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Cost-Sharing

Dentons

Ep. 31 – Implementing a Policy to Manage “Non-Routine” Cost-Sharing Waivers and Write-Offs

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Most healthcare providers understand that routinely waiving patient cost-sharing obligations creates compliance issues under the Anti-Kickback Statute, the Civil Monetary Penalties Law, and third-party payor agreements which...more

Mintz - Health Care Viewpoints

The OIG Issues New FAQs on Financial Assistance Policies and Marketing to Patients

On July 8, 2024, the Office of Inspector General (OIG) updated its General Questions on Fraud and Abuse Authorities (FAQs) related to the Anti-Kickback Statute (AKS) and the Beneficiary Inducement Prohibition of Civil...more

Groom Law Group, Chartered

Latest Update to the Ongoing Challenge to the ACA’s Preventive Services Mandate

On June 21, 2024, the United States Court of Appeals for the Fifth Circuit (“Fifth Circuit”) issued its ruling in Braidwood v. Becerra. The court determined that the Affordable Care Act’s (“ACA”) requirement that group...more

Hall Benefits Law

DOL, HHS, and Treasury Release FAQs about No Surprises Act after TMA III

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The U.S. Departments of Labor (DOL), Health and Human Services (HHS), and Treasury, along with the Office of Personnel Management (OPM), released FAQs about the implementation of Title I of Division BB of the Consolidated...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

California Appeals Court Finds Employer’s Arbitration Agreement With Cost-Sharing and Out-of-State Law Provisions Unconscionable

In a recent ruling, a California appeals court found an arbitration agreement with an eyewear store employee that was presented on a take-it-or-leave-it basis required an arbitrator to apply the laws of another state,...more

McCarter & English, LLP

New Jersey Statutory Update Part I

Every year, the New Jersey legislature passes statutes that impact healthcare beyond rate increases under the Medicaid program. Last year was no different, and the discussion below highlights some of those statutes, such as...more

Holland & Knight LLP

DOE Announces Award Negotiations Updates for Large Capital Projects

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The U.S. Department of Energy, Office of the Under Secretary for Infrastructure (S3) (DOE) held a webinar and released a memorandum on May 24, 2024, that provided key updates and guidance regarding award negotiations for...more

Foley Hoag LLP

Summary and Key Considerations of Recent HHS-OIG Advisory Opinion on Pharmaceutical Patient Assistance Program for Rare Disorders

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On April 8, 2024, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited favorable Advisory Opinion (AO 24-02) for a charitable patient assistance program (PAP) focused on rare...more

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 & Knight LLP

Negotiating Cost Share in Technology Investment Agreements

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Note: This is the second article in our series on capturing industrial base funding from the U.S. Department of Defense In our last post, we discussed the Defense Production Act (DPA) and Technology Investment Agreement...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

ACA-Required Coverage of Contraceptive Care Remains Agency Focus

Once again, the U.S. Departments of Labor, Health and Human Services, and the Treasury have issued guidance on the Affordable Care Act’s (ACA) required coverage of contraception without cost sharing, clarifying the permitted...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

Proskauer - Employee Benefits & Executive...

Transparency in Coverage Rules: When Accurate Estimates for Low‑Utilization Items and Services Are Not Available

Last week, the Departments of Labor, Treasury and Health and Human Services (“the Departments”) issued an FAQ about the final Transparency in Coverage rules (“TiC Rules”). This FAQ addresses compliance with cost‑sharing...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

Groom Law Group, Chartered

HHS Drops Appeal in Drug Coupon Case

On January 16, 2023, the Department of Health and Human Services (“HHS”) dropped its appeal of the U.S. District Court for the District of Columbia’s September 29, 2023 decision that vacated a portion of the 2021 Notice of...more

King & Spalding

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

King & Spalding on

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

Holland & Knight LLP

A First Look at the EPA's Clean Ports Program

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The U.S. Environmental Protection Agency's (EPA) Clean Ports Program is a $3 billion program established by the Inflation Reduction Act (IRA) to fund zero-emission (ZE) port equipment and technology, as well as assist U.S....more

Ballard Spahr LLP

Prescription for Chaos: Copay Accumulator Programs Called Into Question

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Summary - Employers taking advantage of copay accumulator programs now face unexpected administrative complications following a recent federal court decision....more

Goodwin

Federal Court Strikes Down Copay Accumulator Programs

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On September 29, 2023, the U.S. District Court for the District of Columbia vacated a Trump-era rule from 2021 that allowed insurers to exclude drug manufacturer co-pay support coupons and assistance from a patient’s annual...more

Nelson Mullins Riley & Scarborough LLP

The Drive for Equitable Healthcare Access: Departments Seek Public Input on Over-the-Counter Preventive Services

On September 29, the Centers for Medicare & Medicaid Services (CMS) reported that the federal Departments of Health and Human Services, Labor, and the Treasury departments are seeking public input on the possibility of...more

Orrick, Herrington & Sutcliffe LLP

California AG advocates for medical payment reforms

California Attorney General Rob Bonta submitted a letter to federal agencies urging the federal government to adopt regulations and statutory protections to help protect patients who may need to use medical credit cards and...more

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