White House releases HHS Spring 2023 regulatory to do list

via the White House:

Under the President’s leadership, the Biden-Harris Administration has continued its work to invest in America, lower costs for families, combat climate change, and grow the economy from the bottom up and middle out. The Administration is using every available tool to improve Americans’ lives, including Federal regulations that my office—the Office of Information and Regulatory Review (OIRA)—reviews.

Today, OIRA is releasing its Spring Regulatory Agenda , which details additional actions that Federal agencies are considering over the coming months. These actions build on and accelerate this Administration’s progress in delivering for the American people.

The full list for every federal agency includes over 2,600 proposed or final rules. For the Health & Human Services Dept. specifically, there are 189 of them on the list. Many of these fall into categories which are technically connected to the HHS Dept, but are only vaguely related to anything I write about, such as rules involving the USDA, the Farm Service Agency, the dept. of Rural Development and so on.

When you limit it to the Centers for Medicare & Medicaid Services (CMS), there's 45 of them. I'm listing all 45 below, with the abstracts and some commentary on the ones which caught my eye. It's important to note, as the Washington Post did the other day, that "The agenda is a nonbinding list of the administration’s priorities, and agencies often blow past the slated date for releasing their policy proposals."

• (Prerule) Transitional Coverage for Emerging Technologies

• (Proposed) Reporting of Crimes Occurring in Federally Funded Long Term Care Facilities and Enforcement Under Section 1150B of the Social Security Act

• (Proposed) Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program

• (Proposed) Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP) Revisions

• (Proposed) Alternative Payment Model

• (Proposed) Amendments to Rules Governing Organ Procurement Organizations

• (Proposed) Provider Nondiscrimination Requirements for Group Health Plans and Health Insurance Issuers in the Group and Individual Markets
  • This proposed rule would implement section 108 of the No Surprises Act.

• (Proposed) Short-Term Limited Duration Insurance; Update
  • This rule would propose amendments to the definition of ‘short-term, limited-duration insurance’ under section 2791(b)(5) of the Public Health Service Act. The rule’s proposals would be designed to ensure this type of coverage does not undermine the Affordable Care Act, including its protections for people with pre-existing conditions, the Health Insurance Exchanges, or the individual, small group, or large group markets for health insurance in the United States.

(sigh) As warned above, agencies often go way past their supposed deadline for issuing new rules. The new regulations for #ShortAssPlans were supposed to come out two months ago, but they haven't as of yet.

I don't really see why this one is so complicated--I'd advise the Biden Administration to simply go back to the Obama-era STLD regulations: No more than 3 consecutive months and only for 3 months in a given calendar year. That would make STLDs comply with their name: They're supposed to be a short-term solution of limited duration. Beyond that, I could see cracking down on STLDs a bit further by tacking on weaker versions of a few of the ACA's requirements for Qualified Health Plans, such as a minimum actuarial value of, say, 50% (sub-bronze) and so forth.

If the enhanced subsidies provided by the ARP/IRA are made permanent (right now they're scheduled to expire as of the end of 2025), at that point I would crack down much harder on STLDs since there'd be little place for them any longer.

• (Proposed) Ensuring Access to Medicaid Services
  • This rule proposes to address elements related to assuring access in Medicaid and/or the Children's Health Insurance Program (CHIP). These elements could include processes that support the implementation of a comprehensive access strategy as well as payment processes, such as those related to specific payment systems.

• (Proposed) Strengthening Oversight of Accrediting Organizations (AO) and Preventing AO Conflict of Interest, and Related Provisions

• (Proposed) Culturally Competent and Person-Centered Requirements to Increase Access to Care and Improve Quality for All

• (Proposed) Mental Health Parity and Addiction Equity Act and the Consolidated Appropriations Act, 2021

• (Proposed) Coverage of Certain Preventive Services Under the Affordable Care Act
  • This rule proposed amendments to the final rules regarding religious and moral exemptions and accommodations regarding coverage of certain preventive services under title I of the Patient Protection and Affordable Care Act.

I'm assuming this is connected to the ongoing Braidwood vs. Becerra federal lawsuit, most likely relating to the coverage of PrEP services, but beyond that I don't know what it would entail.

• (Proposed) Requirements Related to Advanced Explanation of Benefits and Other Provisions Under the Consolidated Appropriations Act 2021

• (Proposed) Medicaid and Children's Health Insurance Program (CHIP) Managed Care Access, Finance, and Quality
  • This rule would propose additional parameters under managed care delivery systems related to access to care requirements, states’ use of In Lieu of Services or Settings (ILOS), state directed payments, quality rating systems, and other policy and reporting changes to ensure the efficient operation of state managed care programs.

• (Proposed) FY 2024 Skilled Nursing Facility (SNFs) Prospective Payment System and Consolidated Billing and Updates to the Value-Based Purchasing and Quality Reporting Programs

• (Proposed) CY 2024 Home Health Prospective Payment System Rate Update and Home Infusion Therapy Services Payment Update

• (Proposed) FY 2024 Inpatient Rehabilitation Facility (IRF) Prospective Payment System Rate Update and Quality Reporting Program

• (Proposed) CY 2024 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program

• (Proposed) FY 2024 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates

• (Proposed) CY 2024 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B

• (Proposed) Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2024 Rates

• (Proposed) CY 2024 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates

• (Proposed) Independent Dispute Resolution Operations

• (Proposed) Appeal Rights for Certain Changes in Patient Status

• (Proposed) Hospital Outpatient Prospective Payment System: Remedy for 340B-Acquired Drugs Purchased in Cost Years 2018-2022

• (Proposed) Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers II

• (Proposed) HHS Notice of Benefit and Payment Parameters for 2025
  • This annual proposed rule would set forth payment parameters and provisions related to the risk adjustment programs; cost-sharing parameters; and user fees for issuers offering plans on Federally-facilitated Exchanges and State-based Exchanges using the Federal platform. It would also provide additional standards for several other Affordable Care Act programs.

The proposed NHBB rule usually doesn't come out until sometime in early December, with the final rule being issued the following spring, so I won't expect this one for awhile.

• (Proposed) Clarifying Eligibility for a Qualified Health Plan Through an Exchange, Advance Payments of the Premium Tax Credit, Cost-sharing Reductions, A Basic Health Program and Medicaid and CHIP
  • ​​​​​​​This proposed rule would make several clarifications and update the definitions currently used to determine whether a consumer is eligible to enroll in a Qualified Health Plan (QHP) through an Exchange; a Basic Health Program (BHP), in states that elect to operate a BHP; and for some state Medicaid and Children’s Health Insurance Programs (CHIP). This rule would modify the definition of "lawfully present” to include Deferred Action for Childhood Arrivals (DACA) recipients, and make additional technical modifications to the definition.

The Biden Administration rolled this one out back in April It could theoretically impact up to 580,000 DACA enrollees, but more likely would make more like ~230,000 of them eligible.

• (Proposed) Contract Year 2025 Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, and Medicare Cost Plan Programs, and PACE

• (Proposed) Minimum Staffing Standards for Long-Term Care Facilities

• (Final) Administrative Simplification: Adoption of Standards for Health Care Attachment Transactions and Electronic Signatures, and Modification to Referral Certification and Authorization Standard

• (Final) Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories

• (Final) Medicare Secondary Payer and Certain Civil Money Penalties

• (Final) Streamlining the Medicaid, CHIP, and BHP Application, Eligibility Determination, Enrollment, and Renewal Processes
  • This rule implements changes to simplify the processes for eligible individuals to enroll and retain eligibility in Medicaid, the Children's Health Insurance Program (CHIP), and the Basic Health Program (BHP). The changes will be finalized in two rules. The first final rule will remove barriers and facilitate enrollment of new applicants, particularly those dually eligible for Medicare and Medicaid. The second final rule will follow in CY 2024 and implement changes to align enrollment and renewal requirements for most individuals in Medicaid; establish beneficiary protections related to returned mail; create timeliness requirements for redeterminations of eligibility in Medicaid and CHIP; make transitions between programs easier; eliminate access barriers for children enrolled in CHIP by prohibiting premium lock-out periods, waiting periods, and benefit limitations; and modernize recordkeeping requirements to ensure proper documentation of eligibility and enrollment.

• (Final) Administrative Simplification: Modifications to NCPDP Retail Pharmacy Standards

• (Final) Treatment of Medicare Part C Days in the Calculation of a Hospital's Medicare Disproportionate Patient Percentage

• (Final) Mandatory Medicaid and Children's Health Insurance Plan (CHIP) Core Set Reporting
  • This final rule establishes requirements for mandatory reporting of the Core Set of Children’s Health Care Quality Measures for Medicaid and CHIP (Child Core Set), the behavioral health measures on Adult Health Care Quality Measures for Medicaid (Adult Core Set) and the Core Set of Health Care Quality Measures for Medicaid Health Home Programs (Health Home Core Set).

• (Final) Requirements Related to Air Ambulance Services, Agent and Broker Disclosures and Provider Enforcement

• (Final) Disproportionate Share Hospital (DSH) Third Party Payer

• (Final) FY 2024 Hospice Wage Index, Payment Rate Update, and Quality Reporting Requirements

• (Final) CY 2024 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts

• (Final) CY 2024 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement

• (Final) Medicare Part B Monthly Actuarial Rates, Premium Rates, and Annual Deductible Beginning January 1, 2024

• (Final) Medicare Disproportionate Share Hospital (DSH) Payments: Counting Certain Days Associated With Section 1115 Demonstrations in the Medicaid Fraction