Ellyn L. Sternfield

Ellyn L. Sternfield

Mintz Levin

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HRSA Takes its First Steps on 340B Rules

The 340B Drug Discount Program has operated for more than 20 years with just a few governing regulations codified in 42 CFR Part 10. Through the Affordable Care Act (“ACA”), Congress adopted several amendments to the 340B...more

6/23/2015 - Civil Monetary Penalty CMS Drug Pricing HRSA Medicaid Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs Section 340B

Over a Decade in the Making: CMS Releases Long-Awaited Medicaid Managed Care Rule

On May 27, 2015, the Centers for Medicare and Medicaid Services (“CMS”) published a 653-page proposed rule affecting the thirty-nine states (plus the District of Columbia) that use managed care organizations (“MCOs”) to...more

6/8/2015 - CMS Healthcare Providers Managed Care Contracts Medicaid

Will State Action on Biosimilars Thwart Anticipated Savings for Private and Government Health Care Programs?

Government and private health-care program payers have been anxiously awaiting FDA action on biosimilars. Payers anticipate that the ability to substitute and dispense a biosimilar product in lieu of a more expensive...more

6/4/2015 - Biologics Biosimilars Healthcare Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs

CMS Changes Medicare Prescriber Enrollment Requirements

On May 6, 2015, CMS issued interim final rules relating to Medicare Part D beneficiary access to Part D drugs. Through the rules, CMS announced updates regarding the impending prescriber enroll or opt-out effective date,...more

5/15/2015 - CMS Health Care Providers Healthcare Medicare Medicare Part D Prescription Drugs Proposed Regulation

States Move to Impose Limits on Biosimilar Drug Substitution

In early April, Colorado joined multiple other states in passing a biosimilar substitution law that addresses the circumstances under which an FDA-approved interchangeable biosimilar product may be substituted for the...more

4/28/2015 - Biologics Biosimilars FDA Medicaid Medicare Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs

CMS Provides Guidance to States on Managed Care Contract Review

As states attempt to control increasing healthcare costs, many Medicaid programs are seeking approval from the Centers for Medicare & Medicaid Services (CMS) to implement Medicaid managed care programs. In 2013, nearly 68...more

4/16/2015 - CMS Healthcare Interim Guidance Managed Care Contracts Medicaid

CMS Takes Initial Steps to Address Medicare & Medicaid Coverage for Biosimilars

On March 30, 2015, CMS released guidance addressing Medicare and Medicaid coverage for biosimilar drug products. The Medicare/Medicaid coverage guidance comes on the heels of the FDA’s landmark approval of a biosimilar...more

4/10/2015 - Biosimilars Cancer CMS Healthcare Medicaid Medicare Medicare Part B Medicare Part D New Guidance Pharmaceutical Pharmaceutical Manufacturers

$12.6 Million Sandoz ASP Reporting Settlement Raises More Questions Than It Answers

Recently, HHS-OIG announced a first-of-its-kind settlement over pharmaceutical manufacturer reporting of Average Sales Price (ASP). Sandoz, Inc. agreed to pay a civil monetary penalty of $12.64 million for alleged failure to...more

3/24/2015 - Civil Monetary Penalty HHS Pharmaceutical Pharmaceutical Manufacturers Reporting Requirements Sandoz Settlement

Reported Compliance Problems: The Six Stages of Corporate Grief

Last week, I had the honor of participating in a panel discussion about how health care entities deal with reported compliance concerns at the ABA’s 16th Annual Conference on Emerging Issues in Healthcare Law. The panel was...more

3/13/2015 - American Bar Association Chief Compliance Officers Healthcare Professional Conferences Qui Tam

Mother Nature Axes 340B Hearing, But Written Testimony Survives

Mother Nature claimed another victim this week. The U.S. House of Representatives Energy and Commerce Subcommittee on Health was scheduled to hold a hearing on March 5, 2015 – Examining the 340B Drug Pricing Program. But...more

3/6/2015 - 340B HRSA Medicaid Prescription Drug Coverage Prescription Drugs Proposed Legislation

CMS Finalizes Policy Rules For Medicare Parts C and D

Earlier this month, the Centers for Medicare & Medicaid Services (CMS) released its final rules on policy and technical changes to the Medicare Advantage (MA) and Prescription Drug Benefit programs (Part D) for contract year...more

2/17/2015 - CMS Final Rules Healthcare Medicare Medicare Advantage Medicare Part C Medicare Part D

What Indiana’s Medicaid Expansion Means For Other States

Last week, the Centers for Medicare & Medicaid Services (CMS) approved Indiana’s waiver under Section 1115 of the Social Security Act to implement Medicaid expansion, making it the 29th state (including the District of...more

2/4/2015 - CMS Healthcare Medicaid Medicaid Expansion

Pharmacy Qui Tam Based On U&C Price Billing Survives Motion to Dismiss

Once again, a pharmacy employee has filed a qui tam involving a drug discount program, alleging that the failure of the pharmacy to use the discounted pricing as the “usual and customary” price in Medicaid and Medicare Part D...more

1/16/2015 - Discounts False Claims Act Medicaid Medicare Medicare Part D Pharmacies Prescription Drugs Qui Tam

Federal Judge Awards Attorneys’ Fees to Defendant in Dismissed Qui Tam Case, Calls Whistleblower a “Serial Relator”

In November 2013 and this past October, Mintz Levin’s Health Care Qui Tam Update highlighted three separate qui tam False Claims Act (FCA) cases filed by Fox RX, Inc. (Fox), a former Medicare Part D plan sponsor. Fox filed...more

12/8/2014 - Dismissals False Claims Act Generic Drugs Medicare Part D Omnicare PharMerica Qui Tam Whistleblowers

The 340B Mega-Reg is Dead

With all due credit to the Coroner from the Wizard of Oz, like the Wicked Witch of the East crushed by Dorothy’s house, the 340B Drug Discount Program mega-reg is “not only merely dead, it’s really most sincerely dead.” And...more

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

Life Care Centers Seeks Sixth Circuit Review of Decision Allowing Statistical Sampling/Extrapolation in FCA Case

Last week, we posted about U.S. District Court Judge Harry Mattice’s September 29th ruling that government attorneys could extrapolate from a small sample of patient admissions to over 50,000 patient admissions (and over...more

10/17/2014 - Due Process Extrapolation False Claims Act Interlocutory Appeals Nursing Homes Statistical Sampling

The Supreme Court Continues to Punt on False Claims Cases

The first day of the Supreme Court term saw it decline, without comment, certiorari on two cases raising issues of liability and the sufficiency of pleading under the federal False Claims Act (FCA). ...more

10/8/2014 - False Claims Act FDA Omnicare Qui Tam Reporting Requirements SCOTUS

Federal Judge Rules to Allow Extrapolation on More Than 50,000 Claims in FCA Case

Last week, a Tennessee federal district court judge ruled that government attorneys can extrapolate from a small sample of billing statements to over 50,000 claims submitted by Life Care Centers of America, Inc. (a nursing...more

10/7/2014 - False Claims Act Healthcare Life Care Centers Nursing Homes Treble Damages

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

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