AARDA Advocates for Policies Important to People Living with Autoimmune Disease and Their Families
The American Autoimmune Related Diseases Association is actively promoting proposals to protect and improve key policies in the federal and state arenas that are critical to the health and well-being of people living with autoimmune disease and their families. AARDA supports an array of stakeholders that collectively deliver care and innovate for new and more effective treatments.
Autoimmune patients welcome the Administration’s decision to delay implementation of the Medicaid best price rule that would jeopardize critically important copay assistance programs. The two-year delay highlights the flawed nature of this harmful policy. While the action is a step in the right direction, AARDA remains deeply concerned that the proposed change could eventually be implemented. Instead, this provision should be withdrawn.
In a survey earlier this year, AARDA found that 92 percent or more of autoimmune patients report that copay assistance helps them afford medicines and take them as prescribed. Reducing copay assistance programs potentially threatens patient health and well-being by unfairly shifting the burden of cost away from insurers and PBMs and onto patients, who are often struggling to manage costs of care.
Earlier this year, AARDA strongly opposed an equally harmful policy that will permit insurers and PBMs to exclude the value of copay program cost-sharing assistance when calculating a patient’s deductibles and out-of-pocket maximum requirements. Unlike the rule that was just delayed, this rule governing insurance practices could affect patients in the New Year, and a follow-along proposed rulemaking for 2022 further calls into question support for copay assistance support to patients longer-term. Collectively, the Administration’s delayed rule, and those slated for immediate implementation by insurers and in 2022, represent a threat to the ability of patients to access their medicines and take them as prescribed, even as they and their families struggle with negative implications of the COVID-19 pandemic.
AARDA continues to advocate for patients’ access to care, and we urge policymakers and regulators do the same. Patients deserve better. AARDA strongly encourages the new Administration and the new Congress to support copay assistance and put patients’ health and wellness first.
AARDA in Action
AARDA sent a letter to key members of Congress with the undersigned 50+ patient groups on the importance of drug pricing policy concerns, priorities, and solutions for individuals living with autoimmune disease.
Biosimilars play a vital role in treating patients with complex and costly conditions. However, AARDA remains concerned by the increased role Cigna and other health insurance companies are taking to interfere in the patient-clinician treatment decision by attempting to bribe patients to switch from one medicine to another.
In a letter to Health Affairs in May, AARDA was featured with 10 other patient groups voicing concerns about the use of discriminatory measures that deny individuals with disabilities equal opportunity to receive care. The letter urged the Biden administration to prevent the use of quality-adjusted life year (QALY) in policymaking and to address discrimination head-on by adopting the recommendations from the National Council on Disability.
AARDA sent a letter in May to the Oregon legislature expressing serious concerns for a bill (SB 844) that would set an Upper Payment Limit (UPL) on prescription drug reimbursement. AARDA is concerned that the bill would not only limit life-saving treatment to autoimmune patients but could harm providers by limiting reimbursement and forcing the closure of community clinics.
Over 70 patient groups signed on to AARDA led letter to Cigna expressing concerns regarding Cigna’s letters to patients encouraging them to switch from Cosentyx to a preferred drug with a $500 debit card. Specifically, AARDA and the undersigned groups were concerned that this non-medical advice paired with a financial incentive with the express purpose of moving a stable patient to a different drug undermined the shared decision-making between the patient and prescriber.
AARDA lead a sign-on letter with the HIV+Hepatitis Policy Institute addressed to HHS Secretary Becerra on policies to improve prescription drug affordability for patients. 124 patient groups signed-on to policies that included enforcing ACA non-discrimination provisions, cost-sharing caps, requiring insurers to offer first dollar coverage of prescriptions, counting copay assistance toward out-of-pocket maximums, and addressing roles of rebates with pharmacy benefit managers.
AARDA was active in Louisiana to support individuals with rare autoimmune diseases by signing on to a letter of support for HB460, a bill that would create a Rare Disease Advisory Council and prioritize the many living with a rare disease in Louisiana.
ARDA continued its calls to increase federal investment in autoimmune disease research by signing on to the Friends of NIEH FY22 Appropriations Letter. The letter requests $875 million for the NIEHS in FY22 that would go to increasing research in prevention of human illness and disability by understanding how environmental illnesses influence development of diseases including autoimmune disease.
AARDA Endorses Michigan Legislation to Protect Patient Copay Assistance
AARDA on March 3rd endorsed HB4353, a bill in Michigan that would ensure patients and families that rely on copay assistance programs from manufacturers and other organizations continue to receive this assistance. As new “accumulator adjuster programs” sweep across the states attempting to bar copay assistance from counting toward patients’ out-of-pocket costs, AARDA continues to work to protect this assistance.
AARDA Signs on to Letter to South Dakota Delegation Opposing Part D Changes to Six Protected Classes
In a sign on letter to South Dakota’s Congressional delegation on March 1, AARDA asked for the members to oppose the recent changes to Medicare Part D that would have a significant impact on Medicare beneficiaries due to the limit of access to medications within the Six Protected Classes. The demonstration would dismantle important patient protections that many autoimmune patients rely on to live a healthy life and access life-saving medications.
- AARDA Sends Letter of Support to Protect Patient Copay Assistance in Tennessee
AARDA on February 26 sent a letter of support for SB1397, a bill in Tennessee that would ensure that patients and families whom rely on copay assistance programs from manufacturers and other organizations continue to receive this assistance. As new “accumulator adjuster programs” sweep across the states attempting to bar copay assistance from counting toward patients’ out-of-pocket costs, AARDA continues to work to protect this assistance.
- AARDA Signs on to Partnership for Part D Access Letter Opposing Part D Changes to Six Protected Classes
In a sign on letter to HHS with the Partnership for Part D Access, AARDA asked the administration on February 25 to eliminate the policy proposal to allow for flexibilities under Part D plans that participate in its Part D Payment Modernization Model as plans could limit the drugs they cover including medications used to manage complex conditions, including autoimmune disease and other serious illnesses.
- AARDA Signs on to Letter to NIH with Long COVID Coalition Sharing Recommendations for the PASC Initiative
In a letter to NIH February 25 signed on to by AARDA, the Long COVID Coalition recommended that the agency should prioritize the research of those with lingering symptoms, also known as “post-acute sequelae of SARS-CoV-2 infection (PASC)”. The recommendations highlight the needs of individuals living with chronic conditions, including autoimmune disease, and the disproportionate impact this illness has on the lives of those living with the disease. Other recommendations include prioritizing patient engagement, expanded clinical trials, and to diversify those studied in control groups.
- AARDA Signs on to MAPRx Letter Opposing Changes to Medicare Part D
AARDA signed on to a letter February 15 with MAPRx asking HHS to rescind the CMS Part D Payment Modernization Model for plan year 2022 that was announced under the prior administration. These changes allow for flexibilities that could limit drug coverage for those with autoimmune disease and other serious illnesses.
- AARDA Endorses South Dakota Bill Protecting Patient Copay Assistance
AARDA endorsed on February 3rd SB 154, a bill in South Dakota that would protect patient copay assistance by allowing cost-sharing assistance, including copay coupons from manufacturers to count toward a patient’s deductible and out-of-pocket limits. At a time when health insurers and pharmacy benefit managers are adopting practices to keep these programs from counting toward a patient’s deductible, AARDA is proud to endorse legislation to help patients with autoimmune and other related illnesses be able to afford their life-saving medicines.
- AARDA Sends Letter of Support to Nebraska, Arizona, and Arkansas Legislature on Legislation To Protect Patients
AARDA to the Nebraska, Arizona, and Arkansas legislatures for bills that would provide patient protections by requiring step therapy policies in the state to be based on current evidence and for medical reasons only.
- AARDA Endorses Safe Step Act of 2021 with Safe Step Act Coalition
AARDA endorsed the Safe Step Act of 2021, bill that would amend the Employee Retirement Income Security Act (ERISA) to require a group health plan provide an exception process for any medication step therapy protocol. AARDA joined the Safe Step Act Coalition in this sign-on letter.
- AARDA Sends Letter of Support to Nebraska Legislature on Legislation To Protect Patients By Requiring Step Therapy Policies Be Based on Medical Reasons
AARDA sent a letter of support to the Nebraska Legislature on January 29 for LB 337, a bill that would provide patient protections by requiring step therapy policies in the state to be based on current evidence and for medical reasons only.
- AARDA Issues Statement on HHS Decision to Delay Implementation of Rebate Rule
AARDA issued a statement on January 29 urging the Biden Administration to act promptly and without further delay on the HHS rule implementing the final rebate rule that would direct PBM savings to patients. “Many don’t have the luxury of waiting to get access to the treatments they rely upon. Delaying implementation would have significant negative implications on patients.”
- AARDA Signs On to ACS CAN-Partners Letter to HHS Regarding CMMI Part D Payment Modernization Models and the Six Protected Classes Flexibilities
AARDA signed on to a letter on January 28 submitted by ACS CAN Partners commenting on the six protected classes flexibilities in the Centers for Medicaid & Medicaid Innovation (CMMI) Part D Payment Modernization Model for 2022. The two new options allow for Part D plan sponsors to limit drug coverage to at least one drug per class, potentially jeopardizing beneficiary access to medically necessary prescription drugs and harming patients with serious illness.
- AARDA Signs Letter Voicing Concerns on Washington Price Controls Bill Incorporating ICER Value Assessment
AARDA signed on to a letter on January 26 voicing concerns regarding SB 5020, a bill that proposed lowering costs by allowing ICER to make value judgements about patients’ quality of life. AARDA has been vocal regarding ICER’s use of QALY measurements in their value assessments due to these practices being discriminatory against older individuals or those with chronic diseases and disabilities.
- AARDA Sends Letter to UnitedHealthcare Regarding Remicade Coverage
AARDA sent a letter on January 25 to UnitedHealthcare regarding a mid-year change in coverage for Remicade. Abruptly changing Remicade from a preferred to non-preferred medicine in coverage mid-year could be disruptive to stable patients and their care. This action by the plan, and not the patient’s prescriber, is an example of a nonmedical switch. AARDA’s objection to this action is independent of the medication, and believes it to be inconsistent with the principles laid out by Let My Doctors Decide, a campaign endorsed by AARDA and many other organizations representing patient groups.
- AARDA Submits Letter to CMS on Most Favored Nation Model Interim Final Rule
AARDA submitted a letter on January 26 commenting on the Most Favored Nation (MFN) Interim Final Rule with Comment Period (IFC) issued by the Centers for Medicare and Medicaid Services (CMS). AARDA expressed graves concerns regarding the IFC from both a legal and public policy perspective and urged the agency to rescind the IFC. For millions of patients who rely on prescription medications covered under Medicare Part B, this “model” under the IFC, could restrict patients’ access to treatments that manage their conditions, forcing them to either forego therapy or to seek treatments in more expensive and potentially less safe provider settings. This issue, along with procedural, legal, ethical, and other substantive policy concerns force AARDA to request the IFC to be withdrawn.
- AARDA Signs on to ACCC Letter on NBPP 2022
AARDA signed on to the All Copays Count Coalition’s Sign-On Letter regarding the HHS Notice of Benefit and Payment Parameters (NBPP) 2022 Proposed Rule. Specifically, the letter addresses the issue of accumulator adjustment programs in the 2022 NBPP language and asks for a return to the 2020 NBPP Proposed Rule language that would have prohibited payers from excluding copay assistance from counting toward a patient’s cost-sharing
- Championed letter with 153 other national, state, and local organizations urging the HHS Office of Inspector General to expand access to copay assistance to Medicare Part D beneficiaries.
- Letter to USPS with leading health care organizations to raise concerns about USPS performance problems that are having a negative effect on people with autoimmune disease, serious illness, and chronic conditions.
- Campaign to encourage CMS to drop a provision in a Medicaid Pricing Rule that would apply unworkable requirements on drug manufacturers that could undermine copay coupon assistance programs that help patients access and afford their medicines and care, increasing the financial burden to patients during in the challenging environment created by the COVID-19 pandemic
- Signed onto patient group letter encouraging Florida state legislators to guard against high patient cost-sharing for prescription medicines by opposing insurance plan use of accumulators
- Joined patient advocates on a letter to Ohio state legislators requesting action to protect patients from a practice being implemented by various health insurance plans, pharmacy benefit managers, and employers
- Lead sign-on letter with IDF and LFA urging Congressional leadership, as part of the next Coronavirus (COVID-19) legislation, to task the CDC with working with stakeholders to develop a recommendation to ensure the needs of immunocompromised Americans are adequately addressed
- Signed letter in support of the Part B Access to Seniors and Physicians (ASP) Coalition’s mission to preserve patient access to Medicare Part B covered services, including restoration of full access restore unfettered access to Medicare Part B covered drugs for beneficiaries enrolled in Medicare Advantage (MA) plans
- Letter to CMS to encourage you to make the development and availability of treatments for pain – and particularly non-addictive options – a high priority within your agencies
- Joined PIPC on a letter urging ICER to pause any future development of assessments related to COVID-19 and focus on partnering with stakeholders in the development of rigorous and patient-centered methodologies
- Signed onto letter organized by the Aimed Alliance to Congress in support of legislation that would prohibit the use of prior authorization and step therapy during the public health crisis. Comparable to prior letter sent to governors, state legislators, and CMS
- Letter to CMS on the recent interim final rule related to the COVID-19 public health emergency comment period titled Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID–19 Public Health Emergency (IFC), issued by the Centers for Medicare and Medicaid Services
- Joined patient groups advocating to Expand Access to Part B Therapies in a letter calling on CMS calling to allow more flexibility for patients to receive in-home infusions and injections of therapies and treatments
- Signed onto patient group letter encouraging New York state legislators to guard against high patient cost-sharing for prescription medicines by opposing insurance plan use of accumulators
- Joined letter spearheaded by NORM Tennessee opposing TN Blue Cross Blue Shield decision to deny coverage of a new rare disease breakthrough treatment of Thyroid Eye Disease in favor of steroids, which are not approved by the FDA for this purpose
- Letter to HHS urging that the Department’s Office for Civil Rights issue additional guidance to ensure that schemes to ration scarce health care resources during the COVID-19 pandemic comply with federal nondiscrimination laws, with some 400 organizations in conjunction with the Partnership to Improve Patient Care (PIPC)
- Letter to Congress urging expansion of eligibility for the paid family and medical leave program to include individuals determined by the Centers for Disease Control and Prevention (CDC) to be at high risk for adverse complications from COVID-19 and working members of their households, with the Cystic Fibrosis Foundation
- AARDA/NCAPG letter to Senate urging to weigh-in with CMS to assure that patients covered by Medicare Part B are able to access their infusion and injection treatments at home
- Letter to House Appropriations leaders to request continued support for the critical and highly successful defense health research programs funded through the Congressionally Directed Medical Research Programs (CDMRP)
- AARDA comments to CMS on NBPP proposal to undermine copay assistance coupon programs offered by drug manufacturers on behalf of the National Coalition of Autoimmune Patient Groups, and also with the All Copays Count and I Am Essential coalitions
- Comments to CMS regarding proposed rule on Contract Year 2021 and 2022 affecting Medicare Part D beneficiaries, urging reconsideration of a preferred specialty tier, enhancement of real-time benefit tools, and maximum out-of-pocket caps, smoothing mechanisms, and a fix to the out-of-pocket “cliff,” with the MAPRx Coalition
- Letter to Congress promoting passage of the Safe Step Act (HR 2279/S 2546), as part of the Safe Step Act Coalition
- Letters to Governors, State Medicaid Directors, Insurance Commissioners, and Executive Directors of Boards of pharmacy urging that they act to protect rare disease patients and high-risk populations during the COVID-19 crisis, with the Every Life Foundation
- Letter coordinated by the Arthritis Foundation to House leadership supporting an appropriation for osteoarthritis research at the US Department of Defense Congressionally-Directed Medical Research Program, one of many communications to congress supporting funding of general and disease-specific autoimmune research projects at DoD
- AARDA/NCAPG letter to all Senate and House Members to request that any consideration or efforts to use reference international drug prices in setting prices for medicines in American health care be rejected, and also with PIPC and ASP Coalition
- Outreach to Congress in support of “Strengthening Innovation in Medicare and Medicaid Act” and other steps to improve and protect the CMS CMMI with the Healthcare Leadership Council
- Letter to the Food and Drug Administration to oppose any proposed linkage between the Institute for Clinical and Economic Review (ICER) and FDA with the Partnership to Fight Chronic Disease
- Letter to Oklahoma legislators opposing legislation to allow drug importation, coordinated by the National Grange; one of a series of communications with state legislatures on this topic, including Oregon, Maine, and New York
- Letter to House Committee Leadership in support of the “Seniors Prescription Drug Relief Act of 2019,” (S.2911) to provide a much-needed “smoothing” mechanism for Medicare beneficiaries to spread payment for Part D out-of-pocket costs across the calendar year, with MAPRx Coalition
- Letter to Congress urging action to reverse an increase in Medicare Part D out-of-pocket (OOP) costs that will occur in 2020, with MAPRx Coalition
- AARDA at Open Public Hearing to encourage the FDA Dermatologic and Ophthalmic Drugs Advisory Committee to support expedited and favorable consideration of a breakthrough drug for the treatment of Thyroid Eye Disease; TEPEZZA approved for march market launch.
- Comments to CMS opposing advanced rulemaking that would apply international reference pricing and other restrictions affecting Medicare Part B beneficiaries with the Part B Access for Seniors and Physicians (ASP) Coalition and Partnership to Improve Patient Care (PIPC)