Ellyn L. Sternfield

Ellyn L. Sternfield

Mintz Levin

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The Increasingly Murky World of 340B: What’s Next?

For the past 18 months, health care providers and the pharmaceutical industry have been hoping for some clarity regarding 340B Drug Discount Program operations. But things just keep getting murkier....more

9/3/2014 - Health Care Providers Healthcare HRSA OIG Orphan Drugs Pharmaceutical Pharmacies PHRMA Prescription Drugs Section 340B

HRSA “Interprets” Its Enjoined 340 Orphan Drug Rule into Effect

In January, I predicted that 2014 would be a game-changer for the 340B Drug Discount Program, in part because of HRSA’s announcement that, in June 2014, it would for the first time publish an omnibus rule governing 340B...more

6/19/2014 - 340B Drug Manufacturers FDA HRSA Orphan Drugs Pharmaceutical Prescription Drugs

Court Invalidates 340B Orphan Drug Rule

In a blow to government efforts to regulate the 340B Drug Discount Program, U.S. District Judge Rudolph Contreras has ruled that HRSA lacks regulatory authority to promulgate regulations expanding access to 340B discounts for...more

5/29/2014 - 340B HRSA Orphan Drugs Pharmaceutical Prescription Drugs

CMS Releases Physician Medicare Billing Data

The U.S. Department of Health and Human Services (HHS) announced on April 9th a “historic” release of Medicare payment data to provide consumers with “unprecedented transparency on the medical services physicians provide and...more

4/11/2014 - Billing CMS Healthcare HHS Medical Devices Medicare Pharmaceutical Sunshine Act

Supreme Court Declines to Settle False Claims Circuit Split

With its March 31, 2014 denial of certiorari in U.S. ex rel. Nathan v. Takeda, the U.S. Supreme Court declined to wade into the ongoing debate over the degree of particularity with which a false claims relator must plead a...more

4/2/2014 - Certiorari False Claims Act SCOTUS Split of Authority

After Arkansas Supreme Court Reverses $1.2 Billion Medicaid False Claims Verdict, Will State Attorneys General Rethink the Use of...

On March 20, 2014, the Arkansas Supreme Court reversed a $1.2 billion judgment against Johnson & Johnson and its related companies over alleged Medicaid fraud stemming from the off-label marketing of the drug Risperdal. This...more

3/26/2014 - False Claims Act Johnson & Johnson Medicaid Off-Label Promotion Professional Liability

CMS Proposes Major Changes to Medicare Part C and Part D

On Jan. 10, the Centers for Medicare & Medicaid Services (CMS) published proposed rules labeled as ‘‘policy and technical’’ changes to the Medicare Advantage (Part C) and Medicare Prescription Drug Benefit (Part D) Programs....more

3/10/2014 - CMS Healthcare Medicare Medicare Part C Medicare Part D Pharmaceutical Prescription Drugs

CMS Proposes Major Rule Changes to Increase Payment Accuracy and Improve Program Integrity in Medicare Part C and Part D

On Jan. 10, the Centers for Medicare & Medicaid Services published proposed rules labeled as ‘‘policy and technical’’ changes to the Medicare Advantage (Part C) and Medicare Prescription Drug Benefit (Part D) Programs....more

3/10/2014 - CMS Healthcare Medicare Medicare Part C Medicare Part D Pharmaceutical Prescription Drugs

HHS-OIG Criticizes 340B Drug Discount Program

I recently posted that 2014 is expected to be a year of major developments in the 340B Drug Discount Program, with HRSA receiving enhanced funding, stepping up audit activity, and drafting regulations in response to criticism...more

2/11/2014 - Drug Manufacturers Healthcare HHS HRSA OIG Pharmaceutical Prescription Drugs

2014 May Be a Game-Changer for the 340B Drug Discount Program

The year 2014 looks to be a year of major developments for the 340B Drug Discount Program. We have seen (1) a first in terms of the Health Resources and Services Administration (HRSA) imposing sanctions on audited entities,...more

1/30/2014 - Discounts Federal Budget HRSA Manufacturers Orphan Drugs Prescription Drugs

Government Imposes Moratorium on Medicare Hearings and Appeals

The Federal Office of Medicare Hearings and Appeals (OMHA) was established in July 2005 to administer the Medicare appeals program. OMHA adjudicates appeals regarding Medicare entitlement and Medicare provider reimbursement....more

1/28/2014 - Beneficiaries CMS Healthcare Medicare OMHA RACs

CMS Proposes Major Changes to Medicare Parts C and D

On January 10, the Centers for Medicare & Medicaid Services (CMS) published proposed rules labeled as “policy and technical” changes to the Medicare Advantage (Part C) and Medicare Prescription Drug Benefit (Part D) Programs....more

1/22/2014 - CMS Medicare Medicare Part C Medicare Part D

First Circuit Punts on Implied Certification as a Basis for FCA Liability

In August, I wrote about the unusual decision by the U.S. Department of Justice (DOJ) to appeal a district court’s dismissal of a declined qui tam brought under the federal and state false claims acts (FCAs). In appealing...more

12/10/2013 - DOJ False Claims Act FCA Federal Rule 12(b)(6) Qui Tam

OIG Defines its Priorities in 2014-2018 Strategic Plan

Outlining its high-level priorities and goals for the next five years, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) published its Strategic Plan for 2014-2018. In the Strategic...more

11/26/2013 - Enforcement Fraud Fraud and Abuse HHS OIG Waste

Grassley Turns His 340B Microscope on Manufacturers

For the first time, Senator Grassley has turned his scrutiny of the 340B Drug Pricing Program to pharmaceutical manufacturers. As we previously wrote, Senator Grassley has been among the most vocal of critics in...more

10/3/2013 - 340B Charles Grassley Drug Manufacturers Pharmaceutical Prescription Drugs

Will Usual and Customary Price be the Next False Claims Act Battleground?

Recently, a federal judge held that a qui tam relator’s allegations that a pharmacy routinely reported falsely inflated “usual and customary” prices for generic medications in claims submitted to federally funded health care...more

9/24/2013 - Compliance False Claims Act Pharmacies Purchase Price Qui Tam

Fifth Circuit Joins Chorus to Rein in False Claims Act

Add the Fifth Circuit to the list of jurisdictions questioning the use of the federal False Claims Act (FCA) in instances where – using the theory of implied certification - the alleged falsity is not apparent on the face of...more

8/28/2013 - DOJ False Claims Act False Statements

Does District Court Dismissal of Declined Qui Tam Threaten Future DOJ False Claims Enforcement?

The U. S. Department of Justice (DOJ) has taken the unusual step of appealing a federal district court’s dismissal of a declined qui tam brought under the federal and multiple state false claims acts (FCA). Could the...more

8/9/2013 - DOJ Enforcement Actions False Claims Act FDA Healthcare Medicaid Medicare Qui Tam Reporting Requirements

HRSA Clarifies 340B Orphan Drug Exception But 340B Audit Enforcement Remains Murky

Recently, HRSA publicly announced the issuance of a final rule clarifying when 340B covered entities can purchase and distribute orphan drugs through the 340B Drug Pricing Program. Separately, HRSA quietly posted a report on...more

7/30/2013 - 340B Affordable Care Act Audits Covered Entities Drugs Hospitals HRSA Orphan Drugs

Hospitals Fight Back to Defend 340B Program Operations

Adhering to the axiom that the best defense is a good offense, SNHPA (Safety Net Hospitals for Pharmaceutical Access), an organization of close to 1000 hospitals participating in the 340B Drug Pricing Program, is attempting...more

7/11/2013 - 340B GAO Healthcare Healthcare Professionals Hospitals Patients Prescription Drugs SNHPA

Increased Availability of Health Care Data Means More Oversight and More Litigation

The increasing availability of health care claims and payment data may portend the future of government and private health care enforcement and litigation. ...more

6/25/2013 - CMS FOIA Fraud Healthcare Injunctions Medicare Medicare Part D Physician Payments Proposed Legislation Transparency

Texas Makes Changes to Medicaid Laws and Programs

Texas Governor Rick Perry signed a series of bills into law last week modifying some of the state’s Medicaid statutes and programs. The laws will take effect on September 1, 2013....more

6/20/2013 - CHIP Fraud Healthcare Medicaid Medicare New Legislation

Five Takeaways from the OIG’s Special Advisory Bulletin on Exclusion

This week the Office of Inspector General for the Department of Health and Human Services (“OIG”) issued an updated Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs, an...more

5/13/2013 - Exclusions False Claims Act Federal Funding Healthcare Liability OIG Penalties

CMS Proposes to Increase Awards for Non-Qui Tam Whistleblowers

CMS wants to change the way that it rewards non-qui tam whistleblowers who report alleged fraudulent or unlawful conduct related to Medicare or Medicaid. Using an IRS program as a model, CMS recently proposed rule changes to...more

5/1/2013 - CMS IRS Proposed Regulation Qui Tam Whistleblowers

Grassley Questions Hospital 340B Program Profits

In a March 2013 article, I wrote about members of Congress calling for increased oversight of the 340B drug discount program and, in particular, hospital use of 340B drugs. This week, Senator Charles Grassley of Iowa...more

4/5/2013 - 340B Charles Grassley Healthcare Hospitals Medicare Pharmaceutical Prescription Drugs

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