Notice of Benefit and Payment Paramaters 2020

February 19, 2019

The Honorable Alex AzarSecretary U.S. Department of Health and Human Services 200 Independence Avenue, SWWashington, DC 20201The Honorable Seema VermaAdministrator Centers for Medicare & Medicaid Services P.O. Box 8016Baltimore, MD 21244RE:Patient Protection and Affordable Care Act; HHS Notice of Benefit and PaymentParameters for 2020Dear Secretary Azar and Administrator Verma: Thank you for the opportunityto submit comments on theDepartment of Health and Human Services (HHS)Notice of Benefit and Payment Parameters for 2020(NBPP)proposed rule.The undersigned 2organizations write to express our concern over several proposals includedin the proposal. We urge you to modify these proposalsto better protect patients and ensure they will continue to have access to affordable and adequate health care coverage. The 24undersigned organizations represent millions of patients facing serious, acute, and chronic health conditions across the country. Our organizations have a unique perspective on what patients need to prevent disease, cure illness, and manage chronic health conditions. Our diversity enables us to draw upon a wealth of knowledge and expertise that can be an invaluable resource in this discussion. We urge the Department to make the best use of the knowledge and experience our patients and organizations offer in response to this proposed rule. In 2017, our organizations agreed upon three overarching principles1to guide any work to reform and improve the nation’s healthcare system. These principles state that: (1) healthcare must be adequate, meaning healthcare coverage should cover treatments patients need,including the services in the essentialhealth benefit package; (2) healthcare should be affordable, enabling patients to access the treatments they need to live healthy and productive lives; and (3) healthcare should be accessible, meaning that coverage should be easy to understand and not pose a barrier to care. Enrollment should be easy to understand,and benefits should be clearly defined. Using these principles as our benchmark, our organizations are deeply concerned about many of the policies and changes included in the proposed rule and their potential impact on the communities we represent and serve. In the proposed rule, HHS put forwardproposals that would increase costs for consumers on the individual market, limit the effectiveness of navigators, and promote direct enrollment practices thatmay confuse consumers. Based on our principles, our organizations strongly encourage HHS to modify the Notice of Benefit and Payment Parameters for 2020(NBPP) in the final rule in the following areas: Increasing Premiums & Out of Pocket Costs for Consumers Premium Adjustment FormulaIn the proposed rule, the Centers for Medicare and Medicaid Services (CMS)proposeschangingthe premium adjustment factor formula for calculating changes to subsidies, out-of-pocket caps, and other costs. While CMS previously calculated the premium adjustment factor based on employer-sponsored insurance premiums, CMS would nowuse average private health insurance premiums in the formula-raising the premium adjustment factor by 3.6 percent from 2019. Should this proposal be finalizedas drafted, CMS anticipates that premiums for approximately7.3 million subsidy-eligible individuals and familiescould increase by up to $2202,resulting in approximately100,000 consumers losingtheir health insurancecoveragein 2020alone. The proposed change to the premium measure will also result in a faster growth of the net premiums paid by consumers on the Marketplacesand a faster growth in the maximum out of pocket (MOOP) limit paid by all Americans, including those with large group employer coverage. 1Healthcare reform principles. American Heart Association website.http://www.heart.org/idc/groups/heart-public/@wcm/@adv/documents/downloadable/ucm_495416.pdf.2Aviva Aron-Dine and Matt Broaddus. “Change to Insurance Payment Formulas Would Raise Costs for Millions with Marketplace or Employer Plans.” Center on Budget and Policy Priorities. Jan. 18, 2019, available at https://www.cbpp.org/sites/default/files/atoms/files/1-18-19health.pdf.3While most of the100,000 consumers who couldlose coverage areexpected to remain uninsured, some may purchase short-term,limited-duration health plans (STLDHPsor short-term plans)3. STLDHPs do not meet our principles of adequate coverage and will expose consumers to medical debt, scams, and harm to both their short-and long-term health. Further, consumers whoremain uninsured and underinsured will likely delay needed care, resulting in worse health outcomes and potentially increasing uncompensated care costs. Out of Pocket Costs We are concerned that the proposal will lead to higher costs, whichwill result in more Americans forgoingmedically necessary services. This in turn will leadto worse health outcomes and more federal and state uncompensated care by patients accessing expensive and inefficient emergency care..4Studies show that a growing number of Americans are underinsured and therefore experience difficulty paying the out-of-pocket costs associated with their care, including deductibles, copays, and coinsurance.5This holds true for a cross-section of Americans (including those with large group employer coverage as well as those with individual coverage) –and it is an especially pressing concern for people with chronic healthconditions.6The preamble notes thatthe maximum out-of-pocket limit for individuals would increase by $200 to $8,200 for self-only coverage andby$400 for family coverage, up to $16,400, in 2020.7These increased costs will disproportionately impact sick people that need medical services and prescriptions, including persons with chronic illnesses, and do not reflect the out-of-pocket costs paid by these groups for non-covered services. Future Impact on Enrollment & Affordability Finally,we are concerned about thethe compounding impacts of using the alternative premium measure beyond the 2020 plan year. The changes put forward in the proposed rule, if finalized,would erode the premium tax credits,making them less impactful for low to middle income Exchange consumers.This will result in anestimated 100,000 individuals annuallylosing their health coverage. Further,the MOOPlimitwould growat afasterrate, leaving every American with private insurance increasingly vulnerable to higher out-of-pocket costs. We are alarmed at the hypothesis found in the preamble stating that “[e]conomicdistortions may be reduced, and economic efficiency and social benefits improved, because these individuals will be bearing a larger share of the costs of their own health care consumption, potentially reducing spending on health care services that are personally only marginally valued but that imposes costs on the federal government through subsidies.”8A recent study assessing consumer response to high deductible health 384 Fed. Reg. at 308.4Multiple studies for the Medicaid population bear this out. See for example: ChernewM, Gibson TB, Yu-Isenberg K, Sokol MC, Rosen AB, Fendrick AM. Effects of increased patient cost sharing on socioeconomic disparities in health care. J Gen Intern Med. 2008. Aug; 23(8):1131-6. Ku, L and Wachino, V. “The Effect of Increased Cost-Sharing inMedicaid: A Summary of Research Findings.” Center on Budget and Policy Priorities (July 2005), available at http://www.cbpp.org/5-31-05health2.htm. 5Sara R. Collins, Herman K. Bhupal, and Michelle M. Doty. “Health Insurance Coverage Eight Years After the ACA.” The Commonwealth Fund. Feb. 7, 2019, available at https://www.commonwealthfund.org/publications/issue-briefs/2019/feb/health-insurance-coverage-eight-years-after-aca,6Drew Altman. “It’s Not Just the Uninsured –It’s Also the Cost of Health Care.” Axios, Aug. 20, 2018, available at https://www.axios.com/not-just-uninsured-cost-of-health-care-cdcb4c02-0864-4e64-b745-efbe5b4b7efc.html784 Fed. Reg. at 288.884 Fed. Reg. at 308.4plans9aligns with other well-documented data showingthat patients faced with high out-of-pocket costs forgo valuable care at the same rate as unnecessary care. These high out-of-pocket costs include high deductibles, high patient cost-sharing capped by the MOOP limit, payments for uncovered services, and even the full cost of health careborne by those without insurance. Therefore, while we applaud the Administration’s efforts to reduce the cost of care, we urge the Administration to withdraw proposals that would increase the rates of uninsured and reduce coverage and instead to work withus to put forth options that ensure adequate coverage and improve value.Our organizations oppose this unnecessary change to existing policy and urge the Administration to withdraw these changes to the premium adjustment formula. We also request that the Administration not take any additional actions that would further increase premium and out-of-pocket costs for consumers as such changes arelikely to increase the number of people that forgo insurance or purchase inadequate coverage.Navigators & Web Brokers Under the Affordable Care Act (ACA), Navigators assist consumers by providing information regarding enrollment in Qualified Health Plans (QHPs) as well as post-enrollment activities,such as increasing health literacy, assisting with renewals, and educating consumers on how to avoid disenrollment for non-payment.The proposed rule would make these important post-enrollment activities optional for Navigator programs, in an effort to increase flexibility for Federally Facilitated Exchange (FFE) Navigators. FFE Navigators would also no longer have to receive training on 20 currently required training topics. Navigators play an important role for consumers, so our organizations believethat funding and responsibilities for the program should notbe limited, as proposed. As such we urge the Department be to restore funding for this important program and stop pursuing additionallimitsservices. Wehave repeatedly communicated with the Administration about the vital role Navigators play in today’s healthcare marketplace and are disheartened and concerned that the proposal further erodes their ability to assist patients and consumers to enroll in comprehensive coverage, including Medicare and Medicaid, that meets their individual medical needs.10Our organizations strongly oppose the proposed changes to the Navigator program and urge the Administration to restore funding for this important resource. We are also concerned thatthe proposed rule would allow “web brokers” to facilitate marketplace enrollment through the websites of third-party“direct enrollment entities,” including issuers. While webbrokers have been allowed for some time, these new proposals would shift focus away from healthcare.gov and increase the likelihood that web-brokers could recommend plans to consumers, including plans with less than adequate coveragesuch as short-term orassociation health plans, while failing to provide patients and consumers useful information needed to make informed choices. As a result of these concerns, we oppose this change and urge the administration to remove it from the finalrule. 9C. Brot-Goldberg, Zarek & Chandra, Amitabh & R. Handel, Benjamin & T. Kolstad, Jonathan. (2017). What does a Deductible Do? The Impact of Cost-Sharing on Health Care Prices, Quantities, and Spending Dynamics*. Quarterly Journal of Economics. 132. 1261-1318. 10.1093/qje/qjx013.10See letter of July 23, 2018, from 190 patient, consumer, and provider organizations to Sec. Azar and Administrator Verma, requesting a restoration of Navigator funding.https://www.heart.org/-/media/files/get-involved/advocacy/072318-hhs-navigator-funding-cuts-letter–final-w-signatures.pdf?la=en&hash=AE2836DAFFEF647FFC7E6E10909FE4EF7E21F478.5Direct Enrollment Currently, the Marketplace Exchanges relyon healthcare.gov to enroll consumers and patients into health insurance plans. Healthcare.gov has specific safeguards built into the system to help ensure patients and consumers choose a plan that is the best option for them. The Exchangealsoidentifies patients and consumers who are eligible for Medicaid or Medicare. This is a key feature of the Exchange, allowing consumers to enroll in the most affordableand medically appropriateplan. The Exchange also calculates a patient’s advanced premium tax credit (APTC) and eligibility for a cost-sharing reduction (CSR)silver plan. These features allow patients and consumers to accurately compare the cost of the premiums between different plans and metal levels. By knowing the value of the APTC, patients and consumers can purchase the plan that is the best value for them and their healthcare needs. In the proposed rule, HHS proposes expanding direct enrollment,which would allow insurers and web-brokers to enroll consumers in an insurance plan directly. Allowing these entities todirectlyenroll consumers in planswill limit the ability to compare plan price and benefit design andcould ultimately result inharm to patients or consumers who become enrolled in sub-standard or inadequate insurance coverage. This failure to appropriately shield consumersfrom risk, particularly those with pre-existing conditions, is unacceptable. As such, we urge HHSto not finalize this provision of the proposedrule.Changes to direct enrollment under this proposal would also not require an insurer or web-broker to list out all the plans available to a consumer shopping for health insurance. The proposed rule wouldonly require the insurer or web-broker to link to other plans or add a disclaimer that other plans are available at healthcare.gov. Brokers frequently receive bonuses from insurers for signing consumers up for certain plans, creating an incentive for brokers to enroll individuals in plans that may not be the best option for them. Encouragingdirect enrollment will also expose patients and consumers to plans that are not qualified health plans (QHPs) during enrollment –including substandard optionssuch as short-term and association health plans. Currently, every plan sold on the Exchangeis a QHP, meaning it covers the ten essential health benefits(EHB) –including maternity care, emergency room services,and preventive services. Today, consumers can trust that they arepurchasing a health insurance plan that will cover their medical needs to manage their health condition. Insurers and web-brokers selling both QHP plans and non-QHP plans may steer consumers into the less comprehensive, less expensive plans. Non-comprehensive, skimpy health plans do not cover the services and treatments our patients need to manage their diseases and,in many cases, stay alive. Any confusion caused by obscuring the information consumers need to make informed health care decisionscan result in our patients not getting the care they need. Ultimately, this can lead to poor health outcomes and increased healthcare costs for society. Our organizations strongly urge the Department to not adopt this provision in the final rule. Essential Health Benefits (EHBs)Our organizations continue to express our concerns regarding proposals finalized by CMS in the NBPP for 2019 that weakened EHBs. Last year, the Administration movedto destabilize these core patient protections by allowing states to mix and match benefit structures in a waythat could harm patients. We strongly urge the Department not to encourage states to weaken their EHB benchmarks. Only one state, Illinois, chose to utilize these new options by including alternative therapies for chronic pain and 6expanding coverage to opioid and substance use disorder treatment, which we view as a positive use of the flexibility granted by CMS. However, we remain concerned that other states may choose to design new EHB-benchmark plans that offer less generous coverage and would not provide adequate benefits for our patients.We arealsoconcerned that the flexibility allowed under this policy, combined with other administrative actions finalized by the Administration, such as the expansion of AHPs and short-term plans and new guidance on 1332 waivers, could allow states to degrade patient protections and give them authority to offer not just less generous coverage but the leastgenerous coverage –jeopardizing the integrity of the ACA and the policies that underpin its quality. Special Enrollment PeriodsSpecial enrollment periods (SEPs) provide an importantopportunity to enroll incoverage when consumers’ circumstances change during the course of the year.We support HHS’ proposal to establish a special enrollment period for individuals with “off-Exchange” coverage who experience mid-year income changes, to facilitate consumer access to more affordable Marketplace plans when they become eligible for advance payments of the premium tax credits. Given that this SEP may be implemented at the discretion of state-based marketplaces, we strongly encourage HHS to consider requiringstate-based Exchanges to establish an SEP for individuals with off-Exchange coverage who experience mid-year income reductions as well.Risk Adjustment The permanent risk adjustment program plays an integral role in promoting insurance qualitybyminimizing risk selection and encouraging insurers todevelop insurance products that are competitive on price and value. An accurate and effective risk adjustment program is essential inpreventing discriminatory insurance benefit designs and protecting access to care for patients with chronic, acute, and life-threatening diseases. Given the importance of the permanent risk adjustment program in protecting consumers and transferring billions of dollars among participating plans, we support HHS’ proposal to improve the program’s methodology by adding prescription drugs into error estimations. Prescription drugs are an essential and often costly treatment for many conditions, and the newly-proposed risk adjustment program methodology should prevent plans from designing benefit packages to select against patients who rely on prescription therapies. In addition, we support HHS’ proposal to release datarelated to the risk adjustment programfor use by research and public health purposes. A program as important as risk adjustment will benefit from the opportunity for external accountability that comes with providing researchers outside the government with this data.Request for Information The Department has requested information on various policy proposals for future rulemakings. Our organizations have provided feedback on these proposals below. We judgedthese proposals on the potential impact they will have on improvingthe affordability, accessibility and adequacy of health insurance for all patients, especially those with pre-existing conditions:Silver Loading In October of 2017, the Administration, per advice from the Attorney General, stopped funding the cost-sharing reduction payments (CSRs) that section 1402 of the ACA requires insurance companies provide to low-income marketplace enrollees. As issuers were still required to provide the subsidies to low-7income enrollees but no longer received federal funding to pay for them, they increased premiums to cover their costs. The practice of silver loading refers to increasing premiums only for on-Exchange silver plans to cover the cost of CSRs, as opposedto spreading the cost over all individual market plans.An unexpected but beneficial result of silver loading for consumers has been an increase in the value of advanced premium tax credits (APTC), since the government calculates APTCs using the cost of the second-lowest cost marketplace silver plan. This has made it possible for some consumers to pay less for bronze or gold plans than they would have in years past. Silver loading has also kept premiums of bronze, gold, and platinum level plans more affordable than they would have been absent the practice, giving unsubsidized consumers more affordable alternatives. It is important that the Department allow silver loading to continue until such time as a broader solution on CSR payments, stabilization, and marketplace affordability isreachedand current attempts to administratively undermine the ACA cease. Absent silver loading, premiums for all individual market plans will rise and the value of APTCs will fall, exacerbating affordability issues for unsubsidized and subsidized consumers alike and reducing marketplace enrollment.11Our organizations have supported marketplace stabilization efforts in the last Congress and will continue to call for renewed efforts on this topic, evaluating any proposal on itspotential to improve the affordability, accessibility and adequacy of health insurance for all Americans. Until there is a permanent solution regarding the CSR payments and the overarching affordability of insurance premiums, our organizations urge the Department to allow silver loading. Our organizations believe that by staying consistent and keeping silver loading, the market will be more stable, which will be reflected in premiums. A stable market and insurance premiums that reflect market stability are important for patients, especially those with pre-existing health conditions. Patients need to be able to plan healthcare costs more than 12 months into the future. Many of our patients will need treatment for the rest of their lives –it is important that they can plan for their future. Oncepermanent and stableCSRfunding is secured, silver loading will no longer be needed to offset the lack of CSR funding. For some patients this could result in increased out-of-pocket costs for premiums as a result of the less generous APTCs. When and only whenthere is permanent and stable CRS funding, our organizations encourage the Department to phase out silver loadingto lessen the financial impact on patients and keep stability in the marketplace. Our organizations do acknowledge that some consumers are negatively impacted by silver loading, specifically those individuals and families that have incomes over 400 percent of the federal poverty level. With the increased premiums of silver plans, they may have fewer affordable options. Our organizations continue to encourage Congress and the Administration to work together to reduce premiums and stabilize the market for all enrollees. Auto Renewal TheDepartmentseeks comment on possibly changing the process for automatically re-enrolling consumers in health insurance plans offered through an FFE or State-Based Exchange (SBE). Currently, consumers are automatically re-enrolled in their current plan if they do not take active action to change 11Anderson D. et al. Implications of CMS Mandating A Broad Load Of CSR Costs. https://www.healthaffairs.org/do/10.1377/hblog20180511.621080/full/. Accessed February 7, 2019.8their plan. In 2018, approximately 25 percent of consumers were automatically renewed in their plan;12a total of 1.8 million were re-enrolled for plan year 2019. Our organizations are concerned that, if removed, automatic re-enrollment would leave significant numbers of people uninsured or with gaps in coverage. This would be a particular concern among older adults, people with low health literacy, and people at low-income levels. Given the lack of a compelling reason to change the policy, we urge CMS to retain auto-renewal in its current form.ConclusionOur organizations represent millions of patients who need access to quality and affordable healthcare regardless of their income or geographic location. We appreciate the opportunity to provide observations, analyses and recommendations on the proposed rule. However, we would like to reiterate our concern that the cumulative impact of the 2020 NBPP proposed rulecould seriously undermine the key principles of access, adequacy, and affordability that are the underpinnings of current law.As leaders in the health care and research communities and staunch patient advocates, we look forward to working closely with HHS leadership and staff on the direction of such important public policy. Thank you for the opportunity to submit comments on this important rule. If you have any questions, please contact Katie Berge, AHA Government Relations Manager, at [email protected] 202-785-7909.Sincerely, Adult CongenitalHeart AssociationAmerican Cancer Society Cancer ActionNetworkAmerican Heart Association American Liver Foundation American Lung Association Arthritis Foundation Chronic Disease Coalition Crohn’s & Colitis Foundation Epilepsy Association Family Voices Global Healthy Living Foundation Hemophilia Federation of AmericaLeukemia & Lymphoma Society LutheranServices in AmericaMarch of Dimes Muscular Dystrophy Association National Alliance on Mental IllnessNational Hemophilia Foundation National Multiple Sclerosis Society National Organization of Rare DisordersNational Patient Advocate Foundation Susan G. Komen United Ostomy Associationof America, Inc. WomenHeart: National Association for Women with Heart Disease12ArmourS. Trump’s Proposed ACA Rules Could Boost Costs for Millions of People. The Wall Street Journal. 2019. Available at https://www.wsj.com/articles/trumps-proposed-aca-rules-could-lift-costs-for-millions-of-people-11547775475?emailToken=774bc4bebc0f134eb1cbdb62929ce275slrMAjxYosOIBrHl2PV0GhknF/RER9kfvVE2/R4Uup5GtaR04vGLsQ+2sU34h6a/7caWwpP7v/ncdNJP4A8l8U8HSz7rRRnF/utKpV9ZDyiA8UuvgT0Dvn3OvxPwA8JL&reflink=article_email_share.

2We appreciate your consideration of our insights and concerns as we all work to improve the patient experience and health outcomes under the ACA, particularly for those with complex healthcare needs. Proposed New Provision Not CountingCopay Assistance for Brand DrugsWhen a Generic Equivalent ExistsCMS proposesto allow issuers to prohibit countingmanufacturer copay assistance for a brand drug towards the deductible or cost-sharing limitswhen a generic drug is available, on the grounds that copay assistance may steer beneficiaries towards higher cost drugs. While we agree with the goal of reducing the cost of\prescription drugs, we have significant concerns that this proposal puts the burden of high drug list prices on people with serious, chronic conditions who rely on prescription drugs –and on copay assistance to afford their medication.High deductibles and high cost-sharing for specialty medications expose patients to extraordinary out-of-pocket costs when they pick up their prescriptions at the pharmacy. People with complex medical conditions must have meaningful access to the best medication regimen for them, as prescribed by their doctor, even when those medications come with a cost. Many conditions impact each individual differently and similarly, many medications are not interchangeable. People can experience challenging or debilitating side effects from some generics of older generation medications, for instance, making a brand name medication the best option for them. CMS’ proposal to allow issuers to not countthis assistancefor brand drugs when a generic drug is available canundermine meaningful access andexacerbate affordability concerns because of the high cost of many specialty genericdrugs. Shifting Costs to ConsumersIn 2019, the maximum out-of-pocket limit on health insurance plans for an individual is $7,900 and $15,800 for a family, with the average deductible for a silver-level qualified health plan being$4,375. Moreover, specialty medicationsused to treat serious and chronic conditions,are often placed on formulary tiers associated with steep cost-sharing, sometimes upwards of 50 percent co-insurance. Research shows that when patient cost-sharing exceeds $250, 69 percent of new prescriptions are not filled or are abandoned at the pharmacy.1Many insurance plans require people to exhaust their deductibles before contributing to the cost of prescription medications. Copay assistance programs are designed to ensure people are able to fill their prescriptions without having to come up with several thousand dollars at the pharmacy counter. Some stateshave established separate cost-sharing limitations for prescription drugs, butthose limitations generally do not take effect until after the patient has paid thousands of dollars up-front to meet the deductible. Delaware, Louisiana, Maryland, and Washington D.C.have placed co-pay caps on a 30-day supply of specialty-tier drugs at $150, but after the deductibleis met.2California also caps payments at $250 but again, after the deductible has been met.Florida’s 1IQVIA.Patient Affordability Part Two: Implications for Patient Behavior & Therapy Consumption. https://www.iqvia.com/locations/united-states/patient-affordability-part-two. 2Kaminski Luduc, J. July 2016. Office of Legislature Research. https://www.cga.ct.gov/2016/rpt/pdf/2016-R-0134.pdf3Office of Insurance Regulation imposed safe harbor limits for HIV drugs, however many plans circumvent the cap by requiring the deductible to be met before the limitations are applied.3The combination of high deductibles and high cost-sharing for prescription drugs is untenable for many and particularly those who have one or more health care conditions that require ongoing prescription medications. Drug Channels Instituterecently analyzed Centers for Medicare and Medicaid Services’ National Health Expenditure Accounts data, findingthat total consumer out-of-pocket spending on prescription drugswas $12.8 billion higher than consumer out-of-pocket spending on hospital care. However, total U.S.spending on hospital care was $809 billion higher than overall spending on prescription drugs—demonstratingthat consumers are bearing a disproportionate share of total prescription drug costscompared to other health care costs.4The CMS proposals regarding prescription assistance programs will worsen this imbalance, shifting even more of the burden onto the sickest people. Manufacturer copay assistance programs help people access their medications by reducing the cost burden for the individual and helping them meet their deductible and maximum out-of-pocket spending limit.Copay Assistance Used Primarily Where There Are No Generic AlternativesWhile some may claim that coupons are being used to incentivize brand-name drugs over generics, the fact is that 87 percent of the coupons are for drugs that have no generic equivalent. The 13 percent of branded drugs programs in which generic equivalent products are available accounted for only 0.05 percent of all prescriptions filled.5A study by IQVIA found that copay cards for products with a generic alternative areutilized 0.2% of the time a script is filled by any payer in the U.S.; 0.4% by commercial payers; and when isolating only brands with generic alternatives, 14.5% by commercial payers when a generic alternative is available.6A study conducted by a team at USC Schaeffer found that of the top 200 highest-expenditure drugs with a co-pay coupon available, only 19 had a generic alternative. The authors found that there were few drugs that were close therapeutic substitutes and they “may not be suitable due tospecific comorbidities, drug interactions, or other individual circumstances.”7There are generally only brand drugs available for the treatment of many serious, chronic health conditions, such as HIV, epilepsy, cancer, and Lupus.They often are associated with high costs. Generic medications do not exist for many classes of drugs. However, when generic drugs do 3Florida 2019 Safe Harbor Guidelines for HIV/AIDS Drugs https://www.floir.com/sitedocuments/2019HIV-AIDSSafeHarborInstructions.docx4Fein, A. Drug Channels Institute. January2019. Drug Channels News Roundup: Part D Plans Profits, Hospitals vs. Drugs, and BS in Healthcare5IMS Institute for Healthcare Informatics. February 2014.“Patient Savings Program Use Analysis,”6IQVIA. February 2018. “An Evaluation of Co-pay Card Utilization in Brands After Generic Competitor Launch.7Van Nuys, K., Joyce, G., Ribero, R., Goldman, D.P. February 2018. A Perspective on Prescription Drug Copayment Coupons. Leonard D Schaeffer Centerfor Health Policy & Economics. http://healthpolicy.usc.edu/documents/2018.02_Prescription%20Copay%20Coupons%20White%20Paper_Final.pdf4exist, the insurer, who is responsible for the formulary design, can easily select a generic drug and not include the brand drugunder current ACA regulations.Institution of “Copay Accumulator” Programs“Copay accumulators” are a practice that many insurance plans, employers, and pharmacy benefit managers are instituting that impedes access to medications. Such programs prevent manufacturer co-pay assistance contributions from counting towards a beneficiary’s deductible and maximum out-of-pocket spending limits.Currently, many issuers are adopting such policies without regard to the availability of a generic equivalent. This practice poses significant problems for patients, who may only learn about their issuer’s new policy at the pharmacy counter.•Lack of Transparency: Insurance plans, PBMs and employersare implementing copay accumulator programs withoutproviding sufficient consumer notice and buryingtheinformationdeep within their benefit documents. For example, in Virginia, qualified health plans offered by CareFirst and Piedmont Community Health do not count the value of copay cards toward enrollee’s deductibles. These policies were buried in each plans’Scheduleof Benefits documents: on pages 134 and 135 of a 190-page document for CareFirst, and on page 46 of a 101-page document for Piedmont Community Healthcare. The copay accumulator language can also be confusing, leaving the beneficiary wondering if the plan is implementing the policy. Florida Blue’s plans state, “We reserve the right not to applymanufacturer or provider cost share assistance program payments (e.g., manufacturer cost share assistance, manufacturer discount plans, and/or manufacturer coupons) to the Deductible or Out-of-Pocket maximums.”In the case of Health First, also participating in Florida’s individual marketplace, their plan documents did not include amention of their policy on copay accumulators; however, based on communication with a plan representative, they could not guarantee that a copay card will count towards the member’s deductible.This lack of clarity and transparency leaves consumers surprised when they discover mid-year that they have not exhausted their deductible despite having incurred significant prescription drug cost-sharing. At this point, they might be faced with an unexpected several thousand-dollar expenditure, which they will likely be unable to afford.The CMS-issued Guidance for Individual Plan Summary of Benefits and Coverage Requirements edited in February 2016, explicitly states that if there is an out-of-pocket limit the issuer must list any major exceptions with the language, “even though you pay these expenses they don’t count toward the out-of-pocket limit.”8Plans are clearly violating these important transparency requirements and we urge CMS to ensure plans are complying with them. Although we urge CMS to withdraw the proposed 8CMS Summary of Benefits and Coverage; Instruction Guide for Individual Health Insurance Coverage. February 2016. https://www.cms.gov/CCIIO/Resources/Regulations-and-Guidance/Downloads/cciio-Individual-Instructions.PDF5change to § 156.130(h)(2), if CMS does adopt this proposal, it must also ensure that consumers are informed about it and the implications for their out-of-pocket costs. •Issuers Gain Financially from Copay “Accumulator” Policies: When issuers refuse to count manufacturer copay assistance towards deductibles and cost-sharing limits, they are essentially “double [or even triple] dipping,” by accepting the copay assistance dollars from the manufacturer, accepting rebates from the manufacturer (while charging the consumer based on list price), and still requiring the consumer to pay all cost sharing until the deductible and maximum out of pocket is reached. In a case studyof the total payments collected by a plan,modeled by the National Association of State and Territorial AIDS Directors, comparing two scenarios, one when copay assistance counts, and another when it does not under a copay accumulator program,the difference in the amount the plan collects is significant. Where an accumulator policy is not implemented—which permits the copay assistance to count towards the patient’s deductible and out-of-pocket costs—the plan would collect $3,550 in paymentsfrom the beneficiary and the drug manufacturer. Under the scenario with the copay accumulator, the plan collects$10,500.9This is a clear violation ofthe Affordable Care Act’s strict limits on out-of-pocket costs for consumersdefinedas any expenditure required by or on behalf of an enrollee with respect to essential health benefits; such term includes deductibles, coinsurance,copayments, or similar charges,but excludes premiums, balance billing amounts for non-network providers and spending for non-covered services45 CFR 155.20. Generics Are Not Always AffordableCopay assistance clearly does not steer patients to higher priced drugs when all the drugs used to treat a certain condition are brand name. When there is truly a low-cost generic equivalent for a brand drug,we can understand the reasoning behind CMS’ proposal, however, in addition to generics not always being the best fit for an individual due to factors like side effects, not all generic drugs are low cost,and the use of generics do not always translate into low and affordable patient cost sharing.While in some instances a low-cost generic may exist for a brand drug, and it is placed on the generic tier, if the copay was all the patient had to pay, the proposed policy would be acceptable. But, at a time when insurance plan benefit design often includes high deductibles, it is also important to consider the beneficiary’s total costs. Since generic manufacturers also provide copay assistance for high cost generics, CMS’ proposal also would be possible in only those instances when total patient cost sharing for the generic is not greater than the brand drug. People still will need copay assistance to afford and access their medicationseven if a generic exists. While the overall list price for a generic equivalent for a brand name drugs may be lower than the brand drug, that price can still be extremely high. For example, the drug Imatinib, used to treatment cancer had a list price of around $9,000 per month, but the generic at the time of its 9NASTAD. Co-pay Accumulators: Considerations for HIV and Hepatitis. October 2018. https://www.nastad.org/sites/default/files/Uploads/2018/copayaccumulatorfactsheet.pdf6introduction was around $8,000.10Glatiramer acetate is used to treat MS, and the brand hasa list price of about $7,500 per month, while its generic form is $6,000 per month.11The brand drug of entecavir used for the treatment of hepatitis B was $1,260 a month, but the generic today is over $500.12Therefore, for specialty generics, the cost of the drugs remains high and people still require copay assistance to access them.Recently, prices on generic drugs have been rising, steeply in some circumstances. New research has found that at least in one case, rising prices for generic drugs may be tied to more restrictive issuer policies related to cost for brand drugs. “Out-of-pocket drug costs are often tied to undiscounted list prices, and there appears to be a link between rising prices for [Multiple Sclerosis] drugs and more use of restrictive policies by Medicare drug plans,” according to researchers at Oregon Health and Science University.13In fact, the researchers found that at least in one case, “patients who are prescribed the only generic drug in one class –glatiramer acetate –will pay more out of pocket than patients using any brand-name drugs in the same class.”Need for an Exceptions ProcessIf CMS moves forward with some aspect of this proposal, we strongly suggestthat there will be a clear, easily navigated, exceptions process for determining when a generic is “medically-appropriate,” and when it is not. The physician, who has specific knowledge of the individual’s health circumstances as well as the medical expertise, should be the final arbiter and be able to override an issuer decision while the consumer is at the pharmacy. It will be imperative that CMS ensure this is made known to providers, pharmacists, issuers, and patients. QuestionsAdditionally, we have a number of questions that we ask CMS to address:•How will the agency define a “generic equivalent?” •How will biosimilars be treated? •What process will the agency use to ensure that people are able to have their brand name drug copay assistance count towards the deductible and cost-sharing limits when their physician attests that the brand is “medically appropriate” and the generic is not? •What will the process be for determining whether a generic drug is “medically appropriate?” The consumers represented by the I Am Essential Coalition have serious, complex medical conditions, and the answers to these questions will have significant impact on their ability to get the prescription drugs they need. 10Cohen, J. September 2018. Forbes. The Curious Case of Gleevec Pricing. https://www.forbes.com/sites/joshuacohen/2018/09/12/the-curious-case-of-gleevec-pricing/#47a2e79854a311Reinke, Thomas. June 2015. Managed Care Magazine. MS Drug Going Generic without Making Waves. https://www.managedcaremag.com/archives/2015/6/ms-drug-going-generic-without-making-waves12Hill, A., Gotham, D., Gooke, G., Bhagani, S., Andrieux-Meyer, I., Cohn, J., Fortunak., April 2015, Journal of Virus Eradication. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4946675/13Healthday.com. https://consumer.healthday.com/senior-citizen-information-31/medicare-news-422/ms-drug-costs-skyrocket-after-medicare-rule-change-study-742382.html7Implications for Copay Assistance for Brand Drugs When No Generic ExistsAs written, the proposal would prohibit the use of copay assistance for a brand drug when a generic exists. We are assuming that CMS is asserting that copay assistance can be used, and should be counted toward deductibles and cost-sharing, for brand drugs that do not have a medically-appropriate generic.This would therefore forbid copay accumulators for brand name drugs when there are no generic equivalents. We welcome this interpretation and ask CMS to clearly state this policyclearly, enforce it, and tourge state Insurance Commissioners to also enforce this provision in their states. Proposed New Provision Allowing Issuers to Not Consider Brand Drugs Essential Health Benefits (EHB)if the Generic is Available and Medically AppropriateCMS proposes to allow issuers to only cover a generic when there is both a brand and generic available, and to then allow the brand drug to be considered not part of the EHB package. When a drug is notconsidered part of the EHB package, the person’s cost-sharing would not count toward their deductible or the cost-sharing limits. We have significant concerns thatthis proposalwould undermine the definition of the EHB. Issuers already have wide latitude to determine which drugs are covered in their formularies, and to tier drugs such that cost-sharing amounts will steer people toward lower-cost and/or more effective drugs. Plansdo not have to cover brand name drugs for which there is a generic equivalent. Additionally, all states have laws that provide for automatic substitution of a generic drug at the pharmacy when a provider prescribes a brand drug that has a generic alternative. Because there are already many incentives in the system to steer people towards generic drugs, we believe CMS is going after a problem that does not exist.Not all patients respond the same to generic drugs as they do to the brand. While generic drugsare technically the same as brand drugs as far as active ingredients, they are not always identical. A generic may have different side effects or may interact differently with other drugs the patient may be taking. Therefore, it is imperative that the physician be the ultimate decider about whether a patient needs a particular brand drug, and in such cases, the patient should not be subject to cost penalties as a result of their brand drug use. We urge CMS to withdraw this proposal and to clarify that plans should ensure comprehensive access to medicine needed by people with chronic health care conditions, and ensure that people for whom a brand drug is the medically-appropriate option are not penalized by having their cost-sharing not counted toward theirdeductible and cost-sharing limits.Mid-Year Formulary Changesfor Newly Approved GenericsCMS proposes allowing issuers to make mid-year formulary changes when a generic equivalent prescription drug becomes available on the market. While we appreciate efforts to make generics available to enrollees as quickly as possible, we have serious concerns about the proposal to allow issuers to remove brand name drugs from the formulary within the plan year. 8People with serious chronic conditions -like epilepsy, HIV, and mental health conditions -choose plans based on the coverage that is advertised. Treatment regimens for people with chronic conditions is not “one size fits all,” and many are carefully balanced to reduce side effects and drug interactions. Disrupting these regimes risks increasing side effects, adverse reactions and interactions, avoidable hospitalizations and emergency room visitsand in some instances, irreversible damage or a public health concern. Consumers must have correct information when shopping for plans. In the proposed rule, CMS states that it “encourage[s] QHP issuers andExchanges to undertake efforts to engage in consumer-friendly communication of their services to help consumers understand the value of the services they would potentially obtain,” and that such transparency will promote value and improve health outcomes.However, this proposal directly contradicts that effort. If finalized, this rule would allow an issuer to offer a product that is different than was advertised; because consumers are locked into the plan for a year, allowing plans to offer a product different than advertised will undermine consumers’ ability to make the best plan choices for their health. If CMS moves forward with this proposal, it should be limited to adding new drugs to the formulary; issuers should not be allowed to remove drugs until the new plan year. People who do choose to switch to the generic will need time to schedule an appointment with their doctor, discuss side effects, and create a schedule for weaning off of a drug and beginning a new regimen. If CMS moves forward with allowing issuers to remove drugs from the formulary, it should also provide the maximum proposed notice period -120 days -to allow enrollees to develop a new treatment plan. Therapeutic Substitution and Reference Pricing We appreciate the ability to comment on two ideas that CMS is considering for future rulemaking: therapeutic substitution and reference pricing.We have serious concerns about the consideration of therapeutic substitution. Therapeutic substitution may result in serious adverse outcomes for people with chronic conditions, who are frequently on multiple medications and have carefully calibrated treatments that are determined in coordination with their physicians. CMS acknowledges that for therapeutic substitution to become commonplace, “efficient systems that allow for seamless communication among prescribers, pharmacies, and insurance companies would need to be in place.” Such seamless communication does not currently exist. CMS may be considering allowing therapeutic substitution in order to “force” such systems. However, the people most likely to be hurt in that scenario are people with disabilities and chronic conditions, and any savings achieved are likely to be tempered by adverse drug interactions, avoidable admissions, and other poor outcomes. We also have serious concerns about any proposal that seeks to reduce health costs by shifting more costs to consumers, especially those with chronic conditions who already face significant cost sharing. Introducing reference pricing to prescription drugs would only increase these costs and risk limiting patient access to drugs, thereby harming medication adherence. A study published in Health Affairs found that increasing medication adherence, even when controlling for confounding factors such as other indicators of a healthy lifestyle, reduced health care 9utilization and costs.14Consumers -especially those with chronic conditions -already face significant cost sharing, including cost sharing that can impact medication adherence. Silver LoadingWe appreciate CMS’s decision to allow the practice known as “silver loading” to continue. We encourage CMS to continue to allow silver loading unless and until Congress takes action to appropriate cost-sharing reduction payments in a way that protects enrollees and promotes a stable health insurance market. Absent Congressional action, we believe this is the best way to protect low-income consumers and ensure that people are able to afford a health plan and the care they need. Premium Adjustment PercentageAs groups representing people with serious chronic conditions, we have concerns about the proposal to change the calculation of the premium adjustment percentage. As CMS notes in the proposed rule, the change in calculation would result in approximately 100,000 people losing Exchange coverage, with the majority of them becoming uninsured. This proposal will also result in higher premiums and higher cost sharing for Exchange enrollees. Such changes run contrary to the purpose of the Affordable Care Act and the Exchanges, and should not be finalized. We urge CMS to withdraw this proposal.Auto Re-enrollmentWe strongly support HHS continuing auto re-enrollment for consumers who do not take actionto select a new plan. Individuals who purchase their health insurance through the ACA have become accustomed to this practice which ensures continuous healthcare coverage, streamlines the health insurer process, and has also helped maintain a robust risk pool enrolled in the marketplace. Millions may lose coverage and risk interrupted care if auto re-enrollment were to be discontinued in the federally-facilitated marketplaces.In response to HHS seeking comments on the procedures or policies that could help reduce eligibility errors we would recommend strengthening and modernizing data agreements with entities such as the Social Security Administration and Treasury and improve data matching reconciliation to ensure the most accurate information is available to determine an enrollee’s eligibility and improve program integrity.Maintaining and Enforcing Patient ProtectionsAs stated in the Proposed Rule, the Affordable Care Act contains many important patient protections that help in defining EHBand that all issuers must abide to when designing plan benefits. For example, plans must offer all ten categories of the EHB, the benefits must be equal in scope to a typical employer plan, there has to be an appropriate balance across all categories, and plan benefit design cannot discriminate based on an individual’s age or disability. The EHBsmust also consider the health needs of diverse segments of the population including women, children, persons with disabilities, and other groups. In previous regulation, HHS has further defined EHB. For example, for prescription medications, every plan must cover at least the greater of one drug per class or the same number of drugs in 14Health Affairs. https://www.healthaffairs.org/doi/10.1377/hlthaff.2009.108710each category and class as the state’s benchmark plan. Previous regulation also requires plans to be transparent in their coverage of benefits and costs, utilize Pharmacy and Therapeutic Committees, and consider newly approved medications and treatment guidelines. Plans must also not limit delivery of medications to only mail order. Additional regulations have been promulgated to implement Section 1557 of the ACA, which further defines discrimination in healthcare. HHS has also provided examples of discriminatory benefit design to include excessive patient cost-sharing, excessive utilization management techniques, such as prior authorizations, and placing every drug to treat a certain condition on the highest tier. As we wrote in a letter to HHS last year, continuation of these patient protections is critical so that qualified health plans meet the needs of patients, particularly those with serious and chronic conditions. We thank HHS for recognizing their importanceby maintaining them and appreciatethat in the Letter to Issuers for 2020other plan standards and expectations are maintained.Patient protections are meaningless without proper enforcement.Despite the law or regulation, some insurers still design plans that are discriminatory and limit patient access. Beneficiaries continue to encounter plans that lack meaningful formulary coverage for prescription medications, engage in adverse tiering, have high cost-sharing and burdensome utilization management requirements such as extensive and/or unwarranted prior authorization and step therapy requirements. Beneficiaries also still face midyear formulary changes, and can have their medications switched for non-medical reasons. Current regulations and guidelines must be enforced. We encourage HHS to fully enforce the patient protections contained in the law and in regulation, and ensure that if oversight and enforcement responsibilities are assumed by the states, they have the authority and resources necessary to fully address patients’ protections, particularly non-discrimination in plan benefit design.Thank you very much for your consideration of our comments. Should you have any questions, please contact: Carl Schmid, Deputy Executive Director, The AIDS Institute, [email protected]; Laura Weidner, Vice President, Government Relations and Advocacy, Epilepsy Foundation, [email protected]; or Andrew Sperling, Director of Federal Legislative Advocacy, National Alliance on Mental Illness, [email protected],Action WellnessADAP Advocacy Association (aaa+)AIDS Action BaltimoreAimed AllianceAllergy & Asthma NetworkAmerican Association on Health and DisabilityAmerican Autoimmune Related Diseases Association (AARDA ) American Behcet’s Disease Association (ABDA)American Physical Therapy AssociationAutistic Self Advocacy NetworkBronx Cares Family Medicine California Chronic Care CoalitionCalifornia Hepatitis C Task Force, International Association of Hepatitis Task Forces11Cancer Support CommunityCaregiver Action Network Caregiver Voices United Chronic Disease Coalition Clinical Social Work AssociationCoalition on Positive Health EmpowermentCommunity Access National Network (CANN)COPD FoundationEasterseals MassachusettsEPIC Long Island, South Shore Child Guidance CenterEpilepsy Alliance North CarolinaEpilepsy CaliforniaEpilepsy FoundationEpilepsy Foundation of Alabama Epilepsy Foundation of AlaskaEpilepsy Foundation of ArizonaEpilepsy Foundation of Central & South TexasEpilepsy Foundation of ColoradoEpilepsy Foundation of DelawareEpilepsy Foundation of GeorgiaEpilepsy Foundation of Greater Southern IllinoisEpilepsy Foundation of HawaiiEpilepsy Foundation of IndianaEpilepsy Foundation IowaEpilepsy Foundation of KentuckianaEpilepsy Foundation of Long IslandEpilepsy Foundation MarylandEpilepsy Foundation of Michigan Epilepsy Foundation of Minnesota Epilepsy Foundation of MississippiEpilepsy Foundation of Missouri and KansasEpilepsy Foundation of NevadaEpilepsy Foundation New EnglandEpilepsy Foundation of Northeastern New YorkEpilepsy Foundation OhioEpilepsy Foundation of OklahomaEpilepsy Foundation OregonEpilepsy Foundation of UtahEpilepsy Foundation of VermontEpilepsy Foundation of VirginiaEpilepsy Foundation WashingtonEpilepsy Information Service of Wake Forest University School of MedicineGlobal Healthy Living FoundationHealthHIV Hemophilia Federation of AmericaHIV Dental AllianceInternational Foundation for Autoimmune & Autoinflammatory Arthritis (IFAA)International Pain FoundationInternational Pemphigus and Pemphigoid FoundationLakeshore FoundationLet’s Talk About ChangeLupus and Allied Diseases Association, Inc.Lupus Foundation of AmericaLupus Research AllianceMental Health AmericaMLD FoundationNashville CARESNASTADNational Alliance on Mental IllnessNational Association of Nutrition and Aging Services Programs (NANASP)National Coalition for LGBT Health National Consumers LeagueNational Council for Behavioral HealthNational Disability Rights NetworkNational Hemophilia FoundationNational Multiple Sclerosis Society National Patient Advocate FoundationNew Jersey Association of Mental Health and Addiction Agencies,Inc.Prevent BlindnessThe AIDS InstituteThe Arc of the United StatesUS Hereditary Angioedema Association US Pain FoundationUsher 1F Collaborativecc: Randy Pate/CCIIO

2We appreciate your consideration of our insights and concerns as we all work to improve the patient experience and health outcomes under the ACA, particularly for those with complex healthcare needs. Proposed New Provision Not CountingCopay Assistance for Brand DrugsWhen a Generic Equivalent ExistsCMS proposesto allow issuers to prohibit countingmanufacturer copay assistance for a brand drug towards the deductible or cost-sharing limitswhen a generic drug is available, on the grounds that copay assistance may steer beneficiaries towards higher cost drugs. While we agree with the goal of reducing the cost of\prescription drugs, we have significant concerns that this proposal puts the burden of high drug list prices on people with serious, chronic conditions who rely on prescription drugs –and on copay assistance to afford their medication.High deductibles and high cost-sharing for specialty medications expose patients to extraordinary out-of-pocket costs when they pick up their prescriptions at the pharmacy. People with complex medical conditions must have meaningful access to the best medication regimen for them, as prescribed by their doctor, even when those medications come with a cost. Many conditions impact each individual differently and similarly, many medications are not interchangeable. People can experience challenging or debilitating side effects from some generics of older generation medications, for instance, making a brand name medication the best option for them. CMS’ proposal to allow issuers to not countthis assistancefor brand drugs when a generic drug is available canundermine meaningful access andexacerbate affordability concerns because of the high cost of many specialty genericdrugs. Shifting Costs to ConsumersIn 2019, the maximum out-of-pocket limit on health insurance plans for an individual is $7,900 and $15,800 for a family, with the average deductible for a silver-level qualified health plan being$4,375. Moreover, specialty medicationsused to treat serious and chronic conditions,are often placed on formulary tiers associated with steep cost-sharing, sometimes upwards of 50 percent co-insurance. Research shows that when patient cost-sharing exceeds $250, 69 percent of new prescriptions are not filled or are abandoned at the pharmacy.1Many insurance plans require people to exhaust their deductibles before contributing to the cost of prescription medications. Copay assistance programs are designed to ensure people are able to fill their prescriptions without having to come up with several thousand dollars at the pharmacy counter. Some stateshave established separate cost-sharing limitations for prescription drugs, butthose limitations generally do not take effect until after the patient has paid thousands of dollars up-front to meet the deductible. Delaware, Louisiana, Maryland, and Washington D.C.have placed co-pay caps on a 30-day supply of specialty-tier drugs at $150, but after the deductibleis met.2California also caps payments at $250 but again, after the deductible has been met.Florida’s 1IQVIA.Patient Affordability Part Two: Implications for Patient Behavior & Therapy Consumption. https://www.iqvia.com/locations/united-states/patient-affordability-part-two. 2Kaminski Luduc, J. July 2016. Office of Legislature Research. https://www.cga.ct.gov/2016/rpt/pdf/2016-R-0134.pdf3Office of Insurance Regulation imposed safe harbor limits for HIV drugs, however many plans circumvent the cap by requiring the deductible to be met before the limitations are applied.3The combination of high deductibles and high cost-sharing for prescription drugs is untenable for many and particularly those who have one or more health care conditions that require ongoing prescription medications. Drug Channels Instituterecently analyzed Centers for Medicare and Medicaid Services’ National Health Expenditure Accounts data, findingthat total consumer out-of-pocket spending on prescription drugswas $12.8 billion higher than consumer out-of-pocket spending on hospital care. However, total U.S.spending on hospital care was $809 billion higher than overall spending on prescription drugs—demonstratingthat consumers are bearing a disproportionate share of total prescription drug costscompared to other health care costs.4The CMS proposals regarding prescription assistance programs will worsen this imbalance, shifting even more of the burden onto the sickest people. Manufacturer copay assistance programs help people access their medications by reducing the cost burden for the individual and helping them meet their deductible and maximum out-of-pocket spending limit.Copay Assistance Used Primarily Where There Are No Generic AlternativesWhile some may claim that coupons are being used to incentivize brand-name drugs over generics, the fact is that 87 percent of the coupons are for drugs that have no generic equivalent. The 13 percent of branded drugs programs in which generic equivalent products are available accounted for only 0.05 percent of all prescriptions filled.5A study by IQVIA found that copay cards for products with a generic alternative areutilized 0.2% of the time a script is filled by any payer in the U.S.; 0.4% by commercial payers; and when isolating only brands with generic alternatives, 14.5% by commercial payers when a generic alternative is available.6A study conducted by a team at USC Schaeffer found that of the top 200 highest-expenditure drugs with a co-pay coupon available, only 19 had a generic alternative. The authors found that there were few drugs that were close therapeutic substitutes and they “may not be suitable due tospecific comorbidities, drug interactions, or other individual circumstances.”7There are generally only brand drugs available for the treatment of many serious, chronic health conditions, such as HIV, epilepsy, cancer, and Lupus.They often are associated with high costs. Generic medications do not exist for many classes of drugs. However, when generic drugs do 3Florida 2019 Safe Harbor Guidelines for HIV/AIDS Drugs https://www.floir.com/sitedocuments/2019HIV-AIDSSafeHarborInstructions.docx4Fein, A. Drug Channels Institute. January2019. Drug Channels News Roundup: Part D Plans Profits, Hospitals vs. Drugs, and BS in Healthcare5IMS Institute for Healthcare Informatics. February 2014.“Patient Savings Program Use Analysis,”6IQVIA. February 2018. “An Evaluation of Co-pay Card Utilization in Brands After Generic Competitor Launch.7Van Nuys, K., Joyce, G., Ribero, R., Goldman, D.P. February 2018. A Perspective on Prescription Drug Copayment Coupons. Leonard D Schaeffer Centerfor Health Policy & Economics. http://healthpolicy.usc.edu/documents/2018.02_Prescription%20Copay%20Coupons%20White%20Paper_Final.pdf4exist, the insurer, who is responsible for the formulary design, can easily select a generic drug and not include the brand drugunder current ACA regulations.Institution of “Copay Accumulator” Programs“Copay accumulators” are a practice that many insurance plans, employers, and pharmacy benefit managers are instituting that impedes access to medications. Such programs prevent manufacturer co-pay assistance contributions from counting towards a beneficiary’s deductible and maximum out-of-pocket spending limits.Currently, many issuers are adopting such policies without regard to the availability of a generic equivalent. This practice poses significant problems for patients, who may only learn about their issuer’s new policy at the pharmacy counter.•Lack of Transparency: Insurance plans, PBMs and employersare implementing copay accumulator programs withoutproviding sufficient consumer notice and buryingtheinformationdeep within their benefit documents. For example, in Virginia, qualified health plans offered by CareFirst and Piedmont Community Health do not count the value of copay cards toward enrollee’s deductibles. These policies were buried in each plans’Scheduleof Benefits documents: on pages 134 and 135 of a 190-page document for CareFirst, and on page 46 of a 101-page document for Piedmont Community Healthcare. The copay accumulator language can also be confusing, leaving the beneficiary wondering if the plan is implementing the policy. Florida Blue’s plans state, “We reserve the right not to applymanufacturer or provider cost share assistance program payments (e.g., manufacturer cost share assistance, manufacturer discount plans, and/or manufacturer coupons) to the Deductible or Out-of-Pocket maximums.”In the case of Health First, also participating in Florida’s individual marketplace, their plan documents did not include amention of their policy on copay accumulators; however, based on communication with a plan representative, they could not guarantee that a copay card will count towards the member’s deductible.This lack of clarity and transparency leaves consumers surprised when they discover mid-year that they have not exhausted their deductible despite having incurred significant prescription drug cost-sharing. At this point, they might be faced with an unexpected several thousand-dollar expenditure, which they will likely be unable to afford.The CMS-issued Guidance for Individual Plan Summary of Benefits and Coverage Requirements edited in February 2016, explicitly states that if there is an out-of-pocket limit the issuer must list any major exceptions with the language, “even though you pay these expenses they don’t count toward the out-of-pocket limit.”8Plans are clearly violating these important transparency requirements and we urge CMS to ensure plans are complying with them. Although we urge CMS to withdraw the proposed 8CMS Summary of Benefits and Coverage; Instruction Guide for Individual Health Insurance Coverage. February 2016. https://www.cms.gov/CCIIO/Resources/Regulations-and-Guidance/Downloads/cciio-Individual-Instructions.PDF5change to § 156.130(h)(2), if CMS does adopt this proposal, it must also ensure that consumers are informed about it and the implications for their out-of-pocket costs. •Issuers Gain Financially from Copay “Accumulator” Policies: When issuers refuse to count manufacturer copay assistance towards deductibles and cost-sharing limits, they are essentially “double [or even triple] dipping,” by accepting the copay assistance dollars from the manufacturer, accepting rebates from the manufacturer (while charging the consumer based on list price), and still requiring the consumer to pay all cost sharing until the deductible and maximum out of pocket is reached. In a case studyof the total payments collected by a plan,modeled by the National Association of State and Territorial AIDS Directors, comparing two scenarios, one when copay assistance counts, and another when it does not under a copay accumulator program,the difference in the amount the plan collects is significant. Where an accumulator policy is not implemented—which permits the copay assistance to count towards the patient’s deductible and out-of-pocket costs—the plan would collect $3,550 in paymentsfrom the beneficiary and the drug manufacturer. Under the scenario with the copay accumulator, the plan collects$10,500.9This is a clear violation ofthe Affordable Care Act’s strict limits on out-of-pocket costs for consumersdefinedas any expenditure required by or on behalf of an enrollee with respect to essential health benefits; such term includes deductibles, coinsurance,copayments, or similar charges,but excludes premiums, balance billing amounts for non-network providers and spending for non-covered services45 CFR 155.20. Generics Are Not Always AffordableCopay assistance clearly does not steer patients to higher priced drugs when all the drugs used to treat a certain condition are brand name. When there is truly a low-cost generic equivalent for a brand drug,we can understand the reasoning behind CMS’ proposal, however, in addition to generics not always being the best fit for an individual due to factors like side effects, not all generic drugs are low cost,and the use of generics do not always translate into low and affordable patient cost sharing.While in some instances a low-cost generic may exist for a brand drug, and it is placed on the generic tier, if the copay was all the patient had to pay, the proposed policy would be acceptable. But, at a time when insurance plan benefit design often includes high deductibles, it is also important to consider the beneficiary’s total costs. Since generic manufacturers also provide copay assistance for high cost generics, CMS’ proposal also would be possible in only those instances when total patient cost sharing for the generic is not greater than the brand drug. People still will need copay assistance to afford and access their medicationseven if a generic exists. While the overall list price for a generic equivalent for a brand name drugs may be lower than the brand drug, that price can still be extremely high. For example, the drug Imatinib, used to treatment cancer had a list price of around $9,000 per month, but the generic at the time of its 9NASTAD. Co-pay Accumulators: Considerations for HIV and Hepatitis. October 2018. https://www.nastad.org/sites/default/files/Uploads/2018/copayaccumulatorfactsheet.pdf6introduction was around $8,000.10Glatiramer acetate is used to treat MS, and the brand hasa list price of about $7,500 per month, while its generic form is $6,000 per month.11The brand drug of entecavir used for the treatment of hepatitis B was $1,260 a month, but the generic today is over $500.12Therefore, for specialty generics, the cost of the drugs remains high and people still require copay assistance to access them.Recently, prices on generic drugs have been rising, steeply in some circumstances. New research has found that at least in one case, rising prices for generic drugs may be tied to more restrictive issuer policies related to cost for brand drugs. “Out-of-pocket drug costs are often tied to undiscounted list prices, and there appears to be a link between rising prices for [Multiple Sclerosis] drugs and more use of restrictive policies by Medicare drug plans,” according to researchers at Oregon Health and Science University.13In fact, the researchers found that at least in one case, “patients who are prescribed the only generic drug in one class –glatiramer acetate –will pay more out of pocket than patients using any brand-name drugs in the same class.”Need for an Exceptions ProcessIf CMS moves forward with some aspect of this proposal, we strongly suggestthat there will be a clear, easily navigated, exceptions process for determining when a generic is “medically-appropriate,” and when it is not. The physician, who has specific knowledge of the individual’s health circumstances as well as the medical expertise, should be the final arbiter and be able to override an issuer decision while the consumer is at the pharmacy. It will be imperative that CMS ensure this is made known to providers, pharmacists, issuers, and patients. QuestionsAdditionally, we have a number of questions that we ask CMS to address:•How will the agency define a “generic equivalent?” •How will biosimilars be treated? •What process will the agency use to ensure that people are able to have their brand name drug copay assistance count towards the deductible and cost-sharing limits when their physician attests that the brand is “medically appropriate” and the generic is not? •What will the process be for determining whether a generic drug is “medically appropriate?” The consumers represented by the I Am Essential Coalition have serious, complex medical conditions, and the answers to these questions will have significant impact on their ability to get the prescription drugs they need. 10Cohen, J. September 2018. Forbes. The Curious Case of Gleevec Pricing. https://www.forbes.com/sites/joshuacohen/2018/09/12/the-curious-case-of-gleevec-pricing/#47a2e79854a311Reinke, Thomas. June 2015. Managed Care Magazine. MS Drug Going Generic without Making Waves. https://www.managedcaremag.com/archives/2015/6/ms-drug-going-generic-without-making-waves12Hill, A., Gotham, D., Gooke, G., Bhagani, S., Andrieux-Meyer, I., Cohn, J., Fortunak., April 2015, Journal of Virus Eradication. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4946675/13Healthday.com. https://consumer.healthday.com/senior-citizen-information-31/medicare-news-422/ms-drug-costs-skyrocket-after-medicare-rule-change-study-742382.html7Implications for Copay Assistance for Brand Drugs When No Generic ExistsAs written, the proposal would prohibit the use of copay assistance for a brand drug when a generic exists. We are assuming that CMS is asserting that copay assistance can be used, and should be counted toward deductibles and cost-sharing, for brand drugs that do not have a medically-appropriate generic.This would therefore forbid copay accumulators for brand name drugs when there are no generic equivalents. We welcome this interpretation and ask CMS to clearly state this policyclearly, enforce it, and tourge state Insurance Commissioners to also enforce this provision in their states. Proposed New Provision Allowing Issuers to Not Consider Brand Drugs Essential Health Benefits (EHB)if the Generic is Available and Medically AppropriateCMS proposes to allow issuers to only cover a generic when there is both a brand and generic available, and to then allow the brand drug to be considered not part of the EHB package. When a drug is notconsidered part of the EHB package, the person’s cost-sharing would not count toward their deductible or the cost-sharing limits. We have significant concerns thatthis proposalwould undermine the definition of the EHB. Issuers already have wide latitude to determine which drugs are covered in their formularies, and to tier drugs such that cost-sharing amounts will steer people toward lower-cost and/or more effective drugs. Plansdo not have to cover brand name drugs for which there is a generic equivalent. Additionally, all states have laws that provide for automatic substitution of a generic drug at the pharmacy when a provider prescribes a brand drug that has a generic alternative. Because there are already many incentives in the system to steer people towards generic drugs, we believe CMS is going after a problem that does not exist.Not all patients respond the same to generic drugs as they do to the brand. While generic drugsare technically the same as brand drugs as far as active ingredients, they are not always identical. A generic may have different side effects or may interact differently with other drugs the patient may be taking. Therefore, it is imperative that the physician be the ultimate decider about whether a patient needs a particular brand drug, and in such cases, the patient should not be subject to cost penalties as a result of their brand drug use. We urge CMS to withdraw this proposal and to clarify that plans should ensure comprehensive access to medicine needed by people with chronic health care conditions, and ensure that people for whom a brand drug is the medically-appropriate option are not penalized by having their cost-sharing not counted toward theirdeductible and cost-sharing limits.Mid-Year Formulary Changesfor Newly Approved GenericsCMS proposes allowing issuers to make mid-year formulary changes when a generic equivalent prescription drug becomes available on the market. While we appreciate efforts to make generics available to enrollees as quickly as possible, we have serious concerns about the proposal to allow issuers to remove brand name drugs from the formulary within the plan year. 8People with serious chronic conditions -like epilepsy, HIV, and mental health conditions -choose plans based on the coverage that is advertised. Treatment regimens for people with chronic conditions is not “one size fits all,” and many are carefully balanced to reduce side effects and drug interactions. Disrupting these regimes risks increasing side effects, adverse reactions and interactions, avoidable hospitalizations and emergency room visitsand in some instances, irreversible damage or a public health concern. Consumers must have correct information when shopping for plans. In the proposed rule, CMS states that it “encourage[s] QHP issuers andExchanges to undertake efforts to engage in consumer-friendly communication of their services to help consumers understand the value of the services they would potentially obtain,” and that such transparency will promote value and improve health outcomes.However, this proposal directly contradicts that effort. If finalized, this rule would allow an issuer to offer a product that is different than was advertised; because consumers are locked into the plan for a year, allowing plans to offer a product different than advertised will undermine consumers’ ability to make the best plan choices for their health. If CMS moves forward with this proposal, it should be limited to adding new drugs to the formulary; issuers should not be allowed to remove drugs until the new plan year. People who do choose to switch to the generic will need time to schedule an appointment with their doctor, discuss side effects, and create a schedule for weaning off of a drug and beginning a new regimen. If CMS moves forward with allowing issuers to remove drugs from the formulary, it should also provide the maximum proposed notice period -120 days -to allow enrollees to develop a new treatment plan. Therapeutic Substitution and Reference Pricing We appreciate the ability to comment on two ideas that CMS is considering for future rulemaking: therapeutic substitution and reference pricing.We have serious concerns about the consideration of therapeutic substitution. Therapeutic substitution may result in serious adverse outcomes for people with chronic conditions, who are frequently on multiple medications and have carefully calibrated treatments that are determined in coordination with their physicians. CMS acknowledges that for therapeutic substitution to become commonplace, “efficient systems that allow for seamless communication among prescribers, pharmacies, and insurance companies would need to be in place.” Such seamless communication does not currently exist. CMS may be considering allowing therapeutic substitution in order to “force” such systems. However, the people most likely to be hurt in that scenario are people with disabilities and chronic conditions, and any savings achieved are likely to be tempered by adverse drug interactions, avoidable admissions, and other poor outcomes. We also have serious concerns about any proposal that seeks to reduce health costs by shifting more costs to consumers, especially those with chronic conditions who already face significant cost sharing. Introducing reference pricing to prescription drugs would only increase these costs and risk limiting patient access to drugs, thereby harming medication adherence. A study published in Health Affairs found that increasing medication adherence, even when controlling for confounding factors such as other indicators of a healthy lifestyle, reduced health care 9utilization and costs.14Consumers -especially those with chronic conditions -already face significant cost sharing, including cost sharing that can impact medication adherence. Silver LoadingWe appreciate CMS’s decision to allow the practice known as “silver loading” to continue. We encourage CMS to continue to allow silver loading unless and until Congress takes action to appropriate cost-sharing reduction payments in a way that protects enrollees and promotes a stable health insurance market. Absent Congressional action, we believe this is the best way to protect low-income consumers and ensure that people are able to afford a health plan and the care they need. Premium Adjustment PercentageAs groups representing people with serious chronic conditions, we have concerns about the proposal to change the calculation of the premium adjustment percentage. As CMS notes in the proposed rule, the change in calculation would result in approximately 100,000 people losing Exchange coverage, with the majority of them becoming uninsured. This proposal will also result in higher premiums and higher cost sharing for Exchange enrollees. Such changes run contrary to the purpose of the Affordable Care Act and the Exchanges, and should not be finalized. We urge CMS to withdraw this proposal.Auto Re-enrollmentWe strongly support HHS continuing auto re-enrollment for consumers who do not take actionto select a new plan. Individuals who purchase their health insurance through the ACA have become accustomed to this practice which ensures continuous healthcare coverage, streamlines the health insurer process, and has also helped maintain a robust risk pool enrolled in the marketplace. Millions may lose coverage and risk interrupted care if auto re-enrollment were to be discontinued in the federally-facilitated marketplaces.In response to HHS seeking comments on the procedures or policies that could help reduce eligibility errors we would recommend strengthening and modernizing data agreements with entities such as the Social Security Administration and Treasury and improve data matching reconciliation to ensure the most accurate information is available to determine an enrollee’s eligibility and improve program integrity.Maintaining and Enforcing Patient ProtectionsAs stated in the Proposed Rule, the Affordable Care Act contains many important patient protections that help in defining EHBand that all issuers must abide to when designing plan benefits. For example, plans must offer all ten categories of the EHB, the benefits must be equal in scope to a typical employer plan, there has to be an appropriate balance across all categories, and plan benefit design cannot discriminate based on an individual’s age or disability. The EHBsmust also consider the health needs of diverse segments of the population including women, children, persons with disabilities, and other groups. In previous regulation, HHS has further defined EHB. For example, for prescription medications, every plan must cover at least the greater of one drug per class or the same number of drugs in 14Health Affairs. https://www.healthaffairs.org/doi/10.1377/hlthaff.2009.108710each category and class as the state’s benchmark plan. Previous regulation also requires plans to be transparent in their coverage of benefits and costs, utilize Pharmacy and Therapeutic Committees, and consider newly approved medications and treatment guidelines. Plans must also not limit delivery of medications to only mail order. Additional regulations have been promulgated to implement Section 1557 of the ACA, which further defines discrimination in healthcare. HHS has also provided examples of discriminatory benefit design to include excessive patient cost-sharing, excessive utilization management techniques, such as prior authorizations, and placing every drug to treat a certain condition on the highest tier. As we wrote in a letter to HHS last year, continuation of these patient protections is critical so that qualified health plans meet the needs of patients, particularly those with serious and chronic conditions. We thank HHS for recognizing their importanceby maintaining them and appreciatethat in the Letter to Issuers for 2020other plan standards and expectations are maintained.Patient protections are meaningless without proper enforcement.Despite the law or regulation, some insurers still design plans that are discriminatory and limit patient access. Beneficiaries continue to encounter plans that lack meaningful formulary coverage for prescription medications, engage in adverse tiering, have high cost-sharing and burdensome utilization management requirements such as extensive and/or unwarranted prior authorization and step therapy requirements. Beneficiaries also still face midyear formulary changes, and can have their medications switched for non-medical reasons. Current regulations and guidelines must be enforced. We encourage HHS to fully enforce the patient protections contained in the law and in regulation, and ensure that if oversight and enforcement responsibilities are assumed by the states, they have the authority and resources necessary to fully address patients’ protections, particularly non-discrimination in plan benefit design.Thank you very much for your consideration of our comments. Should you have any questions, please contact: Carl Schmid, Deputy Executive Director, The AIDS Institute, [email protected]; Laura Weidner, Vice President, Government Relations and Advocacy, Epilepsy Foundation, [email protected]; or Andrew Sperling, Director of Federal Legislative Advocacy, National Alliance on Mental Illness, [email protected],Action WellnessADAP Advocacy Association (aaa+)AIDS Action BaltimoreAimed AllianceAllergy & Asthma NetworkAmerican Association on Health and DisabilityAmerican Autoimmune Related Diseases Association (AARDA ) American Behcet’s Disease Association (ABDA)American Physical Therapy AssociationAutistic Self Advocacy NetworkBronx Cares Family Medicine California Chronic Care CoalitionCalifornia Hepatitis C Task Force, International Association of Hepatitis Task Forces11Cancer Support CommunityCaregiver Action Network Caregiver Voices United Chronic Disease Coalition Clinical Social Work AssociationCoalition on Positive Health EmpowermentCommunity Access National Network (CANN)COPD FoundationEasterseals MassachusettsEPIC Long Island, South Shore Child Guidance CenterEpilepsy Alliance North CarolinaEpilepsy CaliforniaEpilepsy FoundationEpilepsy Foundation of Alabama Epilepsy Foundation of AlaskaEpilepsy Foundation of ArizonaEpilepsy Foundation of Central & South TexasEpilepsy Foundation of ColoradoEpilepsy Foundation of DelawareEpilepsy Foundation of GeorgiaEpilepsy Foundation of Greater Southern IllinoisEpilepsy Foundation of HawaiiEpilepsy Foundation of IndianaEpilepsy Foundation IowaEpilepsy Foundation of KentuckianaEpilepsy Foundation of Long IslandEpilepsy Foundation MarylandEpilepsy Foundation of Michigan Epilepsy Foundation of Minnesota Epilepsy Foundation of MississippiEpilepsy Foundation of Missouri and KansasEpilepsy Foundation of NevadaEpilepsy Foundation New EnglandEpilepsy Foundation of Northeastern New YorkEpilepsy Foundation OhioEpilepsy Foundation of OklahomaEpilepsy Foundation OregonEpilepsy Foundation of UtahEpilepsy Foundation of VermontEpilepsy Foundation of VirginiaEpilepsy Foundation WashingtonEpilepsy Information Service of Wake Forest University School of MedicineGlobal Healthy Living FoundationHealthHIV Hemophilia Federation of AmericaHIV Dental AllianceInternational Foundation for Autoimmune & Autoinflammatory Arthritis (IFAA)International Pain FoundationInternational Pemphigus and Pemphigoid FoundationLakeshore FoundationLet’s Talk About ChangeLupus and Allied Diseases Association, Inc.Lupus Foundation of AmericaLupus Research AllianceMental Health AmericaMLD FoundationNashville CARESNASTADNational Alliance on Mental IllnessNational Association of Nutrition and Aging Services Programs (NANASP)National Coalition for LGBT Health National Consumers LeagueNational Council for Behavioral HealthNational Disability Rights NetworkNational Hemophilia FoundationNational Multiple Sclerosis Society National Patient Advocate FoundationNew Jersey Association of Mental Health and Addiction Agencies,Inc.Prevent BlindnessThe AIDS InstituteThe Arc of the United StatesUS Hereditary Angioedema Association US Pain FoundationUsher 1F Collaborativecc: Randy Pate/CCIIO