Mintz Levin - Health Law & Policy Matters

FDA’s Enforcement Priorities Likely to Change in 2017 and Other “Unknowable Knowns”

As we enter a new era in which executive agencies are headed by President Trump, we are also faced with many other transformative changes that will affect FDA-regulated entities in a significant and lasting way. This post will…more
| Elections & Politics, Health

Grassley Continues To Press CMS on Medicaid Drug Rebate Classifications: What Will Be the Fallout?

Back in early October, we were all transfixed by the announced Mylan settlement with the U.S. Department of Justice (DOJ) over Mylan’s alleged underpayments of Medicaid Drug Rebates for the EpiPen. Although Mylan indicated that…more
| Health, Science, Computers, & Technology

Beyond the Eleventh Hour: FDA Prepares to Finalize Intended Use Amendments Despite Midnight Rule Relief Act

On Monday, FDA issued a final rule to amend FDA’s established definitions of “intended use” for drugs and devices, the primary consideration in determining whether a product is regulated for a particular use and what regulations…more
| Elections & Politics, Health, Science, Computers, & Technology

Health Care Enforcement Review and 2017 Outlook: Yates Memo in Action

Happy New Year! As we kick off 2017, our Health Care Enforcement Defense team brings you its annual review of key government policies, regulations, and enforcement actions in 2016, and the impact these trends are expected to…more
| Commercial Law & Contracts, Health

OIG Report Offers Glimpse into CMS Progress Towards MACRA Implementation

Last week, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services released a report analyzing CMS’ readiness to implement major parts of the Medicare Access and CHIP Reauthorization Act of…more
| Health

Cures Act Affirms Drug Companies’ Ability to Discuss Certain Information with Payors

Since congressional enactment a presidential signing of the Cures Act into law earlier this month, we have been blogging on discrete regulatory and clinical areas affected by its provisions. One small, but by no means…more
| Health, Science, Computers, & Technology

21st Century Cures Act Requires FDA to Expand the Role of Real World Evidence

As we noted in our December 9th post, the 21st Century Cures Act (the “Cures Act”) requires FDA to develop a framework and guidance for evaluating real world evidence (“RWE”) in the context of drug regulation to support…more
| Health, Science, Computers, & Technology

The Medicare Part B Demo May be Dead, but Drug Pricing Concerns Still Linger

The Centers for Medicare & Medicaid Services (CMS) has withdrawn its controversial rule implementing the Medicare Part B payment demonstration. The agency stated that after consideration of the comments, it will not move forward…more
| Health

President Obama Signs 21st Century Cures Act; Creates Accelerated Approval Pathway for Regenerative Medicine

On Tuesday, President Obama signed the 21st Century Cures Act (the “Act”) into law. The Act is a massive piece of legislation that has implications for many different aspects of the interconnected medical research, product…more
| Health, Science, Computers, & Technology

At Long Last, OIG Issues Final Rule for Beneficiary Inducement Safe Harbors

More than two years since issuing the proposed rule, the HHS Office of the Inspector General (OIG) issued the long-awaited and highly anticipated final rule (the Final Rule) that provides amendments to the Anti-Kickback Statute…more
| Health, Science, Computers, & Technology

Senate Passes 21st Century Cures Act, but Can It Cure an Ailing FDA?

On Wednesday, the U.S. Senate overwhelmingly passed the 21st Century Cures Act (the “Act”) by a vote of 94 to 5. Spearheaded by Michigan Representative Frank Upton, the bill now heads to President Obama who has promised to sign…more
| Administrative Law, Health, Science, Computers, & Technology

In the Wake of the Election, What’s Next for State Drug Pricing Initiatives?

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…more
| Elections & Politics, Health

Forty-Five Days and Counting for Current HHS Leadership: Implications for Rulemaking

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…more
| Elections & Politics, Health

OCR Provides Additional Clarification on Phishing Scam

As we reported earlier this week, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights described a phishing campaign that is attempting to convince recipients of their inclusion in OCR’s Phase 2 audit…more
| Consumer Protection, Health, Privacy, Securities Law

The Future of the Medicare Part B Payment Demo under a Republican-held Congress

There has been much controversy over the Medicare Part B payment demonstration proposed by the Center for Medicare and Medicaid Innovation (CMMI) in March 2016. As we await the release of the final rule, the fate of this…more
| Elections & Politics, Health
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