![](https://www.mintz.com/sites/default/files/styles/banner/public/media/images/2018-05-10/Viewpoint-Landing_Health_Care_Mintz.jpg?itok=GJq7ZUWE)
Health Care
Viewpoints
Filter by:
More Bipartisan Bills Hope to Catch a Ride on the UFA Reauthorization Legislation
May 3, 2017 | Blog | By Joanne Hawana
Just as the public comment period for the bicameral, bipartisan discussion draft of the “FDA Reauthorization Act of 2017” ended on Friday, what we have been calling the User Fee Games got even more interesting and engaging.
Read more
Insiders Say New MACRA Rule Likely as Providers Look to Sec. Price to Ease Burden
May 2, 2017 | Blog
The Trump administration is considering releasing a rule to ease the burden that small practices are facing in trying to comply with the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), according to a recent report in The Hill.
Read more
Join us for our Upcoming Webinar: Patient Assistance Programs & Government Enforcement: What You Need to Know
April 27, 2017 | Blog | By Lauren Moldawer
Patient assistance programs have been a staple within the health care industry for over a decade. These programs, operated by 503(c)(3) charities, may receive funding from pharmaceutical manufacturers or other providers to offer assistance to low-income patients in affording their medications, co-payments, deductibles, premiums, or other related services.
Read more
Supreme Court Hears Oral Argument in Amgen v. Sandoz
April 27, 2017 | Blog
Regular readers of our blog know that we’ve been following developments related to biosimilar products for some time (see our past coverage here). On April 26, 2017, the U.S. Supreme Court heard oral argument in its first case involving the Biologics Price Competition and Innovation Act (“BPCIA”), Amgen v. Sandoz.
Read more
GAO Report: Medicare Reimbursement Policies Impede Telehealth Adoption
April 26, 2017 | Blog | By Carrie Roll
RAlthough telehealth has the potential to improve or maintain quality of care for Medicare beneficiaries, payment and coverage restrictions create barriers that prevent providers from fully utilizing telehealth technologies.
Read more
California Advances PBM Licensing and “Transparency” Law
April 25, 2017 | Blog | By Theresa Carnegie, Tara E. Dwyer
Last week, the California Assembly Committee on Business and Professions voted in favor of Assembly Bill 315.
Read more
A Spring Cheat Sheet to Congressional Health Care Policy
April 24, 2017 | Blog
ML Strategies has provided a Spring Cheat Sheet previewing the coming months in health care policy in the 115th Congress. The Cheat Sheet addresses attempts to amend the American Health Care Act, funding for the federal government, the heath insurance marketplace, FDA user fee acts, and the health care minibus.
Read more
Health Care Weekly Preview from ML Strategies - Week of April 24, 2017
April 24, 2017 | Blog
Today, our colleagues at ML Strategies provided another installment of their Health Care Weekly Preview. The preview highlights upcoming activity in the House and Senate and other hot topics on the Hill.
Read more
Mintz Matrix Updated with New State Data Breach Notification Laws
April 20, 2017 | Blog
Earlier this week, the Mintz Levin privacy team updated the “Mintz Matrix,” a summary of the U.S. state data breach notification laws, with updates from New Mexico, Tennessee, and Virginia. As the privacy team reports, with New Mexico enacting a data breach notification law, only Alabama and South Dakota remain the only states without data breach notification laws.
Read more
Massachusetts Budget Process Continues with Impact on Health Care
April 20, 2017 | Blog
Next week, the Massachusetts House will continue the budget process and debate over 1000 amendments that members filed to the House Ways and Means Committee’s proposed $40.3 billion FY2018 budget.
Read more
New State Substitution Laws, and a Busy Spring for Biosimilars
April 19, 2017 | Blog | By Joanne Hawana
We recently updated our chart that tracks state biosimilar substitution laws to include new laws in Iowa and Montana. These new laws bring the total number of states with biosimilar substitution laws to 27, plus Puerto Rico.
Read more
The Health Care Minibus
April 19, 2017 | Blog
Welcome to Spring Break! That time of the year where college kids head to a beach somewhere, families pack up for some tourist trap to spend lots of money, and Congress gets out of DC and goes back home. This is also a time to consider where we are and where we are heading in terms of health care policy.
Read more
Five Trends in False Claims Act Enforcement: Take Two
April 17, 2017 | Blog | By Theresa Carnegie
In July 2015, we posted about the N.Y. Attorney General’s False Claims Act (FCA) settlements with Trinity HomeCare and its related entities, and how the case provided insight into the future of FCA enforcement. We identified five key trends based on the settlements.
Read more
Congressional Leaders Seek Input in UFA Reauthorization Draft Bill by April 28, 2017
April 17, 2017 | Blog | By Joanne Hawana
On April 14, 2017, leaders from the Senate HELP Committee and the House Energy & Commerce Committee released the first discussion draft of the 2017 FDA user fee reauthorization bill. As we’ve been reporting (see here and here for our past coverage), these two committees have held numerous public hearings since the beginning of March to learn more about FDA’s “big 4” user fee programs.
Read more
Gone Phishin’: Hack Leads to HIPAA Settlement
April 13, 2017 | Blog
Earlier this week, the HHS Office for Civil Rights (“OCR”) announced a $400,000 settlement with Metro Community Provider Network (“MCPN”) related to a 2012 HIPAA breach caused by a phishing scam. The phishing scam, carried out by accessing MCPN employees’ email accounts, gave a hacker access to the electronic protected health information (“ePHI”) of 3,200 individuals.
Read more
The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 1
April 13, 2017 | Blog | By Benjamin Zegarelli
As 2017 began, FDA appeared poised to implement significant changes to the rules governing off-label communications related to drugs, biologics, and medical devices.
Read more
Medicaid Reform Beyond the AHCA
April 7, 2017 | Blog
As 2017 began, the FDA appeared poised to implement significant changes to the rules governing off-label communications related to drugs, biologics, and medical devices.
Read more
Anti-Steering Lawsuit Against Carolinas Healthcare Survives Preliminary Motion for Judgment on the Pleadings
April 5, 2017 | Blog | By Dionne Lomax
On March 30, 2017, in a closely watched case, a federal district court denied the Motion for Judgment on the Pleadings filed by Carolinas Healthcare against a Complaint filed by the DOJ Antitrust Division and the State of North Carolina. The Complaint alleged that Carolinas Healthcare insisted on contract provisions with payors that limited or prohibited steering to lower-cost providers.
Read more
OCR Identifies Continuing HIPAA Enforcement Issues, Areas of Future Guidance and Regulations
April 4, 2017 | Blog
Last week the Health Care Compliance Association hosted its annual "Compliance Institute." Iliana Peters, HHS Office for Civil Rights' Senior Advisor for HIPAA Compliance and Enforcement, provided a thorough update of HIPAA enforcement trends as well as a road map to OCR's current and future endeavors.
Read more
ML Strategies Publishes Weekly Preview for the Week of April 3, 2017
April 3, 2017 | Blog | By Ryan Cuthbertson
ML Strategies has published the first installment of a new weekly preview, designed to give you quick overview of health happenings in the coming week. The preview highlights upcoming activity in the House and Senate and other hot topics on the Hill.
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