News & Analysis as of

Request For Information Prescription Drugs

Holland & Knight LLP

CMS Releases CY 2025 OPPS and ASC Proposed Rule

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The Centers for Medicare & Medicaid Services (CMS) has released the calendar year (CY) 2025 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule (CMS-1809-P),...more

Holland & Knight LLP

Holland & Knight Health Dose: March 12, 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

Quarles & Brady LLP

340B Developments in 2024 – Litigation and Legislation

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Although we are only two and a half months in, 2024 has already seen its fair share of impactful 340B developments on both the litigation and legislative fronts....more

Holland & Knight LLP

Holland & Knight Health Dose: March 5, 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

Foley Hoag LLP

Federal Regulators Examine the Role of Drug Supply Middlemen on Drug Shortages

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The Federal Trade Commission (FTC) and the Department of Health and Human Services (HHS) are soliciting public comments on the root causes of and potential solutions to drug shortages. The request for information (RFI)...more

Foley Hoag LLP - Medicaid and the Law

Gang of Six Introduces Historic 340B “Discussion Draft” Legislation

On February 2, 2024, the “gang of six”—a bipartisan group of six senators who have traditionally championed reforms to the 340B program1 —introduced a discussion draft of a bill that would modify the program that provides...more

McDermott+

McDermottPlus Check-Up: December 8, 2023

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Senate Finance Committee Examines Drug Shortages. The hearing addressed concerns and explored potential solutions related to drug shortages in the United States, particularly focusing on essential medications. The hearing...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

McDermott+

McDermottPlus Check-Up: September 8, 2023

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CONGRESS - House Republicans Release Healthcare Package. On September 6, House Republicans unveiled the Lower Costs, More Transparency Act, a draft package of healthcare transparency provisions, pharmacy benefit manager...more

Holland & Knight LLP

Holland & Knight Health Dose: June 13, 2023

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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

Holland & Knight LLP

CMS Releases CY 2022 OPPS and ASC Proposed Rule

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The Centers for Medicare & Medicaid Services (CMS) on July 19, 2021, released its calendar year (CY) 2022 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - May 2021 #2

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PhRMA Suit Challenges Co-Pay/Accumulator Portion of December 2020 Medicaid Rule - On May 21, 2021, Pharmaceutical Research and Manufacturers of America (PhRMA) filed suit in the US District Court for the District of...more

Epstein Becker & Green

Face or Fingerprint? The DEA Revisits Biometric Identifiers for e-Prescribing Controlled Substances

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On April 21, 2020, the Drug Enforcement Administration (DEA) published a Request for Information (“RFI”) that reopened the comment period for an interim final rule that was published March 31, 2010 (75 FR 16236) (the “2010...more

Epstein Becker & Green

HHS OIG Proposes Anti-Kickback Safe Harbor Amendments to Regulate and Restrict the Provision of Manufacturer Remuneration to Plan...

On January 31, 2019, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a proposed rule (“Proposed Rule”) that would restrict safe harbor protection under the federal Anti-Kickback...more

Sheppard Mullin Richter & Hampton LLP

TRICARE: Defense Health Agency Issues Request for Information Regarding Formulary Management – Submission Deadline: February 5,...

The Defense Health Agency (DHA), which manages the TRICARE health care benefits, has issued a Request for Information (RFI) regarding inpatient-clinic administered pharmaceuticals formulary management. In other words,...more

Baker Donelson

Administration Drug Pricing Proposals Could Reduce Provider Payments

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As the Trump Administration moves forward with proposed policy changes to address high drug prices, a common theme is emerging: a number of the proposals have the potential to reduce Medicare reimbursement to hospitals and...more

Foley & Lardner LLP

The Battle Over Drug Pricing: First Shot Targets Pharmacy Benefit Managers

Foley & Lardner LLP on

On July 18, 2018, the federal Department of Health and Human Services (HHS) sent a proposed rule to the Office of Management and Budget (OMB) for review and clearance. While the substance of the proposed rule is not yet...more

Akin Gump Strauss Hauer & Feld LLP

Trump Administration Drug Pricing Blueprint: Overview and Analysis

• The administration’s drug pricing Blueprint combines proposals that are already under way with new initiatives that may or may not be adopted. • Many of the more dramatic proposals would require federal rulemaking or...more

Epstein Becker & Green

Comment Deadline Approaches for CMS’s Proposed Changes to Medicare Advantage and Part D Programs for CY 2019 – Part 1: Negotiated...

The Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule titled “Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service,...more

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