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Biologics Medicare Pharmaceutical Industry

Alston & Bird

Health Care Week in Review: CMS Finalizes the TCET Pathway for Breakthrough Technologies; HRSA Awards Health Centers Funding for...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Cozen O'Connor

Cozen Currents: Is Harris the Answer?

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The Cozen Lens - While it’s becoming ever clearer Vice President Harris is likely to be the Democratic nominee following President Biden’s decision to step aside, it’s less clear what the impact will be on the presidential...more

Alston & Bird

Health Care Week in Review: House Passes Appropriations Bill and Senate Expected to Vote Shortly, CMS Unveils the ACO Primary Care...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Health Care Week in Review: Congress Passed a New Continuing Resolution for FY 2024 to Avert a Government Shutdown; Biden...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Health Care Week In Review: HHS Selects the First 10 Drugs for Medicare Drug Price Negotiation

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q3 2023 and Beyond

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As the life sciences industry continues to expand and grow increasingly complex, so does its legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging laws and...more

Goodwin

Bipartisan Legislation Introduced to Increase Access to Biosimilars in Medicare Plans

Goodwin on

On April 26, Representatives Paul D. Tonko (D-NY) and Bob Gibbs (R-OH) introduced the Star Rating for Biosimilars Act. The proposed legislation would direct the U.S. Department of Health & Human Services (HHS) to evaluate...more

Akin Gump Strauss Hauer & Feld LLP

What's New in Washington - September 2020

As the November elections rapidly approach, Congress faces a number of key legislative deadlines, including the need to fund federal agencies and extend expiring federal programs at the conclusion of the current fiscal year...more

Robinson+Cole Health Law Diagnosis

CMS Amends Regulations to Lower Drug Prices and Reduce Out-Of-Pocket Expenses in Medicare Advantage and Part D Prescription Drug...

The Centers for Medicare and Medicaid Services (CMS) announced a final rule, to be published on May 23, 2019, amending the Medicare Advantage program (Part C) and Prescription Drug Benefit program (Part D) regulations. ...more

Goodwin

Oversight Committee Launches “Sweeping Drug Price Investigation” Regarding Biologics

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On Jan. 14, Rep. Elijah E. Cummings, the Chairman of the Committee on Oversight and Reform, issued a press release that his office had sent letters to 12 drug companies seeking “detailed information and documents about the...more

Epstein Becker & Green

CMS Releases Medicare Advantage and Part D Drug Pricing Proposed Rule for Contract Year 2020

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On November 26, 2018, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule titled “Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses” (“Proposed Rule”)....more

Holland & Knight LLP

New Proposed Medicare Part B Drug Reimbursement Model Raises Questions

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• The Centers for Medicare & Medicaid Services (CMS) has announced a new proposed reimbursement model for certain Medicare Part B drugs and biologicals. • The proposed structure, called the International Pricing Index (IPI)...more

Hogan Lovells

CMS considers linking Medicare drug payment rates to international prices

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On October 25, 2018, the Centers for Medicare & Medicaid Services (CMS) issued an advance notice of proposed rulemaking (ANPRM) describing a potential mandatory model to test Medicare reimbursement based on an "International...more

Alston & Bird

Alston & Bird Healthcare Week in Review

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Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

Epstein Becker & Green

Comment Deadline Approaches for CMS’s Proposed Changes to Medicare Advantage and Part D Programs for CY 2019 – Part 2: Beneficiary...

On November 28, 2017, 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,...more

Alston & Bird

Alston & Bird Healthcare Week in Review

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On November 15, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Assessing User Fees Under the Biosimilar User Fee Amendments of 2017. The Biosimilar User Fee Amendments of 2017 (BsUFA II)...more

Mintz - Health Care Viewpoints

CMS Urged To Reverse Obama-Era Biosimilar Reimbursement Policy

A bipartisan congressional effort is underway to convince CMS to reverse its biosimilar reimbursement policy implemented under the Obama administration. We discussed the current reimbursement policy in a March 2016 blog post...more

Mintz - Health Care Viewpoints

New State Substitution Laws, and a Busy Spring for Biosimilars

We recently updated our chart that tracks state biosimilar substitution laws to include new laws in Iowa and Montana. These new laws bring the total number of states with biosimilar substitution laws to 27, plus Puerto Rico....more

McDonnell Boehnen Hulbert & Berghoff LLP

Congress Jumps on Bandwagon to Reduce Biologic Drug Exclusivity Term

Ever since the Biologics Price Competition and Innovation Act (BPCIA) was passed along with the rest of the healthcare law commonly called "Obamacare" in 2010, the Obama Administration has included in every budget a proposal...more

Alston & Bird

A&B Healthcare Week in Review

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I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more

Foley & Lardner LLP

CMS Proposed Rule Reduces Drug Payments & Requires Implementation of Value-Based Purchasing Tools

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Proposed Rule - Recently, CMS published a Proposed Rule seeking to test a new model for how Medicare pays for drugs and biologicals paid under the Medicare Part B program. With the goals of determining whether...more

Manatt, Phelps & Phillips, LLP

Biosimilars Coding & Reimbursement Significance under Medicare Part B

On April 15, 2015, CMS issued a preliminary recommendation for a HCPCS code for Zarxio, the first biosimilar product ever to be approved by the FDA. CMS’s recommendation provides the first indication of how the agency will...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: House Ways & Means Committee Holds Markup; Makes Significant Legislative Changes to Health Care Bills... Senate Finance Committee Holds Markup on Medicare Appeals Process Bill... CMS Issues Final Rule on...more

Mintz - Health Care Viewpoints

States Move to Impose Limits on Biosimilar Drug Substitution

In early April, Colorado joined multiple other states in passing a biosimilar substitution law that addresses the circumstances under which an FDA-approved interchangeable biosimilar product may be substituted for the...more

McDermott Will & Emery

Significant Proposed Changes for Federal Health Care Programs in President’s Fiscal Year 2014 Budget Plan

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On April 10, 2013, President Obama released his budget proposal for fiscal year (FY) 2014 (the Budget). The President reiterated his long-standing goal of reducing the deficit by $4.3 trillion over 10 years and his...more

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