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Theresa Carnegie's practice involves a variety of transactional, regulatory, and fraud and abuse matters. Her transactional experience focuses on advising health care clients on joint ventures, mergers and acquisitions, service agreements, and corporate stock and asset acquisitions. She has served as corporate and regulatory counsel to retail pharmacy chains, pharmacy benefit managers, and health care providers in acquisitions, which included due diligence, licensing, change of ownership, Medicare and Medicaid state certification, and contracting. She has deep experience preparing and negotiating pharmacy network agreements, pharmaceutical purchase and distribution agreements, and rebate agreements.

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 models.  Last month, the Health Care Leadership Council released a White Paper entitled “Health System Transformation: Revisiting the Federal Anti-Kickback Statute and Physician Self-Referral (“Stark”) Law to Foster Integrated Care Delivery and Payment Models” (“HCL White Paper”), identifying current fraud and abuse laws as impeding transformation of the healthcare system.  Pharmaceutical and device manufacturers have also taken advantage of the OIG’s Solicitation of New Safe Harbors and Special Fraud Alerts (“OIG Solicitation”) to advocate for more flexible fraud and abuse laws with respect to value-based arrangements. Continue Reading Pharmaceutical Manufacturers and Healthcare Leaders cite Fraud and Abuse Laws as Obstacle to Value-Based Arrangements

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.

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 demonstration will be in the hands of a Republican-held Congress and President-Elect Trump.  To move forward, not only will CMMI need to finalize the implementing regulations, but the Part B payment demonstration will also need to survive review under the Congressional Review Act (CRA). Continue Reading The Future of the Medicare Part B Payment Demo under a Republican-held Congress

Dionne Lomax named Vice Chair of Publications for the AHLA Antitrust Practice Group.

Dionne is a Member in the firm’s Antitrust and Health Law practices and is based in the Washington, DC office. She provides counsel and representation on health care–related mergers and acquisitions, international mergers, joint ventures, other commercial arrangements, antitrust investigations, and other antitrust matters. Her experience also includes serving as a trial attorney at the DOJ Antitrust Division Health Care Task Force Section.

The AHLA Antitrust Practice Group addresses enforcement activity and competition policy that affect all areas of the health care industry.

Connect with Dionne on Twitter and LinkedIn.

 

The pharmacy industry is under increasing scrutiny from all angles. Whether at the legislative or agency level, Washington as well as many states seem intent on addressing perceived issues surrounding drug pricing, reimbursement, and program integrity. For these reasons, Mintz Levin and ML Strategies brought together stakeholders and thought leaders from across the industry to share knowledge and insight on this rapidly shifting landscape at the 2016 Mintz Levin/ML Strategies Pharmacy Industry Summit in Washington, DC on May 10.

Continue Reading Recap: 2016 Mintz Levin/ML Strategies Pharmacy Industry Summit

It is hard to believe that it is now four days and counting until our May 10, 2016 Pharmacy Industry Summit, here in our DC offices.

Here in Washington, it seems everyone has an idea on a drug “fix”:  amendments to the provisions governing Medicare reimbursement, new rebate requirements, changes to price reporting measures, revisions to the 340B Drug Discount Program, etc.  Proposals are interesting, but will Congress actually do anything?  If anything is actually going to pass, it has to get through the Senate.

Our Summit’s working lunch presentation is a Congressional Staff Panel, moderated by Alex Hecht, VP of Government Relations at ML Strategies.  The scheduled panelists include Mark LeDuc, Staff Director for the Senate Special Committee on Aging; Grace Stuntz, FDA Policy Advisor for the Senate HELP Committee; and Matt Kazan, Majority Staff for the Senate Finance Committee.

If you are interested in hearing what they have to say about what may, or may not happen, in the coming months, it is not too late to register to attend the Summit.  Registration can be completed on our Summit Microsite.  We hope to see you there.

Five days and counting until our May 10, 2016 Pharmacy Industry Summit, here in our DC offices.

Following our first panel discussing Drug Pricing Challenges and Opportunities, the second panel, which Theresa is moderating involves a subject near and dear to the heart of many of our clients: The New Wave of Value-Based Pricing and Contracting.  Manufacturers, insurers, PBMs, and health care providers all would like to consider value-based options for pharmaceutical purchases, but may be intimidated by potential legal and regulatory roadblocks.

So we were thrilled when Josh O’Harra, Assistant General Counsel at Lilly, and Jennifer Kowalski, Vice President of Anthem’s Public Policy Institute, agreed to join Theresa to discuss the growing body of value-based pricing benchmark models and how payors and manufacturers are responding to the opportunities and challenges presented by value-based contracting arrangements.

It is not too late to join us and the other Senior Counsel and Policy Executives who are registered to attend the Summit.  Check out the Summit Microsite  and click on the registration tab to complete your registration.  We look forward to seeing you there.

We are thrilled that our inaugural Pharmacy Industry Summit is now less than a week away.  The Summit is next Tuesday May 10th, 2016, here in our DC offices.  Since we started planning for the Summit many months ago, this hottest of topics that we chose to cover, drug pricing, has become even hotter.

The stage for our day will be set by our opening panel: State of The Industry – Drug Pricing Challenges and Opportunities.  The panelists include Andy Cosgrove, VP of Policy for the Pharmaceutical Care Management Association; Matt Eyles, EVP of Policy & Regulatory affairs for America’s Health Insurance Plans; and, Stacie Maas, Senior VP, of Pharmacy Practice and Government Affairs, American Pharmacists Association.  Moderated by Rodney Whitlock, ML Strategies Vice President and former Health Policy Advisor to Senator Grassley, this panel will discuss and consider the root causes of rising drug prices and the myriad of proposed fixes, and try to predict the realities of legislative change.  This panel is sure to spark lively discussion and set the tone for an interesting and thought-provoking day.

Registered attendees for the Summit include Senior Counsel and Policy Executives for insurers, PBMs, drug manufacturers, pharmacies, hospital systems, and other health care providers.  It is not too late to join them.  Please take a look at the full Summit agenda, study the list of participating speakers, and click on the registration bar on the Summit microsite to complete your registration. We look forward to seeing you there.

The pharmacy industry is under increasing scrutiny from all angles. Whether at the legislative or agency level, Washington as well as many states seem intent on addressing perceived issues surrounding drug pricing, reimbursement, and program integrity.

In light of the significant changes in the pharmacy industry in 2015, Mintz Levin/ML Strategies is bringing together stakeholders and thought leaders from across the industry to share knowledge and insight on this rapidly shifting landscape at the 2016 Mintz Levin/ML Strategies Pharmacy Industry Summit.

The Summit will be on May 10 at the Mintz Levin Washington DC office. Event details can be found here.

Session topics will include:

  • State of the Industry – Drug Pricing Challenges and Opportunities
  • The New Wave of Value-Based Pricing and Contracting
  • The Repeal of Medicare Part D Non-Interference – Practical Realities
  • Federal and State Drug Transparency Initiatives
  • Implications of the Final AMP Rule

Space is limited so please register now.

 

 

Last week, the Centers for Medicare & Medicaid Services (CMS) and the Pharmaceutical Research and Manufacturers of America (PhRMA) released proposals to address recent criticism over rising drug prices.  CMS proposed to tackle the rising cost of drugs paid under Medicare Part B by testing an alternative payment model for Part B drugs and biologicals.  Only days after CMS released its proposed rule, PhRMA issued a set of policies to address the high-cost of drugs.  Central to both CMS’s proposed rule and PhRMA’s policies is the use of value-based purchasing.

CMS’s alternative payment model includes two phases.  If finalized, the first phase would change the statutory 6 percent add-on to Average Sales Price (ASP) that is paid to physicians and suppliers to 2.5 percent plus a flat fee of $16.80.  CMS believes that this change, and specifically the change to a flat fee, will minimize providers’ and suppliers’ financial incentives to prescribe more expensive drugs.  Continue Reading Tackling Drug Prices: CMS and PhRMA Propose Steps to Promote Value-Based Purchasing