Ellyn L. Sternfield

Ellyn L. Sternfield

Mintz Levin

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CMS Notifies States of AMP Rule Requirements: 340B Providers Should Take Note

Last week, Mintz Levin and ML Strategies released a joint Alert analyzing key provisions of the Covered Outpatient Drug final rule (“Final AMP Rule”) and their impact on manufacturers, pharmacy benefit managers (“PBMs”), and...more

2/17/2016 - CMS Drug Pricing Final Rules HRSA Medicaid Pharmacies Section 340B

Deciphering the Final AMP Rule – Key Provisions Impacting Pharmacies, PBMs, and Manufacturers

In late January, the Centers for Medicare & Medicaid Services (“CMS”) released the much anticipated Covered Outpatient Drugs Final Rule with Comment (the “AMP Final Rule”). The rule creates the regulatory definition for...more

2/12/2016 - Affordable Care Act CMS Drug Pricing Fair Market Value Final Rules Medicaid Pharmaceutical Industry Pharmacies

The Pharmacy Industry – 2015 Year In Review

With 2015 coming to a close, we wanted to provide a recap of the major updates impacting the pharmacy industry and what pharmaceutical manufacturers, pharmacy benefit managers (“PBMs”), and pharmacies might expect in 2016. ...more

12/9/2015 - AstraZeneca Biosimilars CMS DOJ Drug Pricing FDA Approval HRSA Kickbacks Kmart Novartis Pharmaceutical Industry Pharmacies Section 340B Value-Based Purchasing

OIG Proposes Alternative Part B Payment Methodologies for 340B Drugs: Is This the End of 340B As We Know It?

Last week, under the cover of the impending Thanksgiving Holiday, OIG lobbed another grenade at the 340B Drug Discount Program. The means of delivery was an OIG Report on Medicare Part B payments for 340B drugs which...more

12/4/2015 - Drug Pricing Medicare Part B OIG Section 340B State Medicaid Programs

Does Invalidation of 340B Orphan Drug Rule Doom HRSA’s Guidance?

Our recent post on HRSA’s Omnibus Proposed Guidance for the 340B Drug Discount Program (Proposed Guidance) noted that since the DC District Court had yet to rule on the validity of HRSA’s “interpretive” 340B orphan drug rule,...more

10/21/2015 - Affordable Care Act Comment Period Congressional Committees Congressional Investigations & Hearings Covered Entities Drug Pricing HRSA Interpretive Rule Omnibus Guidance Orphan Drugs Pharmaceutical Industry Pharmacies PHRMA Section 340B

The Proposed 340B Guidance:  Who is the Biggest Loser?

We have now had more than 30 days to digest HRSA’s proposed 340B Drug Pricing Program Omnibus Guidance (“Proposed Guidance”), intended to clarify expectations and provide guidance on key issues in the 340B Program. There are...more

10/8/2015 - Comment Period Covered Entities Drug Pricing Health Care Providers Healthcare Hospitals HRSA Interpretive Rule MCOs Medicaid Medicare Omnibus Guidance Patients Pharmaceutical Industry Pharmacies Proposed Regulation Section 340B State Medicaid Programs

State Pharmaceutical Pricing Disclosure Laws: Old Story, New Refrain

As a veteran of the AWP litigation era, I am struck by the recent state efforts to legislate transparency into pharmaceutical pricing. Multiple states have introduced bills that would require pharmaceutical manufacturers to...more

8/26/2015 - Attorney Generals Disclosure Requirements Drug Pricing Fraud Medicaid Pending Legislation Pharmaceutical Industry Pharmacies Transparency Whistleblowers Wholesale

Off-Label Marketing and the False Claims Act

In a post published earlier this week this week our colleagues Brian Dunphy and Joanne Hawana examined key issues in the recent Amarin decision from the Southern District Court of the New York. The August 7th ruling provided...more

8/21/2015 - Amarin Commercial Marketing False Claims Act (FCA) FDA FDCA Off-Label Promotion Pharmaceutical Industry Ripeness

Emerging State Biosimilar Laws – Reference Chart and Five Issues to Watch

As we’ve previously discussed, states have begun to actively regulate the substitution of interchangeable biosimilars before any FDA-approved biosimilar has even hit the market. State biosimilar legislation passed to date...more

7/29/2015 - Biosimilars FDA Notification Requirements Orange Book Pharmacies Pharmacist

Trinity Homecare Settlement: Five False Claims Trends

New York State Attorney General Eric Schneiderman recently announced that his office had reached a $2.5 million settlement in a federal False Claims Act (FCA) case with Trinity HomeCare and its related entities. The case,...more

7/16/2015 - Attorney Generals Corporate Counsel Declination False Billing False Claims Act (FCA) Medicaid Qui Tam Relators Settlement

Government’s Objections to Non-Intervened FCA Settlement Are Unreasonable – Now What?

Recently, South Carolina U.S. District Judge Joseph Anderson, Jr. issued an opinion in which he struggled with how to handle a non-intervened qui tam brought under the Federal False Claims Act (FCA). In his opinion, Judge...more

7/8/2015 - Damages False Claims Act (FCA) Healthcare Fraud Interlocutory Appeals Nursing Homes Qui Tam Res Judicata Settlement Agreements Skilled Nursing Facility Statistical Sampling

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 Industry 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 Health Care 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 Industry 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 Industry 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 Industry

$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 Industry 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 (ABA) 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 - HRSA Medicaid Prescription Drug Coverage Prescription Drugs Proposed Legislation Section 340B

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 (FCA) 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 (FCA) Generic Drugs Medicare Part D Omnicare Qui Tam Whistleblowers

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