Anil Shankar

Anil Shankar

Foley & Lardner LLP

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HRSA Proposes Administrative Process to Resolve Disputes Between 340B Program Covered Entities and Drug Manufacturers

Taking a step toward completing a requirement imposed by the Affordable Care Act, the federal government has proposed regulations that would create an administrative dispute resolution (“ADR”) process to resolve disputes...more

8/23/2016 - Administrative Proceedings Affordable Care Act Covered Entities Dispute Resolution HRSA Manufacturers Proposed Rules Section 340B

Mid-Year 340B Program Update

Since our last 340B Drug Pricing Program (340B Program) update, the U.S. Centers for Medicare & Medicaid Services (CMS) has issued two regulations, the final Medicaid managed care regulation and a proposed update to the...more

8/4/2016 - CMS Drug Pricing Hospitals HRSA Managed Care Contracts Medicaid Off-Campus Departments OIG Outpatient Services Prescription Drugs Section 340B

“Site Neutrality” for Off-Campus Outpatient Departments: Proposed Rule is Worse than You Expected!

CMS issued its Outpatient Prospective Payment System (“OPPS”) Proposed Rule for 2017 (the “Proposed Rule”) on July 6, 2016. The Proposed Rule will be published in the Federal Register on July 14, 2016. One highly-anticipated...more

7/13/2016 - Bipartisan Budget Act CMS Comment Period Grandfathered Status Health Care Providers Hospitals Medicare MPFS Off-Campus Departments OPPS Proposed Legislation Proposed Regulation Section 340B

CMS Update to Medicaid Managed Care Regulations Should Prompt Significant Change

The Centers for Medicare & Medicaid Services (“CMS”) has released the final version of its much anticipated revisions to the regulations governing Medicaid managed care (the “Final Rule”). First proposed in May 2015, the...more

5/5/2016 - Beneficiaries CMS Fee-for-Service Final Rules Health Care Providers Managed Care Contracts Medicaid Mental Health Prescription Drug Coverage Quality of Care Standards Reporting Requirements Section 340B State Medicaid Programs Subcontractors Value-Based Purchasing

340B Program Update

The new year has already gotten off to a busy start for health care providers that participate in the 340B Drug Pricing Program (“340B Program”) and government agencies that reimburse these providers. Following on the heels...more

2/25/2016 - CMS Drug Pricing Federal Budget Medicaid Medicare Part B MedPAC Prescription Drugs Section 340B State Medicaid Programs

Potential Part B Drug Payment Cuts for 340B Hospitals

The influential Medicare Payment Advisory Commission (MedPAC) has voted to recommend to Congress in its March report that Medicare Part B drug payment rates for 340B drugs be reduced by 10 percent for hospitals participating...more

1/21/2016 - Drug Pricing Hospitals Medicare Part B MedPAC OIG Section 340B

New Guidance Outlines Requirements for State Innovation Waivers

New guidance from Centers for Medicare & Medicaid Services (CMS) places the spotlight on the ability of states to seek approval of “State Innovation Waivers” to test new approaches for delivering health insurance reform....more

12/21/2015 - Affordable Care Act CMS Health Insurance New Guidance Secretary of HHS Waivers

2016 Expected to Be Monumental Year for 340B Drug Discount Program

The 340B Program continues to be an area of focus from federal policymakers, and recent activity and publications indicate that 2016 could be a monumental year for the program. Below is a breakdown of the recent and upcoming...more

12/8/2015 - HRSA MCOs Medicare Part B OIG Orphan Drugs Section 340B

Budget Bill Aims to Kill Any New Off-Campus Provider-Based Facilities

Legislation being drafted as part of a budget deal between members of Congress and the White House includes language that will significantly alter the future of hospital-based outpatient care. The “discussion draft” of the...more

10/30/2015 - Ambulatory Surgery Centers Federal Budget Health Care Providers Healthcare Hospitals Medicare MedPAC OIG OPPS Pending Legislation Physician Fee Schedule Reimbursements

Court Strikes Down 340B Orphan Drug Rule Again: Will This Impact the “Mega Guidance”?

A federal court vacated the Department of Health and Human Services’ (HHS) Orphan Drug Rule that had allowed certain 340B Drug Pricing Program (340B Program) hospital covered entities to receive discounted prices when...more

10/20/2015 - Abuse of Discretion Administrative Procedure Act Arbitrary and Capricious Comment Period Covered Entities Drug Pricing Final Rules HHS Hospitals HRSA Interpretive Rule Omnibus Guidance Orphan Drugs Pharmaceutical Industry PHRMA Section 340B Vacated

Omnibus 340B Guidance Raises New Issues for Covered Entities

The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new –...more

9/1/2015 - Comment Period Covered Entities Draft Guidance Drug Pricing Guidance Update Healthcare Facilities HHS Hospitals MCOs Medicaid Medicare New Guidance Patients Pharmaceutical Industry Pharmacies Physicians Prescription Drugs Recordkeeping Requirements Section 340B

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 - Affordable Care Act Civil Monetary Penalty Covered Entities Drug Distribution HRSA OIG Pharmaceutical Industry Pharmacies Prescription Drug Coverage Rulemaking Process Section 340B

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 - Affordable Care Act CMS Long-Term Care Managed Care Contracts Medicaid Medical Loss Ratio Medicare Quality of Care Standards Section 340B

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 - HRSA Pharmaceutical Industry PHRMA Prescription Drugs Section 340B

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 - Covered Entities Healthcare HHS Hospitals HRSA Interpretive Opinions Pharmaceutical Industry 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 - Affordable Care Act Healthcare HHS HRSA Prescription Drugs Section 340B

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 - Healthcare HHS OIG Pharmacies Prescription Drugs Section 340B

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 - Covered Entities HHS HRSA OIG Pharmaceutical Industry Prescription Drugs Section 340B

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 - Affordable Care Act Audits Compliance Hospitals HRSA Prescription Drugs Recertification Section 340B

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 - Audits Fees GPOs HRSA Proposed Regulation Section 340B

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