The Biden-Harris Administration announced today that sickle cell disease (SCD) will be the first focus of the Cell and Gene Therapy (CGT) Access Model, which was initially announced in February 2023. The model is designed to improve health outcomes, increase access to cell and gene therapies, and lower health care costs for some of the nation’s most vulnerable populations.

Sickle cell disease is an extremely painful condition, which disproportionately impacts Black Americans and has had limited treatment options. In the United States, more than 100,000 people live with SCD. Individuals with the disease have a shorter life expectancy, by more than 20 years, compared to someone living without SCD. Additionally, many long-term health complications from SCD — including stroke, acute chest syndrome, and chronic end-organ damage — can lead to higher rates of emergency department visits and hospitalizations. Patients with SCD experience challenges with access to quality and affordability of care. This model has the potential to help improve health outcomes for patients and families with SCD while also ensuring taxpayer dollars are being used more effectively.

“Medical advancements are bringing us closer to a cure for sickle cell disease (SCD). Yet, many of the more than 100,000 Americans with SCD today face difficulty accessing effective health care and groundbreaking treatments,” said HHS Secretary Xavier Becerra. “Our CGT Access Model gives us a chance to streamline a cumbersome process and put transformative cell and gene therapies within reach for Americans with sickle cell disease.”

The CGT Access Model is part of the Administration’s broader effort to further drive down prescription drug costs and was developed in response to an executive order that President Biden issued in October 2022 directing the Department of Health and Human Services to consider developing models that increase access to novel therapies and lower the high cost of drugs. The model, led by the Centers for Medicare & Medicaid Services’ (CMS’) Innovation Center, will test outcomes-based agreements (OBAs) for groundbreaking CGTs. Successful OBAs will increase affordable access to potentially lifesaving and life-changing treatment. This model will begin in 2025 and may be expanded to other types of CGTs in the future.

“Gene therapies for sickle cell disease have the potential to treat this devastating condition and transform people’s lives, offering them a chance to live healthier and potentially avoid associated health issues,” said CMS Administrator Chiquita Brooks-LaSure. “Increasing access to these promising therapies will not only help keep people healthy, but it can also lead to savings for states and taxpayers as the long-term costs of treating sickle cell disease may be avoided.”

Approximately 50% to 60% of people living with SCD are enrolled in Medicaid. Hospitalizations and other health episodes related to SCD cost the health system almost $3 billion per year. Gene therapies for the treatment of SCD, as well as other complex conditions, hold significant potential to improve patient outcomes and therefore reduce long-term health spending, but they can also pose challenges to state budgets due to the high cost of the therapy. 

Over the next year, CMS will partner with participating states and manufacturers to build a framework that expands access to gene therapies for the treatment of SCD. Under the model, CMS will negotiate an OBA with participating manufacturers, which will tie pricing for SCD treatments to whether the therapy improves health outcomes for people with Medicaid. Negotiations will also include additional pricing rebates and a standardized access policy. Participating states will then decide whether to enter into an agreement with manufacturers based on the negotiated terms and offer the agreed-upon standard access policy in exchange for rebates as negotiated by CMS. As part of the CGT Access Model, CMS will negotiate financial and clinical outcome measures with drug manufacturers and then reconcile data, monitor results, and evaluate outcomes. The CGT Access Model will begin in January 2025, and states may choose to begin participation at a time of their choosing between January 2025 and January 2026.

“The goal of the Cell and Gene Therapy Access Model is to increase access to innovative cell and gene therapies for people with Medicaid by making it easier for states to pay for these therapies,” said Liz Fowler, CMS Deputy Administrator and Director of the CMS Innovation Center. “By negotiating with manufacturers on behalf of states, CMS can ease the administrative burden on state Medicaid programs so they can focus on improving access and health outcomes for people with sickle cell disease.”

CMS anticipates addressing additional care delivery gaps and other hurdles for people receiving cell and gene therapy during the OBA negotiation process, including requiring manufacturers to include a defined scope of fertility preservation services when individuals receive gene therapy for treatment of SCD. CMS will also offer optional funding to states that engage in activities that increase equitable access to cell and gene therapies and promote multi-disciplinary, comprehensive care for people with Medicaid with SCD receiving gene therapy. These activities may include expanding or increasing reimbursement rates for optional Medicaid benefits and services, such as behavioral health or care management services. 

For additional information see the fact sheet and CGT model page.

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By CMS.gov

Under the Biden-Harris Administration, the U.S. Department of Health and Human Services announced today that over 20 million people have selected an Affordable Care Act (ACA) Health Insurance Marketplace plan since the 2024 Marketplace Open Enrollment Period launched on November 1 — a record number of enrollments.

Today’s data represents activity through December 23 (Week 8) for the 32 states using HealthCare.gov and for the 18 states and the District of Columbia with State-based Marketplaces. Total plan selections include more than 3.7 million people (18% of total) who are new to the Marketplaces for 2024, and 16.6 million people (82% of total) who had active 2023 coverage and selected a plan for 2024 coverage or were automatically re-enrolled.  Plan selections so far represent an impressive increase of over 8 million more people who have coverage since President Biden took office.

The 2024 Marketplace Open Enrollment Period runs from November 1, 2023, to January 16, 2024, for states using the HealthCare.gov platform. Consumers who enroll by midnight on January 16 can get coverage that starts February 1, 2024. State-based Marketplace enrollment deadlines vary. State-specific deadlines and other information are available in the State-based Marketplace Open Enrollment Fact Sheet. 

“Today is a momentous day. A record number of people in the United States have health care coverage through the Affordable Care Act’s Marketplace — more than at any point in history. More people with access to preventive care means a healthier country and lower health care costs across the board,” said HHS Secretary Xavier Becerra. “Quality health care gives people the peace of mind they need to participate fully in their communities, spend time with those they love, and pursue their part of the American Dream. President Biden promised increased access to affordable, quality care and these results show he is delivering for the American people. His leadership has been essential.”

“Today’s announcement means more than 20 million people have the security of knowing they have access to affordable health care in 2024. This is a connection to insulin, to high blood pressure medication, to all essential health benefits,” CMS Administrator Chiquita Brooks-LaSure said. “This year’s plan selection is a record-breaking achievement. It shows how far we’ve come and how much this Administration values and is continuing to build on the legacy of the Affordable Care Act nearly 14 years since it was first passed.”

The Biden-Harris Administration has continued its commitment to making health insurance available and affordable to everyone. The Inflation Reduction Act and the American Rescue Plan continue to keep Marketplace coverage more affordable. For this past enrollment cycle, the administration issued almost $100 million in Navigator Awards, allowing organizations to hire staff who are trained to help consumers find affordable, comprehensive health coverage. Navigators, as they are known, have been key to helping consumers enroll in quality health insurance plans in every Marketplace state.

The Biden-Harris Administration encourages all families to visit HealthCare.gov and check out the health care coverage options and savings available to them. Because of continuing provisions in the Inflation Reduction Act, CMS expects nine out of 10 customers to be eligible for savings. 

People with current coverage through HealthCare.gov are encouraged to return and shop to see if another plan better meets their needs at a lower cost.

Today’s release also underscores the importance of Marketplace coverage for people transitioning from Medicaid or the Children’s Health Insurance Program (CHIP) as states conduct Medicaid and CHIP renewals, which restarted in 2023. People who are no longer eligible for Medicaid or CHIP should visit HealthCare.gov to see if they are eligible to enroll in a low-cost, quality health plan today. 

Individuals will also benefit from a highly competitive Marketplace. More than 90% of HealthCare.gov enrollees will be able to choose among three or more plans. Standardized plan options are available and offer the same deductibles and cost sharing for certain benefits. These plans have the same out-of-pocket limits as other standardized plans within the same health plan category, making it easier for consumers to compare and choose plans. Most of these standardized plan options offer many services pre-deductible, including primary care, generic drugs, preferred brand drugs, urgent care, specialist visits, mental health and substance use outpatient office visits, as well as speech, occupational, and physical therapies.

Individuals can enroll or re-enroll in health insurance coverage for 2024 by visiting HealthCare.gov, CuidadoDeSalud.gov, or by calling 1-800-318-2596 to fill out an application. 

Individuals wanting assistance signing up for coverage may go to Find Local Help on HealthCare.gov to find a Navigator, Certified Application Counselor, or agent or broker: 

https://www.healthcare.gov/find-assistance/or https://www.cuidadodesalud.gov/es/find-assistance/.

Marketplace Enrollment Snapshot Overview: 

To view the previous Marketplace enrollment snapshot report, please visit: Marketplace 2024 Open Enrollment Period Report: National Snapshot #2.

Find out more via key highlights and improvements and infographic for the Marketplace 2024 Open Enrollment Period. For more information about how to enroll in Marketplace coverage, visit HealthCare.gov, CuidadoDeSalud.gov or your State-based Marketplace.

Marketplace 2024 Open Enrollment Period Report: National Snapshot

The Centers for Medicare & Medicaid Services (CMS) reports that over 20 million Americans have signed up for 2024 individual market health insurance coverage through the Marketplaces since the start of the 2024 Marketplace Open Enrollment Period (OEP) on November 1. This includes 15.5 million plan selections in the 32 states using the HealthCare.gov platform for the 2024 plan year and 4.8 million plan selections in the 18 states and the District of Columbia with State-based Marketplaces (SBMs) that are using their own eligibility and enrollment platforms, through December 23, 2023 (Week 8). Total nationwide plan selections include 3.7 million consumers (18% of total) who are new to the Marketplaces for 2024, and 16.6 million consumers (82% of total) who had active 2023 coverage and selected a plan for 2024 coverage or were automatically re-enrolled. 

Definitions and details on the data are included in the glossary.

Glossary

HealthCare.gov Marketplace: The 32 Marketplaces that use the HealthCare.gov platform for the 2024 coverage year, including the Federally-facilitated Marketplaces and State-based Marketplaces that use the federal platform (HealthCare.gov). The 32 HealthCare.gov Marketplace states for 2024 include: Alabama, Alaska, Arizona, Arkansas, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Louisiana, Michigan, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, South Carolina, South Dakota, Tennessee, Texas, Utah, West Virginia, Wisconsin, and Wyoming.

State-based Marketplaces (SBMs): The 18 states and the District of Columbia with Marketplaces that operate their own eligibility and enrollment platforms. The 19 SBMs for 2024 include: California, Colorado, Connecticut, the District of Columbia, Idaho, Kentucky, Maine, Maryland, Massachusetts, Minnesota, Nevada, New Jersey, New Mexico, New York, Pennsylvania, Rhode Island, Vermont, Virginia and Washington. Generally, the data metric definitions provided here are applicable to the SBM metrics, with some exceptions. Please contact the SBMs for additional information on their metrics. 

Cumulative Plan Selections: The cumulative metric represents the total number of people who have submitted an application and selected a plan, net of any cancellations from a consumer or cancellations from an insurer that have occurred from November 1, 2023, through the end of the reporting period. To have their coverage effectuated, consumers generally need to pay their first month’s health plan premium. This release does not report the number of effectuated enrollments.

New Consumers (HealthCare.gov Marketplaces): Consumers are considered new if they did not have 2023 Marketplace coverage through the federal platform through December 31, 2023, and made a 2024 plan selection through the federal platform.

New Consumers (SBMs): Consumers are considered new if they did not have 2023 Marketplace coverage in the SBM that uses its own platform where they made a 2024 plan selection through the SBM. 

Returning Consumers (HealthCare.gov Marketplaces): Consumers are considered returning if they have 2023 Marketplace coverage through the federal platform through December 31, 2023, and either actively select the same plan or a new plan for 2024. The returning consumers count includes consumers who have been automatically re-enrolled in their current plan or an alternate suggested plan for 2024 coverage.

Returning Consumers (SBMs): Consumers are considered returning if they have 2023 Marketplace coverage through December 31, 2023, in the same SBM where they actively select the same plan or a new plan for 2024. The returning consumers count includes consumers who have been automatically re-enrolled in their 2023 plan or an alternate suggested plan for 2024 coverage.

###

[1] Cumulative data for SBMs include plan selections from November 1 – December 23, 2023, except Idaho, which has an OEP from October 15, 2023 – December 15, 2023.

[2] Most SBMs (Colorado, Connecticut, DC, Idaho, Kentucky, Maine, Maryland, Massachusetts, Minnesota, New York, Pennsylvania, Vermont, Virginia and Washington) had deadlines for January 1, 2024, coverage that occurred within the SBM reporting period, November 1 – December 23, 2023. The remaining SBMs (California, Nevada, New Jersey, New Mexico, and Rhode Island) had a December 31, 2023, deadline for January 1 coverage.

[3] In addition to reported plan selections, New York and Minnesota have a Basic Health Program (BHP), which provides coverage to consumers with household incomes at or below 200% of the Federal Poverty Level who are not eligible for Medicaid or CHIP and otherwise would be eligible for a QHP. As of December 23, 2023, New York had a total of 1,195,014 individuals enrolled in a BHP. Minnesota’s BHP data was not available at the time of this report. 

[4] Cumulative data for SBMs include plan selections from November 1 – December 23, 2023, except Idaho, which has an OEP from October 15, 2023 – December 15, 2023. 

[5] Most SBMs (Colorado, Connecticut, DC, Idaho, Kentucky, Maine, Maryland, Massachusetts, Minnesota, New York, Pennsylvania, Vermont, Virginia and Washington) had deadlines for January 1, 2024, coverage that occurred within the SBM reporting period, November 1 – December 23, 2023. The remaining SBMs (California, Nevada, New Jersey, New Mexico, and Rhode Island) had a December 31, 2023, deadline for January 1 coverage.

[6] In addition to reported plan selections, New York and Minnesota have a Basic Health Program (BHP), which provides coverage to consumers with household incomes at or below 200% of the Federal Poverty Level who are not eligible for Medicaid or CHIP and otherwise would be eligible for a QHP. As of December 23, 2023, New York had a total of 1,195,014 individuals enrolled in a BHP. Minnesota’s BHP data was not available at the time of this report. 

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The U.S. Department of Health and Human Services (HHS) released new data on state Medicaid and Children’s Health Insurance Program (CHIP) enrollment changes among children and youth since full eligibility renewals for these programs restarted earlier this year. The data released today make it clear that state policy choices have real consequences for children and families during Medicaid and CHIP renewals. States that take up proven flexibilities and strategies from the Centers for Medicare & Medicaid Services (CMS) are better able to protect kids’ coverage – especially when the state has also expanded Medicaid.

According to the data:

• States that have taken up more of the federal strategies provided by CMS and prioritized auto-renewals (ex parte) to reduce red tape for families have helped more eligible children renew Medicaid and CHIP coverage. Many of CMS’ flexibilities make it easier for states to renew eligible children’s coverage by using data the state already has available.
• Barriers to coverage, such as a failure to expand Medicaid, are leading children and youth to fall through the cracks. For example, the 10 states that have not expanded Medicaid – Alabama, Florida, Georgia, Kansas, Mississippi, South Carolina, Tennessee, Texas, Wisconsin, and Wyoming – have disenrolled more children than those that have expanded combined. In non-expansion states, youth who turned 19 while the continuous enrollment condition was in place are at risk of falling in the coverage gap and becoming uninsured; these youth on average account for 27.6% of disenrollments among children in non-expansion states since March 2023, compared to 12.1% of disenrollments in states that have expanded.
• More than 88 million people, including nearly 40 million children and youth, were enrolled in Medicaid and CHIP coverage as of September 2023. Before the pandemic, in February 2020, about 71 million people were enrolled in Medicaid and CHIP, including about 35 million children.

In light of this data, CMS released new comprehensive guidance to states on strategies to protect Medicaid and CHIP coverage for children during this return to regular Medicaid and CHIP renewals. The guidance also announced an extension of these federal strategies for states through the end of 2024. 

Secretary Becerra also sent letters  to the governors of nine states with the highest child disenrollment rates by number and percentage, urging them to adopt additional federal strategies and flexibilities to help prevent children and their families from losing coverage due to red tape. Those states include Arkansas – PDF*, Florida – PDF*, Georgia – PDF*, Idaho – PDF*, Montana – PDF*, New Hampshire – PDF*, Ohio – PDF*, South Dakota – PDF*, and Texas – PDF*. These nine states account for about 60% of the decline in children’s Medicaid and CHIP enrollment from March through September 2023, as indicated in the data release – PDFtoday. This is especially important for children and families of color who are likely disproportionately impacted.

“I urge you to ensure that no eligible child in your state loses their health insurance due to ‘red tape’ or other bureaucratic barriers during the Medicaid enrollment process,” said Secretary Becerra.

Because children’s eligibility thresholds are generally higher than those for adults, many children who have been disenrolled may still meet substantive Medicaid or CHIP eligibility requirements – underscoring the need for states to take further action to prevent eligible children from falling through the cracks. In his letter, Secretary Becerra called on these governors to:

• Adopt the dozens of federal flexibilities and strategies developed to make renewals easier for children and families, including by leveraging guidance and tools published by CMS today;
• barriers, like CHIP enrollment fees and premiums, that make it harder for children to transition to CHIP coverage if they are no longer eligible for Medicaid;
• Reach additional families by reducing call center wait times and partnering with pediatric providers, managed care plans, schools, and community organizations; and
• Expand their Medicaid programs, if states have not done so already, to ensure that young adults over the age of 18 have affordable coverage options and do not fall in the coverage gap.

The actions taken today reflect HHS’ continued commitment to helping people access comprehensive, high-quality health coverage, whether through Medicaid, CHIP, the Health Insurance Marketplaces, Medicare, or an employer. To date, HHS, through CMS, has issued extensive guidance to states on federal Medicaid and CHIP renewal requirements, approved nearly 400 flexibilities for states to make renewals easier for people, made a special enrollment period available on HealthCare.gov to help individuals no longer eligible for Medicaid transition to Marketplace coverage, engaged with stakeholders across the public and private sectors, and conducted extensive outreach and advertising efforts to improve awareness about the return to regular Medicaid and CHIP renewals. HHS will continue to closely monitor states’ renewal efforts to ensure their compliance with federal Medicaid renewal requirements and will not hesitate to take action where it identifies issues of non-compliance.

“CMS is doing everything in our power to protect access to health coverage during the Medicaid and CHIP renewal process, especially for children,” said CMS Administrator Chiquita Brooks-LaSure. “That’s why we’ve put forward dozens of strategies for states to protect children and families’ ability to stay covered. Many states have worked with us to adopt the strategies we’ve put on the table – and we strongly urge all states to do their part to make sure eligible children keep the coverage they need to grow and thrive.”

In addition to this data release – PDF on children and youth, CMS is releasing a CMS Informational Bulletin – PDF that highlights steps states can take to help keep eligible children enrolled in Medicaid and CHIP and announces for the first time that (e)(14) flexibilities will be available at least through the end of 2024, giving states even more opportunity to take up these strategies; new guidance to support transitions – PDF to other forms of coverage, including from Medicaid to CHIP and additional guidance – PDF to help states adopt CMS’ strategies and flexibilities to promote continuity of coverage; and data describing other enrollment trends – PDF during renewals, including trends related to Health Insurance Marketplace® enrollment.

* This content is undergoing Section 508 remediation and people with disabilities may experience issues accessing the content. If you need assistance, contact media@hhs.gov.

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The Centers for Medicare & Medicaid Services (CMS) will begin displaying the ‘Birthing-Friendly’ designation icon on CMS’s Care Compare online tool. CMS created the new designation to identify hospitals and health systems that participate in a statewide or national perinatal quality improvement collaborative program and that implement evidence-based care to improve maternal health. The public can use the Care Compare tool — along with a complementary interactive map —  to find a hospital or health system with the ‘Birthing-Friendly’ designation in their area. Today’s action is one of many key efforts being implemented as part of the White House Blueprint for Addressing the Maternal Health Crisis and is part of Vice President Harris’ nationwide call to action to reduce maternal mortality and morbidity. It also meets a milestone in the CMS Maternity Care Action Plan.

“Today’s launch of the ‘Birthing-Friendly’ designation is another important step to increase and further ensure access to high-quality maternity care,” said Vice President Kamala Harris. “America’s maternal mortality rates are the highest in the developed world, and in response, President Biden and I have made it a key priority to address this crisis by directing government agencies to come up with deliberate and actionable plans. We will always remain committed to supporting the health and well-being of all women, their families, and communities across the nation.”

“Tackling the maternal health crisis is a top priority for the Biden-Harris Administration. We are doing everything in our power to help pregnant and postpartum people find high-quality maternity care. The hospitals and health systems that are designated as ‘Birthing-Friendly’ are an important tool for consumers in their search for first rate care,” said HHS Secretary Xavier Becerra. “We will continue to take action to further advance maternity care quality, safety, and equity.”

“It’s important to center CMS’ work in actions that are results-driven and empower the people we serve. The ‘Birthing-Friendly’ designation is part of our ongoing efforts to improve maternal health in the U.S.,” said CMS Administrator Chiquita Brooks-LaSure. “By highlighting hospitals and health systems demonstrating a strong commitment to maternity care quality, the ‘Birthing-Friendly’ designation is one powerful example of how we are centering health equity in everything we do. As maternal health inequities persist across the nation, the designation offers a tangible marker of the evidence-based practices that hospitals and health systems can pursue to close these gaps and ultimately provide the kind of care all expectant parents deserve.”

Eighty percent of pregnancy-related deaths are preventable, and Black, American Indian and Alaska Native, and Native Hawaiian and Pacific Islander people have the highest rates of pregnancy-related death. Pregnant and postpartum people from some racial and ethnic minority groups are also more likely to have negative health care experiences during pregnancy and delivery that impact the quality of care they receive and health outcomes. The ‘Birthing-Friendly’ designation is a step towards ensuring that all pregnant and post-partum people can find high-quality maternity care.

Last December, CMS hosted the agency’s first-ever Maternal Care Health Convening with government and industry leaders, where more than two dozen health plans committed to using the ‘Birthing-Friendly’ designation on their consumer websites, collectively reaching over 150 million people. 

Today’s announcement is the latest in a series of actions CMS has pursued to further advance maternity care quality, safety, and equity. The Biden-Harris Administration has prioritized maternal health, including by urging all states, Washington, D.C., and all U.S. territories to offer pregnant people and their families the relief of continuous postpartum coverage. Through the American Rescue Plan Act (ARP) of 2021, which allows states to provide continuous Medicaid and Children’s Health Insurance Program (CHIP) coverage for an entire year after pregnancy, CMS has approved Medicaid postpartum coverage extensions in 39 states plus Washington, D.C. and the Virgin Islands. 

Visit Medicare.gov/care-compare to see hospitals with the ‘Birthing-Friendly’ designation.

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The Centers for Medicare & Medicaid Services’ (CMS’) proposed rule will help people with Medicare select and enroll in coverage options that best meet their health care needs by preventing plans from engaging in anti-competitive steering of prospective enrollees based on excessive compensation to agents and brokers, rather than the enrollee’s best interests. The proposed guardrails protect people with Medicare and promote a competitive marketplace in Medicare Advantage, consistent with the goals of President Biden’s historic Executive Order on Promoting Competition in the American Economy. 

The proposed rule will also improve access to behavioral health care by adding a new facility type that includes several behavioral health provider types to Medicare Advantage network adequacy requirements. CMS is also proposing policies to increase the utilization and appropriateness of supplemental benefits to ensure taxpayer dollars actually provide meaningful benefits to enrollees. Additionally, the proposed rule would improve transparency on the effects of prior authorization on underserved communities and proposes more flexibility for Part D plans to more quickly substitute lower cost biosimilar biological products for their reference products.

“The Biden-Harris Administration remains committed to making health care more affordable and accessible for all Americans. By ensuring Medicare recipients have the information they need to make critical decisions about their health care coverage, we are doing just that,” said U.S. Department of Health and Human Services Secretary Xavier Becerra. “Promoting competition in the marketplace helps to lower costs and protect access to care while making the whole process more transparent and accountable.”

“CMS continues to improve the Medicare Advantage and Part D prescription drug programs and maintain high-quality health care coverage choices for all Medicare enrollees,” said CMS Administrator Chiquita Brooks-LaSure. “People with Medicare deserve to have accurate and unbiased information when they make important decisions about their health coverage. Today’s proposals further our efforts to curb predatory marketing and inappropriate steering that distorts healthy competition among plans.” 

CMS has previously taken unprecedented steps to address predatory marketing of Medicare Advantage plans, such as banning misleading TV ads. Many people on Medicare rely on agents and brokers to help navigate Medicare choices. CMS is concerned that some Medicare Advantage plans are compensating agents and brokers in a way that may circumvent existing payment rules, inappropriately steer individuals to enroll in plans that do not best meet their health care needs, and lead to further consolidation in the Medicare Advantage market. To further protect people with Medicare through stronger marketing policies and to promote a competitive marketplace in Medicare Advantage, CMS is proposing added guardrails to plan compensation for agents and brokers, including standardization. These proposals are consistent with the statutory requirement that CMS develop guidelines to ensure that the use of compensation creates incentives for agents and brokers to enroll individuals in the Medicare Advantage plan that is intended to best meet their health care needs. 

CMS also proposes to strengthen and improve access to behavioral health care by adding a new facility type, which includes marriage and family therapists, mental health counselors, addiction medicine clinicians, opioid treatment providers, and others, to CMS’ Medicare Advantage network adequacy requirements. This proposed addition builds on changes finalized last year to strengthen these requirements and would ensure people with Medicare Advantage can access vital mental health and substance use disorder treatment.

“The people we serve are at the center of the Medicare program, and we work each day to make sure the program works for them. Agents and brokers play an important role in guiding people with Medicare to the option that is tuned in to their medical needs. Our proposals on how plans compensate agents and brokers seek to support a competitive marketplace that best serves people with Medicare,” said Dr. Meena Seshamani, CMS Deputy Administrator and Director of the Center for Medicare.

Currently, 99% of Medicare Advantage plans offer at least one supplemental benefit. Over time, the benefits offered have become broader in scope and variety, with more rebate dollars directed toward these benefits. CMS is committed to ensuring these offerings are effectively reaching enrollees and actually meeting their needs, and not just used for attracting enrollees. In today’s rule, CMS proposes requiring Medicare Advantage plans to send a personalized notification to their enrollees mid-year of the unused supplemental benefits available to them to encourage higher utilization. Furthermore, CMS is proposing additional requirements designed to help ensure that benefits offered as special supplemental benefits for the chronically ill (SSBCI) are backed by evidence. CMS is also proposing new marketing and transparency guardrails around these benefits. These proposals will help ensure a robust and competitive Medicare Advantage marketplace made up of plan options with meaningful benefits.

Additionally, CMS is concerned that certain prior authorization policies may disproportionately inhibit access to needed care for underserved enrollees. To provide additional safeguards, CMS is proposing to require that Medicare Advantage plans include an expert in health equity on their utilization management committees and that the committees conduct an annual health equity analysis of the plans’ prior authorization policies and procedures. This analysis would examine the impact of prior authorization on enrollees with one or more of the following social risk factors—eligibility for Part D low-income subsidies, dual eligibility for Medicare and Medicaid, or having a disability—compared to enrollees without these risk factors. These analyses would have to be posted publicly to improve transparency into the effects of prior authorization on underserved populations. To further promote health equity, CMS is also proposing to streamline enrollment options for individuals with both Medicare and Medicaid, providing more opportunities for integrated care. 

To support competition in the prescription drug marketplace, CMS is also proposing to provide more flexibility to substitute biosimilar biological products other than interchangeable biological products for their reference products to give people with Medicare more timely access to lower-cost biosimilar drugs. This proposal would permit Part D plans to treat such substitutions as maintenance changes so that the substitutions apply to all enrollees, not only those who begin the therapy after the effective date of the change, following a 30-day notice.

There will be a 60-day comment period for the notice of proposed rulemaking, and comments must be submitted at one of the addresses provided in the Federal Register no later than January 5, 2024. The proposed rule can be accessed at the Federal Register at https://www.federalregister.gov/public-inspection/2023-24118/medicare-program-contract-year-2025-policy-and-technical-changes-to-the-medicare-advantage-program

View a fact sheet on the proposed rule at cms.gov/newsroom.

View the CMS Blog Important New Changes to Improve Access to Behavioral Health in Medicare at https://www.cms.gov/blog.

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“The Biden-Harris Administration continues to take actions to protect patients from junk health insurance and unfair billing practices. This rule is the next step in ensuring we take patients out of the middle of billing disputes between insurers and health care providers,” said HHS Secretary Xavier Becerra. “Eliminating surprise medical bills, reducing the burden of medical debt, and curtailing junk insurance plans continue to be high priorities.  HHS will continue to do everything in our power to protect patients.”

“The No Surprises Act continues to protect consumers from surprise medical bills,” said CMS Administrator Chiquita Brooks-LaSure. “The Biden-Harris Administration continues to demonstrate a commitment to implementing the law for the American people. Today’s proposed rule will strengthen the communication between health care payers and providers and improve upon the independent dispute resolution process.”

Communication Between Payers and Providers

In response to feedback from payers and providers and to ensure that all parties have the information necessary to determine whether a payment dispute is eligible for the Federal IDR process, the Departments are proposing that payers be required to provide additional information at the time of initial payment or notice of denial of payment. The Departments also propose to require that payers use standardized codes to communicate whether a claim for an item or service furnished by an out-of-network provider or facility is or is not subject to the NSA’s surprise billing provisions and the Federal IDR process. These proposed changes would benefit all disputing parties and reduce the number of ineligible disputes that are submitted to the Federal IDR process.

Open Negotiation and IDR Initiation

The Departments propose several changes to the open negotiation process to encourage disputing parties to engage in meaningful open negotiations before initiating the Federal IDR process. First, the Departments propose to centralize the open negotiation process through the Federal IDR portal. Under this proposed rule, a party choosing to initiate open negotiation must provide an open negotiation notice and a copy of the remittance advice or notice of denial of payment to the other party and the Departments through the Federal IDR portal. Under the current process, a party must contact the other party directly to initiate open negotiations, which has resulted in uncertainty as to whether open negotiation was ever properly initiated.

Additionally, the Departments propose to include new content elements in the open negotiation notice, such as the plan type, the location of service, and the claim number, to help parties identify the relevant item or service and whether the Federal IDR process applies. The Departments also propose provisions that would help ensure parties respond to open negotiation notices and engage with one another during the open negotiation period.

This proposed rule, if finalized, also would revise the process for initiating the Federal IDR process. Specifically, the proposed rule would amend the requirements for the content of the notice of IDR initiation and establish new requirements for a notice of IDR initiation response from the non-initiating party.

IDR Eligibility and Administrative Fee

Eligibility determinations for the Federal IDR process have proven to be complex, time-consuming, and resource-intensive, and certified IDR entities are often uncompensated for such eligibility work. The delays in determining eligibility have impeded certified IDR entities’ ability to make timely payment determinations. This proposed rule would establish a Departmental eligibility review process that could be invoked when dispute volume is high so that the Departments could support eligibility determinations to facilitate faster dispute processing.

As required by statute, both parties to a dispute must pay a non-refundable administrative fee for participating in the Federal IDR process to ensure that the process is financially self-sustaining.

To improve efficiency, the Departments propose to collect the non-refundable administrative fee directly from the disputing parties and layout requirements for when the initiating and non-initiating parties would be required to pay the fee. Further, the Departments propose consequences for failing to pay the fees associated with the Federal IDR process on time.

Additionally, the Departments are proposing a reduced administrative fee structure and amounts for parties in low-dollar disputes to promote equitable access to initiate the Federal IDR process, as well as a reduced administrative fee for non-initiating parties in ineligible disputes.

Batching

Some interested parties have recommended that the Departments provide more flexibility on the ability to include multiple items or services as separate payment determinations in a single dispute (referred to as a “batched dispute”) to improve efficiency and minimize costs for disputing parties. After carefully reviewing this input, the Departments propose new batching provisions to allow qualified IDR items and services to be batched in order to address the unique circumstances of certain medical specialties and provider types.

In combination, the proposed changes in this rule would help improve timely payment determinations and create a more efficient Federal IDR process.

For a fact sheet on the Federal Independent Dispute Resolution (IDR) Process proposed rule, please visit: https://www.cms.gov/newsroom/fact-sheets/no-surprises-act-independent-dispute-resolution-process-proposed-rule-fact-sheet 

To view the Independent Dispute Resolution (IDR) Process proposed rule, please visit: https://public-inspection.federalregister.gov/2023-23716.pdf

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New HHS report shows more than 40 million people are currently enrolled in Marketplace or Medicaid expansion coverage related to provisions of the Affordable Care Act — the highest total on record

The Biden-Harris Administration celebrated the 13^th anniversary of the Affordable Care Act (ACA) by highlighting record-breaking enrollment numbers during the 2023 Marketplace Open Enrollment Period and lower health care costs because of President Biden’s American Rescue Plan (ARP) and Inflation Reduction Act (IRA). Since 2014, when HealthCare.gov was launched, enrollment has doubled from 8 million to more than 16 million. Nearly 16.4 million consumers selected or were automatically re-enrolled in health insurance coverage through HealthCare.gov Marketplaces and State-based Marketplaces (SBMs) during the 2023 open enrollment. Enrollment has increased year-over-year, with 1.8 million more consumers signing up for coverage during the 2023 open enrollment compared to the 2022 open enrollment, a 13% increase, and nearly 4.4 million more consumers signing up compared to the 2021 open enrollment, a 36% increase.

“As we celebrate the anniversary of the Affordable Care Act today, we have even more evidence that this law has lived up to its name, providing a way for Americans to access quality, affordable health coverage,” said HHS Secretary Xavier Becerra. “Thanks to President Biden’s leadership, more than 16 million Americans have health insurance through the Affordable Care Act Marketplaces – an all-time high. We will keep doing everything we can to ensure more people have the peace of mind that comes with high-quality health care.”

“The Biden-Harris Administration has consistently taken steps to fulfill President Biden’s promise to make it easier for Americans to find and enroll in affordable, quality coverage,” said Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure. “We have continued to build on the success of the Affordable Care Act by investing in improvements to the health care system. We continue to see that these investments are paying off through record-breaking enrollment overall and a notable increase in Hispanic/Latino enrollment.”

National estimates show that, on average, consumers receiving advanced premium tax credits (APTC) continue to save over $800 in premiums per year thanks to the expanded subsidies made available through the ARP and continued by the IRA. Nationwide, 4.6 million more consumers are receiving financial assistance in 2023, compared to 2021, representing 90% of all 2023 plan selections – meaning, 90% of people selecting plans are receiving help to pay for premiums. And thanks to these laws passed by the Biden-Harris Administration, 1.4 million middle income consumers (those with household incomes over 400% of the Federal Poverty Level (FPL), or about $54,000 for an individual), who were previously ineligible for assistance, were able to access financial help during the 2023 open enrollment. As a result of the continued expanded subsidies, the average monthly premium after APTC for enrollees fell by 21%.

This year, individuals benefited from a highly competitive Marketplace. Ninety-two percent of HealthCare.gov enrollees had access to plans from three or more insurance companies. Also, new standardized plan options, called Easy Pricing plans, were available in 2023 through HealthCare.gov, which helped consumers compare and select plans.

Open Enrollment outreach included tailored investments to reach audiences that experience lower access to health care. For example, CMS partnered with cultural marketing experts to connect more people to resources including African Americans, Spanish and English-speaking Latinos, and Asian American and Pacific Islander communities in multiple languages. Among consumers who reported their race or ethnicity, 21% identified as Hispanic/Latino in the 2023 Open Enrollment Period, compared to 19% in the 2022 Open Enrollment Period, and 9% identified as Black in the 2023 Open Enrollment Period.

The Administration invested $98.9 million in Navigator grant funding for the 2023 Open Enrollment Period to help reduce health disparities by ensuring robust Navigator services. More than 1,500 Navigators were available to assist consumers with applying for and enrolling in Marketplace coverage for the 2023 plan year in line with the Administration’s goal to expand access to health insurance for America’s families.

More information on applications and plan selections, including state-level premium savings from the ACA and ARP/IRA, are available in the 2023 Open Enrollment Report and a suite of accompanying public use files (PUFs). An additional PUF is available for HealthCare.gov plan selections, including deductibles, Health Savings Account eligibility, and standardized plan option selection rates. The PUFs can be found at: https://www.cms.gov/research-statistics-data-systems/marketplace-products/2023-marketplace-open-enrollment-period-public-use-files.

To view the 2023 Open Enrollment Report, visit: https://www.cms.gov/files/document/health-insurance-exchanges-2023-open-enrollment-report-final.pdf.

Today, HHS also released a report from the Office of the Assistant Secretary for Planning and Evaluation (ASPE) that shows more than 40 million people are currently enrolled in Marketplace or Medicaid expansion coverage related to provisions of the ACA — the highest total on record.

Key points from today’s ASPE report include the following:

• Marketplaces and Medicaid expansion, programs created by the Affordable Care Act (ACA), have enrolled tens of millions of Americans since the programs launched in participating states in 2014.
• An estimated 15.6 million consumers were enrolled in Marketplace plans in February 2023 (across all 50 states and the District of Columbia), and 18.8 million people (across 38 participating states and the District of Columbia) were newly enrolled in Medicaid via the ACA’s expansion of eligibility to adults as of September 2022.
• 1.2 million individuals were enrolled in early 2023 in the ACA’s Basic Health Program option, and 4.6 million previously eligible adults gained coverage under the Medicaid expansion by September 2022 due to enhanced outreach, streamlined applications, and increased federal funding under the ACA.
• Across these coverage groups, a total of 40.2 million Americans were enrolled in coverage related to the ACA based on 2022 and early 2023 enrollment data, the highest total on record.  This represents 9.3 million more people enrolled than in 2021 (a 30% increase) and 27.6 million more people enrolled than in 2014 (a 219% increase, or more than triple). 
• This brief updates our estimate released in April of 2022 where we found more than 35 million people had gained coverage under the ACA. Our current estimate of 40.2 million represents more than 4 million people gaining coverage over the past year. 

Survey results indicate that all 50 states and the District of Columbia have experienced substantial reductions in the uninsured rate since 2013, the last year before implementation of the ACA.

To view the full report, visit: https://aspe.hhs.gov/reports/current-health-coverage-under-affordable-care-act.

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“At President Biden’s direction, this Administration puts consumers first – and we believe consumers deserve transparency,” said HHS Secretary Xavier Becerra. “At HHS, we continue taking unprecedented action to deliver on President Biden’s vision. We are pulling back the curtain and letting the sunshine in on hospital and nursing home ownership because it is what the public deserves. As we work to expand access to high-quality, affordable health care, we will make sure there is transparency to ensure that facilities are held accountable and people can make the best-informed decisions on their care.” 

Today’s announcement builds on the Department’s historic releases of data and unprecedented efforts to increase transparency. In April, CMS released data publicly – for the first time ever – on mergers, acquisitions, consolidations, and changes of ownership from 2016-2022 for hospitals and nursing homes enrolled in Medicare. In September, CMS released additional data publicly on the ownership of approximately 15,000 nursing homes certified as a Medicare Skilled Nursing Facility, regardless of any change in ownership, including providing more information about organizational owners of nursing homes.  

The new information posted today also includes detailed information on the ownership of more than 7,000 Hospitals certified to participate in the Medicare program regardless of any change in ownership. The data elements include:  

1. enrollment information such as organization name, type, practice location addresses (e.g., off campus), National Provider Identifier (NPI), CMS Certification Number (CCN);  
2. detailed information about each owner such as whether it is an organization or an individual and whether it is a direct owner or indirect owner (that is, there is at least one subsidiary between it and the provider); and  
3. a numerical associate ID for each owner to enable linkage to the enrollment file. 

Making facility ownership information transparent benefits researchers and enforcement agencies by allowing them to identify common owners that have had histories of poor performance, to analyze data and trends on how market consolidation impacts consumers with increased costs, without necessarily improving quality of care, and to evaluate the relationships between ownership and changes in health care costs and outcomes. Transparent ownership data benefits the public by assisting patients, and their loved ones, in making more informed decisions about care. HHS plans to analyze these data to identify ways to inform policy approaches that can improve competition in health care, a key priority for the Biden-Harris administration. 

HHS’s Office of the Assistant Secretary for Planning and Evaluation (ASPE) has published a series of reports demonstrating the usefulness of these data sources to examine policy issues including nursing home market concentration, types of facility owners, hospital profit margins and mergers, and the relationship between nursing home acquisitions and quality. 

Review the data posted today on data.cms.gov.  

CMS expects to release updated hospital ownership data on a monthly basis in a searchable format on data.cms.gov, in addition to a flat Excel file available for download to make it easier for researchers to use. 

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In support of President Biden’s plan to protect seniors, additional data files will provide a powerful new tool for researchers, state and federal agencies 

In another effort to improve nursing home transparency, safety and quality, and accountability, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), is making additional data publicly available that provide more information about the ownership of all Medicare-certified nursing homes. This data will, for the first time, give state licensing officials, state and federal law enforcement, researchers, and the public an enhanced ability to identify common owners of nursing homes across nursing home locations. This information can be linked to other data sources to identify the performance of facilities under common ownership, such as owners affiliated with multiple nursing homes with a record of poor performance.

The release of this new data advances the Biden-Harris Administration’s goal of improving transparency of nursing home ownership outlined in  President Biden’s State of the Union Action Plan for Protecting Seniors by Improving Safety and Quality of Care in the Nation’s Nursing Homes.  It is also part of HHS and CMS’s efforts to implement the President’s Executive Order on Promoting Competition. Secretary Becerra serves as a member of President Biden’s White House Competition Council, created by President Biden’s Order on Competition. Secretary Becerra will highlight this new initiative at a Competition Council meeting with President Biden at the White House on Monday.

“President Biden has made clear that we must improve the quality of care in our nation’s nursing homes – and we are taking unprecedented steps to deliver on his call to action,” said HHS Secretary Xavier Becerra. “Every family deserves the peace of mind of knowing their loved ones living in nursing homes are receiving the best possible care. We are continuing to make more data publicly available than ever before to improve transparency for researchers, regulators, and loved ones.”

“We’re taking another major step forward in improving transparency in health care,” said CMS Administrator Chiquita Brooks-LaSure. “Researchers, states, regulators and others will be able to use this new data source to learn more about the impacts that nursing home ownership structures have on the care provided to residents.”

Today’s announcement builds on the historic release of nursing homes and hospitals data by CMS earlier this year following President Biden’s State of the Union call to action. In April, CMS released data publicly – for the first time ever –  on mergers, acquisitions, consolidations, and changes of ownership from 2016-2022 for hospitals and nursing homes enrolled in Medicare.

The information posted today now includes detailed information on the ownership of approximately 15,000 nursing homes certified as a Medicare Skilled Nursing Facility (SNF) – regardless of any change in ownership, including providing more information about organizational owners of nursing homes. For example, the expanded data elements include information about each organizational owner, such as whether it’s a holding company or a consulting firm. CMS has also provided key identifiers that reflect groups of nursing homes with common ownership or managerial control.

The data file on nursing home ownership will be posted to data.cms.gov and updated monthly to help researchers, states, regulators and others analyze how ownership of particular nursing homes or groups of nursing homes impacts the quality of care nursing home residents receive.

While intended primarily for researchers and state and federal agencies, the new nursing home ownership data will also be accessible to consumers through a link in the ownership section of Care Compare on the Medicare.gov website with the next update of the website on September 28^th. CMS will work with consumers to obtain feedback on how best to present provider ownership information in a user-friendly way to support their health care decisions.

For more information on the HHS data release, including publicly available data files, please visit: Skilled Nursing Facility and Ownership Data here:  https://data.cms.gov/provider-characteristics/hospitals-and-other-facilities/skilled-nursing-facility-enrollments

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The U.S. Department of Health and Human Services (HHS) through the Centers for Medicare & Medicaid Services (CMS) announced that during the Biden-Harris Administration 253,000 parents have gained access to 12 months of postpartum coverage through Medicaid and Children’s Health Insurance Program (CHIP) extensions. President Joe Biden and Vice President Kamala Harris have made addressing the maternal mortality and morbidity crisis a key priority for their Administration.

CMS approved actions in Maine, Minnesota, New Mexico, and Washington, D.C., to extend Medicaid and CHIP coverage for 12 months after pregnancy. As a result, up to an additional 15,000 people annually in these states—including 2,000 in Maine; 7,000 in Minnesota; 5,000 in New Mexico; and 1,000 in Washington, D.C.—will have access to Medicaid or CHIP coverage for a full year after pregnancy. This extension of coverage was made possible by a new state plan opportunity established by the President’s American Rescue Plan. Maine, Minnesota, New Mexico, and Washington, D.C., join California, Florida, Kentucky, Oregon, South Carolina, Tennessee, Michigan, Louisiana, Virginia, New Jersey, and Illinois in extending Medicaid and CHIP coverage from 60 days to 12 months after pregnancy.  

“Postpartum coverage not only improves health outcomes, but also saves lives,” said HHS Secretary Xavier Becerra. “Thanks to the American Rescue Plan, new parents will now have access to the ongoing care they need during the most crucial time after giving birth. I applaud Maine, Minnesota, New Mexico, and Washington, D.C, for taking action to join the Administration’s efforts to strengthen maternal health and support safe healthy families.”

“As CMS Administrator and a mother, it’s a privilege to work with states to extend postpartum coverage across the country—most recently in Maine, Minnesota, New Mexico, and Washington, D.C,” said CMS Administrator Chiquita Brooks-LaSure. “The American Rescue Plan gives states an easier pathway to extend postpartum coverage—and gives parents and families the peace of mind of having health coverage during the vital first year after pregnancy.”

CMS continues working to extend coverage for 12 months after pregnancy in other states that have submitted extension proposals, including Connecticut, Indiana, Kansas, Maryland, Massachusetts, North Carolina, Pennsylvania, Washington, and West Virginia. If all states adopted this option, as many as 720,000 pregnant and postpartum individuals across the United States annually could be guaranteed Medicaid and CHIP coverage for 12 months after pregnancy.

Medicaid covers 42% of all births in the nation. But for too long, families have been left behind by a health care system that breaks connections to care when they are needed most. More than half of pregnancy-related deaths in the United States occur in the 12-month postpartum period; 12 percent occur after six weeks postpartum.

This new option for states to extend Medicaid and CHIP postpartum coverage is part of the ongoing efforts of HHS and the Biden-Harris Administration to address disparities in maternal health outcomes by opening the door to postpartum care for hundreds of thousands of individuals. It offers states an opportunity to provide life-saving care that can reduce pregnancy-related deaths and severe maternal morbidity, as well as improve continuity of care for chronic conditions such as diabetes, hypertension, cardiac conditions, substance use disorder, and depression—particularly for underserved communities.

As noted in a report published by the HHS Office of Assistant Secretary for Planning and Evaluation (ASPE), one in three pregnancy-related deaths occur between one week and one year after childbirth. The postpartum period is critical for recovering from childbirth, addressing complications of delivery, ensuring mental health, managing infant care, and transitioning from obstetric to primary care.

States Extending Medicaid and CHIP Postpartum Coverage to 12 Months

Visit Medicaid.gov to learn more about the Medicaid and CHIP state plan amendment extensions of postpartum coverage in Maine, Minnesota, New Mexico, and Washington, D.C.

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