Mintz Levin - Health Law & Policy Matters

Future of the Affordable Care Act and the American Health Care Act

This week, in their “Future of the Affordable Care Act” series on our Employment Matters blog, my colleagues Alden Bianchi and Edward Lenz provided an analysis of the major provisions of the American Health Care Act (“AHCA”)..…more
| Elections & Politics, Health, Insurance

Wyden’s C-THRU Act – Publicizing PBM Rebate Data

Last week, Senate Finance Committee Ranking Member Ron Wyden (D- Ore.) introduced the “Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017.” As its name suggests, it seeks to require parties (e.g., PBMs)…more
| Elections & Politics, Health, Insurance, Science, Computers, & Technology

New York Medical Society Warns Providers to Avoid Percentage-Based Billing

A series of recoupment letters from the New York State Medicaid Fraud Control Unit (MFCU) to healthcare providers who have management or billing company arrangements based on a percentage of collections has prompted the Medical…more
| Business Torts, Government Contracting, Health

Mintz Levin Health Care Qui Tam Update: Recently Unsealed Whistleblower Cases

Featured Unsealed Cases United States ex rel. Thomas v. Best Choice Home Health Care Agency, Inc., No. 2:13-cv-02209 (D. Kan.) - Complaint Filed: May 6, 2013 - Complaint Unsealed: October 24, 2016…more
| Business Torts, Civil Remedies, Criminal Law, Government Contracting, Health

President’s Budget Blueprint Increases Funds For Health Care Fraud Enforcement

The President has released a “budget blueprint” for fiscal year 2018. Although there are many aspects of the budget blueprint to digest, several budget items signal that government health care fraud enforcement remains a…more
| Business Torts, Criminal Law, Elections & Politics, Government Contracting, Health

Cures Act Developments: FDA Proposes Class II Device Exemptions

Since the 21st Century Cures Act became law on December 13, 2016, we have been blogging on regulatory and clinical areas affected by its provisions. On March 14, 2017, FDA made further progress on its Cures Act obligations by…more
| Health, Science, Computers, & Technology

Pharmaceutical Manufacturers and Healthcare Leaders cite Fraud and Abuse Laws as Obstacle to Value-Based Arrangements

As the healthcare industry moves towards value-based purchasing, pay-for-performance, and other payment reform models, industry leaders have identified federal fraud and abuse laws as a barrier to full implementation of such…more
| Business Torts, Criminal Law, Government Contracting, Health, Science, Computers, & Technology

Provider Payments Under a Medicaid Per Capita Cap

In a February 24th blog post, we described Medicaid block grants and per capita caps in terms of A x B = C to demonstrate how those payment policies work. ‘A’ is the amount a state is paid per beneficiary, ‘B’ is the number of…more
| Health

The Uncertain Future of the 340B Drug Discount Program

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…more
| Elections & Politics, Health, Science, Computers, & Technology

Let the 2017 “UFA” Games Begin!

In the alphabet soup that is health and FDA law and policy (if you don’t know what we mean, are you sure you should be reading this blog?), one acronym that doesn’t get a lot of respect is “UFA.” This is the first is a series of…more
| Health

Medicare Advisors Debate Part B Drug Payment Reforms

Last week, the Medicare Payment Advisory Commission (the “Commission”) debated a package of policy reforms that would change the way Medicare reimburses physicians for Medicare Part B drugs. In the midst of calls to lower drug…more
| Health, Science, Computers, & Technology

Advice to Healthcare Providers on Ransomware from the Head of the FBI

On Wednesday, March 8, James B. Comey, Director of the FBI, was at Boston College to deliver the keynote address for the inaugural Boston Conference on Cyber Security (BCCS 2017). Director Comey addressed various industry,…more
| Consumer Protection, Health, Privacy, Science, Computers, & Technology

Massachusetts Department of Public Health – Final Hospital Licensure Regulations

The Massachusetts Department of Public Health (DPH) has promulgated final Hospital Licensure Regulations. Approved by unanimous vote of the Massachusetts Public Health Council (PHC) on March 8, 2017, DPH anticipates that the…more
| Elections & Politics, Health

OIG Releases FY 2016 Statistical Data About Medicaid Fraud Control Units

Earlier this week, the Office of Inspector General for the Department of Health and Human Services (“OIG”) posted its fiscal year (“FY”) 2016 data about Medicaid Fraud Control Units (“MFCUs”) across the country…more
| Health

Trump Executive Orders Create Uncertainty for Health Care & Pharmaceutical Industries

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. However, since…more
| Elections & Politics, Health
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