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Centers for Medicare & Medicaid Services (CMS) Advisory Opinions Medicare

Baker Donelson

Relocation of Physician-Owned Hospitals: CMS Advisory Insights

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The Centers for Medicare and Medicaid Services (CMS) issued CMS Advisory Opinion No. CMS-AO-2025-1 on February 26, 2025, blessing the relocation of a physician-owned hospital. The hospital planned to relocate eight miles from...more

McGuireWoods LLP

CMS Opinion Offers Guidance on Relocation of Physician-Owned Hospitals

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On Feb. 26, 2025, McGuireWoods successfully assisted a physician-owned hospital in obtaining a favorable advisory opinion from the Centers for Medicare & Medicaid Services (CMS) regarding its proposal to relocate the entire...more

Bass, Berry & Sims PLC

More Losses than Gains? OIG Declines to Approve Certain Medicare Advantage Gainsharing Arrangements in Advisory Opinion 24-08

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On September 13, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 24-08, in which it declined to approve a proposal by a Medicare Advantage organization (MAO)...more

McDermott Will & Schulte

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

Foley & Lardner LLP

OIG Opines on Subsidizing Medicare Cost-Sharing for Clinical Trials

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In a recent Advisory Opinion No. 23-11 (Advisory Opinion), the Office of Inspector General (OIG) opined that it will not impose administrative sanctions against a clinical trial sponsor covering up to $2,000 of a clinical...more

Sheppard Mullin Richter & Hampton LLP

OIG Permits Medical Device Manufacturer’s Cost-Sharing Subsidies for Medicare Beneficiaries in Clinical Trial

Last month, in the last advisory opinion issued by the Office of Inspector General (“OIG”) in 2023 – Advisory Opinion No. 23-11 (the “Opinion”) – OIG “blessed” an arrangement involving a medical device manufacturer (the...more

McDermott Will & Schulte

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 the False Claims Act...more

Sheppard Mullin Richter & Hampton LLP

New OIG Opinion Permits Gift Cards to Beneficiaries in Limited Circumstances

On March 24, 2023, the Office of Inspector General (“OIG”) issued Advisory Opinion 23-03 (the “Opinion”), in which it decided not to impose sanctions on an Arrangement to provide prepaid gift cards to patients for certain...more

McDermott Will & Schulte

Healthcare Regulatory Check-up Newsletter | July 2022 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant activity between June 21 and July 20, 2022. During this period, the Supreme Court of the United States overturned Roe v. Wade, which historically...more

King & Spalding

OIG Issues Advisory Opinion for Alzheimer’s Study to Subsidize PET Imaging Coinsurance Costs

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On September 29, 2021, OIG issued Advisory Opinion No. 21-13 analyzing a proposal for a clinical study that would involve subsidizing Medicare beneficiaries’ cost-sharing obligations in connection with a clinical study...more

Nelson Mullins Riley & Scarborough LLP

What the New CMS Advisory Opinion Means for Providers

The Centers for Medicare & Medicaid Services (CMS) has issued Advisory Opinion No. CMS-AO-2021-01 on whether a wholly-owned physician practice that provides designated health services (“DHS”) through one or more wholly-owned...more

Bass, Berry & Sims PLC

CMS Advisory Opinion Provides Flexibility Under Stark for Group Practice Structures Involving Wholly-Owned Physician Practice...

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The Centers for Medicare & Medicaid Services (CMS) recently issued Advisory Opinion No. CMS-AO-2021-01, clarifying that physician groups that furnish designated health services (e.g., laboratory, imaging) through wholly-owned...more

Dorsey & Whitney LLP

CMS Finalizes Changes to the Stark Advisory Opinion Regulations; 2020 DHS Code List and CPI-U Updates

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In the calendar year 2020 Medicare physician fee schedule final rule (“PFS”), which was published in the Federal Register on November 15, 2019 (available here), CMS finalized changes to the advisory opinion process under the...more

Baker Donelson

CMS Advisory Opinion 2019-01 Approves Physician-Owned Hospital's Plan to Use Dormant Remote Operating Rooms

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A physician-owned hospital with operating rooms at a second campus that have been inactive since before March 23, 2010 received approval from CMS to include such spaces within the hospital's aggregate capacity limits,...more

McDermott Will & Schulte

CMS Publishes Proposed Amendments to Stark Law Advisory Opinion Regulations

On July 29, 2019, the Centers for Medicare & Medicaid Services (CMS) published the CY 2020 Medicare Physician Fee Schedule Proposed Rule, which included substantial changes to the physician self-referral law (Stark Law)...more

Holland & Knight LLP

Healthcare Law Update: September 2018

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Regulation - CMS Contemplating Telemedicine Changes - The Centers for Medicare & Medicaid Services (CMS) recently published what it described as a "major proposed rule" that covers a number of topics that could have...more

Baker Donelson

OIG Allows Cost-Sharing Waivers Among Fire Departments for Ambulance Services in Advisory Opinion 18-08

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A group of six government-operated fire departments has received a green light from the Office of Inspector General (OIG) to enter into a mutual aid agreement to provide backup emergency ambulance services and to bill for...more

Baker Donelson

OIG Issues Favorable Advisory Opinion Regarding Employee Lease Arrangement Between Related Entities

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Reviewing an arrangement involving the lease of employees and other operational and management services between a health system and its related psychiatric hospital, the OIG issued a favorable advisory opinion, Advisory...more

Mintz - Health Care Viewpoints

OIG Issues Favorable Advisory Opinion of Hospital Leasing Arrangement

Last week, the Office of Inspector General (OIG) for the Department of Health and Human Services published Advisory Opinion 15-10 (Opinion). The Opinion addressed a hospital system’s proposal to lease non-clinician employees...more

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