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Enforcement Centers for Medicare & Medicaid Services (CMS)

King & Spalding

Texas Sues Federal Government to Protect Medicaid Financing

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On December 11, 2024, the Texas Health and Human Services Commission filed a complaint in the United States District Court for the Western District of Texas. The complaint seeks to block the enforcement of a May 9, 2014,...more

Foley & Lardner LLP

Thorny Laws That ICHRA Vendors Should Consider, Part 2

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As summarized in our prior article on this topic, individual coverage health reimbursement arrangements (ICHRAs) are gaining popularity and constituting a larger part of the overall employer-provided health coverage market. ...more

Holland & Knight LLP

Final Medicare Overpayment Rules a Mixed Bag for Providers

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The Centers for Medicare & Medicaid Services (CMS) released highly anticipated updates this month to the Medicare regulations interpreting the federal 60-day overpayment refund requirement (the Overpayment Statute). The...more

Smith Anderson

Update on Regulatory Relief for North Carolina Long-Term Care Facilities After Hurricane Helene

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The North Carolina Division of Health Service Regulation (“DHSR”) has issued guidance to Adult Care Home (ACH), Family Care Home (FCH), and Skilled Nursing Facility (SNF) providers regarding temporary waivers or modification...more

Health Care Compliance Association (HCCA)

[Webinar] CMS Issues Additional Guidance to Clarify new MA Regulations - October 8th, 12:00 pm - 1:30 pm CT

Learning Objectives: - Discuss the new regulations and subsequent CMS guidance applicable to MAOs regarding coverage criteria and prior authorization - Discuss the broader current landscape between MAOs and providers,...more

Foley & Lardner LLP

Health Care Enforcement: “Tea Leaves” in the 2024 National Health Care Fraud Summer Takedown

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Each summer in recent years, the U.S. Department of Justice (DOJ) and associated fraud enforcement partners have indicted many health care defendants, in multiple cases across the country. This summer continued the tradition....more

King & Spalding

CMS Issues Fiscal Year 2025 Final Rule for Skilled Nursing Facilities

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On July 31, 2024, CMS issued a final rule (the Final Rule) for fiscal year (FY) 2025 updating Medicare payment policies and rates for skilled nursing facilities (SNFs) under the SNF Prospective Payment System (PPS). Under the...more

BakerHostetler

Healthcare Providers Beware: Finalized Disincentives Sharpen the Teeth of Information Blocking Rule

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On June 24, 2024, the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) at the Department of Health and Human Services (HHS) issued the 21st...more

Mintz - Health Care Viewpoints

Five Observations from FDA’s Responses to Comments in the Final Rule on LDTs

Now that the final rule on laboratory developed tests (LDTs) has been available for over a month and the stages of the enforcement discretion phaseout process and the Food and Drug Administration’s (FDA’s) newly proposed...more

King & Spalding

OIG Report Details Weaknesses in Enforcement of Two-Midnight Rule

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CMS estimates that between 2017 and 2021, Medicare Part A improperly paid $23.9 billion for inpatient hospital stays, with $7.8 billion attributable to short stays that did not qualify for Medicare Part A. On June 13, 2024,...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | April 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more

Venable LLP

Summary of LDT Rule: An In-depth Look at the Final Rule Regarding Laboratory-Developed Tests

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The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape for laboratory-developed tests (LDTs) and "correct...more

Gardner Law

CMS Audits on the Horizon: Prepare for Increased CMS Audits Under the Sunshine Act

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Historically, the Centers for Medicare and Medicaid Services (“CMS”) has not aggressively pursued enforcement activity under the Sunshine Act. However, this may change in 2024. Late last year, CMS updated its Open Payments...more

Foley & Lardner LLP

Medicaid: CMS Final Rules Aim to Expand Access, Provide Parity with Commercial Markets

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The Centers for Medicare & Medicaid Services (CMS) published two significant updates to its Medicaid regulations on May 10, 2024. The two Final Rules, a Medicaid Access Rule and a Medicaid Managed Care Rule, impose new...more

Sheppard Mullin Richter & Hampton LLP

Increased Scrutiny into Agents & Brokers in the Medicare Advantage Space

Most Medicare Advantage (“MA”) beneficiaries rely on agents and brokers to help them navigate the complex process of selecting a health plan that will meet their needs. In exchange, brokers and agents received certain fixed...more

King & Spalding

CMS Issues Proposed Rule for Skilled Nursing Facilities

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On March 28, 2024, CMS issued a proposed rule (Proposed Rule) for fiscal year (FY) 2025 that would update Medicare payment policies and rates for skilled nursing facilities (SNFs) under the SNF Prospective Payment System...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | February 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for February 2024. We discuss various regulatory developments, including guidance on the use of AI in coverage decisions and texting...more

Foley & Lardner LLP

“Let’s Talk Compliance”: Medicare Advantage: Compliance Issues and Enforcement

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Editor’s Note: PYA and Foley & Lardner hosted the 6th Annual “Let’s Talk Compliance” two-day Virtual Conference on January 18 and 19, 2024. Panelists included Foley & Lardner attorneys and PYA experts. The event was hosted by...more

NAVEX

Addressing Cybersecurity Expectations in Healthcare

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2024 is shaping up to be a very active year for regulatory and enforcement developments in the healthcare industry – developments that concern not just hospitals and nursing facilities, but many non-healthcare companies as...more

Polsinelli

FTC and DOJ Signal Greatly Increased Scrutiny of Private Equity Firms’ Acquisitions in Health Care

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The top enforcers at the Federal Trade Commission (FTC) and Antitrust Division of the Department of Justice (DOJ) are sending strong signals that private equity (PE) firms are likely to be the next target in the Biden...more

Miles & Stockbridge P.C.

Highlights from the Inaugural Hot Topics in Health Care Law

The Miles & Stockbridge Health Care Practice Group hosted its inaugural Hot Topics in Health Care Law seminar last month for clients from Maryland and beyond. Miles & Stockbridge health care lawyers kicked off the seminar...more

Mintz

EnforceMintz — Artificial Intelligence and False Claims Act Enforcement

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Like most industries, the health care sector is grappling with the uses of artificial intelligence (AI) and what AI means for the future. At the same time, many health care companies already have integrated algorithms and AI...more

Mintz

EnforceMintz — Government Scrutiny of Medicare Advantage Organizations Expected to Continue in 2024

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Medicare Advantage (also known as Medicare Part C) remains a top enforcement priority as evidenced by False Claims Act (FCA) investigations and litigation involving nearly all large Medicare Advantage Organizations (MAOs). As...more

Mintz

EnforceMintz — 2023 Brings Uptick in Cybersecurity Enforcement, Insight Into Potential Risks

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After the Department of Justice (“DOJ”) announced its Civil Cyber-Fraud Initiative in October 2021, many in the False Claims Act (“FCA”) bar expected an onslaught of enforcement actions and qui tam cases. The initiative...more

King & Spalding

CMS Issues Interim Final Rule for CMS Enforcement of State Compliance with Reporting and Federal Medicaid Renewal Requirements

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On December 4, 2023, CMS issued an interim final rule (the Interim Rule) (RIN 0938-AV26) to implement new enforcement authorities that CMS may use if states fail to comply with new reporting requirements or with federal...more

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