Health Care
Viewpoints
Filter by:
Massachusetts Health Care Regulatory Review – Opportunity for Industry Comment
June 25, 2015 | Blog | By Ellen Janos
Health care is big business in Massachusetts, and it is a highly regulated business. But Governor Charlie Baker hopes to simplify the Massachusetts regulatory regime.
Read more
HRSA Takes its First Steps on 340B Rules
June 22, 2015 | Blog | By Bridgette Keller
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 Program.
Read more
Latest Medicare Fraud Strike Force Takedown Is The Most Significant To Date
June 19, 2015 | Blog | By Bridget Rohde
As we discussed yesterday, the Medicare Fraud Strike Force’s eighth annual nationwide takedown resulted in charges in 17 districts against 243 individuals for approximately $712 million in false billings.
Read more
Government Announces Health Care Fraud “Takedown”
June 18, 2015 | Blog | By Brian Dunphy, Bridgette Keller
Earlier today, Attorney General Loretta Lynch announced the largest coordinated crackdown in the Medicare Fraud Strike Force’s eight-year history. The government brought charges against 243 individuals for approximately $712 million in alleged Medicare fraud.
Read more
AMA Ethical Guidelines on Telemedicine Tabled for Further Review
June 10, 2015 | Blog | By Carrie Roll
On Monday, during the annual meeting of the American Medical Association (AMA) House of Delegates, the delegates voted to table a proposed measure to adopt ethical guidelines for physicians who provide telemedicine services.
Read more
CMS Finally Releases Proposed Rules for Medicaid Managed Care
June 10, 2015 | Blog | By Ryan Cuthbertson, Pamela Kramer
On Friday, Mintz Levin published an advisory on CMS’s proposed Medicaid Managed Care rules. This advisory provides contextual background, a helpful overview of the rule’s contents, and an in-depth discussion of some of the rule’s key provisions.
Read more
Mintz Advisory: Hard Switch Between Drugs Likely Violates the Sherman Act
June 10, 2015 | Blog | By Samantha Kingsbury
Last week, Mintz attorneys Bruce Sokler and Timothy Slattery published an advisory regarding the Second Circuit's highly anticipated decision in State of New York v. Actavis PLC.
Read more
Physician Compensation Arrangements – OIG Fraud Alert Warns of Potential Anti-kickback Statute Violations
June 9, 2015 | Blog | By Daria Niewenhous
In a fraud alert released today, the OIG warns that physician compensation arrangements, such as medical directorship compensation, may potentially violate the anti-kickback statute.
Read more
State Action May Block Big Savings on Biosimilars
June 9, 2015 | Blog
The recent influx of state legislation on biologics and biosimilars may actually hinder rather than advance the use of biosimilars. Our colleagues Theresa Carnegie, Joanne Hawana, and Ellyn Sternfield discuss this issue in a recent article published in BNA’s Medicare Report.
Read more
Fingerprint-Based Background Checks Begin August 1st for Medicaid Providers
June 4, 2015 | Blog | By Lauren Moldawer
On June 1st, the Centers for Medicare and Medicaid Services (CMS) released a State Medicaid Director Letter (SMD Letter) providing guidance to states on the criminal background check and fingerprinting requirements for Medicaid provider enrollment.
Read more
Injunction Blocks Implementation of Texas Telemedicine Regulations
June 4, 2015 | Blog | By Dionne Lomax
Late last week, Texas telemedicine practitioners received a temporary reprieve from a new regulation issued by the Texas Medical Board (the “Board”) when a Texas federal court prohibited implementation of the new rule that would have prevented prescribing via telemedicine.
Read more
ML Strategies: Health Care Update & Telehealth Policy Alert
June 3, 2015 | Blog | By Carrie Roll
Yesterday, ML Strategies posted its Health Care Update and Telehealth Policy Alert. This publication provides timely information for those who are already in, or contemplating entering, the telehealth space.
Read more
OIG Releases Semiannual Report to Congress
June 3, 2015 | Blog | By Matthew Levitt
The Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) recently released its Semiannual Report to Congress (“Report”), summarizing OIG’s activities for the six-month period ending on March 31, 2015.
Read more
Supreme Court Decides Qui Tam First-to-File Issues
June 3, 2015 | Blog | By Laurence Freedman
Whether you are on the defense side or the relator side of the qui tam world, you can count the Supreme Court’s opinion in Kellogg, Brown & Root Services, Inc. v. United States ex. Rel. Carter as a win and a loss.
Read more
ACO Model Expansion Hinges on Increasing Medicare Program Flexibility
May 28, 2015 | Blog
Earlier this month, HHS Secretary Silvia Burwell made a game-changing announcement about the Obama Administration’s most significant alternative payment model (APM).
Read more
FDA Makes More Electronic Submissions Mandatory
May 22, 2015 | Blog | By Joanne Hawana
In recent months, the FDA has been pushing forward in its efforts to require that more information from regulated industry be submitted electronically. The move to electronic submissions should create a more efficient and expeditious flow of information about drugs and medical devices from industry to the Agency.
Read more
ML Strategies: 21st Century Cures and Other Health Legislation Markup
May 20, 2015 | Blog | By Bridgette Keller
Earlier this week, ML Strategies posted its weekly Health Care Update which provided timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.
Read more
21st Century Cures Legislation “Punts” on Telemedicine
May 18, 2015 | Blog | By Carrie Roll
On May 13, 2015, the House Energy and Commerce Committee released the latest draft of its 21st Century Cures Legislation.
Read more
ML Strategies: 340B Discount Drug Program Guidance Submitted to OMB
May 15, 2015 | Blog | By Samantha Kingsbury
Earlier this week, ML Strategies (MLS) posted its weekly Health Care Update. This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.
Read more
More Biosimilar Q&A’s Released by FDA
May 14, 2015 | Blog | By Joanne Hawana
After finalizing three key guidance documents on biosimilars at the end of April (reported on our blog here), yesterday FDA released another “Question and Answer” guidance in draft form. The draft guidance is called “Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.”
Read more
Viewpoint Editors
Karen S. Lovitch
Chair, Health Law Practice & Co-Chair, Health Care Enforcement Defense Practice
Joanne S. Hawana
Member
Rachel E. Yount
Of Counsel
Pat G. Ouellette
Associate
Stephnie A. John
Associate
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
- State Attorneys General
- Strategic IP Monetization & Licensing
- Tax
- Technology
- Technology, Communications & Media
- Technology, Communications & Media Litigation
- Trade Secrets
- Trademark & Copyright
- Trademark Litigation
- Value-Based Care
- Venture Capital & Emerging Companies
- White Collar Defense & Government Investigations
- Women's Health and Technology