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Centers for Medicare & Medicaid Services (CMS) Final Rules

King & Spalding

Medicare Finalizes Appeals Process for Reclassified Outpatient Observation Patients

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On October 11, 2024, CMS issued a final rule establishing a new appeals process for Medicare beneficiaries who were initially admitted to a hospital as an inpatient but are later reclassified as an outpatient receiving...more

Arnall Golden Gregory LLP

Second Circuit Rules That “Complaint Surveys” Are Not “Surveys” Under the Statutory Provision Requiring RNs on a Survey Team

All Medicare-certified skilled nursing facilities (“SNFs”) must be surveyed annually and not more than every 15 months, as well as on other occasions, such as for complaint investigations and revisits to determine compliance...more

Bass, Berry & Sims PLC

New Rule Curbs Impact of Suspect DME Claims on 2023 MSSP Financial Calculations

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Effective October 15, a new Final Rule issued by the Centers for Medicare & Medicaid Services (CMS) will allow the Medicare Shared Savings Program (MSSP) to adjust calendar year (CY) 2023 benchmark and expenditure...more

Bricker Graydon LLP

Mental Health Parity and Addiction Equity Act (MHPAEA) Final Regulations Have Been Issued

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If you are a state or local government that sponsors a “self-funded” employee group health plan instead of using an insurance provider, you had previously been allowed to “opt out” of compliance with the following four...more

Ankura

FDA Will Now Regulate Laboratory Developed Tests

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On April 29, 2024, the Food and Drug Administration (FDA) announced a final rule to consider laboratory-developed tests (LDTs) to be medical devices and thus under FDA oversight. LDTs are laboratory tests that are designed,...more

K&L Gates LLP

Long-Awaited Changes to Research Misconduct Rules Have Arrived

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On 12 September 2024, the Office of Research Integrity (ORI) within the US Department of Health and Human Services (HHS) issued a final rule (Final Rule) that significantly modified the standards, procedures, and requirements...more

McDermott+

McDermott+ Check-Up: September 27, 2024

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Congress Votes on CR, Health-Related Legislation. After reaching a deal over the weekend, both chambers passed a CR to avoid a government shutdown and fund the federal government through December 20, 2024. This tees up a push...more

Holland & Knight LLP

CMS Releases Final Rule on the Medicaid Drug Rebate Program

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The Centers for Medicare & Medicaid Services (CMS) on Sept. 20, 2024, released the Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program (CMS-2434) Final Rule....more

Hogan Lovells

CMS issues Final Rule adopting some but not all proposed changes to the Medicaid Drug Rebate Program

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On September 20, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled: Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program....more

Holland & Knight LLP

FDA Warning Letter Marks Significant Shift in Enforcement of Laboratory Developed Tests

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The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more

McDermott+

McDermott+ Check-Up: September 13, 2024

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House Education & the Workforce Health, Employment, Labor, and Pensions Subcommittee Holds Hearing on ERISA’s 50th Anniversary. Members and witnesses assessed how the Employee Retirement Income Security Act of 1974 (ERISA)...more

Holland & Knight LLP

Holland & Knight Health Dose: September 10, 2024

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

McDermott+

Biden Administration Issues Final Reg on Mental Health Parity Requirements

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Biden Administration Issues Final Reg on Mental Health Parity Requirements McDermott+ is pleased to bring you Regs & Eggs, a weekly Regulatory Affairs blog by Jeffrey Davis. Click here to subscribe to future blog posts....more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | July 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including a final rule on provider...more

Baker Donelson

Significant Changes Affecting Hospitals in CMS's FY 2025 IPPS Final Rule

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CMS published its FY 2025 Medicare Hospital Inpatient Prospective Payment System (IPPS) final rule on August 1, 2024. Under this final rule, CMS is implementing several changes to its Hospital Inpatient Quality Reporting...more

Bass, Berry & Sims PLC

CMS Finalizes New Mandatory Value-Based Payment Initiative: The Transforming Episode Accountability Model

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On August 28, as part of its Fiscal Year 2025 Hospital Inpatient Prospective Payment System (IPPS) Final Rule, the Centers for Medicare & Medicaid Services (CMS) finalized the Transforming Episode Accountability Model (TEAM)...more

Ankura

Are You Paying Attention to Prior Authorization? Your Regulators Are.

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With recent CMS mandates and state-level reforms, the healthcare industry faces a pivotal moment to improve prior authorization processes, ensuring timely access to care and integrating health equity considerations....more

McDermott+

Hospitals, Take Note: CMS Adopts Changes to Medicare Rural Designations

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Under Medicare, a plethora of policies directly correlate to whether the patient or provider is located in an urban or rural area when the service is delivered. These policies range from rules that limit coverage of...more

Epstein Becker & Green

CMS Issues Mandatory “TEAM Model” for Acute Care Hospitals to Improve Episode-Based Alternative Payments and Advance Accountable...

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On August 1, 2024, the Centers for Medicare & Medicaid Services (CMS) released a final rule updating the Medicare inpatient prospective payment system (IPPS) for acute care hospitals and the Medicare prospective payment...more

King & Spalding

The Fifth Circuit Affirms Decision Vacating CMS Regulations Implementing the No Surprises Act IDR Process

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On August 2,2024, the Fifth Circuit affirmed the vacatur of federal rulemaking related to the No Surprises Act’s (NSA) Independent Dispute Resolution (IDR) process. The Court held that the No Surprises Act does not permit the...more

Holland & Knight LLP

CMS Releases Fiscal Year 2025 Inpatient Prospective Payment System Final Rule

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The Centers for Medicare & Medicaid Services (CMS) issued the final rule for fiscal year (FY) 2025 Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) on Aug. 1, 2024....more

King & Spalding

CMS Provides Instructions and Timelines for Processing of Pre-October 1, 2013 SSI Realignment Requests

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On July 26, 2024, CMS issued Change Request (CR) No. 13413 providing instructions and timelines for Medicare Administrative Contractors (MACs) for the processing of SSI realignment requests for cost reporting periods before...more

King & Spalding

CMS Publishes FY 2025 Inpatient Psychiatric Facilities Prospective Payment System and Quality Reporting Updates Final Rule

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On July 31, 2024, CMS published a final rule updating the Medicare rates and policies applicable to inpatient psychiatric facilities (IPFs) under the IPF Prospective Payment System (PPS) and the IPF Quality Reporting Program...more

King & Spalding

CMS Issues FY 2025 Inpatient Rehabilitation Facility Prospective Payment System and Quality Reporting Program Final Rule

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On July 31, 2024, CMS published a final rule updating the Medicare rates and policies applicable to inpatient rehabilitation facilities (IRFs) under the IRF Prospective Payment System (PPS) and the IRF Quality Reporting...more

King & Spalding

CMS Issues Final Rule Updating Hospice Payment Rates for Fiscal Year 2025

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On July 30, 2024, CMS issued (CMS-1810-F), its final rule updating the Medicare hospice payment rates and aggregate cap amount for fiscal year (FY) 2025 (the Final Rule). Highlights of the Final Rule are below....more

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