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Health Care Providers Pharmaceutical Industry Prescription Drug Coverage

Akerman LLP - Health Law Rx

When a Gift Becomes a Kickback: Gifts from Florida Pharmacies to Long-Term Care Facilities

The Florida Board of Pharmacy permits pharmacies serving residents and patients at long-term care facilities (nursing homes, ALFs, homes for DD residents, etc.) as either Special Closed System Pharmacies or Community...more

Hogan Lovells

Inflation Reduction Act’s Medicare Part B and D inflation rebates explained

Hogan Lovells on

In the second of a three-part webinar series on the recently enacted Inflation Reduction Act of 2022 (IRA), Hogan Lovells partners Alice Valder Curran and Ken Choe, as well as David Chan, President and General Manager of...more

Hogan Lovells

[Ongoing Program] Unpacking the prescription drug provisions of the Inflation Reduction Act of 2022 - Part 3: Medicare Part D...

Hogan Lovells on

On August 7, 2022, the Senate passed the proposed Inflation Reduction Act of 2022, which includes a number of significant prescription drug-related provisions. The bill generally revives many of the prescription drug...more

Hogan Lovells

[Ongoing Program] Unpacking the prescription drug provisions of the Inflation Reduction Act of 2022 - Part 2: Medicare Part B and...

Hogan Lovells on

On August 7, 2022, the Senate passed the proposed Inflation Reduction Act of 2022, which includes a number of significant prescription drug-related provisions. The bill generally revives many of the prescription drug...more

Hogan Lovells

[Ongoing Program] Unpacking the prescription drug provisions of the Inflation Reduction Act of 2022 - Part 1: Drug price...

Hogan Lovells on

On August 7, 2022, the Senate passed the proposed Inflation Reduction Act of 2022, which includes a number of significant prescription drug-related provisions. The bill generally revives many of the prescription drug...more

American Conference Institute (ACI)

[Webinar] Navigating New Risks and Litigation Challenges Facing Payors in the COVID-19 Context and Beyond - May 13th, 12:00 pm -...

What will the post-pandemic world look like? What risks and challenges will it raise and how to navigate the new litigation landscape? These are the most relevant questions amid the pandemic. To respond to them and provide...more

King & Spalding

U.S. House of Representatives Passes Drug-Pricing Bill

King & Spalding on

On December 12, 2019, the U.S. House of Representatives passed a major Democratic drug-pricing bill, H.R. 3, or the “Elijah E. Cummings Lower Drug Costs Now Act.” If enacted, HHS would be allowed to negotiate the prices of...more

The Volkov Law Group

Avanir Pharmaceuticals Pays More than $108 Million to Settle Kickback Violations

The Volkov Law Group on

Just to repeat myself – pharmaceutical and medical device firms face extraordinary risks of enforcement under the False Claims Act.  While everyone likes to write and focus on FCPA or anti-corruption risks for global drug and...more

Holland & Knight LLP

OIG Considers Drug Pricing History in an Unfavorable Advisory Opinion on Free Drugs

Holland & Knight LLP on

• The OIG issued an unfavorable advisory opinion on a proposed program by which a marketer would provide free drugs to hospitals to utilize in an inpatient setting to treat infantile epilepsy. • Contrary to the typical...more

Sheppard Mullin Richter & Hampton LLP

Blog Series Part 6: CMS Proposed Rule on Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug...

Dual Special Needs Plans - This part 6 of our 7 part series focuses on the provisions regarding dual special needs plans (“D-SNPs”) released by the Centers for Medicare and Medicaid Services (“CMS”) in the proposed rule...more

Sheppard Mullin Richter & Hampton LLP

Blog Series Part 5: CMS Proposed Rule on Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug...

Part D Plan Sponsors’ Access to Medicare Parts A and B Claims Data Extracts - As detailed in previous posts in this series, one major objective that the Centers for Medicare and Medicaid Services (“CMS”) addressed in a...more

Sheppard Mullin Richter & Hampton LLP

Blog Series Part 4: CMS Proposed Rule on Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug...

Quality Improvement Programs - The proposed rule issued November 1, 2018 (the “Proposed Rule”) by the Centers for Medicare and Medicaid Services (“CMS”) includes two technical changes to 42 C.F.R. Part 422. The first change...more

Sheppard Mullin Richter & Hampton LLP

Blog Series Part 3: CMS Proposed Rule on Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug...

Medicare Advantage and Part D Preclusion List - The proposed rule issued November 1, 2018 (the “Proposed Rule”) by the Centers for Medicare and Medicaid Services (“CMS”) includes a number of regulatory changes to the...more

Sheppard Mullin Richter & Hampton LLP

Blog Series Part 2: CMS Proposed Rule on Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug...

Requirements for MA Plans Offering Additional Telehealth Benefits - As part of the proposed rule issued November 1, 2018 by the Centers for Medicare and Medicaid Services (“CMS”) regarding updates to the Medicare Advantage...more

Sheppard Mullin Richter & Hampton LLP

Blog Series: CMS Proposed Rule on Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit,...

On October 26, 2018, the Centers for Medicare and Medicaid Services (“CMS”) released for viewing a proposed rule that includes significant changes for Medicare Advantage organizations (“MAOs”), Part D prescription drug plan...more

Sheppard Mullin Richter & Hampton LLP

Health Plans and Pharmacy Benefit Managers – Past and Future

Historically, health plans and pharmacy benefit managers (“PBMs”) have been uncomfortable neighbors. Plans provide drug coverage, but contract out the provision of such drugs to independent PBMs. PBMs in turn earn market...more

Goodwin

FDA Commissioner Gottlieb Gives Speech on Biosimilars

Goodwin on

Earlier today, FDA Commissioner Scott Gottlieb, MD, gave a speech focusing on biosimilars at America’s Health Insurance Plans’ National Health Policy Conference in Washington, D.C. In his speech, Commissioner Gottlieb...more

Alston & Bird

Updates on Biosimilar Reimbursement Pathways in the Face of a Changing Market

Alston & Bird on

Though the biosimilars market has evolved, and more companies are seizing the opportunities, reimbursement regulations have been unclear at best. Our Health Care Group untangles the latest rules from the Centers for Medicare...more

Mintz - ML Strategies

Health Care Update - August 2015 #2

Mintz - ML Strategies on

Major Medicaid Drug Payment Rule Under OMB Review: Last week a highly anticipated rule that could set the standards for the Medicaid Drug Rebate program arrived at the White House for final review. The Medicaid Outpatient...more

BakerHostetler

Following FDA’s First Biosimilar License, CMS Issues Guidance on Reimbursement for Biosimilars

BakerHostetler on

On March 6, 2015, FDA released a statement announcing its issuance of the first biosimilar license to Zarxio. In the same month, CMS issued a number of guidance documents addressing reimbursement for biosimilars under the...more

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