This week, the focus shifts back to the Congressional push around addressing the opioid epidemic after the President’s speech on drug pricing was postponed. Both committees of jurisdiction in the House and Senate are moving on opioid legislation this week, so that has our immediate attention. The speech delay offers a momentary reprieve for stakeholders, but there’s still a Request for Information of some kind pending at the Office of Management and Budget, so it is likely that there will be action in this eventually.

Additionally, on our radar are new Democratic proposals around expansion of health coverage as well as the Administration’s potential action regarding ACA nondiscrimination protections. We cover this and more in this week’s health care preview, which you can find here.

On Monday, CMS published a number of policies changing the dynamics of the individual market, including the Benefit and Payment Parameters for 2019 Final Rule, guidance on hardship exemptions, and a bulletin on transitional (grandmothered) plans. When interpreting all of these policies it’s important to keep in mind the following: What is success? And who is defining it?

The Obama Administration managed ACA implementation with the clear intention of making sure the outcome met the goals of the law: more people covered, more choices of coverage for those people, and lower premiums.  While the success of their efforts can be debated, the intention was always known.

For the Trump Administration, it is not necessarily clear how successful implementation of this next rule will be judged.  Are they trying to maximize the number of people covered, maximize the number of choices available or lower premiums?  What is the organizing principle?  Is it as simple as providing additional regulatory flexibility?

There are two other stakeholders who also have to determine their definition of success in the face of this rule: states and insurers.  For states, they will have to determine if and how they will use the additional flexibility granted to them under their rule.  Insurers, with the loss of the individual mandate and CSRs, and the looming threat of STLDIs and AHPs, have to decide if the rule provides a stable environment for participation.

From now through the start of the next open enrollment period, we expect significant backstage drama as insurers, states, and the Administration answer these questions.  The offerings and premiums available to Americans six days before the midterm elections depend on these decisions. Continue Reading CMS Benefit and Payment Rule: What is Success for the ACA?

Congress will continue its work in addressing the opioid crisis this week with a hearing in the Senate Finance Committee. There were reports last week that Congress will also consider legislation around telemedicine, which is sure to capture stakeholders attention. The Administration is also going to take another look at drug pricing which is setting the stage for another busy work period. We cover this and more in this week’s preview, which you can find here.

In March, the Medicaid and CHIP Payment and Access Commission (MACPAC) released its biannual report to Congress. MACPAC is an independent congressional agency that advises Congress on issues relating to Medicaid. In its report, the Commission made a three part recommendation in regards to streamlining Medicaid managed care authorities. Continue Reading Federal Commission Recommends Streamlining Medicaid Waiver Authorities

This week, Congress returns from recess with its eyes set on addressing the opioid crisis. We expect to see some form of bipartisan legislation considered between now and Memorial Day. We will also see Congress dive into appropriations which will eat up plenty of time, not to mention nominations of Cabinet officials and appointments to the federal bench. We cover this and more in this week’s health care preview, which you can find here.

In early January, Idaho Governor Butch Otter signed an executive order (EO) directing the state’s Department of Insurance (DOI) to “seek creative options” to expand “access” to health insurance coverage for Idahoans. The EO essentially deemed to allow health carriers in the state to offer plans on the health insurance exchanges created by the Affordable Care Act (ACA) “even if not all [ACA] requirements are met.”[1]  For many spectators, the most significant aspect about the order was not that it instructed a state agency to ignore federal law, but that it left open the question whether the Centers for Medicare & Medicaid Services (“CMS”), under the direction of Trump Administration appointee Seema Verma, would step in to enforce the ACA.  CMS’s response in early March was that it would enforce the ACA’s penalties against carriers that attempted to sell non-compliant plans, which was a rare instance of the Administration defending a law that it has otherwise attempted to eliminate. Continue Reading What Lessons Can We Take From The Administration’s Refusal to Allow Idaho to Dismantle the ACA Marketplaces?

As of March 2018, there are twenty-four Medicaid 1115 waivers pending CMS approval.   Medicaid 1115 waivers, Research and Demonstration Projects, give states experimental, pilot, or demonstration projects likely to assist in promoting the objectives of Medicaid. 1115 waivers allow states additional flexibility to design and improve their programs, i.e., to demonstrate and evaluate state-specific policy approaches to better serving Medicaid populations.

In general, 1115 waivers can be comprehensive, such as expanding Medicaid to the new adult group, or narrow to target a specific benefit or population. 1115 waivers must be budget neutral, meaning the waiver cannot exceed the federal costs if the waiver never existed. States must include a research and evaluation component of the 1115 waiver.

Proposals and concepts in 1115 waivers are developed at the state level. The state then submits an application to Centers for Medicare and Medicaid Services (CMS) for approval. CMS and the state then negotiate the terms of the waiver application. Typically, 1115 waivers are approved for five years and then renewed for up to three years at a time. Continue Reading Trends in 1115 Medicaid Waivers and Summaries of Each Pending Application

Mintz Levin and ML Strategies will host the 3rd Annual Pharmacy & Pharmaceutical Industry Summit on May 8, 2018!  This year’s summit will take place in Boston and we are thrilled to announce that Massachusetts Governor Charlie Baker will be the keynote speaker.  The Summit brings together stakeholders and thought leaders to discuss current hot topics facing manufacturers, PBMs, payors, pharmacies, and other providers.  This year’s Summit will include sessions on:

  • The evolving drug supply chain – distruptor models and the Amazon effect
  • Addressing drug pricing and supply chain economics – government investigations and ERISA litigation
  • The uncertain state of the 340B program
  • Government enforcement targeting financial relationships
  • Combatting the opioid crisis

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

In January 2018, in the wake of the publication of the House Energy and Commerce Committee’s Review of the 340B Drug Discount Program, I wrote that it was too soon to know whether 2018 will be a game-changing year for the 340B Program. In sum, there were just too many moving parts to discern whether there was a path forward for legislative change.

Multiple bills are now on file proposing substantive changes to the 340B Program. And the Senate Committee on Health, Education, Labor & Pensions (HELP) convened its first hearing on the 340B Program. There seems to be a rallying cry for “transparency” in the 340B Program.

So three months into the year, are things any clearer? Now may be a good time to take a step back and recap where we are and what the future may hold for 340B.  Continue Reading The Uncertain State of the 340B Program: Where Are We Now?

Congress has until Friday to finalize a government spending bill. Over the next couple of days it will decide whether to move forward with a number of consequential health care issues, market stabilization and drug pricing chief among them. There is also the possibility of movement around short-term health plans. We cover this and more in this week’s health care preview, which can be found here.