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Centers for Medicare & Medicaid Services (CMS) Cost-Sharing

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 & Hart LLP

Patient Inducements: Law and Limits

Holland & Hart LLP on

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

Foley & Lardner LLP on

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

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

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

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

Mintz - Health Care Viewpoints

CMS Releases Draft Part One Guidance on the Maximum Monthly Cap on Cost-Sharing Payments Program to Part D Plans

Most of the recent focus around the implementation of the Inflation Reduction Act (IRA) by the press and the industry has been on the Medicare Drug Price Negotiation Program and its potential impact on manufacturers. But the...more

ArentFox Schiff

No More Surprise Medical Bills: Providers Score Yet Another Victory as Texas Court Again Vacates Provisions of Biden...

ArentFox Schiff on

On August 24, 2023, health care providers in Texas scored yet another victory when a federal court vacated additional portions of the Biden Administration’s rulemaking under the federal No Surprises Act (the Act). This marked...more

McDermott Will & Emery

CMS Releases the CY 2024 Advance Notice for Medicare Advantage and Part D

On February 1, 2023, the US Centers for Medicare & Medicaid Services (CMS) released the Advance Notice of Methodological Changes for Calendar Year (CY) 2024 for Medicare Advantage (MA) Capitation Rates and Part C and D...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | October 2022 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant activity between September 21 and October 20, 2022. We review several criminal and civil enforcement actions related to Anti-Kickback Statute...more

Hogan Lovells

Government declines to appeal ruling in PBM accumulator programs MDRP final rule litigation

Hogan Lovells on

On Tuesday, May 17, 2022, the U.S. District Court for the District of Columbia issued a decision granting the Pharmaceutical Research and Manufacturers of America’s (PhRMA)’s motion for summary judgment and vacating (i.e.,...more

Rivkin Radler LLP

Transparency in Coverage Final Rule Took Effect on July 1

Rivkin Radler LLP on

The Centers for Medicare & Medicaid Services’ Transparency in Coverage Final Rule took effect on July 1, following a six-month delay in implementation to allow payers to come into compliance....more

King & Spalding

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

King & Spalding on

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

Blank Rome LLP

Surprise! Federal Court Invalidates CMS Arbitration Procedure under No Surprises Act

Blank Rome LLP on

The Eastern District of Texas recently issued its opinion in Texas Medical Association v. United States Department of Health and Human Services, et al., invalidating key portions of regulations implementing the out-of-network...more

King & Spalding

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

King & Spalding on

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

McGuireWoods Consulting

The Courts and Healthcare Policy - August 2021

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

Chambliss, Bahner & Stophel, P.C.

HHS and Other Agencies Issue Interim Final Rule on Surprise Billing

Earlier this month, the U.S. Department of Health and Human Services, Department of Labor, Department of the Treasury, and the Office of Personnel Management issued an interim final rule with a comment period on the issues of...more

Husch Blackwell LLP

Federal Guidance On Balance Billing: The No Surprises Act And Its Interim Final Rule: Part I

Husch Blackwell LLP on

On July 1, 2021, the Office of Personnel Management (“OPM”), the Internal Revenue Service (“IRS”), the Department of Treasury (“Treasury”), the Employee Benefits Security Administration (“EBSA”), the Department of Labor...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

Tucker Arensberg, P.C.

FAQs Issued About COVID Diagnostic Testing and Vaccinations

The CMS, DOL and Treasury Departments recently and jointly issued FAQs about how group health plans are required to cover COVID-19 Diagnostic Testing without cost-sharing. The guidance makes clear that private group health...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

McGuireWoods LLP

Fraud and Abuse Rules Part II: Amended EHR and New Cybersecurity Donation Safe Harbors and Exceptions

McGuireWoods LLP on

As discussed in a previous McGuireWoods alert, the U.S. Department of Health and Human Services (HHS) published final rules expected to be effective Jan. 19, 2021, that significantly amend the Physician Self-Referral Law...more

Manatt, Phelps & Phillips, LLP

Oregon Public Option Report: An Evaluation and Comparison of Proposed Delivery Models

Section 9 of Senate Bill 770 (SB 770), signed into law in 2019, directed the state of Oregon to engage in an analysis to help policymakers develop policy around a public option or Medicaid buy-in model for Oregon. The goal of...more

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