Policy Round-Up: Private Equity in Health Care, Web Accessibility, New Monoclonal Antibody Authorized, and More

April 30, 2024

Vicki Gottlich, Deputy Administrator for Policy and Evaluation

In this Policy Round-Up:

Input needed: HHS, DOJ, and FTC seek input on private equity in health care (Comments due 5/6).
DOJ finalizes web accessibility rule for state and local government sites and apps.
FDA authorizes Pemgarda monoclonal antibody to help prevent COVID-19 for immunocompromised people.
Medicare, Medicaid, and CHIP:
- CMS takes additional actions to help people stay covered during Medicaid and CHIP renewals.
- CMS issues final rule that provides protections to people with Medicare Advantage and prescription drug coverage.
- Updated Medicaid and CHIP telehealth toolkit.
- Updated vaccine toolkit for Medicaid, CHIP, and BHP.
Marketplaces and private health insurance:
- Departments of HHS, Labor, and Treasury release final rules limiting short-term insurance plans, increasing transparency.
- CMS finalizes rule to make marketplace coverage more accessible and expand essential health benefits.
HHS releases suicide prevention strategy and action plan.
Annual Disability Statistics Collection released.
ED’s OCR releases disability data snapshot and resources on rights of students with asthma, diabetes, food allergies, and GERD.
SSA releases guidance on overpayments incurred during the COVID-19 emergency.
ICYMI: Medicaid “Access Rule” and 1557 Rule include important provisions for disabled people and older adults.

Input Needed: HHS, DOJ, and FTC Seek Input on Private Equity in Health Care

The Departments of Health and Human Services (HHS) and Justice (DOJ) and the Federal Trade Commission (FTC) released a request for information (RFI) seeking public comment on private equity and other corporations’ increasing control over health care, including home and community-based services. Specifically, the RFI seeks input on the effects of transactions conducted by private equity funds or other alternative asset managers, health systems, or private payers that involve health care providers, facilities, or ancillary products or services. Ancillary services include other services relevant to the provision of health care but that do not involve providing direct care. Examples include IT services, laboratories, and staffing services.

The RFI is intended to complement the Centers for Medicare & Medicaid Services’ (CMS) RFI on Medicare Advantage that seeks public feedback on enhancing Medicare Advantage data capabilities and transparency, which we discussed previously.

Agencies are seeking input because of concerns that these transactions may place profits over patients’ health, workers’ safety, and health care more affordability. Patients and workers are encouraged to share information on how acquisitions and mergers in the health care industry have affected them directly. For example, the RFI seeks information on how consolidation may affect patients’ access to care, the quality of their experience, the cost of care, language access, and staffing levels, as well as how consolidation may have affected workers’ take-home pay and workplace safety and protocols.

The RFI also asks for comment on what actions the agencies should consider taking to identify and address transactions that may have major adverse impacts on patients, public and private payers, providers, health care workers, support staff, and employers who provide health insurance for their employees. Furthermore, the agencies seek comment on whether and how they should promote greater transparency to the public on mergers, acquisitions, and other transactions.

Comments on the RFI can be submitted online or by mail until May 6, 2024.

The agencies also held a joint workshop on private equity in health care on March 5, 2024. You can view the video or read the transcript for more information.

DOJ Finalizes Web Accessibility Rule for State and Local Government Sites and Apps

The DOJ has finalized a rule that establishes accessibility standards for state and local governments’ web and mobile app-based services.

The rule proposes Web Content Accessibility Guidelines Version 2.1, Level AA as the technical standard for web content and mobile apps that state and local governments would be required to follow. In response to disability advocates comments and concerns, the final rule eliminated exceptions included in the proposed rule for password-protected educational sites.

This rule will better enable state and local governments to meet their obligation under the Americans with Disabilities Act (ADA) to provide equal access to their services, programs, and activities for people with disabilities. It establishes clear technical standards, such as including text descriptions of images so people using screen readers can understand the content, providing captions on videos, and enabling navigation through use of a keyboard instead of a mouse for those with limited use of their hands.

State and local governments use websites and mobile apps for many of their services, programs, and activities. When these websites and mobile apps are not accessible, they can create barriers for people with disabilities trying to, for example, request an absentee ballot; learn about, and participate in, public meetings; and access information from their child’s school. Clearer standards will both ensure that people with disabilities can access vital services and make it easier for states and localities to understand their ADA obligations.

For more on the rule, check out this fact sheet.

FDA Authorizes Pemgarda Monoclonal Antibody To Help Prevent COVID-19 for Immunocompromised People

The Food and Drug Administration (FDA) has authorized a monoclonal antibody to help prevent COVID-19 for people who are moderately or severely immunocompromised, ages 12 and older, and weighing at least 88 pounds.

In addition to vaccination, Pemgarda may provide another layer of protection against COVID-19 and can be given at least two weeks after receiving a COVID-19 vaccine

A health care provider gives Pemgarda as a single intravenous infusion over 60 minutes at a doctor’s office or health care facility. If continued protection is needed, additional doses may be given every three months.

People who are privately insured or have Medicare part B may receive Pemgarda for free.

CMS Takes Additional Actions To Help People Stay Covered During Medicaid and CHIP Renewals

CMS recently announced additional actions it is taking to help people maintain coverage as states continue Medicaid and Children’s Health Insurance Program (CHIP) eligibility renewals, which all states resumed last spring following a pause during the COVID-19 pandemic public health emergency. To help ensure people who are no longer eligible for Medicaid or CHIP can transition to other coverage, CMS announced an extension of the temporary special enrollment period (SEP) in states using HealthCare.gov. The end date of the temporary SEP will now be extended from July 31, 2024, to November 30, 2024.

CMS also released guidance and tools for states reinforcing important federal renewal requirements that states must follow, developed in response to questions from both states and partners. The guidance reinforces requirements that are crucial for people with disabilities, including the requirement to provide renewal forms, adverse action notices, and other notices in languages other than English to households that have requested it and ensure effective communication with individuals with disabilities. It also reiterates the requirement not to terminate coverage, or take other adverse action, until after advance notice, including an explanation of fair hearing rights, is provided.

Along with these resources, CMS released guidance to Medicaid managed care plans on completing signatures for enrollees so plans can help more people renew coverage and new resources for partners to help families navigate their state Medicaid fair-hearing process, including in situations where they disagree with a decision to deny, suspend, terminate, or reduce their Medicaid eligibility or services.

CMS Issues Final Rule That Provides Protections to People With Medicare Advantage and Prescription Drug Coverage

The Centers for Medicare & Medicaid Services (CMS) finalized a rule that strengthens enrollee protections and guardrails for Medicare Advantage and Medicare Part D prescription drug plans.

The final rule puts in place many important changes, including:

Establishing guardrails for compensation to agents and brokers to prevent individuals from being steered into Medicare Advantage plans that don’t best meet their health care needs.
Increasing access to behavioral health care services for Medicare Advantage plan enrollees by updating network adequacy standards. The updates include adding a new “Outpatient Behavioral Health” facility-specialty provider category, for which CMS sets Medicare Advantage plan network adequacy standards. The new provider category includes:
- Marriage and family therapists.
- Mental health counselors.
- Opioid treatment program providers.
- Community mental health centers.
- Addiction medicine physicians.
- Other providers who furnish addiction medicine and behavioral health counseling or therapy services as part of Medicare.
Establishing requirements designed to help ensure that benefits offered as special supplemental benefits for the chronically ill (SSBCI) are backed by evidence.
Making changes to Dual Eligible Special Needs Plan (D-SNP) enrollment and offerings, including changes that would promote enrollment in integrated D-SNPs.
Providing greater flexibility for Part D plans to substitute, more quickly, lower cost biosimilar biological products (biosimilars) for their reference products.

More information can be found in this fact sheet.

Updated Medicaid and CHIP Telehealth Toolkit

CMS released an updated State Medicaid & Children's Health Insurance Program (CHIP) Telehealth Toolkit. The toolkit compiles strategies and resources for states to consider when using telehealth to deliver Medicaid and CHIP benefits and services.

Topics covered in the toolkit include:

Telehealth platforms.
Billing best practices.
Best practices from states during and after the COVID-19 Public Health Emergency.
Strategies to promote the delivery of accessible and culturally competent care through telehealth, including:
- Using telehealth in schools.
- Strategies for telehealth in value-based care.
- Evaluation strategies to understand how telehealth affects quality, outcomes, and cost.
- Strategies for communicating, training, and providing resources on telehealth for providers and for beneficiaries, including beneficiaries with disabilities.

Updated Vaccine Toolkit for Medicaid, CHIP, and BHP

In addition to the toolkit discussed above, CMS has also released an updated vaccine toolkit for Medicaid, the Children’s Health Insurance Program (CHIP), and Basic Health Program (BHP). The toolkit consolidates and compiles vaccination policy resources for states to consider as they transition away from the COVID-19 Public Health Emergency and implement the new requirement for state Medicaid and CHIP programs to cover vaccination and administration of adult vaccines, which we’ve discussed previously.

It also includes additional considerations states may consider to enhance vaccination coverage and access, including provider qualifications, immunization registries, and payment considerations.

Departments of HHS, Labor, and the Treasury Release Final Rules Limiting Short-Term Insurance Plans, Increasing Transparency

The Departments of HHS, Labor, and the Treasury have released final rules that increase transparency and place important limitations on certain less comprehensive health plans, including short-term, limited-duration insurance (STLDI) and independent, noncoordinated excepted benefits coverage.

STLDI is a type of health insurance that is typically designed to fill temporary gaps in health insurance coverage. Unlike most health insurance plans, STLDI plans are not subject to the Affordable Care Act’s critical consumer protections, including guaranteeing coverage for people with pre-existing conditions and prohibiting discrimination based on health status, age, or gender. These final rules will limit these “short-term” plans to no more than four months instead of three years.

The rules also require short-term plans — as well as “fixed indemnity” insurance policies that provide a fixed, cash payment for a health care event — to include a clear, easy-to-understand consumer notice on marketing, application, enrollment, and reenrollment materials to help ensure that consumers do not mistakenly enroll in these types of insurance plans as substitutes for comprehensive coverage.

For more on the final rules, check out this fact sheet.

CMS Finalizes Rule To Make Marketplace Coverage More Accessible and Expand Essential Health Benefits

CMS finalized a rule for the Affordable Care Act Marketplaces that makes it easier for low-income people to enroll in coverage through the Affordable Care Act Marketplaces, expands essential health benefits (EHBs), and sets network adequacy standards for the time and distance people travel for appointments with in-network providers.

The rule establishes a number of improvements, including:

Creating more consistent nationwide standards on how far and how long people have to travel to see various types of providers.
Making clear most prescription drugs that a plan covers in excess of those covered by a state’s essential health benefit (EHB) benchmark plan are subject to EHB protections, including the annual cost sharing limits and annual and lifetime dollar limits.
Allowing states the option to add routine adult dental services as an EHB, starting on January 1, 2027.
Requiring Marketplaces to allow the submission of the single, streamlined application for enrollment in qualified health plans (QHPs) and insurance affordability programs by consumers through the Marketplace’s website.
Helping prevent coverage gaps for those transitioning between different Marketplaces or from other insurance coverage by allowing people selecting coverage during special enrollment periods to receive coverage beginning the first day of the following month, as opposed to coverage beginning at a later date, if they enroll between the 15th and the end of the month.
Requiring most Marketplaces to hold Open Enrollment from November 1-January 15.

For more on the rule, check out this fact sheet.

HHS Releases Suicide Prevention Strategy and Action Plan

HHS has released the 2024 National Strategy for Suicide Prevention, which outlines a 10-year, comprehensive, whole-of-society approach to suicide prevention that provides concrete recommendations for addressing gaps in the suicide prevention field.

The strategy seeks to prevent suicide risk in the first place, identify and support people with increased risk through treatment and crisis intervention, prevent reattempts, promote long-term recovery, and support survivors of suicide loss. For the first time, the strategy includes a pillar prioritizing equity, an essential requirement to meet the specific and urgent need to address populations disproportionately impacted by suicide.

The strategy is accompanied by the first-ever Federal Action Plan, which identifies 200 discrete actions to be initiated and evaluated over the next three years. Actions include:

Identifying ways to address substance use and suicide risk together in the clinical setting.
Funding a mobile crisis locator for use by 988 crisis centers.
Increasing support for survivors of suicide loss and others whose lives have been impacted by suicide.
Evaluating promising community-based suicide prevention strategies.

Annual Disability Statistics Collection Released

The ACL-funded Center for Research on Disability at the University of New Hampshire Institute on Disability has released the Annual Disability Statistics Collection, which fills critical gaps in national, state, and historic data related to people with disabilities by combining complex data from numerous U.S. federal agencies into accessible formats and putting them all in one place.

The resources in the collection include:

ED’s OCR Releases Disability Data Snapshot; Resources on Rights of Students With Asthma, Diabetes, Food allergies, and GERD

The Department of Education’s (ED's) Office for Civil Rights (OCR) released four new resource guides addressing the civil rights of students with disabilities. In addition, OCR released a data snapshot on education access for students with disabilities drawn from OCR’s 2020-21 Civil Rights Data Collection (CRDC).

The resources were developed to inform students with disabilities, and their families and schools, about their legal rights under Section 504, which prohibits discrimination against students with disabilities by schools that accept federal financial assistance.

Each of the four resource guides addresses a common medical conditions that can be considered a disability under Section 504 of the Rehabilitation Act: asthma, diabetes, food allergies, and GERD. They explain when a student with one of these conditions may qualify for protections under Section 504, what kind of modifications schools may need to make, and what schools may need to do to remedy past discrimination.

The data snapshot shows troubling differences in the experiences of students with disabilities compared to their peers without disabilities. According to the data snapshot, students with disabilities were:

More likely to be physically restrained or secluded than students without disabilities.
Overrepresented in disciplinary actions.
Underrepresented in Advanced Placement courses, gifted and talented programs, and dual enrollment or dual credit programs.

SSA Releases Guidance on Overpayments Incurred During the COVID-19 Emergency

Late last year, the Social Security Administration (SSA) reached a settlement to remedy issues that led to the reduction or discontinuation of benefits for some low-income older adults and people with disabilities who receive Supplemental Security Income (SSI) during the pandemic. As we discussed previously, as part of the settlement, SSA agreed to issue guidance reminding its workers to consider COVID-19 related circumstances when making determinations about overpayments that happened during the COVID-19 National Emergency.

SSA has now issued that guidance, which reminds workers to consider circumstances including:

COVID-19 related failed attempts to contact the agency, including inability to visit a field office, inability to access mail services, and inability to access transportation.
Government-imposed COVID-19 travel restrictions.
Overpaid individual’s COVID-19-related serious illness.
Child- or family-care changes due to COVID-19 stay-at-home orders or remote school requirements.
COVID-19-related death or serious illness of the overpaid person’s representative payee.
COVID-19-related death or serious illness in the overpaid individual’s immediate family.

ICYMI: Medicaid “Access Rule” and 1557 Rule Include Important Provisions for Disabled People and Older Adults

In recent weeks, HHS has released two important final rules that advance the rights of older adults and people with disabilities:

On April 22, CMS released the Ensuring Access to Medicaid Services final rule (Access Rule) which creates national standards that will allow people enrolled in Medicaid to better access care when they need it and also strengthens home and community-based services (HCBS), which millions of older adults and people with disabilities rely upon to live in the community. This final rule includes new requirements related to the direct care workforce, access to home and community-based services (HCBS), health and safety protections, quality measures, and more. This ACL blog post describes key provisions impacting HCBS.
On April 26, HHS issued a final rule implementing Section 1557 of the Affordable Care Act — which prohibits discrimination based on race, color, national origin, sex, age, and disability. The final rule would strengthen civil rights protections for people who use health programs and services funded by HHS and includes a number of provisions that are particularly relevant for older adults and people with disabilities — including provisions on accessible telehealth and services in integrated community settings.

These rules are being finalized during a once-in-a-generation moment for civil rights regulations, particularly for people with disabilities. ACL has created this website to help you track the development of various disability-related regulations.