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Congress Adds AKS and Stark Law Exceptions for Certain Wellness Programs

As a part of the Consolidated Appropriations Act, 2023 (CAA), Congress passed new exceptions to the Physician Self-Referral Law (Stark Law) and the federal Anti-Kickback Statute (AKS) allowing certain...

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Healthcare Regulatory Check-Up | April 2023

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for April 2023. We discuss several criminal and civil enforcement actions related to the...

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SuperValu: It’s Not Super Bad! A Practical Look at the Supreme Court’s Recent...

Two separate lawsuits alleging False Claims Act (FCA) violations by retail drug pharmacies made their way to the Supreme Court of the United States this term. The lawsuits decided whether the...

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Healthcare Regulatory Check-Up Newsletter - May 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for May 2023. We discuss several criminal and civil enforcement actions that involve violations of...

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Top Takeaways | 2023 Physician Practice Management & ASC Symposium 2023 |...

In this session, McDermott Will & Emery Partners Denise Burke, Tony Maida and Monica Wallace discussed top issues and enforcement trends that physician practice management companies (PPMs) and...

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Healthcare Regulatory Check-up Newsletter | June 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for June 2023. We discuss several civil enforcement actions involving false claims, the Anti-Kickback...

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Hospitals: Check Your Addresses or Face Medicare Claims Returns!

Following an implementation delay during the COVID-19 public health emergency (PHE), on August 1, 2023, the Centers for Medicare and Medicaid Services (CMS) initiated Medicare hospital claims edits...

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Healthcare Regulatory Check-up Newsletter | July 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for July 2023. We discuss several criminal and civil enforcement actions that involve violations of...

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Healthcare Regulatory Check-Up - August 2023

AUGUST REGULATORY UPDATE SUMMARY - This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for August 2023. We discuss several criminal and civil enforcement...

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[Hybrid Event] Healthcare Litigation, Compliance and Investigations Forum...

McDermott’s Healthcare Litigation, Compliance and Investigations Forum is back when you need it the most. Heightened regulatory scrutiny and enforcement activity pose legal, financial and reputational...

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OIG Pathology Lab: Don't Pay for Services You Don't Need

In September, the US Department of Health and Human Services Office of Inspector General (OIG) issued an unfavorable advisory opinion to a pathology laboratory concerning a proposed services...

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OIG Issues General Compliance Program Guidance Updates

On November 6, 2023, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published the General Compliance Program Guidance (GCPG) as a revised reference guide for the...

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Healthcare Regulatory Check-up Newsletter | October 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for October 2023. We discuss several enforcement actions that involve violations of the False Claims...

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Private Equity and REITs, Take Note! CMS Finalizes Nursing Facility Ownership...

On November 17, 2023, the US Department of Health and Human Services (HHS) published a final rule requiring nursing facilities participating in Medicaid and skilled nursing facilities participating in...

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Private Investors and Digital Health Attracting OIG Attention: General...

On November 6, 2023, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published the General Compliance Program Guidance (GCPG) as a revised reference guide for the...

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Medicare Provider and Supplier Enrollment Requirements: Program Integrity...

The US Centers for Medicare & Medicaid Services (CMS) finalized important changes to the Medicare provider and supplier enrollment regulations, including adding marriage and family therapists...

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Stark Law Changes for 2024: CMS Updates Designated Health Services Code List

On November 29, 2023, the Centers for Medicare & Medicaid Services (CMS) published the 2024 annual update to the designated health services (DHS) Code List. This annual update includes important...

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Healthcare Regulatory Check-Up Newsletter | November 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for November 2023. We discuss several US Department of Health and Human Services (HHS) agency actions, including...

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Healthcare Regulatory Check-Up Newsletter | December 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for December 2023. We discuss several civil and criminal enforcement actions that involve alleged...

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Healthcare Regulatory Check-Up Newsletter | January 2024 Recap

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

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CMS Finalizes Important Changes to Medicare Enrollment Requirements for...

The US Centers for Medicare & Medicaid Services (CMS) finalized important changes to the Medicare enrollment regulations applicable to hospices and home health agencies (HHAs), including increasing...

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DOJ and OIG Actions: 2023 Enforcement Trends Recap

This report reviews notable areas for government enforcement actions during 2023 that were discussed in our monthly Healthcare Regulatory Check-Up reports. In the past year, we saw the relevant federal...

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Healthcare Regulatory Check-up Newsletter - March 2024

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for March 2024. We summarize a US Court of Appeals for the Second Circuit decision interpreting the intent...

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CMS Advises Preparatory Steps for Anticipated PrEP Coverage Transition to...

On April 15, the Centers for Medicare & Medicaid Services (CMS) released a fact sheet on the potential national coverage determination (NCD) for pre-exposure prophylaxis (PrEP) using antiretroviral...

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[Event] Physician Practice Management and ASC Symposium 2024 - May 15th -...

The Physician Practice Management (PPM) and ASC Symposium 2024 is the destination event for PPM and ASC industry leaders and health industry investors. Join us as we deliver actionable insights on the...

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Healthcare Regulatory Check-up Newsletter - April 2024 Recap

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...

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Healthcare Regulatory Check-Up Newsletter | May 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2024. We discuss several notable cases and enforcement resolutions, including the US Court of Appeals for...

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CMS Issues FAQs to Aid Pharmacies in Preparing for Medicare Part B Coverage...

As we previously advised, the Centers for Medicare & Medicaid Services (CMS) is preparing to issue a national coverage determination (NCD) for pre-exposure prophylaxis (PrEP) using antiretroviral...

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Healthcare Regulatory Check-Up Newsletter | June 2024 Recap

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

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Healthcare Regulatory Check-up Newsletter | September 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for September 2023. We discuss several criminal and civil enforcement actions that involve violations of the...

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Healthcare Regulatory Check-up Newsletter | February 2024 Recap

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...

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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...

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Healthcare Regulatory Check-Up Newsletter | August 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for August 2024. We discuss several enforcement actions pertaining to healthcare fraud, including alleged...

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Healthcare Regulatory Check-Up Newsletter | September 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for September 2024. We discuss several enforcement actions pertaining to healthcare fraud, including alleged...

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CMS Extends Remote Direct Supervision Flexibilities in CY 2025 Physician Fee...

On November 1, 2024, the Centers for Medicare & Medicaid Services (CMS) issued the calendar year 2025 final rule for services reimbursed under the Medicare physician fee schedule. Among other...

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Healthcare Regulatory Check-Up Newsletter | October 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for October 2024. We discuss several enforcement actions pertaining to healthcare fraud, including alleged...

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New Year Brings Material Changes to Medicare Overpayment Rule

The Centers for Medicare and Medicaid Services (CMS) finalized material changes to the overpayment rules for Medicare Parts A, B, C, and D effective January 1, 2025. These changes create new ambiguity...

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Healthcare Regulatory Check-Up Newsletter | November 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for November 2024. We discuss several US Department of Justice (DOJ) enforcement actions involving the False...

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CMS Updates Scope of Providers Subject to Provisional Period of Enhanced...

The Centers for Medicare & Medicaid Services’ (CMS) 2025 Home Health Prospective Payment System final rule (Final Rule) expanded the scope of providers subject to a provisional period of enhanced...

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New Requirements for Illinois Dental Practices Using Third-Party Financing

Third-party financing services are frequently used by patients to finance out-of-pocket dental expenses. Effective January 1, 2025, dental practices in Illinois are prohibited from facilitating or...

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Hospital Provider-Based Compliance: Top 10 Myths and Truths

Medicare reimbursement for hospital outpatient services has come under attack in recent years, with a focus on “site neutral” payment policies that would pay hospitals for outpatient services furnished...

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Healthcare Regulatory Check-Up Newsletter | December 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for December 2024. We discuss several civil and criminal enforcement actions pertaining to healthcare fraud and...

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HHS OIG Releases Updated Nursing Facility Compliance Program Guidance:...

Nursing facilities and skilled nursing facilities that participate in the Medicare and Medicaid programs must comply with certain mandatory compliance program requirements of participation (ROPs)....

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Healthcare Regulatory Check-Up Newsletter | January 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2025. This month features long-awaited proposed and final rules regarding the Health Insurance...

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OIG Nursing Facility Compliance Program Guidance: Renewed Focus on Fraud and...

The US Department of Health and Human Services Office of Inspector General’s (OIG’s) release of Nursing Facility Industry Segment-Specific Compliance Program Guidance (ICPG) for the first time since...

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Healthcare Regulatory Check-Up Newsletter | February 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for February 2025, including long-awaited proposed and final rules regarding the Health Insurance Portability and...

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CMS Updates SNF Attachment Guidance Ahead of May 1 Enrollment Deadline

Skilled nursing facilities (SNFs) historically have been required to disclose ownership and managerial control information as part of their Medicare enrollment. However, these requirements were...

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CMS Poised for Medicare, Medicaid Integrity Enforcement Actions

The Trump administration and 119th Congress are preparing to reduce federal expenditures by targeting Medicare and Medicaid fraud, waste, and abuse. Medicare enrollment revocations, Medicaid enrollment...

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Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights key regulatory and enforcement activity for March 2025. This month features: - Noteworthy enforcement actions demonstrating that the...

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Healthcare Regulatory Check-Up Newsletter | April 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2025, including Centers for Medicare & Medicaid Services (CMS) updates to Medicare Advantage (MA)...

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