Health Care
Viewpoints
Filter by:
It’s Not Really ”Repeal and Replace”; It’s Transition
November 14, 2016 | Blog
For the last six years, Republicans have talked about repeal and replacement of the Affordable Care Act. The election outcome now puts Republicans in a position of authority to take action on the Affordable Care Act. As we look ahead to the 115th Congress, it is important to move away from political rhetoric and consider what can actually be achieved as a matter of public policy.
Read more
Massachusetts Licensure of Hospice Programs Proposed Regulations - Key Take-Aways
November 14, 2016 | Blog | By Ellen Janos
Last week, the Massachusetts Department of Public Health issued another round of proposed amendments to its regulations, continuing the Baker Administration’s regulatory reform efforts. Today, we take a closer look at the proposed amendments to the proposed regulations governing the licensure of hospice programs.
Read more
What the Election Means for Health Care - Insight from ML Strategies
November 11, 2016 | Blog
Today, our colleagues at ML Strategies released their first look at what the results of Tuesday's election mean for health care. The client alert addresses both the lame duck session and what to expect in 2017 and beyond.
Read more
Massachusetts Regulatory Overhaul Continues
November 10, 2016 | Blog | By Daria Niewenhous
At yesterday's Public Health Council meeting, the Massachusetts Department of Public Health (DPH) released yet another round of proposed regulatory amendments. On deck were regulations concerning Long Term Care Facilities, Hospice Programs, and Temporary Nursing Service Agencies, as well as requirements for Training of Nurses’ Aides in Long-Term Care Facilities.
Read more
CMS Delays Enforcement of Part D Prescriber Enrollment Requirements
November 8, 2016 | Blog | By Lauren Moldawer
Last week, CMS released a Fact Sheet announcing that it is further delaying enforcement of the Medicare Part D Prescriber Enrollment Requirements, with full enforcement to begin on January 1, 2019.
Read more
HOSPITAL ADVERSE EVENT REPORTING SYSTEM TO BE INTEGRATED INTO FDA NEST PROGRAM
November 1, 2016 | Blog
Based on recent FDA statements, it looks as though the FDA would like to integrate hospital medical device reporting obligations into the National Evaluation System for health Technology (NEST) framework.
Read more
Massachusetts Health Policy Commission's Annual Cost Trends Hearings
November 1, 2016 | Blog | By Daria Niewenhous
Continuing our current coverage of health policy issues and trends, Mintz Levin's Health Law Practice and ML Strategies have issued a joint Alert regarding the Massachusetts Health Policy Commission’s Annual Cost Trends Hearings.
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
Updates on Privacy and Security in the EU
October 20, 2016 | Blog
If you missed the Mintz Levin Privacy and Security Practice Webinar last week, you can still get it! The current Privacy Webinar Series is focusing on the EU General Data Protection Regulation (GDPR), which will impact how US businesses handle and process personal data from the EU, including possible changes to business processes.
Read more
Massachusetts Licensure of Clinics Proposed Regulations – Key Take-Aways
October 19, 2016 | Blog | By Ellen Janos, Daria Niewenhous
In previous blog posts, we addressed the Massachusetts Department of Public Health’s (DPH) proposed regulations that affect hospitals, dialysis clinics and medical marijuana programs. In this final post on DPH’s recent regulatory review and overhaul, we address the proposed amendments to the clinic licensure regulations.
Read more
HHS Publishes Guidance on HIPAA and Cloud Computing
October 19, 2016 | Blog | By Dianne Bourque
On October 7, 2016, the U.S. Department of Health and Human Services' Office for Civil Rights (OCR) published guidance to assist cloud service providers (CSPs) and their customers with HIPAA compliance.
Read more
CMS Releases MACRA Final Rule, Easing 2017 Reporting Requirements
October 18, 2016 | Blog
On October 14, 2016, the Centers for Medicare and Medicaid Services (CMS) released the final rule for the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).
Read more
FDA Opens Comment Period for Harmonized SaMD Clinical Evaluation Guidance
October 17, 2016 | Blog | By Benjamin Zegarelli
On October 14, 2016, FDA released draft guidance entitled Software as a Medical Device (SaMD): Clinical Evaluation (the "SaMD Draft Guidance"). The draft guidance was prepared by the SaMD Working Group of the International Medical Device Regulators Forum (IMDRF), chaired by Bakul Patel, Associate Director for Digital Health at CDRH, and was endorsed by the IMDRF Management Committee in September 2016.
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
FTC Gets Creative to Help Failing Medical Practice
October 13, 2016 | Blog | By Bridgette Keller
Earlier this week my colleagues, Bruce Sokler and Farrah Short published an alert detailing the FTC's creative solution to permit a presumptively anticompetitive merger for a financially failing medical practice.
Read more
Senate Bill Targets Part D DIR Fees
October 11, 2016 | Blog | By Tara E. Dwyer
Just last month the “Improving Transparency and Accuracy in Medicare Part D Spending Act” was introduced in the Senate to amend the Social Security Act. The bill seeks to prohibit Part D plans (and their contracted pharmacy benefit managers (PBMs)) from retroactively reducing payments to pharmacies for clean claims.
Read more
CMS releases Final Rule Overhauling Long-Term Care Facility Requirements
October 10, 2016 | Blog | By Lauren Moldawer, Cassandra Paolillo
The Centers for Medicare & Medicaid Services (CMS) recently released its final rule overhauling long-term care (LTC) facility participation requirements for Medicare and Medicaid (“Final Rule”).
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
Medical Marijuana in Massachusetts – DPH Proposes Amendments to Regulations
October 4, 2016 | Blog | By Daria Niewenhous
The Massachusetts Department of Public Health (DPH) has released for public comment proposed amendments to DPH’s Medical Marijuana Regulations (105 CMR 725) (the “regulations”).
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
- 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