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. The settlement amount and terms were generally announced by Mylan in October 2016 – but back then DOJ refused to confirm the settlement.

Back in October 2016, we theorized that the announced “settlement” was likely a handshake deal, not yet reduced to writing and not signed off on by the necessary parties.  It’s not surprising that it would take ten months to finalize a health care false claims settlement.  In Ellyn’s government days, she worked cases that took years, not months, to get from handshake deal to announced settlement.

And in reviewing the EpiPen settlement and related unsealed documents, there were things we expected to see in the settlement; admittedly we are grizzled veterans when it comes to false claims settlements.  But there were some things about this settlement that raised our eyebrows. So we will (briefly) recap how we got here and the settlement terms, and discuss the four things that surprised us about this settlement.  Continue Reading The Four Things That Surprised Us in the EpiPen False Claims Settlement

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.  A common thread ran through the testimony of the three testifying witnesses:  Erin Bliss, Assistant Inspector General with HHS-OIG; Dr. Debra Draper, Director of Health Care at the GAO; and, Captain Krista Pedley, Director of the Office of Pharmacy Affairs at HRSA:  Congress needs to legislatively grant HRSA more administrative authority over the 340B Drug Discount Program.  Continue Reading Witnesses at Congressional Hearing on 340B Urge Congress To Give HRSA Broader Regulatory Authority

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.”

I reasoned that CMS already knew that “Medicare pays more for 340B drugs than the covered entities’ acquisitions cost.”   Continue Reading Six Questions and Answers About CMS’ Recommended Changes to 340B Medicare Reimbursement

6350-Pharma-Summit-blog-buttonMintz Levin 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.

With a new administration and state legislatures taking aim at the pharmacy industry, manufacturers, PBMs, payors, and pharmacies face a number of unknowns and questions:

  • What is the fate of FDA User Fees?
  • Will Senator Wyden’s Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act gain traction?
  • What are state legislatures proposing to address drug pricing?
  • Will the Republicans take another shot at the Affordable Care Act?
  • What is President Trump’s “new system” for competition in the drug industry referenced in his March 7th tweet?
  • What’s new in value-based contracting and what does the future hold for innovative contracting arrangements?

With sessions focusing on the Affordable Care Act developments, drug pricing, state law developments, value-based contracting, and the FDA impact on the supply chain, among others, we plan to discuss these and many other issues impacting the pharmacy industry.

For additional information on the Summit, including an agenda and registration information, please visit our event website.

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.  In fact, the only thing that appears certain for the 340B program is that nothing is certain.  So let’s review several recent 340B developments, and potential developments to come.

Omnibus Guidance

In June 2016, I predicted in this blog that the final version of the long-promised HRSA 340B Omnibus Guidance, which would have provided clarity on 340B program standards, would never actually be issued or implemented.  And in fact, at the end of January 2017, HRSA withdrew the final 340B Omnibus Guidance while it is was still pending at OMB.  Even if it had issued, the Guidance would have been subject to the terms of the regulatory freeze President Trump imposed by Executive Order immediately after his inauguration on January 20, 2017. Continue Reading The Uncertain Future of the 340B Drug Discount Program

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 (see here and here). However, since taking office, President Trump has followed through on his campaign promise to significantly roll back Federal regulations and has taken several actions aimed at slowing and reversing agency regulatory processes, including processes at the DHHS sub-agencies CMS and FDA. These executive actions are creating a climate of uncertainty for regulated industries and their stakeholders. Continue Reading Trump Executive Orders Create Uncertainty for Health Care & Pharmaceutical Industries

6350-Pharma-Summit-blog-buttonThe 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.  Our 2017 Pharmacy Industry 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 and to assess the various swirling initiatives and their potential impact on the industry.

The Summit will be held on April 5-6 at the Mintz Levin Washington, DC office.  Event details can be found here.

Session topics will include:

  • A Keynote Address from Mark Merritt, President and CEO of The Pharmaceutical Care Management Association (PCMA)
  • An update on the current state of Affordable Care Act Reform
  • Drug Pricing Debate and the Evolving Role of Pharmacy Industry Players
  • State Issues Affecting the Pharmaceutical Industry
  • Congressional Staffer Panel
  • Value-Based and Innovative Contracting and Reimbursement
  • FDA’s Impact on the Supply Chain – Evolving Policies and Changing Priorities
  • Government Enforcement and the Pharmaceutical Industry

We hope you can join us! Please register by March 29, 2017.

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.

On Friday February 17, 2017, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued an Online Portfolio on Drug Pricing and Reimbursement, pulling together OIG’s body of work related to drug pricing and reimbursement in HHS programs, including Medicaid and Medicare, since 2010.  Continue Reading OIG Publishes Online Portfolio Highlighting its Body of Work on Drug Pricing and Reimbursement

image3_417910087A 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%). This clear-cut defeat came as a surprise to many considering that polls taken just a couple of months earlier showed widespread support for the initiative. The California ballot initiative was introduced last year in the midst of widespread criticism of soaring drug prices. The initiative had early support but floundered leading up to the election when major pharmaceutical companies expended considerable resources into the campaign to defeat it. Continue Reading In the Wake of the Election, What’s Next for State Drug Pricing Initiatives?

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. A perusal of the Federal Register reveals that in the wake of the election, federal agencies are issuing proposed and final rules at a swift pace.

So it may be wise to consider what HHS rules have been published, and what rules could still be acted on by the Office of Management and Budget (OMB) and published before the inauguration of the new administration.  And we also need to consider what action Congress may take on those rules. Continue Reading Forty-Five Days and Counting for Current HHS Leadership: Implications for Rulemaking