News & Analysis as of

Patient Protection and Affordable Care Act (PPACA) Final Rules Prescription Drugs

The Patient Protection and Affordable Care Act (PPAC), also known as Obamacare, is a United States federal statute passed in March of 2010. The Act creates a nationwide insurance system and provides federal... more +
The Patient Protection and Affordable Care Act (PPAC), also known as Obamacare, is a United States federal statute passed in March of 2010. The Act creates a nationwide insurance system and provides federal subsidies to reduce the number of uninsured citizens. less -
Goodwin

Health Headlines: July 2025

Goodwin on

Welcome to the sixth issue of Health Headlines, a newsletter created by lawyers in our Healthcare practice....more

ArentFox Schiff

New ADR Rule to Govern Disputes Between 340B Covered Entities and Drug Manufacturers

ArentFox Schiff on

Disputes between 340B Drug Pricing Program-covered entities and the drug manufacturers required to sell outpatient drugs to those entities at discounted prices will be governed by an alternative dispute resolution (ADR)...more

Hogan Lovells

CMS finalizes regulation specifying all covered prescriptions drugs are essential health benefits

Hogan Lovells on

On April 2, 2024, the Centers for Medicare & Medicaid Services (CMS) released the 2025 Notice of Benefit and Payment Parameters (NBPP) final rule (Final Rule), finalizing policies applicable to qualified health plans offered...more

Ballard Spahr LLP

HHS Announces Temporary Copay Accumulator Non-Enforcement Policy

Ballard Spahr LLP on

The United States Department of Health and Human Services (HHS) has filed court pleadings stating that it does not intend to initiate enforcement actions against plans that maintain copay accumulator programs....more

Fisher Phillips

Departments Delay Enforcement of Transparency Disclosure Requirements

Fisher Phillips on

Group health plan sponsors soon will face daunting new disclosure and transparency requirements under multiple laws including the Affordable Care Act (ACA), the No Surprises Act (the Act) and the Consolidated Appropriations...more

Sheppard Mullin Richter & Hampton LLP

Federal Government Announces Enforcement Discretion, Deferral For Certain Price Disclosures And Future Rulemakings

Health plans and issuers racing to implement overlapping price transparency and disclosure requirements in response to the Transparency in Coverage final rule (TiC Final Rule) and the Consolidated Appropriations Act, 2021...more

McDermott Will & Schulte

Agencies Issue Final Employer Healthcare Price Transparency Rule

McDermott Will & Schulte on

On October 29, 2020, the US Departments of Health and Human Services, Labor and Treasury (collectively, the Departments) issued the Transparency in Coverage final rule (the Rule), along with a fact sheet, setting forth...more

Mintz - Health Care Viewpoints

ML Strategies Health Care Preview - May 2019 #4

We are a few legislative days from the Memorial Day recess with the trajectory of issues like drug pricing and surprise medical billing still emerging. The House has passed several drug pricing bills in the past month, with...more

K&L Gates LLP

K&L Gates Triage: Triage in 2019: Health Care Topics to Watch in the New Year

K&L Gates LLP on

As K&L Gates begins its third season of Triage: Rapid Legal Lessons for Busy Health Care Professionals, Hilary Bowman previews several topics that the health care practice group anticipates will have a significant impact on...more

Hogan Lovells

HRSA Releases Ceiling Price and CMP Final Rule

Hogan Lovells on

The Health Resources and Services Administration (HRSA) released its Final Rule regarding the calculation of the 340B ceiling price and the imposition of civil monetary penalties (CMPs) on manufacturers that knowingly and...more

McCarter & English, LLP

Health Law Insights Newsletter - Issue 10 - June 2016

McCarter & English, LLP’s Health Care Group presents Issue 10 of the Health Law Insights, which discusses the latest legal issues in the health care industry. NATIONAL - Drug Diversion Case Raises Red Flags for...more

Morgan Lewis

The CMS Final Covered Outpatient Drug Rule Addresses Many Industry Concerns

Morgan Lewis on

The rule implementing the Medicaid Drug Rebate Program is less burdensome and costly than what was originally proposed. In 2010, the Affordable Care Act (ACA) directed the US Centers for Medicare and Medicaid Services...more

Foley Hoag LLP

Medicaid Program: Covered Outpatient Drugs, Final Rule with Comment Period Summary

Foley Hoag LLP on

On January 21, 2016, the Centers for Medicare & Medicaid Services (CMS) released the final rule implementing the prescription drug rebate provisions enacted as part of the health care reform law, the Affordable Care Act...more

Epstein Becker & Green

CMS Issues Final Rule on Covered Outpatient Drugs

On January 21, 2016, the Centers for Medicare & Medicaid Services (“CMS”) released a final rule (“Final Rule”) addressing key areas of Medicaid reimbursement for outpatient drugs and changes made to the Medicaid Drug Rebate...more

King & Spalding

CMS Issues Pared-Down Final Rule on Medicare Part D and Medicare Advantage

King & Spalding on

CMS recently issued a Final Rule with respect to the Medicare Part D and Medicare Advantage programs (the “Final Rule”) implementing certain Affordable Care Act provisions. The Final Rule follows a January 10, 2014 Notice of...more

King & Spalding

CMS Medicaid Rule Greatly Restricts 2014 Mandatory Prescription Drug Coverage for “Expansion Population” - May Also Impact...

King & Spalding on

On July 15, 2013, CMS issued its Final Rule addressing prescription drug coverage for the Medicaid expansion population. Among other things, the Final Rule defines the scope of the ten applicable “essential health benefits”...more

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