January 25th 2019
Seema Verma, MPHAdministratorCenters for Medicare & Medicaid ServicesU.S. Department of Health and Human ServicesAttention: CMS-1693-P,P.O. Box 8016,Baltimore, MD 21244-8016Re: Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses (CMS-4180-P)Delivered electronically to http://www.regulations.govDear Administrator Verma:On behalf of the Global Healthy Living Foundation (GHLF), thank you for the opportunity to comment on the proposed rule: Modernizing Part B and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses (CMS-4180-P). GHLF is a 20-year-old 501(c)(3) patient organization representing chronically ill patients and their caregivers across the country. Wework to improve the quality of life for patients living with chronic disease by making sure their voices are heard and advocating for improved access to care at the community level. Our patients suffer from chronic conditions including arthritis, psoriasis, gastrointestinal disease, cardiovascular disease and migraine. It is on behalf of the patients we represent that we are commenting on theseproposed changesto the Medicare.Step Therapy Leads to Worse Health Outcomes and Increased Long-Term Costs We strongly oppose the proposal to allow step therapy and other forms of utilization management in Part B Medicare Advantage (MA) plans. Step therapy, also known as fail firstpolicies,limit the options available for patients and their physicians to treat conditions, forcing individuals to try the treatment that is preferred by the insurance company (often an older, cheaper medicine) rather than the treatment their physicians feel is the most appropriate optiongiven the patient’s individual medical history and life goals. Medical literature and news media
are rife with data on the negative effects of these policies on patients and caregivers.12Every patient has different needs, and often the treatment that best meets an individual’s clinical circumstances and preferences conflicts with an insurer’s one-size-fits-all step therapy requirement. GHLF is supportive of the Administration’s efforts to reduce drug pricesand submitted public comment in 2018 on that shared goal; however, accomplishing itby hindering patients’ accessto treatment willharm patientsandis unacceptable. For this reason, we are concerned about the proposed changes to thesixprotected classes of drugsas well. GHLF supports the continued existence of these classes, including the immunosuppressant drugs on which many of our patients rely. Current policy requires that Part D plans cover at least two drugs in each protected class to enable adequate access to therapyand we believe thatplans already have enough discretion and flexibility in developingformularies. We urge the Administration to not finalize the proposed policy in the rule or take any actionthat would either eliminatea class altogether or enable plans to no longer provide coverage of these much needed therapieswithin a class.Not only because it will harm patients, but we do not believe it will lead to cost savings as patients unable to access treatment will experience additional morbidity from their disease resulting in increased healthcare costs. Lowering Costs Helps Patients Achieve Greater Health OutcomesWhile we have significant concerns about the provisions mentioned above and their potential to hinder access to treatments, we were pleased to see the inclusion of several changes that will inure to the benefit of patients such as CMS’seffort to end the practice of “product hopping”: Drug manufacturers should not be allowed to change the formula of their drug in order to stifle generic competition. Generic drugs offer a financial lifeline for patients desperate for lower drug costs; when manufactures stifle thegrowth of the generic marketpatients suffer. GHLF would like to see CMS work to end “product hopping” and other loopholes that extendpatents generally in order to ensure that patients with all types of disease are able to benefit from this change.Additionally, we support the expansion of the e-prescribing systems in order to increase price transparencyfor patients. It is difficult for physicians to account for patient pricing when prescribing medication.Rebates between insurers, pharmacy benefit managers, manufacturers, and pharmacies have created a system that often leaves patients in the dark about their medical costs until the they have left their physician’s office. Additionally, it has been shown that the price that a patient pays directly impacts their chance of adhering to their treatment plan. 1Carlton, PharmD, Rashard I., et al. “Review of Outcomes Associated With Formulary Restrictions: Focus on Step Therapy.”PharmacoEconomics & Outcomes News, vol. 683, no. 1, 2013, pp. 9–9., doi:10.1007/s40274-013-0580-6.https://www.ajpb.com/journals/ajpb/2010/vol2_no1/review-of-outcomes-associated-with-formulary-restrictions-focus-on-step-therapy2Park, Yujin, et al. “The Effect of Formulary Restrictions on Patient and Payer Outcomes: A Systematic Literature Review.”Journal of Managed Care & Specialty Pharmacy, vol. 23, no. 8, 2017, pp. 893–901., doi:10.18553/jmcp.2017.23.8.893.
Expandingthe e-prescribing system and increasing transparency of the rebate system will allow physicians and patients todetermine a treatment plan that is not only effective for the patient, but one that they will be more likely to adhere to.GHLF is also encouraged by the proposed changes to point-of-sale price concessions. In previous comments submitted to CMS for the Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program,GHLF expressed our support fora 100% pass through of rebates to patients. While we do understand that a 100% pass through may lead to higher premiums, we believe that the savings that patients will experience from lower copays and deductibles will lead to an overall reduction in out-of-pocket patient costs. While consumers may be drawn to plans that have lower premiums, the lowering ofout-of-pocket costs for medications for chronically ill patients is of paramount concern to lead to both better health outcomes for patients and lower care costs in the long term. In conclusion, GHLF commends the Agency for its continued commitment to lower drug prices, however, westrongly urge you to not finalizethe proposed policies that would disrupt patient accessto their medications.We look forward to working with CMS on this issue and hope you will view GHLF as a resource moving forward. If you have any questions about our comments, please feel free to contact Steven Newmark at [email protected], Steven NewmarkDirector of Policy and General CounselGlobal Healthy Living Foundation