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Audits Pharmacies

Proskauer - Health Care Law Brief

NYS DFS Revisits PBM Regulation with Scaled-Back Draft Rules

On February 6, 2024, the New York State Department of Financial Services (“DFS”) released “pre-proposed” consolidated rulemaking related to the business practices of Pharmacy Benefit Managers (“PBMs”) licensed to operate in...more

McDermott Will & Emery

This Week in 340B: December 21, 2023 – January 8, 2024

McDermott Will & Emery on

We’re back from the holidays with updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country as we move into 2024. Each week we comb through the dockets of more than 50 340B...more

Harris Beach PLLC

New York OMIG Posts 2024 Work Plan

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On January 3, 2024, the New York State Office of the Medicaid Inspector General (“OMIG”) posted its 2024 Work Plan. This is the first update since its 2019 – 2020 Work Plan and OMIG notes that the Work Plan does not reflect...more

Gardner Law

REMINDER: Nevada Certification Submission Deadline is June 1

Gardner Law on

Nevada state law requires all drug and device manufacturers doing business in Nevada to complete its Marketing Code of Conduct Annual Filing Form (previously referred to as AB128). Completed forms are due June 1st annually,...more

Oberheiden P.C.

10 Keys to a Successful Pharmacy Audit Appeal

Oberheiden P.C. on

Medicare, Medicaid, and pharmacy benefit manager (PBM) audits can result in substantial losses for pharmacies. If auditors uncover evidence—or apparent evidence—of overpayments, not only can they initiate recoupments, but...more

Bradley Arant Boult Cummings LLP

Attention Healthcare Companies! New Strike Force Based in Nashville Means New Scrutiny - Government Enforcement Update

It’s Time to Review Your Compliance, Data and Auditing Plans - As we near the end of 2018, healthcare providers and companies are understandably focused on 2019 and the trends ahead. In planning for next year, however,...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

Baker Donelson

HRSA Guidance Updates Suggest Tightening of 340B Covered Entity Repayment Rules

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Over the past several months, the Health Resources and Services Administration (HRSA) has issued a number of guidance updates related to the agency's expectations for health care providers participating in the 340B drug...more

Holland & Knight LLP

HHS Issues Proposed 340B Program Omnibus Guidance: Five Things to Watch

Holland & Knight LLP on

The 340B Drug Pricing Program (340B Program), established by Section 602 of the Veterans Health Care Act of 1992, is administered by the Health Resources and Services Administration (HRSA) of HHS. The 340B Program requires...more

BakerHostetler

340B Guidance: Eight Key Points Covered Entities Should Consider

BakerHostetler on

On August 27, 2015, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), released the 340B Drug Pricing Program Omnibus Guidance (Guidance). Referred to...more

King & Spalding

HRSA Publishes Proposed 340B Drug Pricing Program Omnibus Guidance - Comments Due to HRSA on or before Tuesday, October 27, 2015

King & Spalding on

On Friday, August 28, 2015, the Health Resources and Services Administration (“HRSA” or “the Agency”) published in the Federal Register Notice of its proposed “omnibus” or “mega” guidance (“Proposed Guidance”) regarding...more

Manatt, Phelps & Phillips, LLP

Will NYSDEC's Audit Agreement for Retail Pharmacies Provide a Path to Increased Compliance?

Federal and state hazardous waste handling and disposal requirements, which were established to address issues related to industrial waste generators and disposal facilities, are often a complicated and awkward fit for retail...more

Cooley LLP

Blog: HHS OIG Hands Out 2015 Work Plan For Halloween

Cooley LLP on

On Friday October 31, 2014, the U.S. Department of Health & Human Services (HHS) Office of Inspector General (OIG) released its annual “Work Plan” for fiscal year 2015. The Work Plan is a compilation of the OIG’s plans for...more

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