Health Care

This week, Republicans will ramp up efforts to pass a tax reform package. We should also get signs that a year-end spending deal is coming together. How things play out this week -- both inside and outside the Beltway -- will have implications for taxes, health care, and funding the government.

Americans today are facing an opioid epidemic that stems in part from the misuse of prescription drugs. CMS takes aim at this crisis in its CY 2019 Medicare Advantage and Part D  Proposed Rule (Proposed Rules) by setting out a framework for Part D plans to monitor and reduce the potential misuse of frequently abused prescription drugs. 

Following weekend passage of the Senate tax bill, we return this week with Congress needing to pass a government-spending bill. While it’s widely expected that this will be a two-week continuing resolution (CR), giving lawmakers time to hash out a long-term deal, a short-term extension still requires Democratic votes since spending measures can be filibustered (e.g., October 2013).

Earlier this week we released a Health Care Enforcement Advisory about a recent decision from the U.S. Court of Appeals for the Fifth Circuit that may have a significant impact on the element of “materiality” in False Claims Act (FCA) cases.

Medicare Part D plan sponsors and pharmacies are often confused by the program's any willing pharmacy (AWP) requirements while allowing any pharmacy willing to accept the terms and conditions to participate in the sponsor’s network (AWP Requirements).

The U.S. Court of Appeals for the Fifth Circuit recently decided a case that could have a substantial impact on False Claims Act (“FCA”) jurisprudence with respect to the element of “materiality.”

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.

Congress has its work cut out for itself between now and the end of the year. Between addressing the programs that constitute the Health Care Minibus, funding the government, and tax reform, there are also questions related to a market stabilization package (Alexander-Murray), the 340B program, the opioid epidemic, and another hurricane relief package.

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.

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.

The release of the House and Senate GOP tax plan this month has left Washington on edge as it comes to grips with the realities of tax reform. However, the elimination of the medical expense tax deduction in the House Republicans' tax reform package stands out above the rest as misguided.

It's all about tax reform in Congress. This week, the House will look to pass its version of tax reform while the Senate begins marking up its package. Meanwhile, the end of the year is fast approaching and there are number of issues, including the health care minibus, that will need to be addressed.

The U.S. Department of Health and Human Services' Office for Civil Rights (OCR) released its October Cybersecurity Newsletter last week with a focus on mobile devices. Given the amount of work conducted on mobile devices (odds are that at least some of you are reading this on a smart phone), the newsletter is practical for many in the health care industry.

The CHIP Reauthorization fight heads to the Senate where it faces an uncertain path forward as neither side can agree on payfors and the Senate Finance Committee focuses in on tax reform. While the Trump Administration is reportedly preparing an executive order that would eliminate the individual mandate, they are in a holding pattern to see if it gets included in the tax reform package.

On November 1, 2017, CMS announced that it is in fact cutting Medicare Part B reimbursement for 340B drugs to the tune of $1.6 billion. To be accurate, what CMS announced is its intent to finalize proposed rule changes to the Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems Quality Reporting Program.

Given the uncertainty in reimbursement from private insurance and government programs such as Medicare and Medicaid, it is important early on to consider how best to land and leverage relationships with key customers and strategic partners.

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.

As the calendar turns to November, pressure continues to grow in Congress to pass a CHIP extension and address outstanding minibus extenders. Also on the radar is the first open enrollment period under the Trump Administration and the implications this could have for other policy issues.

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. 

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.