Health Care
Viewpoints
Filter by:
Join Mintz & ML Strategies for the 3rd Annual Pharmacy & Pharmaceutical Industry Summit
March 22, 2018 | Blog
Mintz and ML Strategies will host the 3rd Annual Pharmacy & Pharmaceutical Industry Summit on May 8, 2018! This year's summit will take place in Boston and we are thrilled to announce that Massachusetts Governor Charlie Baker will be the keynote speaker.
Read more
The Uncertain State of the 340B Program: Where Are We Now?
March 21, 2018 | Blog
In January 2018, in the wake of the publication of the House Energy and Commerce Committee’s Review of the 340B Drug Discount Program, I wrote that it was too soon to know whether 2018 will be a game-changing year for the 340B Program. In sum, there were just too many moving parts to discern whether there was a path forward for legislative change.
Read more
ML Strategies Health Care Preview - Week of March 12th
March 12, 2018 | Blog
This week, Congress returns to Washington with 11 days to finalize a government spending bill. Standing in the way are a number of unresolved health care issues, including drug pricing and market stabilization.
Read more
ML Strategies Health Care Preview - Week of February 12th
February 12, 2018 | Blog
This week, the President's FY 2019 budget will be released, and the Administration will spend the next couple of weeks touting its goals. How this activity is received in Congress will play out in various committee hearings, as will issues like drug pricing, which the Administration is closely examining.
Read more
The Administration's Budget Proposal for FY2019
February 12, 2018 | Blog
Today, the White House released its FY 2019 budget proposal, outlining its policy priorities for the fiscal year. In health care, the President's budget focuses on prescription drug pricing and opioid funding.
Read more
This Year May be a Game Changer for 340B Drug Discount Program, Take Two
January 17, 2018 | Blog
I previously said that the year 2014 may be a game-changer for the 340B Drug Discount Program. Increasing HRSA audits, a lawsuit over the 340B Orphan Drug Rule, and HRSA’s promise to issue a 340B mega-regulation, all pointed to major changes in how the 340B Program operates.
Read more
Azar's Nomination Hearing Highlights Medicare Negotiation of Part B Drug Prices
January 10, 2018 | Blog | By Tara E. Dwyer
On January 9th, the Senate Committee on Finance conducted its nomination hearing of Alex Michael Azar II, President Trump’s nominee for Secretary of Health and Human Services. Under President George W. Bush, Mr. Azar served in HHS, first as general counsel to HHS and then as deputy secretary.
Read more
ML Strategies December 2017 Legislative Preview
November 27, 2017 | Blog
Congress has its work cut out for itself between now and the end of the year. Between addressing the programs that constitute the Health Care Minibus, funding the government, and tax reform, there are also questions related to a market stabilization package (Alexander-Murray), the 340B program, the opioid epidemic, and another hurricane relief package.
Read more
CMS Finalizes Medicare Part B Reimbursement Cut for 340B – What Does it Mean?
November 2, 2017 | Blog
On November 1, 2017, CMS announced that it is in fact cutting Medicare Part B reimbursement for 340B drugs to the tune of $1.6 billion. To be accurate, what CMS announced is its intent to finalize proposed rule changes to the Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems Quality Reporting Program.
Read more
Six Key Follow-Up Questions Asked by Congress in 340B Hearing
October 31, 2017 | Blog
Earlier this month the House Energy and Commerce Committee's subcommittee on Government Oversight and Investigations held its second hearing on the 340B Drug Discount Program.
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
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
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
Join Mintz and ML Strategies for the 2nd Annual Pharmacy Summit
April 3, 2017 | Blog | By Lauren Moldawer
Mintz and ML Strategies will be hosting the 2nd Annual Pharmacy Industry Summit on April 5th and 6th! The Summit will bring together stakeholders and thought leaders from across the industry to discuss legal and policy challenges facing manufacturers, PBMs, payors, pharmacies, and providers.
Read more
The Uncertain Future of the 340B Drug Discount Program
March 14, 2017 | Blog
Here we are in March 2017 and no one is sure where things stand with the 340B Drug Discount Program. HRSA and its oversight of the 340B program are subject to the recent Executive Orders restricting issuance of federal regulations and the promised repeal of the Affordable Care Act (ACA) has the potential to impact 340B operations.
Read more
Trump Executive Orders Create Uncertainty for Health Care & Pharmaceutical Industries
March 8, 2017 | Blog | By Joanne Hawana
As we’ve previously discussed on Health Law and Policy Matters, agencies within the Department of Health and Human Services (DHHS) pushed through several final rules towards the end of the Obama Administration.
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
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
In the Wake of the Election, What’s Next for State Drug Pricing Initiatives?
December 8, 2016 | Blog | By Carrie Roll
A Trump victory was not the only surprise on election night. California’s drug pricing initiative, which would have required state agencies to negotiate drug prices at least as low as those paid by the U.S. Department of Veterans Affairs, was defeated by a wide margin (46% to 54%).
Read more
Forty-Five Days and Counting for Current HHS Leadership: Implications for Rulemaking
December 7, 2016 | Blog
Before we all turn our full attention to the nominations of Representative Tom Price as Secretary of Health and Human Services, and policy consultant Seema Verma to lead CMS, we need to remember that there are still approximately 45 days remaining in the current administration.
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
- 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