Anil Shankar

Anil Shankar

Foley & Lardner LLP

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HRSA Proposes Civil Monetary Penalties for Drug Manufacturers that Overcharge 340B Covered Entities

The Health Resources and Services Administration (HRSA) within the U.S. Department of Health and Human Services (HHS) published a notice of proposed rulemaking impacting the 340B Drug Pricing Program (340B Program) on June...more

6/19/2015 - 340B Affordable Care Act Civil Monetary Penalty Covered Entities Drug Distribution Drug Manufacturers HRSA OIG Pharmaceutical Manufacturers Pharmacies Prescription Drug Coverage Rulemaking Process

CMS Proposes Major Update to Medicaid Managed Care Regulations

The Centers for Medicare and Medicaid Services (“CMS”) released, on May 26, 2015, the a far-ranging proposal for revising the Medicaid managed care regulations (“Proposed Rule”). The number of individuals enrolled in Medicaid...more

5/28/2015 - 340B Affordable Care Act CMS IMD Long-Term Care Managed Care Contracts Medicaid Medical Loss Ratio Medicare Quality of Care Standards

CMS Proposes Expansion of Medicaid Mental Health Parity Requirements

The Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule, on April 10, 2015, addressing the application of the Mental Health Parity and Addiction Equity Act of 2008 (“MHPAEA”) to the Medicaid and CHIP...more

4/23/2015 - CHIP CMS ERISA Healthcare Medicaid MHPAEA Proposed Regulation

HHS Withdraws Proposed 340B Drug Pricing Program "Mega Regs": Further Guidance Forthcoming

The Department of Health and Human Services (HHS) has withdrawn its greatly anticipated 340B Drug Pricing Program (340B Program) proposed regulations. The proposed regulations, nicknamed the 340B Program “Mega-Regs,” had been...more

11/19/2014 - HHS HRSA Prescription Drugs Proposed Regulation Section 340B

340B Drug Pricing Program Interpretative Rule Survives (for Now)

A federal court entered a new order, on August 27, 2014, in an ongoing dispute between the Health Resources and Services Administration (HRSA) and the Pharmaceutical Manufacturers of America (PhRMA) regarding HRSA’s issuance...more

9/3/2014 - 340B HRSA Pharmaceutical PHRMA Prescription Drugs

HRSA Issues Interpretive Rule on 340B Drug Pricing Program

On July 21, 2014, the Health Resource and Services Administration (HRSA) within the U.S. Department of Health and Human Services (HHS) issued a new interpretive rule addressing the treatment of orphan drugs by certain...more

7/23/2014 - 340B Covered Entities Healthcare HHS Hospitals HRSA Interpretive Opinions Pharmaceutical Prescription Drugs Section 340B

Recent Court Decision May Impact 340B Drug Pricing Program "Mega-Reg"

A federal district court invalidated the first regulation published by the U.S. Department of Health and Human Services (HHS) addressing the 340B Drug Pricing Program (340B Program), on May 23, 2014, ruling that HHS had not...more

6/24/2014 - 340B Affordable Care Act Healthcare HHS HRSA Prescription Drugs

OIG Publishes Report Identifying Issues With 340B Contract Pharmacy Arrangements

On February 5, 2014, the Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS) published a report (OIG Report) describing the results of a survey it had conducted of the use of contract...more

2/13/2014 - 340B Healthcare HHS OIG Pharmacies Prescription Drugs

340B Drug Pricing Program Developments in the New Year

On January 9, 2014, the Health Resources and Services Administration (HRSA) posted an update on its current and anticipated 340B drug pricing program (340B) program integrity efforts.1 The update includes a discussion of...more

1/14/2014 - 340B Covered Entities Drug Manufacturers HHS HRSA OIG Prescription Drugs

340B Drug Pricing Program Update: Hospital Recertification and Recent Audit Activity

As part of its expanded authority resulting from the Patient Protection and Affordable Care Act (PPACA), the Health Resources and Services Administration (HRSA) is continuing its efforts to ensure compliance with 340B Drug...more

8/20/2013 - 340B Affordable Care Act Audits Compliance Hospitals HRSA Prescription Drugs Recertification

340B Drug Pricing Program: Recent Developments

The 340B Drug Pricing Program (340B Program) continues to undergo a period of intense scrutiny and debate over how compliance with program rules is enforced. As previously reported in the May 30, 2012 edition of Foley’s Legal...more

4/19/2013 - 340B Audits Fees GPOs HRSA Proposed Regulation

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