News & Analysis as of

Cost-Sharing Medicare

Holland & Knight LLP

Holland & Knight Health Dose: May 7, 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

Arnall Golden Gregory LLP

OIG Approves Arrangement Regarding Patient Assistance Funds for Patients With Certain Rare Diseases, Pending Medicare Part D...

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-02 (the “Opinion”) to a nonprofit organization that provides...more

Holland & Hart LLP

Patient Inducements: Law and Limits

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Although often well-intentioned, offering free or discounted items or services to patients (e.g., gifts, rewards, writing off copays, free screening exams, free supplies, etc.) may violate federal and state laws governing...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

King & Spalding

OIG Issues Favorable Advisory Opinion Regarding the Subsidization of Certain Medicare Cost-Sharing Obligations in the Context of a...

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On December 21, 2023, the OIG issued a favorable advisory opinion (Advisory Opinion 23-11) regarding the proposed subsidization of certain Medicare cost-sharing obligations in the context of a clinical trial. The...more

McGuireWoods LLP

Medical Device Legal News with Sam Bernstein: Episode 19

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The HHS Office of Inspector General issues a favorable advisory opinion regarding a sponsor’s payment of cost-sharing amounts in a Medicare Category B IDE Clinical Study; the FDA issues guidance regarding the use of Digital...more

Nelson Mullins Riley & Scarborough LLP

Expanded Behavioral Health Access, Enhanced Price Transparency, and the 340B Remedy in the CY 2024 Hospital Outpatient and...

The Centers for Medicare & Medicaid Services (CMS) has announced new measures to enhance access to behavioral health services for Medicare beneficiaries and improve hospital price transparency as part of the final rule for...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

Mintz - Health Care Viewpoints

Mintz IRA Update — Other Key IRA Programs and Developments: The Medicare Prescription Drug Inflation Rebate Program and Maximum...

Although most of the recent focus around the implementation of the Inflation Reduction Act (“IRA”) by the press and industry stakeholders has been on the Medicare Drug Price Negotiation Program, the IRA has several other...more

MoFo Life Sciences

Supreme Court Denies Review Of Cost Sharing Assistance Program

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The U.S. Supreme Court recently declined to review a Second Circuit decision that blocked Pfizer from implementing a cost sharing assistance program. Pfizer had sought to cover out-of-pocket expenses for financially eligible...more

Holland & Knight LLP

OIG Advisory Opinion Highlights Further Concerns for Patient Assistance Programs

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Patient assistance programs (PAPs) that seek to subsidize patient co-payments for drugs covered by Medicare may involve compliance challenges. A recent U.S. Department of Health and Human Services (HHS) Office of Inspector...more

King & Spalding

OIG Declines to Impose Sanctions Against Device Manufacturer’s Medicare Cost-Sharing Subsidy in Clinical Trial

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On March 11, 2022, OIG issued Advisory Opinion No. 22-05 in which it responded to a request for an advisory opinion regarding a proposed subsidization of certain cost-sharing obligations in the context of a clinical trial...more

Robinson+Cole Health Law Diagnosis

Advisory Opinion 22-05: OIG Declines to Impose Sanctions Against Device Manufacturer’s Medicare Cost-Sharing Subsidy in Clinical...

On March 16, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-05 (Advisory Opinion) in which it declined to impose sanctions against a medical device manufacturer (Requestor) that proposes to pay...more

Sheppard Mullin Richter & Hampton LLP

OIG Advisory Opinion Alert: Yet Another Favorable Decision for Medical Device Manufacturers

On Thursday, March 16, the Office of the Inspector General for the Department of Health and Human Services (“OIG”) issued OIG Advisory Opinion (“AO”) No. 22-05, relating to subsidization of certain Medicare cost-sharing...more

King & Spalding

OIG Issues Advisory Opinion Permitting Cost-Sharing for Medicare-Reimbursable Items and Services in a Clinical Trial

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On November 19, 2021, OIG issued Advisory Opinion No. 21-17 in which it responded to a request for an advisory opinion regarding a proposed subsidization of certain Medicare cost-sharing obligations in the context of a...more

White & Case LLP

HHS Report Reiterates Biden Administration Support for Wide-Ranging Action to Address Drug Prices

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On September 9, 2021, the Department of Health and Human Services ("HHS") released its widely anticipated "Comprehensive Plan for Addressing High Drug Prices." The HHS report supports far-reaching legislative and...more

McGuireWoods Consulting

The Courts and Healthcare Policy - April 2021

2020 saw the courts continuing to play an important role in health policy with several notable lawsuits related to the Affordable Care Act (ACA). Several other Trump administration policies were challenged, including Medicare...more

McGuireWoods LLP

Update: House Passes, President to Sign American Rescue Plan With Senate Healthcare Provisions

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On March 10, 2021, the U.S. House of Representatives narrowly passed H.R. 1319, the American Rescue Plan Act of 2021, on a largely partisan basis by a 220-211 vote. Final passage came four days after the U.S. Senate amended...more

Manatt, Phelps & Phillips, LLP

Year-End Appropriations Bill Includes Myriad Medicare Policy Changes

The Big Picture - Until late December, few if any Medicare policy changes were anticipated as part of a year-end healthcare package, barring extensions of funding for programs that otherwise would have expired. But after...more

King & Spalding

CMS Implements Requirements that Medicare and Most Private Health Plans Cover COVID-19 Vaccines Without Cost-Sharing Requirements

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On October 28, 2020, CMS released an interim final rule with comment period (IFC) that implements several CARES Act requirements to prepare for the availability of a COVID-19 vaccine. Among other changes, the IFC establishes...more

King & Spalding

OIG Issues Advisory Opinion for Pharmaceutical Manufacturer’s Cost-Sharing Assistance Proposal

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On September 18, 2020, OIG issued Advisory Opinion No. 20-05 analyzing a pharmaceutical manufacturer’s proposal to offer direct cost-sharing assistance to Medicare beneficiaries prescribed certain of the manufacturer’s new...more

Manatt, Phelps & Phillips, LLP

OIG Advisory Opinion Rejects Pharmaceutical Manufacturer’s Proposed Beneficiary Cost-Sharing Program

On September 18, 2020, the Department of Health and Human Services Office of Inspector General (OIG) issued an unfavorable Advisory Opinion, No. 20-05 (the Opinion), that a pharmaceutical manufacturer’s (Requestor) proposed...more

Manatt, Phelps & Phillips, LLP

The Benefits of Capping Medicare Part D Out-of-Pocket Costs Will Vary Substantially Depending on the Drugs That Beneficiaries Use

Although delayed as a result of the COVID-19 public health emergency, there are persistent and ongoing efforts to reform the Medicare Part D benefit. Since its June 2016 Report to Congress, the Medicare Payment Advisory...more

Hinshaw & Culbertson - Health Care

Medicare Telehealth COVID-19 Waivers Expand Opportunities to Provide Telehealth Services to Medicare Beneficiaries

The Coronavirus Preparedness and Response Supplemental Appropriations Act (the "Act") includes a provision allowing the U.S. Department of Health and Human Services (HHS) to waive certain Medicare telehealth payment...more

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