HealthCare Roundtable e-News – November 21, 2022

 

Top News

Seniors’ Advocates Push CMS to Test Monthly $35 Cap on More Prescription Drugs

Advocates are pushing the Centers for Medicaid & Medicare Services (CMS) to test $35 out-of-pocket caps on prescription drugs other than insulin. In October, President Joe Biden signed an executive order directing CMS’ Innovation Center to assess to new ways to lower prescription drug costs, with recommendations due in January. According to a study from Avalere Health, capping monthly out-of-pocket spending for all Part D drugs would reduce beneficiaries’ spending by an average of up to 45%, or $339 per month. These savings are in addition to the benefits from the redesigned Medicare Part D program, which takes effect in 2025 following the passage of the Inflation Reduction Act this summer. Avalere projected the demo would increase federal Part D spending by $56 billion. CMS is allowed to expand new strategies into national programs without the consent of Congress if they either reduce Medicare spending without hurting the quality of care or improve care without increasing spending.

 

Stricter FTC Enforcement Policy May Discourage Drug Rebates

Last week, Democratic commissioners on the Federal Trade Commission voted (subscription required) 3-1 to approve a long-dormant policy that may dissuade drug companies from using rebates and discount bundles. The policy calls for rigorous enforcement of Section 5 of the FTC Act, which prohibits the use of unfair methods of competition across multiple industries. The policy statement nullifies previous restrictions to enable the FTC to fight anticompetitive behavior more aggressively. The statement also highlights examples of conduct FTC has considered unfair, including mergers and acquisitions, loyalty rebates, tying, bundling, and exclusive dealing arrangements that tend to transform into antitrust law violations. The policy does not single out the prescription drug industry, but manufacturers may adjust some drug discounting practices.

 

COVID-19 PHE Likely to Continue Through Mid-April

The COVID-19 Public Health Emergency (PHE) will likely be extended at least through mid-April 2023, as HHS previously stated they would give stakeholders 60-day notice to prepare for the end of PHE waivers and flexibilities. That 60-day notice period has since passed on November 11th. These flexibilities include the Medicaid maintenance of effort requirement to receive the enhanced FMAP, waivers for telehealth services, and waivers for provider staffing.

Administrative Action

  • Last Thursday, HHS (through SAMHSA) released a new report, National Guidelines for Child and Youth Behavioral Health Crisis Care, which describes the urgent need to improve crisis response services for children, youth, and families and provides guidance on how communities can address the existing gaps in care for youth. The National Guidelines aims to offer best practices, implementation strategies, and guidance for the design and development of services that meet the needs of children, youth, and their families experiencing a behavioral health crisis.

  • Last Thursday, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) released results from the 2022 nationwide National Youth Tobacco Survey (NYTS). The CDC found that 3.08 million (11.3%) U.S. middle and high school students reported current (past 30-day) use of any tobacco product in 2022, which includes 2.51 million (16.5%) high school students and 530,000 (4.5%) middle school students. This study’s findings suggest continuing disparities in tobacco product use, which are likely attributed to greater exposure to tobacco promotion and advertising and greater tobacco retail outlet density in racial and ethnic minority communities, among other systemic factors.

Regulatory Action

This week, the Food and Drug Administration (FDA) announced its preliminary assessment that certain naloxone products may be approvable and safe for nonprescription, over-the-counter (OTC) use. FDA’s final determination on whether these products can be widely provided without a prescription is dependent upon receiving additional data on the safety and efficacy of the specific products. Naloxone nasal sprays and autoinjectors are used to counter the effects of opioid overdoses and reduce deaths. Advocates and harm-reduction experts have previously called upon federal leaders to expand access to Naloxone by allowing it to be sold over the counter, without a prescription.

Congressional Action

  • With the majority of congressional and state races decided, it is now clear the Democrats will maintain control of the U.S. Senate and the Republicans the U.S. House by a slim margin. Mid-term elections (referring to an off year from Presidential elections) historically have led to reduced seats in Congress for the President’s party, particularly in the U.S. House, often with a switch in party control. However, the 2022 mid-term election bucked that trend as Democrats maintained theirdaca majority in the Senate and lost fewer seats in the House than expected. Many factors appear to have influenced the election dynamic including the economy, inflationary pressures, and abortion access. Healthsperien has created a special memo outlining the election results’ impact on health policy for the rest of the year, in the upcoming 118th Congress, and the Biden Administration’s future health agenda. Download the analysis here.

  • A group of bipartisan legislators is urging (subscription required) passage of Medicare Multi-Cancer Early Detection (MCED) Screening Coverage Act of 2021 (H.R. 1946/S.1873) that would allow the Centers for Medicare and Medicaid Services to consider coverage for MCED screening tests for Medicare beneficiaries following approval by the Food and Drug Administration (FDA). Still unapproved by the FDA, MCEDs use blood samples to test for biological indicators of multiple cancers. According to the letter, the bill’s supporters include 243 representatives and 54 senators who state that MCEDs could potentially address cancer disparities by early detection thereby saving lives and improving health outcomes. These legislators are working to pass the measure before 2023, either in a year-end package or a standalone bill.

  • Nearly 90 members of Congress urged the Department of Health and Human Services (HHS) Secretary Xavier Becerra to grant Deferred Action for Childhood Arrivals (DACA) recipients access to benefits under the Patient Protection and Affordable Care Act (ACA) and Children’s Health Insurance Program (CHIP). If granted, DACA recipients would be able to obtain comprehensive Medicaid or CHIP coverage under the state, purchase health plans from the ACA Marketplace, and receive federal premium tax credits to make private insurance affordable in the Marketplace. Proponents assert that expansion of these benefits to those with DACA would increase the number of young, healthy adults in the ACA insurance pool and address existing health disparities across communities of color.

Medicare

The Federation of American Hospitals (FAH) called for greater rural hospital support through the reauthorization of the Low-Volume Hospital (LVH) adjustment and Medicare-Dependent Hospital (MDH) programs. These programs ensure eligible small rural hospitals are fully reimbursed for their services and provide much-needed revenue. Similarly, the Centers for Medicare and Medicaid Services (CMS) released its new Framework for Advancing Health Care in Rural, Tribal, and Geographically Isolated Communities. The framework focuses on six priority areas to boost access and equity goals over the next five years.

Medicaid

During the COVID-19 public health emergency (PHE) – which will likely extend at least through April – states are prohibited from disenrolling people in exchange for enhanced federal Medicaid funding. However, once the PHE ends, state Medicaid agencies will have conduct redeterminations for their Medicaid populations. Consequently, many beneficiaries – particularly children and young adults – are expected to become ineligible for coverage and will have to find alternative sources of coverage. Using Health Reform Monitoring Survey data from June 2022, the Urban Institute found that most adults with family Medicaid enrollment were largely unaware of the changes to Medicaid renewals upon PHE expiration. 

Marketplace

Last week, Amazon announced the launch of its new healthcare service— ‘Amazon Clinic’— a message-based online healthcare service offering treatments for 20+ “common health conditions” (i.e., acne, hair loss, seasonal allergies, etc.) to customers. The service allows customers to select a condition they need treatment for, provides a list of preferred telehealth providers, and connects them via a secure message-based portal. In addition, customers receive a personalized treatment plan and any necessary prescriptions—filled by Amazon Pharmacy or a local Pharmacy. Consultations can last up to two weeks, and clinicians will set prices upfront for customers. Currently, Amazon Clinic does not accept insurance but is Flexible Spending Account (FSA) and Health Savings Account (HSA) eligible. The new service comes on the news of Amazon closing Amazon Care, which launched in 2019 and will shut down on December 31st.

Industry

  • Last week, the Children’s Hospital Association and American Academy of Pediatrics sent a letter to President Biden and HHS Secretary, Xavier Becerra, stating the need for an emergency declaration to provide funding and flexibility to overburdened hospitals and health systems as they struggle to deal with rising respiratory virus and mental health caseloads. In the letter, pediatric providers ask for flexibility to use new spaces to provide care, the ability to use telehealth in more cases, lessening of requirements to speed patient transfers, and less stringent state Medicaid regulations. Over four million workers have left the healthcare industry in the first eight months of 2022, according to new Bureau of Labor Statistics dataBurnout is a driving factor, and workers are also leaving for pharmacies and Big Tech companies that are encroaching into the healthcare space. To improve retention and attract new workers, health systems are opting for more flexible staffing arrangements, remote work opportunities, and technology-enabled recruiting.

  • Last week, in a letter to HHS Secretary Xavier Becerra, the Workgroup for Electronic Data Interchange (WEDI) stated its strong support of the overall goals of the No Surprises Act, which addresses surprise medical bills and increases consumer price transparency. However, WEDI outlined significant concerns regarding the ability of stakeholders to meet the Good Faith Estimate (GFE) “convening provider” provision, and Advanced Explanation of Benefits (AEOB) requirements of the legislation and offered recommendations for an industry glide path to adopt these changes over time.