Health Care
Viewpoints
Filter by:
Fall Health Care Preview
August 31, 2017 | Blog
Our colleagues at ML Strategies have provided their Fall Health Care Preview for Fall 2017.
Read more
Community Health Center Fund: A Minibus Rider
August 30, 2017 | Blog
Over the past month, we provided additional details on the structure, funding, and evaluation of the Maternal, Infant, Early Childhood, Home Visiting (MIECHV) program and Medicare Therapy Caps. In this post we will go into detail on the structure, funding, and outlook of the “primary care cliff,” and specifically the three programs relating to community health centers.
Read more
Hospitals and Others Respond to "Red Tape Relief Project" Requests
August 30, 2017 | Blog
Last week, a number of health care industry associations sent letters to Congress detailing ways in which the government could relieve them of the burdens associated with "red tape." The letters are in response to the first stage of a House initiative dubbed the "Medicare Red Tape Relief Project," which was announced earlier this summer by the House Committee on Ways and Means' Subcommittee on Health.
Read more
Massachusetts Moves Forward with Efforts to Shore up MassHealth
August 24, 2017 | Blog | By Lauren Moldawer
Our colleagues on the Employment Matters blog have been following Massachusetts' efforts to make up a funding shortfall in the Commonwealth’s Medicaid program and its Children’s Health Insurance Program (CHIP).
Read more
Implied False Certification Theory Fails in FCA Case Against Billing Agent
August 23, 2017 | Blog | By Laurence Freedman
A court in the Southern District of New York (“SDNY” or the “Court”) recently released an important decision applying the Supreme Court’s landmark Escobar ruling to a qui tam action involving percentage fee arrangements for billing agents.
Read more
The Four Things That Surprised Us in the EpiPen False Claims Settlement
August 23, 2017 | Blog
On August 17, 2017, the U.S. Department of Justice (DOJ) announced that it had reached a $465 million false claims settlement with Mylan, the manufacturer of EpiPen, over the company’s alleged underpayment of Medicaid Drug Rebates for EpiPen.
Read more
CMS Proposes to Cancel Bundled Payment and Incentive Models
August 21, 2017 | Blog
The U.S. Centers for Medicare & Medicaid Services (CMS) published a proposed rule last week regarding the cancellation of three bundled payment models and an incentive payment model while also reducing the scope of a third type of payment model.
Read more
District Court Finds Hospital's Joint Venture Not "Per Se" Unlawful
August 16, 2017 | Blog | By Dionne Lomax
On the eve of trial, and after years of litigation (including an appeal to the Sixth Circuit), all claims by Dayton, Ohio hospital The Medical Center at Elizabeth Place ("MCEP") against Premier Health Partners ("Premier") have been dismissed with prejudice. This case represents an important development in the body of case law addressing the antitrust risk introduced by joint ventures.
Read more
The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 4
August 14, 2017 | Blog | By Benjamin Zegarelli
Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent trends in FDA enforcement and guidance related to off-label promotion. Not surprisingly, FDA has taken a hard-line approach in its guidance on off-label communications, similar to the Agency’s forceful January 2017 memo.
Read more
CMS May Decide to Permit Labs to Bill for Certain Tests Provided to Outpatients
August 10, 2017 | Blog | By Ryan Cuthbertson, Karen Lovitch
In the recently published proposed rule related to the CY 2018 Hospital Outpatient Prospective Payment System (OPPS), the Centers for Medicare & Medicaid Services (CMS) announced that it is considering changes to the regulation governing the date of service (DOS) for clinical laboratory and pathology specimens.
Read more
Mintz’s Health Care Enforcement Defense Group Publishes New Qui Tam Update
August 8, 2017 | Blog | By Samantha Kingsbury
Last week, Mintz’s Health Care Enforcement Defense Group published a new Qui Tam Update, which analyzes 21 health care-related False Claims Act qui tam cases unsealed in May 2017.
Read more
Holdout States Loosen Restrictions on Telemedicine but Obstacles Remain
August 3, 2017 | Blog | By Carrie Roll
A few months ago, two states that previously imposed onerous telemedicine requirements – Texas and Oklahoma – enacted laws that loosen restrictions on telemedicine providers and generally fall into line with what a vast majority of states already permit.
Read more
August 2017 Is Here - Will FDARA Get Done Soon?
August 2, 2017 | Blog | By Joanne Hawana
It has been some time since we provided a detailed update on the status of FDA's user fee legislation making its way through Congress, so that's what is on tap for today. The House passed the lengthy FDA Reauthorization Act (FDARA) on July 13, 2017 as H.R. 2430, and House members have now left Washington, D.C. for the traditional August recess.
Read more
The HIPAA “Wall of Shame” is Now Easier to Navigate
July 31, 2017 | Blog | By Ryan Cuthbertson, Dianne Bourque
Last week, the HHS Office for Civil Rights (OCR) launched an improved version of their HIPAA Breach Reporting Tool (HBRT), commonly referred to by OCR and regulated entities alike as the HIPAA “Wall of Shame.” OCR has also made minor changes to the interface for breach reporting.
Read more
Health Care Weekly Preview from ML Strategies – Week of July 31, 2017
July 31, 2017 | Blog
Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of July 31, 2017. This week’s preview focuses on the fallout from the failed vote to repeal the Affordable Care Act (ACA)Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of July 31, 2017. This week’s preview focuses on the fallout from the failed vote to repeal the Affordable Care Act (ACA).
Read more
Witnesses at Congressional Hearing on 340B Urge Congress To Give HRSA Broader Regulatory Authority
July 25, 2017 | Blog
On July 18, 2017, just days after CMS went public with its proposal to reduce Medicare Part B reimbursement to certain 340B covered entities, Congress held its first hearing on 340B Program Oversight since March 2015.
Read more
Health Care Weekly Preview from ML Strategies - Week of July 24, 2017
July 24, 2017 | Blog
Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of July 24, 2017. This week's preview focuses on the Better Care Reconciliation Act and Senate parliamentary rules.
Read more
DOJ and OIG Announce Largest Ever National Health Care Fraud Takedown; Focus on Opioids
July 21, 2017 | Blog | By Eoin Beirne
Continuing its annual tradition, the U.S. Department of Justice (“DOJ”) and the U.S. Department of Health and Human Services (“HHS”) announced last week the largest ever health care fraud enforcement action by the Medicare Fraud Strike Force. As part of the national health care fraud takedown, the government charged 412 defendants with approximately $1.3 billion in alleged fraud.
Read more
Medical Marijuana in Massachusetts: Reasonable Accomodations in the Workplace
July 21, 2017 | Blog | By Daria Niewenhous
While we continue to follow the recreational marijuana legalization saga and the Massachusetts Department of Public Health’s Medical Marijuana Program, our colleagues on the employment law side of the equation are monitoring decisions regarding the ability of employers to take disciplinary action against employees for using marijuana at work.
Read more
Six Questions and Answers About CMS’ Recommended Changes to 340B Medicare Reimbursement
July 17, 2017 | Blog
In March, I posted about the Uncertain Future of the 340B Drug Discount Program. When opining about What Could Happen Next, I speculated about possible changes to government reimbursement for 340B drugs “so that government safety net programs share in 340B savings.”
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