Healthcare Updates for Medicaid Access, Cyberattack Testimony

This week’s intake

• House Energy and Commerce Health Subcommittee holds legislative hearing on improving access to Medicaid. Daniel Tsai, Deputy Administrator and Director of the Centers for Medicaid and CHIP Services (CMCS), testified. Members discussed 19 legislative proposals to improve accountability for Medicaid spending and highlighted recent related regulatory activity.
• UnitedHealth Group CEO testifies on Change cyber attack. The Senate Finance Committee and the House Energy and Commerce Oversight and Investigations Subcommittee held a hearing on the Change Healthcare cyberattack with UnitedHealth Group CEO Andrew Whitty.
• Senate Health, Education, Labor, and Pensions Committee holds hearing on minority health care worker shortage and maternal health crisis. Members and experts discussed the importance of investing in education and community health centers.
• FDA releases final rule for laboratory-developed tests. The U.S. Food and Drug Administration (FDA) has released a final rule and two draft guidance.
• DOL issues AHP final rule. The U.S. Department of Labor’s (DOL) final rule supersedes the 2018 Association Health Plan (AHP) final rule.
• HHS issues final rule to prevent discrimination. This regulation ensures protection for LGBTQ+ individuals and people with disabilities.
• CMS expands health care access for DACA recipients. The Centers for Medicare and Medicaid Services (CMS) has finalized a rule that allows Deferred Action for Childhood Arrivals (DACA) recipients to become eligible to enroll in a Qualified Health Plan (QHP) or Basic Health Program (BHP). .

meeting

House Energy and Commerce Health Subcommittee holds legislative hearing on Improving Medicaid Access and Program Integrity. of hearing We discussed 19 legislative proposals to ensure that Medicaid spending is accountable to the neediest beneficiaries, including those who rely on long-term services and supports. Daniel Tsai, Deputy Administrator and Director of CMCS, emphasized the need for CMS to ensure fiscal responsibility while maintaining access and quality care for Medicaid beneficiaries.Democrats generally supported recently announced policies. Nursing staff allocation ratio rules long-term care facilities and Medicaid access rulesA requirement that states ensure that home and community-based service providers spend at least 80% of the Medicaid payments they receive on compensation for personal care, homemaker, and home health aide services. Republicans, by contrast, expressed support. HR 7513 HR 8114 (no bill text yet) would prohibit implementation of both recent regulations. Bipartisan support was expressed for the following bills:

• HR 8106 aims to improve transparency and remove the requirement that individuals require facility-level care to qualify for home and community-based services under Medicaid waivers. Masu.
• HR 8111 establishes a process to routinely obtain address information for individuals enrolled in Medicaid plans from reliable data sources and allows managed care organizations to provide address information to states for plan enrollees. Mandatory.
• H.R. 8109. It supports the state’s strategy to rebalance long-term care services and makes permanent the Money Follows the Person demonstration, which supports systems from facilities to community-based care.

Read the hearing notes for details on all legislative proposals discussed. here.

UnitedHealth Group CEO testifies on Change cyber attack. UnitedHealth Group CEO Andrew Whitty spoke on both sides of the Capitol on May 1 as Congress seeks continued insight into the Change cyberattack, which had widespread impact on the healthcare sector. Attended the public hearing held in

in Senate Finance Committee Hearingthere was bipartisan concern about several issues.

• the size of UnitedHealth Group and the broader impact of consolidation in the healthcare sector;
• How UnitedHealth Group failed Cyber ​​Security 101. This is because the violation occurred because he failed to enforce two-factor authentication.
• National security implications of data breaches of protected health information.
• delays by UnitedHealth Group in notifying affected patients;
• The financial burden on health care providers and how UnitedHealth Group is working with them to restore health after this incident.

Senators called for minimum healthcare cybersecurity standards and discussed implementing best practices.

Then Witty appeared in a place House Energy and Commerce Oversight and Investigations Subcommittee Hearing, members highlighted concerns about the impact of cyberattacks on small health care provider operations, pharmacies, and patient access to care. Much of the hearing focused on the negative effects of UnitedHealth Group’s vertical integration, which members argued led to increased costs, decreased quality of care, and single points of failure. Members also spoke about national cybersecurity standards and called on private companies to implement best practices in this area.

The Senate Health, Education, Labor, and Pensions Committee holds a hearing on the minority health care worker shortage and maternal health crisis. inside hearing, senators sought solutions to improve the pipeline for minority health care workers, including investments in K-12 education, community colleges, medical schools, and historically black colleges and universities. There was bipartisan support for removing economic barriers for students of color and investing in science, technology, engineering, and math education. Senators and witnesses also spoke about the important role of community health centers in improving maternal health outcomes.

management

FDA releases final rule for laboratory-developed tests. of final rule Amends FDA regulations to clarify that in vitro diagnostic (IVD) products are devices under the Federal Food, Drug, and Cosmetic Act, even if the IVD is manufactured by a laboratory. This is important because FDA has historically exercised enforcement discretion with respect to most of these tests and has not required laboratories providing these tests to comply with FDA’s regulatory requirements for medical devices. is important. The final rule makes clear that FDA will phase out its current general enforcement discretion approach for laboratory-developed tests over a four-year period. In a change from the proposed rule, the agency significantly expanded the list of tests that are subject to some form of “grandparenting” (In other wordscontinued enforcement discretion).

In addition to the final rule, FDA has issued two draft guidances.of beginning Enforcement discretion policy for certain laboratories that provide certain unlicensed IVDs in immediate response to emergencies, such as infectious disease outbreaks, in the absence of a public health emergency declaration applicable to IVDs. provide the authorities’ views onof Number 2 provides FDA’s views on the factors it intends to consider when developing policy regarding enforcement discretion for certain IVDs during public health emergencies.

The FDA webinar See press release for May 14, 2024 final rule. here.Learn more about +insight.

DOL issues AHP final rule. AHP final rule Officially rescinds the 2018 AHP rule that expanded the types of employer groups and entities that can sponsor a single group health plan under the Employee Retirement Income Security Act. Due to the court’s ruling, the 2018 regulations were not fully implemented. DOL currently does not require AHPs in the large group market to provide essential health benefits, so 2018 rule provisions could increase out-of-pocket costs and reduce access to care. I think it’s sexual. The DOL believes that no business is relying on the 2018 rules, so this revocation would maintain the status quo. The new AHP regulations will take effect on June 29, 2024.

HHS issues final rule to prevent discrimination. The U.S. Department of Health and Human Services (HHS), through the Office for Civil Rights and the Assistant Secretary for Finance, announced two final regulations to ensure nondiscrimination in HHS-funded programs and services.of beginning Protect LGBTQ+ individuals by clarifying the prohibition against discrimination based on gender, including sexual orientation and gender identity.of Number 2 Protects people with disabilities in programs and activities that receive federal financial assistance by addressing health care discrimination, adding legally enforceable standards for accessible medical diagnosis, and ensuring accessible web content. Strengthen. Here is the fact sheet for the second rule: here.

CMS expands health care access for DACA recipients. CMS has released: final rule This ensures that DACA recipients are eligible to enroll in a QHP through the Affordable Care Act’s health insurance marketplace or receive coverage through BHP. CMS estimates that this rule could result in 100,000 previously uninsured His She DACA recipients getting health insurance through the Marketplace or his BHP.Read the press release here.

quick hit

• CMS holds national stakeholder meeting. The leaders will address prescription drug affordability, nursing home staffing requirements, Medicaid and Medicaid managed care eligibility and enrollment policies, and a new alternative payment model, the Primary Care Flex Model for Accountable Care Organizations. and discussed the change episode responsibility model.A review of the call will be posted here soon.
• FTC challenges validity of drug patent list. The Federal Trade Commission (FTC) Warning statement It accused 10 drug companies of improperly listing more than 300 patents to slow generic drug competition. The letter targeted drugs used to treat diabetes, weight loss, asthma, and chronic obstructive pulmonary disease.
• CMS announces new IDR resubmission process. CMS plans to streamline the new No Surprises Act independent dispute resolution (IDR) process for resubmitting disputes that were initially determined to be improperly batched or bundled.The new Web Forms User Guide can be found here here.
• HRSA invests $105 million to improve maternal and child health. Health Resources and Services Administration (HRSA) funding supports more than 100 community-based organizations that support the medical and social needs of mothers and babies in high-needs communities. HRSA is part of her HHS.Press release can be viewed here here.
• HHS announces plan to promote responsible use of AI. of plan Provides recommendations for the use of artificial intelligence (AI) in state, local, tribal, and territorial governments.
• GAO announces MACPAC appointment. U.S. Government Accountability Office (GAO) appointed Two new members and four current members were reappointed to the Medicaid and CHIP Payment and Access Committee (MACPAC). In the announcement, GAO also named the chair of MACPAC.
• CMS releases draft guidance for drug price negotiation programs. of draft guidance Establishes parameters for a second round of negotiations under the Medicare Drug Price Negotiation Program established by the Inflation Control Act.Read the fact sheet here.

next week’s diagnosis

Parliament is scheduled to meet next week, and medical action is likely to be carried out at the committee level.