Health Care
Viewpoints
Filter by:
Pharmaceutical Manufacturers and Healthcare Leaders cite Fraud and Abuse Laws as Obstacle to Value-Based Arrangements
March 15, 2017 | Blog | By Theresa Carnegie, Lauren Moldawer
As the healthcare industry moves towards value-based purchasing, pay-for-performance, and other payment reform models, industry leaders have identified federal fraud and abuse laws as a barrier to full implementation of such models.
Read more
OIG Releases FY 2016 Statistical Data About Medicaid Fraud Control Units
March 9, 2017 | Blog | By Samantha Kingsbury
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.
Read more
Registration for the 2017 Mintz/ML Strategies Pharmacy Industry Summit is Open! (April 5-6, 2017)
March 6, 2017 | Blog | By Theresa Carnegie
The pharmacy industry continues to be under scrutiny from all angles. As legislative, agency, and enforcement priorities take shape under the new administration, the industry is faced with what seems like daily developments in terms of policy updates, legislation, and potential regulation.
Read more
Fourth Circuit Permits DOJ to Reject an FCA Settlement, But Punts Decision on Statistical Sampling
February 22, 2017 | Blog | By Brian Dunphy, Laurence Freedman
In a closely watched False Claims Act (“FCA”) case, the Fourth Circuit Court of Appeals decided that the Department of Justice (“DOJ”) has an unreviewable right to object to a proposed settlement agreement between a relator and a defendant when the Government has declined to intervene in the case.
Read more
OIG Publishes Online Portfolio Highlighting its Body of Work on Drug Pricing and Reimbursement
February 21, 2017 | Blog
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 provide the information necessary to forge a solution.
Read more
Another Court Agrees That A Difference Of Opinion On Medical Necessity Is Insufficient to Show Falsity Under the False Claims Act
February 14, 2017 | Blog | By Samantha Kingsbury, Laurence Freedman
Last month, the U.S. District Court for the District of Utah joined the AseraCare court and others in finding that a relator cannot successfully allege violations of the False Claims Act (“FCA”) based on a purported lack of medical necessity unless there is an objective standard articulated by Medicare.
Read more
FDA’s Enforcement Priorities Likely to Change in 2017 and Other “Unknowable Knowns”
January 17, 2017 | Blog | By Joanne Hawana
As we enter a new era in which executive agencies are headed by President Trump, we are also faced with many other transformative changes that will affect FDA-regulated entities in a significant and lasting way. This post will outline some of our thoughts related to what could face FDA and its various stakeholders as we go forward into the great unknown.
Read more
Grassley Continues To Press CMS on Medicaid Drug Rebate Classifications: What Will Be the Fallout?
January 12, 2017 | Blog
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.
Read more
Health Care Enforcement Review and 2017 Outlook: Significant Health Care Fraud and Abuse Civil Settlements and Criminal Resolutions
January 10, 2017 | Blog | By Brian Dunphy, Karen Lovitch, Kevin McGinty
In this final installment of our Health Care Enforcement Review and 2017 Outlook series, we analyze health care enforcement trends gathered from 2016 civil settlements and criminal resolutions of health care fraud and abuse cases. Behind the headlines covering enormous recoveries in 2016, several themes are apparent.
Read more
Health Care Enforcement Review and 2017 Outlook: Significant Regulatory Developments
January 6, 2017 | Blog | By Laurence Freedman, Karen Lovitch
While 2016 marked one of the least productive years in the history of Congress, the same cannot be said of health care enforcement and regulatory agencies. Perhaps motivated by the impending change in administration, these agencies promulgated a number of notable regulations in 2016.
Read more
Health Care Enforcement Review and 2017 Outlook: Major Case Developments
January 5, 2017 | Blog | By Ryan Cuthbertson
Today, my colleagues Laurence Freedman, Samantha Kingsbury, and Karen Lovitch released the latest in our ongoing series reviewing health care enforcement activities in 2016 and their impacts looking forward to 2017.
Read more
Health Care Enforcement Review and 2017 Outlook: FDA's Wide-Ranging Activities
January 4, 2017 | Blog | By Joanne Hawana, Benjamin Zegarelli
Over the past year, clear trends have emerged in FDA’s enforcement activities. Enforcement arising from alleged violations of the Federal Food, Drug, and Cosmetic Act (FFDCA) can take many forms, including FDA advisory actions such as warning letters, adverse inspectional observations that can lead to specific administrative action.
Read more
Health Care Enforcement Review and 2017 Outlook: Yates Memo in Action
January 3, 2017 | Blog | By Eoin Beirne
Happy New Year! As we kick off 2017, our Health Care Enforcement Defense team brings you its annual review of key government policies, regulations, and enforcement actions in 2016, and the impact these trends are expected to have on enforcement in the year ahead.
Read more
At Long Last, OIG Issues Final Rule for Beneficiary Inducement Safe Harbors
December 12, 2016 | Blog | By Carrie Roll
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 Statute (AKS) regulatory safe harbors and adds protections for certain payment practices and business arrangements under the beneficiary inducement provisions of the Civil Monetary Penalty Law (CMP).
Read more
2017 OIG Work Plan: For Medicare Plans
November 16, 2016 | Blog | By Tara E. Dwyer
Last week, the OIG posted its Work Plan for 2017. In it, the OIG announced many goals touching on programs including, but not limited to, Medicare, Medicaid, Insurance Marketplace (Health Exchanges), Indian Health Service, TANF and Head Start. Below are some of the OIG’s action items that Medicare Advantage and Part D plans should be aware of.
Read more
FCA Settlement Involves Waiver of Medicare Coinsurance Amounts
October 25, 2016 | Blog | By Karen Lovitch
The waiver of copayments, coinsurance, and deductibles owed by patients treated by out-of-network laboratories and other providers is a hot topic in the health care industry.
Read more
Reminder: Pharmaceutical Industry Enforcement Webinar - Wednesday, October 26
October 24, 2016 | Blog
Pharmaceutical industry enforcement has been one of the hottest topics in the news in the past month. Last week, Ellyn Sternfield and Rodney Whitlock were quoted by cnbc.com regarding the recent Mylan settlement.
Read more
Five Things to Know About the Mylan EpiPen "Settlement" - What It Is and What It Isn't
October 14, 2016 | Blog
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 obligations for EpiPen.
Read more
Join Us For A Webinar On October 26th Discussing Pharmacy Industry Enforcement
October 6, 2016 | Blog | By Brian Dunphy
Please join Mintz Levin for a webinar discussing health care fraud enforcement in the pharmacy and pharmaceutical industry on October 26, 2016 at 1 pm (ET). My colleagues Theresa Carnegie, Larry Freedman, and Ellyn Sternfield, members of Mintz Levin’s Health Law and Health Care Enforcement Defense practices, will discuss enforcement trends facing the industry.
Read more
Billing Companies Beware – OIG Signals a Crack Down on Fraud and Abuse at All Levels
September 28, 2016 | Blog | By Carrie Roll
In an unprecedented administrative action, the U.S. Department of Health & Human Services Office of the Inspector General (“HHS-OIG”) penalized a medical billing company for preparing and submitting claims to Medicare for diagnostic tests that were never conducted.
Read more
Explore Other Viewpoints:
- Antitrust
- Appellate
- Arbitration, Mediation & Alternate Dispute Resolution
- Artificial Intelligence
- Awards
- Bankruptcy & Restructuring
- California Land Use
- Class Action
- Complex Commercial Litigation
- Construction
- Consumer Product Safety
- Cross-Border Asset Recovery
- Debt Financing
- Direct Investing (M&A)
- Diversity
- EB-5 Financing
- Education & Nonprofits
- Employment
- Energy & Sustainability
- Environmental Enforcement Defense
- Environmental Law
- FDA Regulatory
- Federal Circuit Appeals
- Financial Institution Litigation
- Government Law
- Growth Equity
- Health Care
- Health Care Compliance, Fraud and Abuse, & Regulatory Counseling
- Health Care Enforcement & Investigations
- Health Care Transactions
- Health Information Privacy & Security
- IP Due Diligence
- IPRs & Other Post Grant Proceedings
- Immigration
- Insolvency & Creditor Rights Litigation
- Institutional Investor Class Action Recovery
- Insurance & Financial Services
- Insurance Consulting & Risk Management
- Insurance and Reinsurance Problem-Solving & Dispute Resolution
- Intellectual Property
- Investment Funds
- Israel
- Licensing & Technology Transactions
- Life Sciences
- Litigation & Investigations
- M&A Litigation
- ML Strategies
- Medicare, Medicaid and Commercial Coverage & Reimbursement
- Mergers & Acquisitions
- Patent Litigation
- Patent Prosecution & Strategic Counseling
- Pharmacy Benefits and PBM Contracting
- Portfolio Companies
- Privacy & Cybersecurity
- Private Client
- Private Equity
- Pro Bono
- Products Liability & Complex Tort
- Projects & Infrastructure
- Public Finance
- Real Estate Litigation
- Real Estate Transactions
- Real Estate, Construction & Infrastructure
- Retail & Consumer Products
- Securities & Capital Markets
- Securities Litigation
- Special Purpose Acquisition Company (SPACs)
- Sports & Entertainment
- Strategic IP Monetization & Licensing
- Tax
- Technology
- Technology, Communications & Media
- Technology, Communications & Media Litigation
- Trade Secrets
- Trademark & Copyright
- Trademark Litigation
- Venture Capital & Emerging Companies
- White Collar Defense & Government Investigations
- Women's Health and Technology