Inside this EditionHealthsperien Coverage of Senate HELP Hearing on Insulin and PBMs | CMS Releases FAQ Sheet on the Expiring Continuous Enrollment Condition | FDA Approves First Drug to Treat Agitation Symptoms Associated with Alzheimer’s Disease | Executive Action | Regulatory Action | Congressional Action | Medicare | Medicaid | Research
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Healthsperien Coverage of Senate HELP Hearing on Insulin and PBMs
On Wednesday, the Senate Committee on Health, Education, Labor, & Pensions (HELP) held a legislative hearing titled “The Need to Make Insulin Affordable for All Americans.” Leading pharmacy benefit managers (PBMs) and drug companies were present as witnesses during this hearing, including Eli Lily and Company, Novo Nordisk, Sanofi, CVS Health, Express Scripts, and OptumRx.
Additionally, yesterday, the Senate Committee on HELP held a continuation of last week’s session to advance four bipartisan bills that would increase access to generic drugs and rein in PBMs as part of an overall effort to lower health care costs. The session featured discussions on S. 1067, The Ensuring Timely Access to Generics Act of 2023, S. 1114, The Expanding Access to Low-Cost Generics Act of 2023, S. 1214, The RARE Act, and S.1339, The Pharmacy Benefit Manager Reform Act and concluded with a vote to advance the four pieces of legislation forward.
Healthsperien covered both hearings and full notes can be accessed here (Wednesday hearing) and here (Thursday hearing).
CMS Releases FAQ Sheet on the Expiring Continuous Enrollment Condition
Today, the Centers for Medicare & Medicaid Services (CMS) released a frequently asked questions (FAQ) document regarding the March 31st expiration of the Medicaid Continuous Enrollment Condition. Key topics addressed in the FAQs include questions relating to the Consolidated Appropriations Act 2023 (CAA, 2023) returned mail condition for states claiming the increased Federal Medical Assistance Percentage (FMAP) available under the Families First Coronavirus Response Act (FFCRA), reestablishment of premiums in Medicaid and CHIP, renewal requirements for individuals who receive Social Security Income, and Medicaid and CHIP agency capacity to share beneficiary data with enrolled providers to support renewals. The FAQs also address questions regarding eligibility changes to the former foster care children (FFCC) group made by the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act.
FDA Approves First Drug to Treat Agitation Symptoms Associated with Alzheimer’s Disease
Yesterday, the U.S. Food and Drug Administration (FDA) announced the supplemental approval of Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s disease. Rexulti is a drug used to treat schizophrenia, major depressive disorder and psychosis, however, this is the first FDA-approved treatment option for agitation associated with dementia. Agitation is considered to be among the most persistent, complex, stressful and costly aspects of care among patients with behavioral and psychological symptoms of dementia. The effectiveness of Rexulti for the treatment of agitation was determined through two 12-week, randomized, double-blind, placebo-controlled, fixed-dose studies, among participants between the ages of 51 and 90 who had a probable diagnosis of Alzheimer’s dementia, a score between 5 to 22 on the Mini-Mental State Examination, and exhibited the type, frequency, and severity of agitation behaviors that require medication.
- Last Friday, Department of Health and Human Services (HHS) Secretary Xavier Becerra announced new initiatives by the Biden-Harris Administration to increase access to mental health resources and support at the HHS Mental Health Summit. The two initiatives – FindSupport.gov and HHS Children and Youth Resilience Challenge, will increase access to health resources and support for those working to address mental health challenges. The launch of FindSupport.gov will help Americans identify available resources, explore information about various treatment options, and learn how to reach out to get the support they need for issues related to mental health, drugs, or alcohol. The HHS Children and Youth Resilience Challenge will provide $1 million in funding for innovative community-led solutions to promote resilience in children and adolescents affected by the COVID-19 pandemic and other disasters and promote positive strategies to help children and adolescents thrive.
- Recently, the Drug Enforcement Administration (DEA), in conjunction with the Substance Abuse and Mental Health Services Administration (SAMHSA), announced the temporary extension of Public Health Emergency (PHE) flexibilities allowing telehealth prescribing of controlled substances when a provider has never conducted an in-person medical evaluation of the patient. The temporary extension grants the agencies more time to tailor the final telehealth-controlled substances rules by providing a six-month extension and one-year grace period of PHE-era prescribing flexibilities. The extension came two days before those flexibilities were scheduled to end with the PHE’s conclusion on Thursday, May 11, and after the agencies received a record-breaking 38,000 comments on the proposed rule to require in-person visits for controlled substances.
- On Tuesday, the U.S. Preventive Services Task Force (USPSTF), a panel of experts that issues guidelines about preventive care, published a draft recommendation that all women get screened for breast cancer every other year starting at age 40 (consumer guide). The Task Force’s review of screening strategies indicated the change could increase the survival rate by almost 20 percent. Overall, the USPSTF report that biennial screening starting at age 40 and continuing until age 74 will avert 1.3 additional breast cancer deaths per 1,000 women, compared with screening that stats at age 50. The Task Force is urgently calling for more research on whether additional screening with breast ultrasounds or MRIs for women with dense breasts are beneficial, and the benefits and harms of screening for those older than age 75.
- Recently, two expert advisory committees at the U.S. Food and Drug Administration (FDA) voted unanimously to recommend the agency approve the first birth control pill for over-the-counter (OTC) use. The drug under consideration, Opill, is a progestin-only birth control pill manufactured by HRA Pharma and was originally approved for prescription use by the FDA in 1973. While the FDA often follows the recommendation of its advisory committees, they are not binding. A briefing document published ahead of the advisory committee meetings contained concerns from the FDA’s scientists about the additional data provided by the manufacturer and the potential for patient misuse of the medication. The FDA is expected to decide whether to approve the pill for OTC use later this summer.
- On Thursday, the Food and Drug Administration (FDA) issued a Guidance for Industry in preparation to loosen restrictions on blood donation by men who have sex with men. This guidance will update risk-based individual questionnaires to help reduce the risk of transfusion-transmitted HIV. Currently, men who have sex with men must abstain from sex for three months before giving blood. The new policy still limits people who have certain risk factors, such as history of non-prescription injection drug use, those who have exchanged sex for money or drugs, or those who previously tested HIV-positive from donating. The FDA said it “strongly believes” the new policy will not hurt the safety or availability of the nation’s blood supply.
- The U.S. Senate Health, Education, Labor, and Pensions (HELP) Commttee held a legislative hearing titled, “The Need to Make Insulin Affordable for All Americans.” Chairman Sanders (I-VT) provided opening remarks in which he detailed real-world examples of patients who have passed away due to the inability to afford increasing insulin prices over the past several decades to cultivate a sense of urgency in drug companies and Pharmacy Benefits Managers (PBMs) to help fix this problem. Ranking Member Cassidy (R-LA) and Senator Braun (R-IN) added to Sanders’ remarks by explaining that the U.S. needs to expedite efforts in finding common ground on lowering costs and improving patient access to insulin. Many leaders of PBMs and drug companies were present as witnesses during the hearing, including Eli Lily and Company, Novo Nordisk, Sanofi, CVS Health, Express Scripts, and OptumRx.
- The U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee advanced four new bills as part of a legislative package to boost generic drug competition and rein in pharmacy benefit managers (PBMs). This week’s session continued last week’s attempted markup and featured a handful of bipartisan amendments. However, prior to the hearing, Chairman Sanders (I-VT) and Ranking Member Cassidy (R-LA) agreed to table amendments they believed to be “fatal to the bipartisan adoption of this package in committee or on the floor.” Chairman Sanders also expressed that all amendments must have a Congressional Budget Office score and technical assistance from relevant agencies to be considered during the markup. The Committee passed the following: 1) S.1067, Ensuring Timely Access to Generics Act of 2023; 2) S.1114, Expanding Access to Low-Cost Generics Act of 2023; 3) S.1214, the RARE Act; and 4) S.1339, the Pharmacy Benefit Manager Reform Act.
- A new report from Argentum details how assisted living is the most cost-effective model for the U.S. health care system and could save Medicare and Medicaid billions of dollars in light of the number of seniors in need of long-term supports and services increases drastically with the aging of the baby boomer population. Assisted living providers have asked policymakers to increase Medicaid reimbursement for the program and expand waivers to complement efforts by the American Health Care Association (AHCA) and National Center for Assisted Living (NCAL). The report states that assisted living saves Medicaid around $43 billion annually, while reduced hospitalization and social isolation rates in assisted living communities save Medicare $15.4 billion annually. In addition, a recently published white paper released by NCAL describes the extensive waitlists for home and community-based services that drive the need for expanding assisted living programs, thereby increasing Medicaid and Medicare savings.
- The Centers for Medicare and Medicaid (CMS) released an informational bulletin regarding the end of the COVID-19 National Emergency on April 10, 2023, and the expected expiration of the COVID-19 Public Health Emergency (PHE) on May 11, 2023. In the bulletin, CMS outlines the expiration date of various Medicaid and Children’s Health Insurance Program (CHIP) flexibilities in relation to the end of these declared emergencies. Of note, the bulletin clarifies that telehealth flexibilities under Medicaid and CHIP are not tied to the COVID-19 PHE, and that these flexibilities continue to be available after the PHE ends based on the decisions of individual state Medicaid agencies.
- On Thursday, Health Affairs released an article outlining the progress made by the Centers for Medicare and Medicaid Services Innovation Center (CMMI) toward its 2022 Health Equity Initiative and described their additional focus areas for the future of health equity. The CMS Innovation Center proposed four core goals and made progress under each goal within the past year; the four goals include: 1) Developing new models and revising existing models to promote and incentivize equitable care; 2) Increasing participation of safety-net providers; 3) Increasing collection and analysis of equity data; 4) Monitoring and evaluating models for health equity impact.
- Last week, AARP released a poll which found that over two-thirds of all voters, and 75% of voters over age 50, say it is very important for Congress to help seniors live in their own homes, and over half want Congress to address family caregiving issues. The report highlighted that 77% of women, 82% of Black voters, 71% of Latinos, and 77% of Democrats say expanding services to help seniors live independently in their own homes instead of a nursing home is very or extremely important. In addition, the poll showed that 89% of Democratic voters and 72% of Republican voters specifically support expanding access to home-based services that will enable seniors to live at home. AARP recommended that federal and state lawmakers: 1) Provide paid family leave so family caregivers can care for loved ones without losing their job or salary; 2) Expand access to family caregiver support and respite services to allow family caregivers to take a break; and 3) Expand services to help seniors remain in their homes as they age.