Medication Access and Prior Authorization
HHS Finalizes 2025 Exchange Plan Rules
On April 2, 2024, the Department of Health and Human Services (HHS) issued its 2025 Notice of Benefit and Payment Parameters (NBPP), finalizing changes to Exchange plans established under the Affordable Care Act. The final rule includes that prescription drugs in excess of those covered by a state’s essential health benefits (EHB) benchmark are subject to both the annual limitation on cost sharing and the restriction on annual and lifetime dollar limits. HHS indicates that it is working with the Departments of Labor and Treasury on a proposed rulemaking that would align the standards applicable to large group market health plans and self-insured group health plans with those applicable to individual and small group market plans. HHS also finalized an exception process that would allow issuers to offer additional non-standardized plan options focused on chronic and high-cost conditions. Read more in the comments AAAAI filed with HHS below, and view the side-by-side comparison of the proposed and final rules.
January 29, 2024
On January 17, CMS released its Advancing Interoperability and Improving Prior Authorization Processes final rule, which aims to improve the electronic exchange of health care data and streamline processes related to prior authorization through new requirements for Medicare Advantage organizations, state Medicaid fee-for-service (FFS) programs, state Children’s Health Insurance Program (CHIP) FFS programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan issuers on the Federally-facilitated Exchanges. While the rule does not cover prior authorization for drugs, it still represents important advances that can lead to greater change for public and private payers. In addition, CMS estimates that these policies will result in total cost savings for providers of at least $16 billion over 10 years. Read the document for a comprehensive analysis of the rule by our experts at Hart Health Strategies.
Janaury 4, 2024
Academy Calls for Improved Oversight of Exchange Plans
The Department of Health and Human Services 2025 Notice of Benefit and Payment Parameters (NBPP) proposes changes to plans established by the Affordable Care Act (ACA), commonly referred to as Exchange or Marketplace plans, including proposals impacting network adequacy, provision of essential health benefits, prescription drug coverage, and non-standardized plan options. The AAAAI’s response urges CMS to provide enhanced oversight on non-standardized plan options in the health insurance marketplace, voicing concern that such options might further hinder access to care for those with chronic and high-cost conditions such as asthma and primary immunodeficiency diseases. The AAAAI also urged CMS to protect access to specialty drugs for patients in exchange plans and highlighted emerging challenges with “alternative funding” practices that may diminish access.
December 20, 2023
AAAAI wrote a letter in response to proposed Centers for Medicare and Medicaid Services (CMS) Technical Changes to the Medicare Advantage Program and Medicare Prescription Drug Benefit Program. The AAAAI urges CMS to finalize the proposed changes concerning communication and marketing, establish standards to ensure adequate notice regarding supplemental benefits coverage, and opposes the CMS proposals to remove the discernable distinction between biosimilars and interchangeable biosimilars.
December 14, 2023
The AAAAI wrote to Senators Maria Cantwell (D-WA) and John Grassley (R-IA) in support of their legislation S. 127, the Pharmacy Benefit Manager (PBM) Transparency Act. The measure seeks to increase transparency in the drug supply system by holding PBMs accountable for deceptive practices that lead to increased costs for patients at the pharmacy counter.
October 25, 2023
The AAAAI in coalition with others wrote to the authors of Protecting Patient Access to Cancer and Complex Therapies Act of 2023 to thank them for their leadership in protecting patient access and quality care for Medicare beneficiaries and to urge passage of this legislation.
September 20, 2023
The AAAAI joined 61 organizations to provide feedback to the Centers for Medicare and Medicaid Services (CMS) on its Medicare Prescription Payment Plan (MP3). The letter emphasizes support for CMS’ proposed beneficiary protections, including a payment grace period, reinstatement process for beneficiaries, and appeals process, and asks the agency to finalize these provisions. In August, CMS released guidance on its MP3 and solicited feedback from stakeholders.
August 17, 2023
The AAAAI wrote to sponsors Congressman Michael C. Burgess, M.D. (R-TX) and Congressman Vicente Gonzalez (D-TX) in support of their legislation, the “Getting Over Lengthy Delays in Care As Required by Doctors (GOLD CARD) Act of 2023”. If enacted, the measure would allow physicians who have received high prior authorization approvals to earn a “gold card” and be exempt from certain prior authorization requirements in caring for Medicare beneficiaries.
July 26, 2023
The House Ways and Means Committee markup of H.R. 4822, Health Care Price Transparency Act and H.R. 3284, Providers and Payers COMPETE Act, included extensive discussion of Medicare Advantage, prior authorization, and other major healthcare issues. AAAAI members can read a summary of the hearing provided by our government relations experts at Hart Health Strategies, and an AMA summary of major provisions supported in committee on prior authorization can be read here.
June 29, 2023
The AAAAI expressed support for H.R.3800, authored by Representatives Wenstrup (R-OH) and Blumenauer (D-OR) to provide some employers the flexibility to cover fourteen chronic care management services, including asthma inhalers, before an individual reaches their deductible for high deductible health plans.
The Impact of Prior Authorization in Allergy/Immunology: A Position Statement of the American Academy of Allergy, Asthma & Immunology. (February 2023)
March 13, 2023
Prior Authorization in 2024 Medicare Advantage proposals – AAAAI feedback on program and drug benefit program changes
After widely popular, bipartisan legislation to address prior authorization in Medicare Advantage plans failed in the 117th Congress because of a cost estimate of $16 billion, CMS developed proposed regulations to cut those costs. The proposed regulations were posted for public comment, the AAAAI submitted this letter in response, supporting changes and asking that changes go further to provide access to medications administered in physicians’ offices.
February 13, 2023
AAAAI feedback supports Medicare Advantage changes and updates, calls for CMS to end to step therapy requirements
While proposed changes to the Medicare Advantage, Drug Benefits and other program specifications were generally supported in comments submitted by the AAAAI, our letter called on CMS to stop damaging step therapy requirements. Read the AAAAI letter.
November 29, 2022
The AAAAI wrote to sponsors Senators Marshall and Hassan and Representatives Kelly and O’Halleran in support of their legislation, the “Medicare and You Handbook Improvement Act.” The legislation seeks to improve Medicare beneficiary education by updating materials shared during the open enrollment period for seniors to make more informed decisions on health plan selection. It is a complementary bill to the Seniors’ Timely Access to Care Act, and the AAAAI and others are working to support passage of both bills yet this session.
Prior authorization can be burdensome, unpredictable and time-consuming for physicians, and cause harmful delays in patient access to care. The American Medical Association (AMA) provides information on their campaign to change prior authorization processes here.
The AAAAI invites you to help in our advocacy efforts on prior authorization by sending us your experiences with prior authorization in which patient outcomes were negatively impacted, where physician burden was unnecessarily increased, and/or in your care for your patients was complicated, undermined or delayed. Please send us specifics of the issue with dates, the payer, and the patient’s demographic information included, but personal health information excluded, to advocacy@aaaai.org.
August 17, 2022
AAAAI supports ‘Gold Card’ bill in Congress
The AAAAI sent a letter to sponsors of a bill in Congress to allow physicians who have received at least 90% of prior authorization approvals in the preceding year to be exempt from certain prior authorization requirements for Medicare beneficiaries. The AAAAI continues to advocate for this and other reform efforts to reduce physician burden and unnecessary harm and delays to patient care.
June 21, 2022
The AAAAI with others wrote to U.S. Senate and House leadership to urge their support for additional COVID-19 relief funding that prioritizes therapeutic purchasing and research for new therapeutics for the care of millions of Americans with impaired immune systems. Read the letter.
May 25, 2022
AAAAI cites prescription access barriers causing patient harm in comments to FTC
AAAAI submitted feedback in response to a solicitation for comments by the Federal Trade Commission (FTC), which is considering whether to conduct a comprehensive study of the pharmacy benefit manager (PBM) industry. The FTC requested information about the business practices of the PBM industry and, specifically, the impact of those business practices on patients. We provided several real-world examples from our members of patients who experienced harmful delays and outright denials of medically necessary and appropriate care due to utilization management protocols. Over 24,000 comments were filed with the FTC, many of which expressed similar concerns, so we hope that our patients’ stories will help make the case to the FTC that a comprehensive study of the PBM industry is needed. Once completed, such a study could serve as the basis for legislative and regulatory reforms to reduce patient harm and reduce physician burden.
May 19, 2022
The Improving Seniors Timely Access to Care Act (H.R. 3173) surpassed 290 cosponsors in the House of Representatives. This gives the bill’s sponsors the option to file a motion to add the bill to the House Consensus Calendar—bypassing the committee process and moving it to the House floor for a vote after 25 legislative days. The legislation, endorsed by the AAAAI, seeks to reform and streamline the prior authorization process for Medicare Advantage plans. The Senate companion bill (S. 3018) has 28 bipartisan cosponsors. Earlier today, the AAAAI contacted all Senators who have not yet signed on as cosponsors to ask them to do, sharing our letter endorsing the legislation. Read our earlier letter to House sponsors here.
Follow Prescription Drug Access developments in State Legislatures and in Congress
Review a summary of state and federal legislation specific to existing and pending step therapy, non-medical switching, accumulator adjustment program, and uniform prior authorization laws here (provided by the Coalition of State Rheumatology Organizations (CSRO) and maintained by Hart Health Strategies, expert government relations consultants to both the AAAAI and CSRO).
The AAAAI Advocacy Committee works with a drug policy specialist on the Hart Health team to help guide our advocacy and outreach efforts. Questions or concerns? Please contact advocacy@aaaai.org.