On Monday, June 24, 2024, the U.S. Supreme Court agreed to review last year’s Sixth Circuit decision that allowed Tennessee to keep its ban on gender-affirming care for minors in place. The Supreme Court will determine whether the Tennessee restrictions on gender-affirming care infringe on the Fourteenth Amendment rights of transgender youth for equal protection under the law.[1] The Court did not act on the Biden administration’s petition to review a similar case focused on Kentucky’s gender-affirming care ban for minors; however, the Court’s decision on the Tennessee ban will ultimately determine how the Kentucky case moves forward. The Court will begin their arguments on the Tennessee gender-affirming care ban in the fall. The decision to review the Biden administration’s appeal comes at a time when 39% of transgender youth aged 13-17 are living in states that have bans on gender-affirming care.[2]Continue Reading What to Know about Gender-Affirming Care Following the Supreme Court’s Agreement to Review Sixth Circuit Decision
An Overview of the ACO Primary Care Flex (ACO PC Flex) Model
In March 2024, the Centers for Medicare & Medicaid Services (CMS) released a new voluntary model called the ACO Primary Care Flex Model (ACO PC Flex Model). This model focuses on primary care delivery within the Medicare Shared Savings Program (MSSP), which is Medicare’s longest-running program whereby health care practitioners and other providers and suppliers form an Accountable Care Organization (or ACO) to provide coordinated, high quality care to Medicare beneficiaries. Continue reading to learn more about the ACO PC Flex model.Continue Reading An Overview of the ACO Primary Care Flex (ACO PC Flex) Model
An Overview of the States Advancing All-Payer Health Equity Approaches and Development (AHEAD) Model
In September 2023, the Centers for Medicare & Medicaid Services (CMS) released a new state total cost of care (TCOC) model called the States Advancing All-Payer Health Equity Approaches and Development (AHEAD) Model. This model follows in the footsteps of other successful state total cost of care (TCOC) models to improve health care spending, improve population health, and advance health equity by reducing disparities in health outcomes. Continue reading to learn more about the AHEAD model.Continue Reading An Overview of the States Advancing All-Payer Health Equity Approaches and Development (AHEAD) Model
Healthcare Policy Developments to Watch in 2024
The ever-changing healthcare policy landscape will witness at the federal level regulatory changes driven by the need to transform healthcare delivery, quality and innovation. Looking forward in 2024, this summary examines a number of healthcare innovation topics that have seen significant policy activity in recent years and that are relevant to healthcare stakeholders, including providers, plans, electronic health record (EHR) vendors and health technology companies.
Stakeholders should use this summary to examine existing regulatory and compliance gaps, prepare their organizations to comply with forthcoming federal regulations, and keep apprised of federal funding opportunities. For more information on these policy developments, please contact the professionals listed below, or your regular Crowell contact.Continue Reading Healthcare Policy Developments to Watch in 2024
CMS Innovation Center Announces Sickle Cell Disease Focus under Cell and Gene Therapy Access Model
On January 30, the Centers for Medicare & Medicaid Services’ (CMS’) Innovation Center announced that sickle cell disease (SCD) will be the first focus of the Cell and Gene Therapy (CGT) Access Model, a model for eligible states and pharmaceutical manufacturers designed to improve Medicaid beneficiaries’ access to cell and gene therapies.Continue Reading CMS Innovation Center Announces Sickle Cell Disease Focus under Cell and Gene Therapy Access Model
CMS Finalizes CY 2024 Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems Rule
On November 2, 2023, the Centers for Medicare & Medicaid Services (“CMS”) released the calendar year (“CY”) 2024 Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems Final Rule (“CY 2024 OPPS/ASC Final Rule”). The final rule with comment period finalizes payment rates and policy changes affecting Medicare services furnished in hospital
Current CMS Policy Priorities and Initiatives in Quarter 4
On October 17, 2023, CMS held their quarterly National Stakeholder Call to provide updates on recent accomplishments and how their initiatives advance CMS’ Strategic Plan. Administrator Chiquita Brooks-LaSure, kicked off the call by announcing the start of Medicare open-enrollment and how the entire agency is focused on educating beneficiaries on all 2024 benefits and encouraging people to renew their vaccinations which are available at no additional cost. Brooks-LaSure also revealed how for the first-time, high-cost prescription drugs will have a “catastrophic limit” in 2024. Dr. Meena Seshamani, the Director for the Center for Medicare explained that in 2024, Part D enrollees who reach what CMS calls “catastrophic fees” (the maximum threshold for paying out of pocket) will no longer have to pay a co-pay or out of pocket costs at the pharmacy. Dr. Seshamani also shared that beneficiaries taking insulin will not have to pay more than $35 for each supply of insulin products covered under part D and that people will not have to pay nothing out of pocket for recommended vaccines like shingles. CMS also spoke about the drugs selected for the Medicare Drug Price Negotiation program. CMS will have a patient-focused listening session on 11/15 for each selected drug to provide an opportunity for patients, beneficiaries, caregivers, and patient organizations can share relevant input for these selected drugs. Lastly, Dr. Seshamani shared that ACOs participating in the Medicare Shared Savings Program (MSSP) saved Medicare $1.8 billion in 2022. This is the 6th consecutive year that the program has generated overall savings, and the 2nd highest annual savings accrued for Medicare since the program’s inception.Continue Reading Current CMS Policy Priorities and Initiatives in Quarter 4
CMS releases updates to the ACO REACH model to advance health equity and increase participation
The Centers for Medicare & Medicaid Services (CMS) published new changes to the ACO REACH model to increase predictability for participating ACOs, protect against inappropriate risk score growth, and to advance health equity starting in performance year 2024 (PY2024). The ACO REACH model was created to deliver high-quality and coordinated care to patients while improving costs and health outcomes. Patients in a REACH ACO get help to manage chronic conditions, to receive more preventative health services, to receive care in more convenient ways like telehealth, and to better navigate the health system. When ACOs in the program achieve these goals of providing higher-quality care at a lower cost, they may be eligible to share in those savings. There are currently 132 ACOs participating in this model.Continue Reading CMS releases updates to the ACO REACH model to advance health equity and increase participation
CMS Outlines Plan for Medicare Beneficiaries to Pay Prescription Drug Costs in Monthly Installments
On August 21, 2023, the Centers for Medicare & Medicaid Services (CMS) released draft guidance, pursuant to the Inflation Reduction Act (IRA), to implement the Medicare Prescription Payment Plan, a new program to help Medicare Part D beneficiaries more easily afford their out-of-pocket (OOP) costs for prescription drugs. The IRA, among other provisions aimed at lowering prescription drug costs for Medicare beneficiaries, requires, starting in 2025, that Medicare Part D plan sponsors offer beneficiaries the option to pay their OOP costs for prescription drugs monthly over a year instead of at the point of sale. Under the new program, referred to as the Medicare Prescription Payment Plan, Part D sponsors must pay the pharmacy the OOP cost-sharing that beneficiaries would have paid if they were not in the program. Part D plan sponsors then will bill beneficiaries monthly for their OOP responsibility.Continue Reading CMS Outlines Plan for Medicare Beneficiaries to Pay Prescription Drug Costs in Monthly Installments
CMS Proposes Transitional Medicare Coverage Pathway for Emerging Technologies
On June 21, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed notice with comment period outlining a transitional Medicare coverage pathway for emerging technologies through the national coverage determination (“NCD”) process in addition to several guidance documents that describe CMS’ approach to coverage reviews and evidence development, including the National Coverage Analysis Evidence Review and Clinical Endpoints Guidance: Knee Osteoarthritis.Continue Reading CMS Proposes Transitional Medicare Coverage Pathway for Emerging Technologies