RE: Essential Health Benefits: Follow Up from the October 2014 Patient Coalition Meeting

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1 Mr. Kevin Counihan Marketplace Chief Executive Officer (CEO) Centers for Medicare & Medicaid Services 7501 Wisconsin Avenue Bethesda, MD November 18, 2014 RE: Essential Health Benefits: Follow Up from the October 2014 Patient Coalition Meeting Dear Mr. Counihan: We appreciated the opportunity to meet with your colleagues on October 16 to discuss patient concerns with prescription drug coverage through the essential health benefits (EHB) package. We greatly appreciated their time, as well as their active, thoughtful engagement during our discussion. The patient perspective is fundamentally important to successful implementation of the Affordable Care Act (ACA). The Center for Consumer Information and Insurance Oversight s (CCIIO) consideration of our collective experiences and recommendations, and invitation to continue this dialogue, demonstrates the Center s strong commitment to patients throughout the country. In this letter, we summarize high-priority areas for patients and respond to certain questions raised in our discussion. We also provide examples illustrating a number of our concerns and propose steps to address these concerns in forthcoming regulations and guidance. I. Overview of High-Priority Areas for Patients The patient coalition has strongly supported the passage and implementation of the ACA; however, certain issues regarding EHB prescription drug coverage still require attention. On behalf of the tens of millions of patients whom we collectively serve across the nation, we want to work with you on EHB prescription drug coverage improvements in the following areas: A. Limited Benefits B. High Cost-Sharing C. Lack of Transparency D. Discrimination Concerns These issues are top priorities for us because they are true barriers to access and affordability. We include in this letter specific concerns, examples, and recommendations for each of these areas. A. Limited Benefits As discussed in our meeting, many of our patients are encountering formulary restrictions in their Marketplace health plans, which are seriously limiting coverage of critical medications.

2 As you know, these health plans must cover at least the greater of: (1) one drug in every United States Pharmacopeia (USP) therapeutic category and class; or (2) the same number of drugs in each USP category and class as the state s EHB-benchmark plan. According to Avalere s January 2014 PlanScape: Review of Formulary Coverage, Cost Sharing and Access in Top Exchange Plans, only 56% of oncology drugs are covered in six classes; 72% of HIV/AIDS drugs are covered in four classes; and 55% of all mental health drugs are covered in four classes. Notably, these medications largely overlap with those identified in long-standing CMS guidance as classes of clinical concern (or protected classes ) within the Medicare program. CMS has long recognized under Part D that medicines in the classes of clinical concern are not always interchangeable for patients suffering from serious and chronic health conditions. These same concerns apply to individuals in Exchange plans, and CCIIO should consider including similar patient protections as part of EHB regulations. To ensure meaningful access to critical medications, actions are needed to address formulary restrictions; reliance on the benchmark approach and the USP categories and classes; limited options for adding new drugs; and onerous utilization management techniques. 1. Formulary Restrictions Due to the way EHBs are defined for plan years 2014 and 2015, many plans do not include all medications that may be prescribed for patients. Patient experiences, and analyses to date, show that many Qualified Health Plans (QHPs) limit coverage of critical medications, either by excluding them from the formulary, or by placing all treatments for a condition on the highest ( specialty ) tier. Specialty tiers typically include restrictive cost-sharing and utilization management techniques. These types of benefit designs have a disproportionate impact on seriously ill patients, thus undermining the ACA s goal to provide affordable and quality coverage to those who were previously ineligible for coverage due to pre-existing conditions. 2. Benchmark Approach and Reliance on USP Categories and Classes Building on these concerns, we believe that the benchmark approach of the current EHB rules does not provide adequate prescription drug coverage, particularly for those with complex health issues. When a benchmark plan lacks coverage of a category or class of medicines, only one drug per class is required, which may limit access to the full range of necessary medications. This issue is exacerbated by the current rules reliance on the Model Formulary Guidelines of the USP for the categories and classes for which at least one drug per class must be covered. The reliance on the USP s Model Formulary Guidelines is troubling for several reasons: 1. The USP classification system was designed with the Medicare Part D population in mind, consistent with the Medicare Part D statutory instructions to USP. The Marketplaces serve a population that is broader than the Medicare population. Certain 2

3 therapeutic categories and classes that may benefit the Marketplace population are not adequately represented in the USP guidelines. 2. The USP has updated its Model Formulary Guidelines only once every three years, making the guidelines outdated for long periods of time and, therefore, inadequate as a guide for EHB plans formulary requirements. 3. The current EHB rules rely on the USP version 5.0, even though USP released a version 6.0 in early As we raised in our meeting, the EHB rules, to date, indicate that version 5.0 will be used to evaluate EHB formularies through plan years 2014 and No Existing Process for Adding New Drugs to Formularies An Analysis of Coverage of New-to-Market Drugs by Health Insurance Exchange Plans, prepared by Avalere in October 2014, found that many plans fail to add new medications to their formularies, and if they do, it is not done in a timely manner. In an analysis of 81 plan formularies from across the country, the Avalere study concluded that only 41 of the 81 formularies had been updated to add new drugs approved between October 2013 and September This analysis also found that, out of 27 newly-approved medications, the 15 states with the highest enrollment numbers only covered an average of seven or eight of these new drugs. In fact, some states covered, on average, only 1 of the newly approved drugs as of September Specifically, neither the EHB Final Rule nor existing EHB guidance require or clarify a pathway to include newly approved drugs on a plan s existing formulary. This omission may restrict access to new therapies based solely on the approval date of these drugs. Several federal programs, including the Federal Employees Health Benefits Program (FEHBP) and Medicare Part D, offer options for adding new medications to existing formularies. For example, Medicare Part D requires an expedited 90-day pharmacy & therapeutics committee review of new drugs in the protected classes and a 180-day review of other drugs. Finally, we note that these rules also do not prohibit plans from removing medications during the plan year provided that the plan continues to meet the state s benchmark requirements. 4. Utilization Management We are deeply concerned that current EHB rules do not protect against onerous utilization management practices or provide meaningful guidance on reasonable or appropriate utilization management practices. For example, the EHB rules state explicitly in the Prohibition on Discrimination regulation that [n]othing in this section shall be construed to prevent an issuer from appropriately utilizing reasonable medical management techniques. Yet, current regulations and guidance contain no clarifications on what is considered reasonable as a utilization management technique, nor do they address what it means for a plan to appropriately utiliz[e] such techniques. As a result, even when a drug may be included on a formulary, prior authorization, step therapy, and other restrictive utilization management requirements may prevent meaningful access to covered drugs. 3

4 These requirements are particularly problematic when such restrictions apply to entire categories and classes of drugs treating specific health conditions. For example, prior authorization occurs 56% of the time in the oncology drug class, and step therapy occurs 31% of the time for mental health drugs, according to Avalere analysis. Multiple studies from peerreviewed journals and from the Congressional Budget Office have shown that these utilization management restrictions lead to more hospitalizations, relapses, deteriorating conditions, and higher overall health spending. 5. Appeals We appreciate the improvements to the appeals process in the 2014 Final Rule on Exchange and Insurance Market Standards for However, we believe that additional improvements and protections are needed for the EHB prescription drug coverage exceptions and appeals processes. Importantly, the Department of Health and Human Services (HHS) does not need to reinvent the wheel in order to include a meaningful appeals process in Marketplace plans. Safeguards and procedures that already apply in the FEHBP and Medicare Part D provide existing models for further improvements that HHS can implement in the EHB context. B. High Cost-Sharing High cost-sharing is another area where Marketplace enrollees, particularly those with serious health conditions, are experiencing significant access barriers. In fact, Marketplace plans have required 30%, 40%, and even 50% co-insurance for each prescription. These high coinsurance rates often are applied only to medications that treat illnesses such as HIV/AIDS, bipolar disorder, or cancer, which are often placed on the highest tiers as well. For example 1. In June 2014, Avalere released An Analysis of Exchange Plan Benefits for Certain Medicines which reported that 86% of Silver plans (in a review of 123 formularies) place all covered drugs, including generics, in at least one therapeutic class on the highest formulary tier. Further, more than 60% of Silver plans reviewed place all covered medications for certain chronic illnesses on the highest formulary tier. 2. The same study found that in seven sample classes, more than one-third (39%) of Silver plans reviewed require co-insurance of 40% or more for all drugs in at least one class. The classes in that sample review included HIV/AIDS, mental health, oncology, diabetes, rheumatoid arthritis, multiple sclerosis, and asthma. Disease specific examples of high cost-sharing include the following 1. The AIDS Foundation of Chicago and The AIDS Institute found that many plans on the Illinois and Florida Marketplaces put all HIV medications (including generics) on the highest formulary tier. Similarly, Avalere s June 2014 analysis has reported that around 25% to 35% of Marketplace plans that it reviewed placed all covered HIV medications on the highest tier. 2. The AIDS Institute found that several insurers in the Florida Marketplace offered plans that required at least 40% co-insurance for all HIV medications. 4

5 3. Avalere s June 2014 analysis described in Access to Rheumatoid Arthritis Medicines in Exchange Plans found that rheumatoid arthritis medicines are subject to an average co-insurance requirement of 35% of the cost of the drug. At that level, a patient could pay $150 to $3,000 per month for one medicine. Avalere found comparable results for other therapies. The result of these cost-sharing policies by Marketplace plans is that many with chronic conditions cannot afford critical medications prescribed by their physicians. C. Lack of Transparency We recognize and appreciate the formulary and network transparency improvements that HHS is requiring plans to meet starting in We look forward to reviewing the 2015 plans to ensure that the requirements included in the 2015 Letter to Issuers regarding transparency are appropriately implemented and enforced. Even with these improvements, more work must be done to increase transparency. When formulary information is available, it often does not provide up-to-date information on the applicable utilization management practices, drug coverage, and cost-sharing requirements. Having access to all of this information prior to plan enrollment is extremely important to patients, especially those who rely on specific medications. D. Discrimination Concerns Non-discrimination is a key principle of the ACA, which prohibits denials or exclusions based on pre-existing conditions. Allowing discriminatory practices, such as restrictive formularies, high cost-sharing, and inadequate transparency, to continue through back door policies defies the letter and spirit of the law. A top priority for patients is to understand the baseline standards that HHS will use to define discrimination, and how plans will be evaluated to determine whether they are complying with these standards. Clear and transparent standards are necessary, as well as strong and consistent enforcement in both federally-facilitated and state-based Marketplaces. These key protections of the ACA become hollow if plans can evade the law s non-discrimination requirements by continuing to follow practices that (1) discourage individuals with serious and chronic conditions from enrolling in plans; and (2) create barriers to accessible and affordable coverage for patients based on their health conditions. II. Our Recommendations If the ACA is to deliver on its promises for patients, the issues outlined above require immediate attention. We look forward to working with you to reshape the EHB standards, ensure meaningful access to medications, and create a strong oversight system. Specific recommendations on how to accomplish these goals are summarized below. 5

6 A. Limited Benefits. We recommend that CCIIO strengthen benefit requirements by: 1. Requiring plan formularies to cover the full range of medications in the Medicare Part D six protected classes and creating a process to review new drugs for inclusion on formularies. 2. Clarifying appropriate utilization management techniques by plans. 3. Establishing more robust requirements for the appeals process for plan years 2016 and beyond. 4. Revisiting and updating existing EHB standards, including the benchmark approach and prescription drugs coverage standards. 5. Amending current EHB rules to make clear that a plan may not remove a drug or change its tier status during a plan year, except in special circumstances. B. High Cost-Sharing. We recommend that CCIIO reduce high cost-sharing by: 1. Specifying additional requirements for plans prescription drug cost-sharing structures, including appropriate limits for the use of specialty tiers and coinsurance. 2. Establishing maximum patient cost-sharing per prescription that will make access to medications affordable and attainable. 3. Requiring cost-sharing for patients who rely on off-formulary medications to be included in the patient maximum out of pocket amount. 4. Clarifying that prescription drugs approved by a plan as clinically appropriate will be covered services. This step will prevent unlimited costsharing. C. Lack of Transparency. We recommend that CCIIO improve transparency on plan information by: 1. Requiring plans to provide direct URL links to their current formularies, so that patients may review the plans covered drugs prior to enrollment. a. This consumer friendly information should include a complete list of covered medications, prescription drug tier(s), utilization management requirements, and transparent cost-sharing information, including patient costs for prescriptions that are subject to co-insurance. b. Access to this information before choosing a plan is extremely important to our patients. 2. Including an interactive web tool. 6

7 a. An interactive web tool should include a plan finder, benefit calculator, and/or cost calculator on each Marketplace website. b. Models for these tools already exist in Medicare Part D and provide tremendous value to consumers. D. Discrimination Concerns. We recommend that CCIIO prevent discrimination by: 1. Clarifying, enforcing, and offering guidance on the ACA s non-discrimination standards. 2. Defining discrimination in a way that ensures robust formularies and reasonable cost-sharing designs that do not violate the ACA nondiscrimination requirements. We believe these recommendations are important steps to assure that all enrollees have affordable and meaningful access to critical medications. Thank you, again, for your attention to our perspective and concerns. We look forward to continuing our dialogue with you as we work together to support and improve ACA implementation. Sincerely, American Autoimmune Related Diseases Association, Inc. Virginia Ladd, President Epilepsy Foundation Angela Ostrom, Chief Operating Officer National Alliance on Mental Illness Andrew Sperling, Director of Legislative Advocacy National Council for Behavioral Health Rebecca Farley, Director, Policy and Advocacy National Kidney Foundation Troy Zimmerman, Vice President for Government Relations The AIDS Institute Carl Schmid, Deputy Executive Director cc: The Hon. Marilyn Tavenner, Administrator Centers for Medicare & Medicaid Services 7

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