. Discrimination Again, we are disappointed that HHS has not taken the opportunity in this proposed rule to define proposals to protect patients from discrimination. Despite HHS cautionary language in regulations and guidance for 2016 and 2017, as well as the final 1557 nondiscrimination regulations, we believe there are currently inadequate patient protections against discrimination in the FFEs. In particular, people with arthritis can experience a range of discriminatory practices, including high specialty tier co-insurance, inappropriate tiering of drugs and inappropriate use of utilization management techniques. According to a 2016 survey of Arthritis Foundation advocates, 45% had to go through a step therapy protocol with 33% of those advocates having to try three or more medications before getting the one initially prescribed by their provider. The Benefit and Payment Parameters rule is an important vehicle for addressing

6 discrimination, and we urge HHS to address discrimination in the final rule for the 2018 plan year. Again, thank you for the opportunity to comment on the HHS Notice of Benefit and Payment Parameters for 2018 Proposed Rule, CMS-9934-P. Please contact Sandie Preiss, Arthritis Foundation National Vice President of Advocacy and Access, at or with questions or for more information. Sincerely, Sandie Preiss Vice President, Advocacy and Access Arthritis Foundation i ii Avalere Planscape (2015). iii Thorpe, Kenneth; Allen, Lindsay; Joski, Peter. Out-Of-Pocket Prescription Costs Under A Typical Silver Plan Are Twice As High As They Are In The Average Employer Plan. Health Affairs. Vol 34, No 10 (2015):