The rising cost of drugs in the U.S. is frequently in the news. So it is not surprising that in its contract year 2019 Proposed Medicare Advantage and Part D Regulations (Proposed Rule), the Centers for Medicare & Medicaid Services (CMS) seeks to address Part D drug prices. CMS proposes making certain changes that might lower drug costs (for Plan Sponsors and beneficiaries) and requests information regarding avenues to potentially lower Medicare beneficiaries’ point-of-sale drug costs. The three provisions in the Proposed Rule that most directly relate to drug pricing address: (1) generic drug formulary placement, (2) cost-sharing for follow-on biological products, and (3) whether and how to reduce point-of-sale drug prices based on manufacturer rebates and pharmacy price concessions that a Plan Sponsor might receive months after the beneficiary receives the drugs. We will concentrate on the first two provision in this post. The third provision, which is a request for information, will be discussed in a later post.  Continue Reading Proposed Medicare Advantage and Part D Regulations for CY 2019 – CMS Takes Aim at Drug Prices

Last Thursday, November 17, 2017, the Centers for Medicare & Medicaid Services (CMS) released its proposed contract year 2019 Medicare Advantage and Part D regulations. The proposed rule is scheduled to be published in the Federal Register on November 28, 2017.

The proposed rule focuses on many issues including but not limited to:

  • Implementing certain parts of the Comprehensive Addiction and Recovery Act of 2016, aimed at establishing additional methods that Part D plans can use to reduce abuse or misuse of frequently abused drugs;
  • Changes to certain Medicare Advantage provisions relating to marketing and delivery of information;
  • Establishing “preclusion lists” under Medicare Advantage and Part D to limit when a Medicare Advantage organization and Part D plan sponsor may pay for a service or drug based on the provider who prescribed or furnished the service or drug;
  • Part D Network requirements relating to any willing provider, including defining mail-order pharmacy;
  • Part D beneficiaries’ access to generic drugs and follow-on biological products;
  • Changes to medical loss ratio calculation and reporting; and
  • Updates to the Medicare Advantage and Part D Star Rating System.

Within the proposed rule, CMS also included a request for information regarding the application of manufacturer rebates and pharmacy price concessions to drug prices at the point of sale. CMS has been gathering information regarding this topic for a number of years but appears to be seeking more detailed information in this request.

In the coming weeks we will be issuing detailed posts on these topics as well as others.

Based on the significance and number of the changes proposed, we anticipate that CMS will receive many comments from all segments of industry and beneficiary groups that may be affected by the proposed changes.  Comments are due to CMS before 5:00 pm on January 16, 2018.

On Monday, November 13, our colleagues in the Antitrust Section published an alert on the recent FTC workshop, “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics.” The workshop, which was held on November 8, 2017, began with two keynote addresses from FTC Acting Chairman Maureen Ohlhausen and FDA Commissioner Dr. Scott Gottlieb. Both speakers focused on the beneficial effects of greater competition on prescription drug prices and signaled that the branded drug manufacturers may be discouraging generic drug manufacturers from entering the market. However, Acting Chairman Ohlhausen stated that any FTC antitrust enforcement actions in this space will be based on the specific facts of a case rather than a broad-based action against particular industry practices.

The alert goes on to summarize the content of each of the four workshop panels:

  • Panel 1: Generic Drug Competition: Understanding Demand, Price and Supply Issues
  • Panel 2: Understanding Intermediaries: Pharmacy Benefit Managers
  • Panel 3: Understanding Intermediaries: Group Purchasing Organizations
  • Panel 4: Potential Next Steps to Encourage Entry and Expand Access Through Lower Prices

Click here to read the full summary of the FTC workshop.

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. The hearing followed on the heels of a July 18th hearing in which officials from the Health Resources and Services Administration (HRSA), the Government Accountability Office (GAO), and the Department of Health and Human Services Office of Inspector General (HHS-OIG) testified about the challenges faced in overseeing the 340B Program.

This hearing was called Examining How Covered Entities Utilize the 340B Drug Pricing Program.  Representatives of five different covered entities were asked to address three questions in their testimony:

  • How much do 340B Covered Entities save when purchasing 340B drugs?
  • How are those savings tracked?
  • How are those savings used?

However, it was the follow-up questions from subcommittee and committee members that may indicate where Congress is headed in legislating changes to the 340B Program. Continue Reading Six Key Follow-Up Questions Asked by Congress in 340B Hearing

On October 23, 2017, a company that developed software to track and trace pharmaceuticals filed a complaint against a pharmaceutical distributors trade association that currently dominates the market for such software, alleging a conspiracy to lock up long-term contracts with customers and exclude competition in violation of the Sherman Act and the Virginia Antitrust Act.  Tracelink, Inc. v. Healthcare Distribution Alliance, Case No. 1:17-cv-01197-AJT-IDD (E.D. Va. Oct. 23, 2017). Continue Reading Pharma Distributors Trade Association Sued for Conspiracy to Exclude Competition for its Track and Trace Software

In this post, I will be focusing on the intersection of off-label communications with government enforcement of health care fraud through the False Claims Act. Over the past eight years, the U.S. Department of Justice (“DOJ”) has been particularly aggressive in using the False Claims Act to pursue recoveries from individuals, health care providers, and drug manufacturers that participate in federal health benefit programs. In fact, from 2009 to 2016, DOJ collected $19.3 billion from health care False Claims Act settlements and judgments, with $2.5 billion recovered in fiscal year 2016, alone. (More DOJ false claims statistics can be found here.) DOJ’s enforcement efforts are not solely targeted against garden variety billing fraud, but also involve claims arising from alleged violations of health care regulatory requirements. Among other things, the DOJ has been targeting claims for reimbursement for off-label uses of regulated products. DOJ’s aggressive policy of holding manufacturers accountable for off-label claims under the False Claims Act is entirely consistent with FDA’s stance on off-label communications as described in the January memo. However, recent court interpretations of off-label communications as protected First Amendment speech, as well as interpretations of the causality component of False Claims Act claims, have apparently caused DOJ to reconsider its strategy with respect to such cases. Continue Reading The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 5

On November 8, 2017, the Federal Trade Commission (FTC) will hold a workshop entitled, “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics.” Acting FTC Chairman Maureen K. Ohlhausen and U.S. Food and Drug Commissioner Dr. Scott Gottlieb will give the keynote addresses. Part of the goal of the workshop is to identify obstacles to competition and discuss policy steps that can increase the availability of generic drugs to consumers.

The Hatch-Waxman Act (the Act), which Congress passed over 30 years ago, provides a regulatory and judicial framework to expedite generic entry into U.S. prescription drug markets. For many drugs, the Act has helped reduce patent-related barriers to generic drug entry, which, in turn, has increased competition that has led to lower drug prices. In 2010, Congress created a similar framework for biosimilar drug development under the Biologics Price Competition and Innovation Act. Continue Reading Federal Trade Commission Announces Workshop on Competition in the Prescription Drug Market

Since our  March 17th post about President Trump’s executive actions aiming to implement his deregulatory agenda, several important developments related to the so-called “2-for-1” Executive Order (E.O. 13,771) have occurred at the Executive Branch management level.  In addition, of great interest to us is the fact that the Food and Drug Administration (FDA) took its first major public step toward implementing the goals laid out in the President’s directive. On September 8th, the FDA issued seven Requests for Information that solicit “broad public comment on ways [FDA] can change [its] regulations to achieve meaningful burden reduction while continuing to achieve [its] public health mission and fulfill statutory obligations.” As detailed below, FDA issued one notice for each major product-focused Center, and one specific to cross-cutting agency regulations.

This post outlines the backdrop for–followed by the details of–FDA’s public request for input about which regulations should be cut or modified. Continue Reading FDA Takes First Steps to Cut Regulations, Solicits Public Feedback

In a major public move that has been long-awaited by proponents of evidence-based stem cell science, FDA Commissioner Scott Gottlieb issued a lengthy statement on August 28, 2017 “on the FDA’s new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine.” Continue Reading FDA Commissioner Announces Stem Cell Enforcement Shift, Plans to Develop Comprehensive Regenerative Medicine Policies

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