Ellyn L. Sternfield

Ellyn L. Sternfield

Mintz Levin

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The Uncertain Future of the 340B Drug Discount Program

Here we are in March 2017 and no one is sure where things stand with the 340B Drug Discount Program. HRSA and its oversight of the 340B program are subject to the recent Executive Orders restricting issuance of federal...more

3/16/2017 - Affordable Care Act Drug Pricing Executive Orders HRSA Medicaid Pharmaceutical Industry Prescription Drugs Proposed Legislation Repeal Section 340B Trump Administration

OIG Releases FY 2016 Statistical Data About Medicaid Fraud Control Units

Earlier this week, the Office of Inspector General for the Department of Health and Human Services (“OIG”) posted its fiscal year (“FY”) 2016 data about Medicaid Fraud Control Units (“MFCUs”) across the country....more

3/9/2017 - False Claims Act (FCA) Fraud Health Care Providers Investigations Medicaid OIG

OIG Publishes Online Portfolio Highlighting its Body of Work on Drug Pricing and Reimbursement

For several years now, the public outcry over the issue of drug pricing and reimbursement has increased in frequency and fervor. At least one government agency wants you to know that it has been listening and wants to help...more

2/21/2017 - Audit Reports Drug Pricing HHS Medicaid Medicare OIG Pharmaceutical Industry Reimbursements

Grassley Continues To Press CMS on Medicaid Drug Rebate Classifications: What Will Be the Fallout?

Back in early October, we were all transfixed by the announced Mylan settlement with the U.S. Department of Justice (DOJ) over Mylan’s alleged underpayments of Medicaid Drug Rebates for the EpiPen. Although Mylan indicated...more

1/13/2017 - Charles Grassley CMS DOJ False Claims Act (FCA) Medicaid Mylan Pharmaceuticals Pharmaceutical Industry Rebates

At Long Last, OIG Issues Final Rule for Beneficiary Inducement Safe Harbors

More than two years since issuing the proposed rule, the HHS Office of the Inspector General (OIG) issued the long-awaited and highly anticipated final rule (the Final Rule) that provides amendments to the Anti-Kickback...more

12/12/2016 - Affordable Care Act Anti-Kickback Statute Civil Monetary Penalty Co-payments False Claims Act (FCA) Final Rules Generic Drugs HHS Hospitals Inducements OIG Pharmaceutical Industry Safe Harbors

Forty-Five Days and Counting for Current HHS Leadership: Implications for Rulemaking

Before we all turn our full attention to the nominations of Representative Tom Price as Secretary of Health and Human Services, and policy consultant Seema Verma to lead CMS, we need to remember that there are still...more

12/7/2016 - CHIP Congressional Review Act Healthcare Reform HHS Medicaid OIG OMB Omnibus Guidance Proposed Rules Section 340B

Five Things to Know About the Mylan EpiPen “Settlement” – What It Is and What It Isn’t

Our eyebrows were raised by Mylan’s October 7, 2016 announcement that it had reached a $465 million “settlement” with the United States Department of Justice (DOJ) and “other government agencies” over its Medicaid Drug Rebate...more

10/14/2016 - CMS DOJ HHS Medicaid Medical Devices Mylan Pharmaceuticals OIG Pharmaceutical Industry Settlement

Delays in 340B Mega-Guidance and a Recap of the Latest 340B Updates

Thus far, 2016 has been a relatively quiet year for the 340B program at the federal level. Neither Congress nor the Health Resource and Service Administration (HRSA) has shown an appetite to take on the issues plaguing the...more

6/8/2016 - HHS HRSA Medicare Omnibus Guidance Prescription Drug Coverage Prescription Drugs Section 340B

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

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