Health Care Watch: April 29, 2024
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from April 22 – April 27. Where available, hyperlinks are included to the relevant documents. Please let us know if you have any questions or would like additional information on the items below.
LEGISLATIVE UPDATE
House
On April 26, Budget Committee Chairman Jodey Arrington (R-TX) and Rep. Michael Burgess (R-TX) asked the Government Accountability Office (GAO) to assess the funding and performance of the Centers for Medicare & Medicaid Services’ (CMS’) Center for Medicare & Medicaid Innovation (CMMI), citing disappointment with CMMI’s efficiency and outcomes.
The House returns to session on April 29.
Senate
The Senate returns to session on April 29.
REGULATORY UPDATE
On April 22, CMS released the Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting final rule. The rule finalizes a nurse staffing standard of 3.48 hours per resident day (HPRD), which must include at least 0.55 HPRD of direct registered nurse (RN) care and 2.45 HPRD of direct nurse aide care. Facilities may use any combination of nurse staff to account for the additional 0.48 HPRD needed to comply with the total nurse staffing standard. CMS also finalized enhanced facility assessment requirements and a requirement to have an RN onsite 24 hours a day, seven days a week, to provide skilled nursing care. The final rule provides a staggered implementation timeframe of the minimum nurse staffing standards and 24/7 RN requirement based on geographic location as well as possible exemptions for qualifying facilities for some parts of these requirements based on workforce unavailability and other factors. A fact sheet detailing the final rule can be found here.
On April 22, CMS released the Ensuring Access to Medicaid Services final rule. The final rule aims to advance access to care and quality of care and improve health outcomes for Medicaid beneficiaries across fee-for-service (FFS) and managed care delivery systems, including home- and community-based services (HCBS) provided through those delivery systems. Specifically, the final rule requires at least 80% of Medicaid payments for home health services to be directed toward workers’ wages, rather than overhead or profit. States will also be required to disclose how much they pay for home care services and establish a rate-setting advisory group to consult on provider compensation. Additionally, the rule requires states to report how they establish and maintain HCBS wait lists, assess wait times, and report on quality measures. A fact sheet detailing the final rule can be found here.
On April 22, CMS released the Medicaid and Children’s Health Insurance Program (CHIP) Managed Care Access, Finance, and Quality final rule. The final rule improves access to care, accountability and transparency for Medicaid and CHIP beneficiaries who are enrolled in a managed care plan. Specifically, the final rule: strengthens standards for timely access to care and states’ monitoring and enforcement efforts; enhances quality and fiscal and program integrity standards for state directed payments (SDPs); specifies the scope of in lieu of services and settings (ILOSs) to better address health-related social needs (HRSNs); further specifies medical loss ratio (MLR) requirements; and establishes a quality rating system (QRS) for Medicaid and CHIP managed care plans. A fact sheet detailing the final rule can be found here.
On April 22, the Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) released the HIPAA Privacy Rule to Support Reproductive Health Care Privacy final rule. The final rule strengthens the Health Insurance Portability Act of 1996 (HIPAA) Privacy Rule by prohibiting the disclosure of protected health information (PHI) related to lawful reproductive health care in certain circumstances. The final rule aims to bolster patient-provider confidentiality and help promote trust and open communication between individuals and their health care providers or health plans. Specifically, the final rule: prohibits the use or disclosure of PHI when it is sought to investigate or impose liability; requires a regulated health care provider, health plan, clearinghouse, or their business associates, to obtain a signed attestation that certain requests for PHI potentially related to reproductive health care are not for these prohibited purposes; and requires regulated health care providers, health plans, and clearinghouses to modify their Notice of Privacy Practices to support reproductive health care privacy. A fact sheet detailing the final rule can be found here.
On April 22, HHS, through the Office of the National Coordinator for Health Information Technology (ONC), released the Common Agreement Version 2.0 (CA v2.0). The Common Agreement establishes the technical infrastructure model and governing approach for different health information networks and their users to securely share clinical information with each other. Specifically, CA v2.0 includes enhancements and updates to require support for Fast Healthcare Interoperability Resources (FHIR) Application Programming Interface (API) exchange. The seven designated Qualified Health Information Networks (QHINs) under the Trusted Exchange Framework and Common Agreement (TEFCA) can now adopt and begin implementing the new version.
On April 22, the Food & Drug Administration (FDA) approved Rezenopy, a 10-milligram naloxone hydrochloride intranasal spray indicated to treat opioid overdose.
On April 23, the Federal Trade Commission (FTC) voted 3-2 to approve a proposal to ban noncompete agreements for most U.S. workers. Under the final rule, employers cannot include noncompete clauses in contracts and companies using them must notify workers that existing noncompete clauses are nonenforceable as of the regulation’s effective date. The existing noncompetes for senior executives are grandfathered, meaning they will stay in effect. The FTC estimates that the policy will save up to $194 billion in health-care costs over the next decade. The FTC press release can be found here.
On April 23, FDA announced the Home as a Health Care Hub. The initiative aims to help reimagine the home environment as an integral part of the health care system and is intended to enable solutions that integrate medical devices and health care into people's home lives. FDA stated that it will keep the public informed as additional information becomes available on the initiative.
On April 24, CMS announced the agency’s latest update to the 2022 National Quality Strategy, the Quality in Motion: Acting on the CMS National Quality Strategy. The action plan discusses how CMS is putting quality-focused goals into motion in four priority areas: 1) outcomes and alignment; 2) equity and engagement; 3) safety and resiliency; and 4) interoperability and scientific advancement.
On April 24, FDA published a revised draft guidance on Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products – Questions and Answers. The revised draft guidance is an update to an earlier version of the draft guidance issued in February 2020. According to the FDA, the revisions in the draft guidance are intended to “address questions firms may have when developing FDA-regulated promotional communications for prescription reference products or prescription biosimilar products, including interchangeable biosimilar products.” The revised guidance warns manufacturers to not imply in their promotional and advertising materials that reference drugs are superior to their biosimilars, or that interchangeable biosimilars are clinically distinct from other biosimilars. Comments on the guidance are due by June 25.
On April 25, CMS issued a statement on a recently proposed Local Coverage Determination (LCD) by the Medicare Administrative Contractors (MACs) to provide appropriate coverage for skin substitute grafts used for chronic non-healing diabetic foot and venous leg ulcers. The MACs issued the collaborative proposed Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers (DFUs) and Venous Leg Ulcers (VLUs) LCD to make sure that Medicare covers skin substitute products that are supported by evidence that shows that they are reasonable and necessary for the treatment of diabetic foot and venous leg ulcers in the Medicare population and that coverage aligns with professional guidelines for appropriately managing these wounds. CMS strongly encourages interested parties to take advantage of the opportunity under the LCD process to provide comments to the MACs during the public comment period, which is open until June 8, 2024. As part of the LCD process, each of the MACs will be holding public listening sessions in May to provide additional engagement opportunities on this proposed coverage policy.
On April 25, HHS announced that 20 states have been selected to participate in two separate technical assistance programs that aim to help participating states better recruit, train, and retain direct care workers, who provide HCBS for older adults and people with disabilities. Six of the chosen states will receive up to 250 hours of individualized technical assistance, have a coach, and have access to subject matter experts to support them in addressing their state's unique direct care workforce (DCW) challenges. Each team includes representatives from the state's Medicaid, aging, disability, and workforce development agencies, in addition to other stakeholders. Synopses of each state's areas of focus and goals for the program can be found here.
White House
On April 22, Vice President Kamala Harris held a roundtable discussion on nursing home care. The roundtable discussion preceded the release of the minimum staffing standards rule and discussed nursing home care and caregiver support. A fact sheet detailing the final rule can be found here. A readout of Vice President Harris’s comments can be found here.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
CMS
Healthcare System Resiliency and Modernization (CMS-3426); Proposed Rule; 10/12/23
Alternative Payment Model Updates; Increasing Organ Transplant Access (IOTA) Model (CMS-5535); Proposed Rule; 11/9/23
Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program (CMS-2434); Final Rule; 3/22/24
CY 2025 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS-1805); Proposed Rule; 4/18/24
CY 2025 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1807); Proposed Rule; 4/18/24
CY 2025 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1809); Proposed Rule; 4/24/24
FDA
Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies; Guidance for Industry; Notice; 4/10/24
ONC
Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability; Proposed Rule; 1/18/24
UPCOMING HEARINGS
House
Energy and Commerce Committee
Health Subcommittee
May 1; 2:00 PM EST; 2123 Rayburn
Examining the Change Healthcare Cyberattack
Witness: United Health Group CEO Andrew Witty
April 30; 10:00 AM; 2123 Rayburn
Legislative Proposals to Increase Medicaid Access and Improve Program Integrity
Witness: Daniel Tsai, Deputy Administrator and Director of the Center for Medicaid and CHIP Services, CMS
Legislation to be considered:
H.R. 124, Byron Nash Renal Medullary Carcinoma Awareness of 2023;
H.R. 468, Building America’s Health Care Workforce Act;
H.R. 670, Think Differently Database Act;
H.R. 3227, Ensuring Seniors’ Access to Quality Care Act;
H.R. 7513, Protecting America’s Seniors Access to Care Act;
H.R. 7573, Stop Unfair Medicaid Recoveries Act;
H.R. 8084, To amend title XIX of the Social Security Act to require States to verify certain eligibility criteria for individuals enrolled for medical assistance quarterly;
H.R. 8089, To amend title XIX of the Social Security Act to require certain additional provider screening under the Medicaid program;
H.R. 8094, To amend title XIX of the Social Security Act to modify certain recovery rules;
H.R. 8106, To amend title XIX of the Social Security Act to remove the requirement that an individual need an institutional level of care in order to qualify for home and community-based services under a Medicaid waiver;
H.R. 8107, To amend title XIX of the Social Security Act to remove certain age restrictions on Medicaid eligibility for working adults with disabilities;
H.R. 8108, To amend title XIX of the Social Security Act to require medical assistance under the Medicaid program for certain home and community-based services for military families;
H.R. 8109, To amend the Deficit Reduction Act of 2005 to make permanent the Money Follows the Person rebalancing demonstration;
H.R. 8110, To amend title XIX of the Social Security Act to make permanent the State option to extend protection against spousal impoverishment for recipients of home and community-based services under Medicaid;
H.R. 8111, To amend title XIX of the Social Security Act to ensure the reliability of address information provided under the Medicaid program;
H.R. 8112, To amend title XIX of the Social Security Act to require certain additional provider screening under the Medicaid program;
H.R. 8113, To amend title XIX of the Social Security Act to require certain directed payments under the Medicaid program;
H.R. 8114, To prohibit the Secretary of Health and Human Services from finalizing a rule proposed by the Centers for Medicare and Medicaid Services to place certain limitations on Medicaid payments for home and community-based services; and
H.R. 8115, To amend title XIX of the Social Security Act to allow for the deferral or disallowance of portions of payments for certain managed care violations under Medicaid.
A background memo can be found here.
Appropriations
April 30; 10:00 AM; 2358-C Rayburn
Labor, Health and Human Services, Education, And Related Agencies – Member Day
Select Subcommittee on the Coronavirus Pandemic
June 3; TBD
Hearing on the COVID-19 Pandemic and Pandemic Response
Possible Witnesses: Dr. Anthony Fauci
Senate
Finance Committee
May 1; 9:00 AM; 215 Dirksen
Hacking America’s Health Care: Assessing the Change Healthcare Cyber Attack and What’s Next
Witness: United Health Group CEO Andrew Witty
Health, Education, Labor & Pensions Committee
May 2; 10:00 AM; SD-430
What Can Congress Do to Address the Severe Shortage of Minority Health Care Professionals and the Maternal Health Crisis?
Witnesses: TBD
Budget Committee
TBD
Hearing on Competition on Health Care