Inside this EditionHealthsperien Releases Summary on 2024 Medicare Advantage and Part D Proposed Rule | FDA Rejects Eli Lilly’s Request for Accelerated Approval for Alzheimer’s Drug | SAMHSA Releases Guide on Behavioral Health Services for People Experiencing Homelessness | Executive Action | Congressional Action | Medicare | Research
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Healthsperien Releases Summary on 2024 Medicare Advantage and Part D Proposed Rule
Last month, CMS released their annual Medicare Advantage (MA) and Part D Proposed Rule for 2024 (fact sheet) which governs requirements for MA and Part D plans. Healthsperien developed a comprehensive section-by-section summary of the rule, covering a wide range of critical topics, including changes to utilization management, Star Ratings, plan marketing, behavioral health, and the Medication Therapy Management program. The rule also proposes several changes to better incorporate health equity into Medicare plan requirements. Healthsperien’s summary can be used as a resource to inform comment development on the rule, with responses due to CMS by February 13th.
FDA Rejects Eli Lilly’s Request for Accelerated Approval for Alzheimer’s Drug
Yesterday, Eli Lilly announced that the Food and Drug Administration (FDA) rejected their application seeking accelerated approval of their drug, donanemab, a treatment for individuals with early-stage Alzheimer’s disease. Lilly filed for accelerated approval based on a mid-stage study that showed donanemab lowered levels of amyloid, a toxic protein in the brain that is believed to drive the advancement of Alzheimer’s. The FDA stated Lilly’s data did not include enough patients who had taken the medication for at least a year and requested that they provide safety data on at least 100 patients who received donanemab for a minimum of one year.
Lilly noted that its mid-stage study enrolled more than 100 patients, but rapid amyloid plaque reduction allowed many of them to stop taking donanemab as early as six months after treatment, resulting in fewer than 100 patients having one year’s worth of drug exposure/safety follow-up. Lilly highlighted that they plan to collect the safety data requested by the FDA to complete their Phase 3 study, which will be read out in the middle of this year.
SAMHSA Releases Guide on Behavioral Health Services for People Experiencing Homelessness
This month, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a resource guide aimed at expanding access to behavioral health services for people experiencing homelessness. This guide highlights strategies for behavioral health and housing providers to conduct outreach and engage with individuals experiencing homelessness, initiate the use of behavioral health treatment as they wait to receive stable housing, and retain them in their recovery efforts once housed.
Studies show higher rates of physical health issues, mental health and/or substance use disorders among populations experiencing homelessness than people who are stably housed. To help mitigate these factors, the guide focuses on five programs and practices that have shown success in improving mental health and substance use outcomes during homelessness, which include medications for opioid use disorder (MOUD), motivation interviewing (MI), intensive case management, Community Reinforcement approach (CRA), and peer support.
An overview of the resource guide can be found here.
- On January 17, the White House Initiative on Asian Americans, Native Hawaiians, and Pacific Islanders (WHIAANHPI) convened federal government officials and community leaders to release the Biden-Harris Administration’s National Strategy to Advance Equity, Justice, and Opportunity for Asian American, Native Hawaiian, and Pacific Islander (AA and NHPI) Communities. Per Executive Order 14031, HHS has identified five high-priority goals that will span the next two years: 1) enhancing the availability, quality, collection, and use of disaggregated data on AA and NHPI populations 2) increasing language access across HHS programs for AA and NHPI communities 3) raising awareness of hate crimes and hate incidents and address anti-Asian and NHPI discrimination 4) combatting human trafficking of AA and NHPI populations 5) strengthening AA and NHPI health research.
- Recently, Senator Mark Warner (D-VA), Senate Cybersecurity Caucus co-founder, shared he is aiming to introduce health care cybersecurity legislation during the first quarter of 2023 which may set minimum standards for health care organizations to protect patient data. He noted the need for strong leadership by the Department of Health and Human Services (HHS) and potential for enforcement through Medicare or Medicaid payments. Warner is exploring partnerships with other Committee leaders, including Senate HELP and Homeland Security and Governmental Affairs, to advance the effort. Late last year, Warner produced a congressional report that found poor cybersecurity in the health care sector threatens patients’ lives. The report comes at a time of widespread data breaches affecting health care organizations, which affected nearly 50 million people in 2021.
- On January 19, the House Committee on Energy & Commerce Ranking Member Frank Pallone (D-NJ) sent a letter to the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) to express concern about medical product sponsors’ compliance with ClinicalTrials.gov reporting requirements. The law requires that clinical trial sponsors report certain results to ClinicalTrials.gov to provide safety and efficacy information and expand the knowledge base. The letter states that the FDA, which oversees large clinical trials, and the NIH, which oversees publicly funded clinical trials, have conducted limited enforcement activities for failure to comply with these requirements. The committee asks that the FDA and NIH provide information on the compliance and enforcement actions taken by the agencies by February 17.
- On Tuesday, Centers for Medicare and Medicaid Services (CMS) announced that three innovative accountable care initiatives—the Medicare Shared Savings Program (MSSP), the Accountable Care Organization Realizing Equity, Access, and Community Health (ACO REACH) Model, and the Kidney Care Choices (KCC) Model—will grow and provide higher quality care to more than 13.2 million Medicare beneficiaries in 2023. The MSSP leads all programs with 10.9 million assigned beneficiaries, ACO REACH has an estimated 2.1 million beneficiaries, and KCC has approximately 250,000. More than 700,000 health care providers will participate in at least one of the three initiatives listed by CMS. This participation growth furthers CMS’ goal of having all people with Traditional Medicare in an accountable care relationship with their health care provider by 2030.
- This past Wednesday, CMS announced that it is taking several actions to improve the quality of care provided in nursing homes, in alignment with the Biden Administration’s nursing home safety and quality of care action plan. First, CMS will begin auditing nursing homes to ensure that residents are being appropriately diagnosed with schizophrenia and treated with antipsychotics. They note that antipsychotic medications can have potentially dangerous side effects, including death, for the populations served in nursing homes. CMS will also downgrade Five-Star Quality Measure Ratings for facilities that have a pattern of inaccurately coding individuals with schizophrenia. Finally, survey deficiencies that are disputed by the facility will begin to be displayed on the Care Compare website on January 25, 2023.
- On January 3, the Department of Health and Human Services Office of the Inspector General (HHS OIG) issued two reports on Medicare Part B drugs, recommending CMS to improve its oversight of Medicare Part B drugs’ average sales prices (ASPs). CMS uses ASP to calculate payment amounts for the program; inaccurate ASPs can increase costs or lead to issues in drug access. In the first report, HHS OIG found that audits have struggled to define noncompliance because of broad CMS regulations and recommended that CMS review ASP-related guidance to determine whether manufacturers need additional guidance. In the second report, HHS OIG recommended that CMS increase its oversight of manufacturer-reported data because current gaps limit CMS’ ability to ensure accurate ASPs. CMS agreed with the recommendations in the reports.
- Recently, the Institute for Clinical and Economic Review (ICER) published its second annual “Barriers to Fair Access” report on prescription drug coverage policies. Of the payers it assessed in 2022, the analysis found that most had policies that supported fair access to drugs on criteria such as cost sharing, clinical eligibility, step therapy, and provider restrictions. However, ICER recommended improvements in the transparency of coverage policy information for consumers and for prior authorization processes. The ICER applied criteria to 19 drugs and looked at coverage policies from 18 formularies and 15 commercial insurers. Over the course of the assessment, five payers revised policies for 11 drugs that brought the coverage into alignment with the fair access criteria.
- A recent Gallup poll showed the percentage of Americans who report delaying medical treatment in 2022 due to cost rose 12 percentage points, to 38%. Every year since 2001, Gallup has tracked Americans’ self-reports of delaying medical care in the past 12 months due to cost, with the most recent year being the highest and sharpest year-to-year increase to date. This shift occurred during the highest inflation rate in the United States in more than 40 years and follows two years of the COVID-19 pandemic, which resulted in reports of 26% of Americans delaying medical care due to cost. According to the 2022 report, lower-income adults, young adults, and women are more likely to report delaying care. In addition, 27% of respondents say the medical treatment they delayed was for a very or somewhat serious condition. The perceived seriousness of forgone treatment in 2022 is the second largest to a 17-point gap in 2019.
- A study published on Wednesday found that two years after starting gender-affirming hormone therapy, transgender and nonbinary youth had improved life satisfaction and decreased anxiety and depression symptoms. This study joins a small but growing body of research showing that gender-affirming care improves mental health in transgender and nonbinary populations. The American Medical Association and many other national medical associations or societies have publicly recognized that gender-affirming care is appropriate and medically necessary for these youth and teens.