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. For the complete December preview, please click here.

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. This elimination would not only affect filers using the deduction, but it also stands to have broader implications for our health care system.

ML Strategies has published a new blog post in Health Affairs on the consequences of the deduction’s removal to the Medicaid program. It can be found here.

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

As a part of our ongoing blog series we have provided details on the structure, funding, and outlook of several expiring health care provisions, that we’ve referred to as the health care minibus. The minibus includes all of the health care extenders left behind from the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Health care extenders refer to a number of temporary policies that need reauthorization or annual appropriations, including but not limited to, the Children’s Health Insurance Program (CHIP), the Maternal, Infant, and Early Childhood Home Visiting (MIECHV) program, community health center funding, therapy caps, special needs plans (SNPs), and Medicaid disproportionate share hospital (DSH) payment reductions.

In this post we will discuss Medicaid DSH funding cuts and recent activity to address such cuts. Continue Reading Disproportionate Share Hospital Payments: A Minibus Rider

Our colleagues on the Employment Matters blog have been following Massachusetts’ efforts to make up a funding shortfall in the Commonwealth’s Medicaid program and its Children’s Health Insurance Program (CHIP). Back in May, they blogged on the two options introduced by the Senate to offset these rising costs: (1) a “play-or-pay” option that would impose a per employee assessment on companies that do not offer their workers’ health plans, or (2) an across the board increase in the Employer Medical Assistance Contribution (or “EMAC”).

Last week, they provided an update on the Commonwealth’s effort. On August 1, Massachusetts Governor Charlie Baker signed into law H. 3822, “An Act Further Regulating Employer Contributions to Health Care” (the “Act”). This Act (i) increases the Employer Medical Assistance Contribution (“EMAC”) from an annual maximum fee of $51 per employee to $77 per employee; and (ii) imposes a penalty on employers of up to $750 for each non-disabled worker who receives health insurance coverage through MassHealth or the Massachusetts Health Connector (i.e., the Commonwealth’s Affordable Care Act marketplace).

Read their full update here.

A court in the Southern District of New York (“SDNY” or the “Court”) recently released an important decision applying the Supreme Court’s landmark Escobar ruling to a qui tam action involving percentage fee arrangements for billing agents.  Among other claims, the City of New York (“the City”) and its billing agent, Computer Sciences Corporation (“CSC”) allegedly used an illegal incentive-based compensation arrangement for CSC’s services when billing New York Medicaid for services provided to eligible children under New York’s Early Intervention Program (“EIP”).   EIP provides “early intervention services” to certain children with development delays using federal funds provided under the Individuals with Disabilities Education Act.  EIP allows municipalities like the City to pay providers directly for EIP services and then seek reimbursement from other payors, like third party payors and New York Medicaid.

Continue Reading Implied False Certification Theory Fails in FCA Case Against Billing Agent

Children in United States receive their health insurance from multiple sources: the Children’s Health Insurance Program (CHIP), Medicaid, employer-sponsored insurance, or a qualified health plan on the Marketplace. This creates a fragmented system of coverage for children and families, particularly for low- and moderate-income families, who often have children and parents enrolled in across separate coverage sources.

With CHIP funding scheduled to expire on September 30, 2017, the future of children’s coverage will be up for debate again. Proposals have called for an extension of CHIP funding. However, as Katie Weider and Rodney Whitlock of ML Strategies discuss in their latest Health Affairs blog, it is time for us to stop talking about CHIP, and instead start talking about integrating the myriad of children’s coverage sources.  That blog is available here.

 

UPDATE: Shortly after this post went live, Senate Majority Leader Mitch McConnell announced that he would be delaying the vote on the Better Care Reconciliation Act until after the Fourth of July recess.  Stay tuned for further updates and analysis from the team at ML Strategies!

The Senate bill to repeal the Affordable Care Act is currently being poured over by Senate Republicans and their staff, but the early prognosis for a vote this week is not good. Senate leadership had set a goal of voting on this legislation – known as the Better Care Reconciliation Act (BCRA) – before the Fourth of July recess, which means by this Friday. However, calls for more time to review the bill as well as concerns over certain key provisions – like those touching Medicaid – may stall Senate progress at a critical moment for health care repeal efforts. Here’s where things stand: Continue Reading Capitol Hill Update: Affordable Care Act Repeal on the Ropes?

As we gear up for a busy week in Washington, D.C., our colleagues at ML Strategies have provided a Health Care Weekly Preview.  This week’s preview describes upcoming hearing on safety net health programs and prescription drug costs along with the progress of the American Health Care Act.  Stay tuned for additional updates and analysis from ML Strategies.