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Medicare Beneficiaries

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

King & Spalding

Transitional Coverage for Emerging Technologies: CMS’s Latest, But Not Necessarily Greatest, Coverage with Evidence Approach

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On August 7, 2024, the Centers for Medicare & Medicaid Services (“CMS” or the “Agency”) issued a final procedural notice (“Notice”) outlining a new Medicare coverage pathway, aimed at achieving timelier and predictable access...more

King & Spalding

D.C. Circuit Upholds Dismissal of Proposed Class Action Against HHS for Home Health Aid Shortage

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On August 9, 2024, the U.S. Court of Appeals for the District of Columbia upheld a lower court’s decision to dismiss a proposed class action accusing HHS of causing a shortage of home health aides willing to assist Medicare...more

Klein Moynihan Turco LLP

Medicare Marketing One-to-One Consent Rules Effective October 1, 2024!

On April 23, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule implementing one-to-one consent rules for Third Party Marketing Organizations (“TPMOs”) that engage in Medicare-related advertising....more

ArentFox Schiff

Investigations Newsletter: FCA Enforcement & Compliance Digest — Summer 2024 False Claims Act Newsletter

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Welcome to the Summer 2024 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and...more

King & Spalding

CMS Issues Proposed Rule Updating Payment Rates and Policies for End Stage Renal Disease and Acute Kidney Injury Dialysis...

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On June 27, 2024, CMS issued a proposed rule updating payment rates and policies under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for renal dialysis services provided to Medicare beneficiaries on or...more

King & Spalding

CMS Releases Fifth Annual Report on Bundled Payments for Care Improvement Advanced Model

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On May 29, 2024, CMS released its fifth annual report evaluating the Bundled Payments for Care Improvement Advanced Model (BPCI Advanced Model). The BPCI Advanced Model is designed to reduce Medicare spending and maintain or...more

King & Spalding

CMS Finalizes Rule Regarding Marketing Changes, Beneficiary Protections, and Coverage for Medicare Parts C and D

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On April 4, 2024, CMS published a final rule implementing certain policy changes to the Medicare Advantage (MA) Program (Medicare Part C) and the Medicare Prescription Drug Benefit Program (Medicare Part D). According to the...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

Sheppard Mullin Richter & Hampton LLP

District Court Elucidates the Meaning of “to Induce” Under the Federal Health Care Program Anti-Kickback Statute

The United States District Court for the Eastern District of Virginia recently dismissed an appeal by the Pharmaceutical Coalition for Patient Access (“PCPA”) that challenged a negative opinion issued by the U.S. Department...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

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

Cornerstone Research

Potential Unintended Economic Impacts of the Inflation Reduction Act on the Pharmaceutical Industry

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The Inflation Reduction Act (IRA) was signed into law in August 2022 with the goal of curbing inflation by, among other things, lowering prescription drug prices. Notable prescription drug provisions of the IRA include the...more

Ankura

Summary: The Government Accountability Office's Report on Medicare Part D Rebates

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On September 5, 2023, the United States Government Accountability Office (GAO) published its report titled Medicare Part D: CMS Should Monitor Effects of Rebates on Plan Formularies and Beneficiary Spending.The report...more

Mintz - Health Care Viewpoints

Mintz IRA Update — The First Anniversary of the Inflation Reduction Act: A Year in Review

August 16, 2023 marked the one-year anniversary of the enactment of the Inflation Reduction Act (“IRA”). The first 365 days since the IRA’s passage brought the implementation of a number of significant changes to the Medicare...more

ArentFox Schiff

Investigations Newsletter: Texas Clinical Laboratory and Owner to Pay $5.7 Million to Resolve Outstanding FCA Judgment

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Texas Clinical Laboratory and Owner to Pay $5.7 Million to Resolve Outstanding FCA Judgment - Defunct BestCare Laboratory Services LLC and its founder will pay $5.7 million to settle an outstanding 2018 False Claims Act...more

White and Williams LLP

Are Syndicated Loans Securities?

The ongoing case of Kirschner v. JP Morgan Chase Bank, N.A., which has traveled through the New York federal court system since 2018, is now before the Second Circuit, who are tasked with deciding the following: are...more

Foley & Lardner LLP

CMS’ Latest Innovation Model – The Making Care Primary (MCP) Model Includes Focus on Social Determinants of Health

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On June 8, 2023, the Centers for Medicare and Medicaid Services (CMS) announced a new voluntary primary care model, the Making Care Primary (MCP) Model. Highlights include the following: The MCP Model will run for 10.5...more

McDermott Will & Emery

CMS Streamlines Medicare Enrollment and Standardizes Nondiscrimination Language

In late January 2023, the Centers for Medicare and Medicaid Services (CMS) issued two updates relevant to provider and supplier organizations enrolled in Medicare: (1) a redesign to the Provider Enrollment, Chain and...more

Mintz - Health Care Viewpoints

CMS Announces Changes to the MSSP Designed to Increase MSSP Participation and Promote Equity within the MSSP

The Centers for Medicare & Medicaid Services (CMS) recently announced changes to the Medicare Shared Savings Program (MSSP) designed to improve equity within the MSSP and increase the percentage of Medicare beneficiaries in...more

King & Spalding

OIG Recommends CMS Use OIG Hospital Compliance Audits to Enhance its Medicare Oversight

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On October 26, 2022, OIG published a report summarizing the results of 12 OIG hospital compliance audits covering Medicare claims paid from 2016 through 2018. OIG recommends, among other things, that CMS follow up on...more

Sheppard Mullin Richter & Hampton LLP

Senate Committee Issues Report On Deceptive Marketing Practices in Medicare Programs

On Monday, we discussed that the Centers for Medicare and Medicaid Services (“CMS”) has heightened oversight of Medicare Advantage (“MA”) organizations’ and Part D sponsors’ marketing practices. We also noted that the United...more

Foley & Lardner LLP

Managed Care & the FCA: Are Courts Getting It Right?

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Courts are grappling with unique questions in the context of managed care programs in False Claims Act (FCA) cases. But are they getting it right? Two questions trending in courts relate to: (1) materiality under the FCA when...more

Harris Beach PLLC

Inspector General Issues Report on Telehealth Services During Pandemic

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Recently, the Office of Inspector General (“OIG”) for the Department of Health and Human Services published its Report on Medicare Telehealth Services During the First Year of the Pandemic: Program Integrity Risks...more

ArentFox Schiff

OIG Reports Indicate the Government's Interest in Balancing Ongoing Telehealth Access With Increased Oversight

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A pair of reports recently issued by the US Department of Health and Human Services (HHS) Office of the Inspector General (OIG) highlight the important role telehealth services have played in ensuring access to medical...more

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